Blood Banking

Photo by Elise Amendola

The US Food and Drug Administration (FDA) has approved the first tests to screen blood donors for Babesia parasites.

The Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA) is approved for the detection of antibodies to Babesia microti in plasma samples, and the Imugen Babesia microti Nucleic Acid Test (NAT) is approved for the detection of Babesia microti DNA in whole blood samples.

These tests are intended to be used on samples from volunteer donors of whole blood and blood components as well as living organ and tissue donors.

The tests are not intended for use in the diagnosis of babesiosis infections.

The approval of the Imugen Babesia microti AFIA and NAT tests was granted to Oxford Immunotec, Inc. Both assays are in-house tests that can only be performed at the Norwood, Massachusetts facility.

The applications for the tests were granted priority review. The FDA aims to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.

The FDA grants priority review to applications for products expected to significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition.

“While babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“Today’s actions represent the first approvals of Babesia detection tests for use in screening donors of whole blood and blood components, and other living donors.”

About babesiosis

Babesiosis is caused by Babesia parasites that are transmitted by Ixodes scapularis ticks, also known as blacklegged or deer ticks. Babesia microti is the main species of parasite that causes infection in the US.

There are about 1000 to 2000 cases of babesiosis reported in the US each year, with the majority reported from states in the Northeast and upper Midwest.

Most people infected with Babesia microti do not have symptoms and are never diagnosed. Some people develop flu-like symptoms, such as fever, headache, and body aches.

For certain people, especially those with a weak immune system, babesiosis can be a severe, life-threatening disease. And although blood-borne transmission of babesiosis is thought to be uncommon, it is the most frequently reported transfusion-transmitted parasitic infection in the US.

At present, there is no FDA guidance for the testing of donor samples for Babesia. However, the FDA is planning to issue a draft guidance later this year that will include recommendations for reducing the risk of transfusion-transmitted babesiosis.

Photo by Elise Amendola

The US Food and Drug Administration (FDA) has approved the first tests to screen blood donors for Babesia parasites.

The Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA) is approved for the detection of antibodies to Babesia microti in plasma samples, and the Imugen Babesia microti Nucleic Acid Test (NAT) is approved for the detection of Babesia microti DNA in whole blood samples.

These tests are intended to be used on samples from volunteer donors of whole blood and blood components as well as living organ and tissue donors.

The tests are not intended for use in the diagnosis of babesiosis infections.

The approval of the Imugen Babesia microti AFIA and NAT tests was granted to Oxford Immunotec, Inc. Both assays are in-house tests that can only be performed at the Norwood, Massachusetts facility.

The applications for the tests were granted priority review. The FDA aims to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.

The FDA grants priority review to applications for products expected to significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition.

“While babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“Today’s actions represent the first approvals of Babesia detection tests for use in screening donors of whole blood and blood components, and other living donors.”

About babesiosis

Babesiosis is caused by Babesia parasites that are transmitted by Ixodes scapularis ticks, also known as blacklegged or deer ticks. Babesia microti is the main species of parasite that causes infection in the US.

There are about 1000 to 2000 cases of babesiosis reported in the US each year, with the majority reported from states in the Northeast and upper Midwest.

Most people infected with Babesia microti do not have symptoms and are never diagnosed. Some people develop flu-like symptoms, such as fever, headache, and body aches.

For certain people, especially those with a weak immune system, babesiosis can be a severe, life-threatening disease. And although blood-borne transmission of babesiosis is thought to be uncommon, it is the most frequently reported transfusion-transmitted parasitic infection in the US.

At present, there is no FDA guidance for the testing of donor samples for Babesia. However, the FDA is planning to issue a draft guidance later this year that will include recommendations for reducing the risk of transfusion-transmitted babesiosis.

Photo by Elise Amendola

The US Food and Drug Administration (FDA) has approved the first tests to screen blood donors for Babesia parasites.

The Imugen Babesia microti Arrayed Fluorescent Immunoassay (AFIA) is approved for the detection of antibodies to Babesia microti in plasma samples, and the Imugen Babesia microti Nucleic Acid Test (NAT) is approved for the detection of Babesia microti DNA in whole blood samples.

These tests are intended to be used on samples from volunteer donors of whole blood and blood components as well as living organ and tissue donors.

The tests are not intended for use in the diagnosis of babesiosis infections.

The approval of the Imugen Babesia microti AFIA and NAT tests was granted to Oxford Immunotec, Inc. Both assays are in-house tests that can only be performed at the Norwood, Massachusetts facility.

The applications for the tests were granted priority review. The FDA aims to take action on a priority review application within 6 months of receiving it, rather than the standard 10 months.

The FDA grants priority review to applications for products expected to significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition.

“While babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“Today’s actions represent the first approvals of Babesia detection tests for use in screening donors of whole blood and blood components, and other living donors.”

About babesiosis

Babesiosis is caused by Babesia parasites that are transmitted by Ixodes scapularis ticks, also known as blacklegged or deer ticks. Babesia microti is the main species of parasite that causes infection in the US.

There are about 1000 to 2000 cases of babesiosis reported in the US each year, with the majority reported from states in the Northeast and upper Midwest.

Most people infected with Babesia microti do not have symptoms and are never diagnosed. Some people develop flu-like symptoms, such as fever, headache, and body aches.

For certain people, especially those with a weak immune system, babesiosis can be a severe, life-threatening disease. And although blood-borne transmission of babesiosis is thought to be uncommon, it is the most frequently reported transfusion-transmitted parasitic infection in the US.

At present, there is no FDA guidance for the testing of donor samples for Babesia. However, the FDA is planning to issue a draft guidance later this year that will include recommendations for reducing the risk of transfusion-transmitted babesiosis.

Photo from UAB Hospital

A study of US hospital discharges revealed a decrease in the use of red blood cell (RBC) and plasma transfusions—but not platelet transfusions—in recent years.

Researchers examined a sample of US hospital inpatient discharges from 1993 to 2014.

Overall, platelet, plasma, and RBC transfusions increased from 1993 to 2010.

However, from 2011 to 2014, there was a significant decrease in both plasma and RBC transfusions. Platelet transfusions remained stable over that period.

Aaron A. R. Tobian, MD, PhD, of Johns Hopkins University in Baltimore, Maryland, and his colleagues reported these findings in a letter to JAMA.

The researchers analyzed data from the National Inpatient Sample, which uses a stratified probability sample of 20% of all inpatient discharges in the US.

The team looked at transfusion trends from 1993 to 2014 but focused on trends from 2011 to 2014 because there was an inflection point in RBC transfusion in 2011. They used multivariable Poisson regression to estimate adjusted risk ratios (aRRs) comparing the risk of transfusion in 2011 and 2014.

The researchers found that RBC transfusions decreased from 6.8% in 2011 to 5.7% in 2014 (aRR=0.83; 95% confidence interval [CI], 0.78-0.88; P<0.001).

Plasma transfusions decreased from 1.0% to 0.87% (aRR=0.87; 95% CI, 0.80-0.95; P=0.003). And platelet transfusions remained stable (aRR=0.99; 95% CI, 0.89-1.10; P=0.93).

The researchers also conducted subgroup analyses to explore trends in RBC transfusion. They found that, from 2011 to 2014, there were significant reductions in RBC transfusions regardless of patients’ sex, race/ethnicity, risk severity, payer type, and admission type.

However, there was no significant reduction in RBC transfusions among patients younger than 18 years of age or in private investor–owned hospitals.

The researchers said the diagnostic coding used for this study was carried out primarily for billing purposes, and it was not possible to verify its accuracy. They also noted that the study only covered inpatient transfusions, so the results may not be generalizable to outpatient transfusions.

Photo from UAB Hospital

A study of US hospital discharges revealed a decrease in the use of red blood cell (RBC) and plasma transfusions—but not platelet transfusions—in recent years.

Researchers examined a sample of US hospital inpatient discharges from 1993 to 2014.

Overall, platelet, plasma, and RBC transfusions increased from 1993 to 2010.

However, from 2011 to 2014, there was a significant decrease in both plasma and RBC transfusions. Platelet transfusions remained stable over that period.

Aaron A. R. Tobian, MD, PhD, of Johns Hopkins University in Baltimore, Maryland, and his colleagues reported these findings in a letter to JAMA.

The researchers analyzed data from the National Inpatient Sample, which uses a stratified probability sample of 20% of all inpatient discharges in the US.

The team looked at transfusion trends from 1993 to 2014 but focused on trends from 2011 to 2014 because there was an inflection point in RBC transfusion in 2011. They used multivariable Poisson regression to estimate adjusted risk ratios (aRRs) comparing the risk of transfusion in 2011 and 2014.

The researchers found that RBC transfusions decreased from 6.8% in 2011 to 5.7% in 2014 (aRR=0.83; 95% confidence interval [CI], 0.78-0.88; P<0.001).

Plasma transfusions decreased from 1.0% to 0.87% (aRR=0.87; 95% CI, 0.80-0.95; P=0.003). And platelet transfusions remained stable (aRR=0.99; 95% CI, 0.89-1.10; P=0.93).

The researchers also conducted subgroup analyses to explore trends in RBC transfusion. They found that, from 2011 to 2014, there were significant reductions in RBC transfusions regardless of patients’ sex, race/ethnicity, risk severity, payer type, and admission type.

However, there was no significant reduction in RBC transfusions among patients younger than 18 years of age or in private investor–owned hospitals.

The researchers said the diagnostic coding used for this study was carried out primarily for billing purposes, and it was not possible to verify its accuracy. They also noted that the study only covered inpatient transfusions, so the results may not be generalizable to outpatient transfusions.

Photo from UAB Hospital

A study of US hospital discharges revealed a decrease in the use of red blood cell (RBC) and plasma transfusions—but not platelet transfusions—in recent years.

Researchers examined a sample of US hospital inpatient discharges from 1993 to 2014.

Overall, platelet, plasma, and RBC transfusions increased from 1993 to 2010.

However, from 2011 to 2014, there was a significant decrease in both plasma and RBC transfusions. Platelet transfusions remained stable over that period.

Aaron A. R. Tobian, MD, PhD, of Johns Hopkins University in Baltimore, Maryland, and his colleagues reported these findings in a letter to JAMA.

The researchers analyzed data from the National Inpatient Sample, which uses a stratified probability sample of 20% of all inpatient discharges in the US.

The team looked at transfusion trends from 1993 to 2014 but focused on trends from 2011 to 2014 because there was an inflection point in RBC transfusion in 2011. They used multivariable Poisson regression to estimate adjusted risk ratios (aRRs) comparing the risk of transfusion in 2011 and 2014.

The researchers found that RBC transfusions decreased from 6.8% in 2011 to 5.7% in 2014 (aRR=0.83; 95% confidence interval [CI], 0.78-0.88; P<0.001).

Plasma transfusions decreased from 1.0% to 0.87% (aRR=0.87; 95% CI, 0.80-0.95; P=0.003). And platelet transfusions remained stable (aRR=0.99; 95% CI, 0.89-1.10; P=0.93).

The researchers also conducted subgroup analyses to explore trends in RBC transfusion. They found that, from 2011 to 2014, there were significant reductions in RBC transfusions regardless of patients’ sex, race/ethnicity, risk severity, payer type, and admission type.

However, there was no significant reduction in RBC transfusions among patients younger than 18 years of age or in private investor–owned hospitals.

The researchers said the diagnostic coding used for this study was carried out primarily for billing purposes, and it was not possible to verify its accuracy. They also noted that the study only covered inpatient transfusions, so the results may not be generalizable to outpatient transfusions.

Cord blood donation

Simple interventions can increase cord blood donations, according to research published in Scientific Reports.

Researchers saw a significant increase in cord blood donation when expectant mothers received information about the procedure and were asked to indicate their interest in donating at both early and late stages of their pregnancies.

“We more than doubled the number of cord blood units that were collected,” said study author Nicola Lacetera, PhD, of the University of Toronto Mississauga in Ontario, Canada.

“We learned a lot, and we did a little bit of good too, so that feels nice.”

Dr Lacetera and his colleagues conducted this study in Milan, Italy, where private cord blood banking is banned.

The team set out to determine if providing expectant mothers with information about cord blood donation and prompting them to consider the procedure would increase donations to a public cord blood bank.

Interventions

The researchers enrolled 850 expectant mothers and divided them into 6 treatment cohorts.

The T0 cohort included 217 control subjects who did not receive any information on cord blood donation.

The T1 cohort included 64 subjects who received information on cord blood donation during their first trimester.

The T2 cohort included 88 subjects who were given information on cord blood donation and asked about their intentions to donate in their first trimester.

The T3 cohort included 197 subjects who received information on cord blood donation in their third trimester.

The T4 cohort included 249 subjects who were given information on cord blood donation and asked about their intentions to donate during their third trimester.

The T5 cohort included 35 subjects who were given information on cord blood donation and asked about their intentions to donate during the first trimester and the third trimester.

Results

The researchers found that T5 subjects had the highest donation rate.

In the entire study sample, the donation rate was 2.3% (5/217) in controls, 6.3% (4/64) in T1 subjects, 1.1% (1/88) in T2, 8.1% (16/197) in T3, 10.0% (25/249) in T4, and 17.1% in T5 (6/35).

These results may not be entirely accurate, however, because the researchers could only confirm patients’ donation status if mothers delivered their babies at the study hospital, Ospedale dei Bambini Vittore Buzzi (also known as Buzzi Hospital, BH).

Among women who delivered at BH, donation rates were 2.7% (5/183) in controls, 11.7% (4/34) in T1, 2.2% (1/45) in T2, 8.9% (16/179) in T3, 11.4% (25/42) in T4, and 21.4% (6/28) in T5.

Though these data suggest the various interventions tested can increase cord blood donations, donation rates in this study could have been even higher, according to the researchers.

There were 197 women who submitted consent forms to donate cord blood, were medically eligible to donate, and delivered their babies at BH. However, only 57 of these women successfully donated cord blood.

There were 62 women (56.9%) who could not donate because of medical complications during delivery.

Thirty-three women (30.3%) failed to donate because of organizational reasons, including overcrowding of the delivery room and the absence of obstetric nurses certified to collect and process cord blood at the time of delivery.

There were 14 women (7.1%) who did not donate for institution-related reasons. For example, the women gave birth when the Milan Cord Blood Bank was closed.

There were no details on the remaining 31 women who failed to donate.

Cord blood donation

Simple interventions can increase cord blood donations, according to research published in Scientific Reports.

Researchers saw a significant increase in cord blood donation when expectant mothers received information about the procedure and were asked to indicate their interest in donating at both early and late stages of their pregnancies.

“We more than doubled the number of cord blood units that were collected,” said study author Nicola Lacetera, PhD, of the University of Toronto Mississauga in Ontario, Canada.

“We learned a lot, and we did a little bit of good too, so that feels nice.”

Dr Lacetera and his colleagues conducted this study in Milan, Italy, where private cord blood banking is banned.

The team set out to determine if providing expectant mothers with information about cord blood donation and prompting them to consider the procedure would increase donations to a public cord blood bank.

Interventions

The researchers enrolled 850 expectant mothers and divided them into 6 treatment cohorts.

The T0 cohort included 217 control subjects who did not receive any information on cord blood donation.

The T1 cohort included 64 subjects who received information on cord blood donation during their first trimester.

The T2 cohort included 88 subjects who were given information on cord blood donation and asked about their intentions to donate in their first trimester.

The T3 cohort included 197 subjects who received information on cord blood donation in their third trimester.

The T4 cohort included 249 subjects who were given information on cord blood donation and asked about their intentions to donate during their third trimester.

The T5 cohort included 35 subjects who were given information on cord blood donation and asked about their intentions to donate during the first trimester and the third trimester.

Results

The researchers found that T5 subjects had the highest donation rate.

In the entire study sample, the donation rate was 2.3% (5/217) in controls, 6.3% (4/64) in T1 subjects, 1.1% (1/88) in T2, 8.1% (16/197) in T3, 10.0% (25/249) in T4, and 17.1% in T5 (6/35).

These results may not be entirely accurate, however, because the researchers could only confirm patients’ donation status if mothers delivered their babies at the study hospital, Ospedale dei Bambini Vittore Buzzi (also known as Buzzi Hospital, BH).

Among women who delivered at BH, donation rates were 2.7% (5/183) in controls, 11.7% (4/34) in T1, 2.2% (1/45) in T2, 8.9% (16/179) in T3, 11.4% (25/42) in T4, and 21.4% (6/28) in T5.

Though these data suggest the various interventions tested can increase cord blood donations, donation rates in this study could have been even higher, according to the researchers.

There were 197 women who submitted consent forms to donate cord blood, were medically eligible to donate, and delivered their babies at BH. However, only 57 of these women successfully donated cord blood.

There were 62 women (56.9%) who could not donate because of medical complications during delivery.

Thirty-three women (30.3%) failed to donate because of organizational reasons, including overcrowding of the delivery room and the absence of obstetric nurses certified to collect and process cord blood at the time of delivery.

There were 14 women (7.1%) who did not donate for institution-related reasons. For example, the women gave birth when the Milan Cord Blood Bank was closed.

There were no details on the remaining 31 women who failed to donate.

Cord blood donation

Simple interventions can increase cord blood donations, according to research published in Scientific Reports.

Researchers saw a significant increase in cord blood donation when expectant mothers received information about the procedure and were asked to indicate their interest in donating at both early and late stages of their pregnancies.

“We more than doubled the number of cord blood units that were collected,” said study author Nicola Lacetera, PhD, of the University of Toronto Mississauga in Ontario, Canada.

“We learned a lot, and we did a little bit of good too, so that feels nice.”

Dr Lacetera and his colleagues conducted this study in Milan, Italy, where private cord blood banking is banned.

The team set out to determine if providing expectant mothers with information about cord blood donation and prompting them to consider the procedure would increase donations to a public cord blood bank.

Interventions

The researchers enrolled 850 expectant mothers and divided them into 6 treatment cohorts.

The T0 cohort included 217 control subjects who did not receive any information on cord blood donation.

The T1 cohort included 64 subjects who received information on cord blood donation during their first trimester.

The T2 cohort included 88 subjects who were given information on cord blood donation and asked about their intentions to donate in their first trimester.

The T3 cohort included 197 subjects who received information on cord blood donation in their third trimester.

The T4 cohort included 249 subjects who were given information on cord blood donation and asked about their intentions to donate during their third trimester.

The T5 cohort included 35 subjects who were given information on cord blood donation and asked about their intentions to donate during the first trimester and the third trimester.

Results

The researchers found that T5 subjects had the highest donation rate.

In the entire study sample, the donation rate was 2.3% (5/217) in controls, 6.3% (4/64) in T1 subjects, 1.1% (1/88) in T2, 8.1% (16/197) in T3, 10.0% (25/249) in T4, and 17.1% in T5 (6/35).

These results may not be entirely accurate, however, because the researchers could only confirm patients’ donation status if mothers delivered their babies at the study hospital, Ospedale dei Bambini Vittore Buzzi (also known as Buzzi Hospital, BH).

Among women who delivered at BH, donation rates were 2.7% (5/183) in controls, 11.7% (4/34) in T1, 2.2% (1/45) in T2, 8.9% (16/179) in T3, 11.4% (25/42) in T4, and 21.4% (6/28) in T5.

Though these data suggest the various interventions tested can increase cord blood donations, donation rates in this study could have been even higher, according to the researchers.

There were 197 women who submitted consent forms to donate cord blood, were medically eligible to donate, and delivered their babies at BH. However, only 57 of these women successfully donated cord blood.

There were 62 women (56.9%) who could not donate because of medical complications during delivery.

Thirty-three women (30.3%) failed to donate because of organizational reasons, including overcrowding of the delivery room and the absence of obstetric nurses certified to collect and process cord blood at the time of delivery.

There were 14 women (7.1%) who did not donate for institution-related reasons. For example, the women gave birth when the Milan Cord Blood Bank was closed.

There were no details on the remaining 31 women who failed to donate.

Photo by Graham Colm

A new blood stabilization method significantly prolongs the lifespan of blood samples for microfluidic sorting and transcriptome profiling of rare circulating tumor cells (CTCs), according to researchers.

The method involves reducing the storage temperature to 4° C to reversibly slow down cellular processes while also counteracting the platelet activation that can occur because of the low temperature.

The researchers said this work overcomes a significant barrier to the translation of liquid biopsy technologies for precision oncology and other applications.

Keith Wong, PhD, of the Massachusetts General Hospital Center for Engineering in Medicine (MGH-CEM), and his colleagues described this work in Nature Communications.

When isolating CTCs from fresh, unprocessed blood, timing is everything. Even minor changes in the quality of a blood sample—such as the breakdown of red cells, leukocyte activation, or clot formation— can greatly affect cell-sorting mechanisms and the quality of the biomolecules isolated for cancer detection.

According to published studies, factors such as the total number of CTCs in a sample and the number with high-quality RNA decrease by around 50% within the first 4 to 5 hours after the sample is collected.

“At Mass. General, we have the luxury of being so integrated with the clinical team that we can process blood specimens in the lab typically within an hour or 2 after they are drawn,” Dr Wong said.

“But to make these liquid biopsy technologies routine lab tests for the rest of the world, we need ways to keep blood alive for much longer than several hours, since these assays are best performed in central laboratories for reasons of cost-effectiveness and reproducibility.”

With this in mind, Dr Wong and his colleagues set out to preserve blood in its native state with minimal alterations.

“We wanted to slow down the biological clock as much as possible by using hypothermia, but that is not as simple as it sounds,” said study author Shannon Tessier, PhD, also of MGH-CEM.

“Low temperature is a powerful means to decrease metabolism, but a host of unwanted side effects occur at the same time. In some ways, these challenges are similar to those we face in organ preservation, where we have to optimize strategies for a very complex mix of cells.”

To achieve these goals, the researchers first analyzed the effects of hypothermic storage conditions.

The team found that hypothermic storage (4° C) of blood anticoagulated with acid citrate dextrose maintained “cellular morphology, integrity, and surface epitope stability of diverse hematologic cell types” over 72 hours.

However, the researchers also observed platelet activation.

“We are preserving the blood very well, including the coagulation function of platelets,” Dr Wong said. “But, unfortunately, cooling causes profound activation of platelets. Now, we need a targeted approach for platelets so they don’t form nasty clots in the microfluidic blood-sorting device.”

Fortunately, the researchers found that glycoprotein IIb/IIIa inhibitors were able to counter cooling-induced platelet aggregation. And ion chelation treatment with ethylenediaminetetraacetic acid removed activated platelets from leukocytes.

The team said these steps—hypothermic storage, treatment with glycoprotein IIb/IIIa inhibitors, and ion chelation—allowed whole blood preserved for 3 days to be processed as if it were freshly drawn, with very high purity and virtually no loss in CTC numbers.

“The critical achievement here is that the isolated tumor cells contain high-quality RNA that is suitable for demanding molecular assays, such as single-cell qPCR, droplet digital PCR, and RNA sequencing,” Dr Tessier said.

To test their blood preservation method, Dr Tessier and her colleagues used blood specimens from a group of 10 patients with metastatic prostate cancer.

The researchers compared CTC analysis in preserved blood samples and paired fresh samples from the same patients.

There was 92% agreement in the detection of 12 cancer-specific gene transcripts between the fresh and preserved blood samples.

In addition, there was 100% agreement in the detection of a transcript called AR-V7. Recently published studies showed that the presence of AR-V7 mRNA in prostate cancer CTCs predicts resistance to androgen receptor inhibitors, indicating that chemotherapy may be a better option for such patients.

“The ability to preserve the blood for several days and still be able to pick up this clinically relevant biomarker is remarkable,” said study author David Miyamoto, MD, PhD, of MGH Cancer Center.

“This is very exciting for clinicians because AR-V7 mRNA can only be detected using CTCs and not with circulating tumor DNA or other cell-free assays.”

The researchers highlighted the universal nature of their blood preservation approach by pointing to its compatibility with the microfluidic CTC-iChip device, which isolates tumor cells by rapid removal of blood cells. The team said this suggests the potential impact of this work extends beyond cancer detection.

“With exciting breakthroughs in immunotherapy, stem cell transplantation, and regenerative medicine—in which peripheral blood is often the source of cells for functional assays or ex vivo expansion—the ability to preserve live cells will greatly ease logistical timelines and reduce the cost of complex cell-based assays,” Dr Wong said.

Photo by Graham Colm

A new blood stabilization method significantly prolongs the lifespan of blood samples for microfluidic sorting and transcriptome profiling of rare circulating tumor cells (CTCs), according to researchers.

The method involves reducing the storage temperature to 4° C to reversibly slow down cellular processes while also counteracting the platelet activation that can occur because of the low temperature.

The researchers said this work overcomes a significant barrier to the translation of liquid biopsy technologies for precision oncology and other applications.

Keith Wong, PhD, of the Massachusetts General Hospital Center for Engineering in Medicine (MGH-CEM), and his colleagues described this work in Nature Communications.

When isolating CTCs from fresh, unprocessed blood, timing is everything. Even minor changes in the quality of a blood sample—such as the breakdown of red cells, leukocyte activation, or clot formation— can greatly affect cell-sorting mechanisms and the quality of the biomolecules isolated for cancer detection.

According to published studies, factors such as the total number of CTCs in a sample and the number with high-quality RNA decrease by around 50% within the first 4 to 5 hours after the sample is collected.

“At Mass. General, we have the luxury of being so integrated with the clinical team that we can process blood specimens in the lab typically within an hour or 2 after they are drawn,” Dr Wong said.

“But to make these liquid biopsy technologies routine lab tests for the rest of the world, we need ways to keep blood alive for much longer than several hours, since these assays are best performed in central laboratories for reasons of cost-effectiveness and reproducibility.”

With this in mind, Dr Wong and his colleagues set out to preserve blood in its native state with minimal alterations.

“We wanted to slow down the biological clock as much as possible by using hypothermia, but that is not as simple as it sounds,” said study author Shannon Tessier, PhD, also of MGH-CEM.

“Low temperature is a powerful means to decrease metabolism, but a host of unwanted side effects occur at the same time. In some ways, these challenges are similar to those we face in organ preservation, where we have to optimize strategies for a very complex mix of cells.”

To achieve these goals, the researchers first analyzed the effects of hypothermic storage conditions.

The team found that hypothermic storage (4° C) of blood anticoagulated with acid citrate dextrose maintained “cellular morphology, integrity, and surface epitope stability of diverse hematologic cell types” over 72 hours.

However, the researchers also observed platelet activation.

“We are preserving the blood very well, including the coagulation function of platelets,” Dr Wong said. “But, unfortunately, cooling causes profound activation of platelets. Now, we need a targeted approach for platelets so they don’t form nasty clots in the microfluidic blood-sorting device.”

Fortunately, the researchers found that glycoprotein IIb/IIIa inhibitors were able to counter cooling-induced platelet aggregation. And ion chelation treatment with ethylenediaminetetraacetic acid removed activated platelets from leukocytes.

The team said these steps—hypothermic storage, treatment with glycoprotein IIb/IIIa inhibitors, and ion chelation—allowed whole blood preserved for 3 days to be processed as if it were freshly drawn, with very high purity and virtually no loss in CTC numbers.

“The critical achievement here is that the isolated tumor cells contain high-quality RNA that is suitable for demanding molecular assays, such as single-cell qPCR, droplet digital PCR, and RNA sequencing,” Dr Tessier said.

To test their blood preservation method, Dr Tessier and her colleagues used blood specimens from a group of 10 patients with metastatic prostate cancer.

The researchers compared CTC analysis in preserved blood samples and paired fresh samples from the same patients.

There was 92% agreement in the detection of 12 cancer-specific gene transcripts between the fresh and preserved blood samples.

In addition, there was 100% agreement in the detection of a transcript called AR-V7. Recently published studies showed that the presence of AR-V7 mRNA in prostate cancer CTCs predicts resistance to androgen receptor inhibitors, indicating that chemotherapy may be a better option for such patients.

“The ability to preserve the blood for several days and still be able to pick up this clinically relevant biomarker is remarkable,” said study author David Miyamoto, MD, PhD, of MGH Cancer Center.

“This is very exciting for clinicians because AR-V7 mRNA can only be detected using CTCs and not with circulating tumor DNA or other cell-free assays.”

The researchers highlighted the universal nature of their blood preservation approach by pointing to its compatibility with the microfluidic CTC-iChip device, which isolates tumor cells by rapid removal of blood cells. The team said this suggests the potential impact of this work extends beyond cancer detection.

“With exciting breakthroughs in immunotherapy, stem cell transplantation, and regenerative medicine—in which peripheral blood is often the source of cells for functional assays or ex vivo expansion—the ability to preserve live cells will greatly ease logistical timelines and reduce the cost of complex cell-based assays,” Dr Wong said.

Photo by Graham Colm

A new blood stabilization method significantly prolongs the lifespan of blood samples for microfluidic sorting and transcriptome profiling of rare circulating tumor cells (CTCs), according to researchers.

The method involves reducing the storage temperature to 4° C to reversibly slow down cellular processes while also counteracting the platelet activation that can occur because of the low temperature.

The researchers said this work overcomes a significant barrier to the translation of liquid biopsy technologies for precision oncology and other applications.

Keith Wong, PhD, of the Massachusetts General Hospital Center for Engineering in Medicine (MGH-CEM), and his colleagues described this work in Nature Communications.

When isolating CTCs from fresh, unprocessed blood, timing is everything. Even minor changes in the quality of a blood sample—such as the breakdown of red cells, leukocyte activation, or clot formation— can greatly affect cell-sorting mechanisms and the quality of the biomolecules isolated for cancer detection.

According to published studies, factors such as the total number of CTCs in a sample and the number with high-quality RNA decrease by around 50% within the first 4 to 5 hours after the sample is collected.

“At Mass. General, we have the luxury of being so integrated with the clinical team that we can process blood specimens in the lab typically within an hour or 2 after they are drawn,” Dr Wong said.

“But to make these liquid biopsy technologies routine lab tests for the rest of the world, we need ways to keep blood alive for much longer than several hours, since these assays are best performed in central laboratories for reasons of cost-effectiveness and reproducibility.”

With this in mind, Dr Wong and his colleagues set out to preserve blood in its native state with minimal alterations.

“We wanted to slow down the biological clock as much as possible by using hypothermia, but that is not as simple as it sounds,” said study author Shannon Tessier, PhD, also of MGH-CEM.

“Low temperature is a powerful means to decrease metabolism, but a host of unwanted side effects occur at the same time. In some ways, these challenges are similar to those we face in organ preservation, where we have to optimize strategies for a very complex mix of cells.”

To achieve these goals, the researchers first analyzed the effects of hypothermic storage conditions.

The team found that hypothermic storage (4° C) of blood anticoagulated with acid citrate dextrose maintained “cellular morphology, integrity, and surface epitope stability of diverse hematologic cell types” over 72 hours.

However, the researchers also observed platelet activation.

“We are preserving the blood very well, including the coagulation function of platelets,” Dr Wong said. “But, unfortunately, cooling causes profound activation of platelets. Now, we need a targeted approach for platelets so they don’t form nasty clots in the microfluidic blood-sorting device.”

Fortunately, the researchers found that glycoprotein IIb/IIIa inhibitors were able to counter cooling-induced platelet aggregation. And ion chelation treatment with ethylenediaminetetraacetic acid removed activated platelets from leukocytes.

The team said these steps—hypothermic storage, treatment with glycoprotein IIb/IIIa inhibitors, and ion chelation—allowed whole blood preserved for 3 days to be processed as if it were freshly drawn, with very high purity and virtually no loss in CTC numbers.

“The critical achievement here is that the isolated tumor cells contain high-quality RNA that is suitable for demanding molecular assays, such as single-cell qPCR, droplet digital PCR, and RNA sequencing,” Dr Tessier said.

To test their blood preservation method, Dr Tessier and her colleagues used blood specimens from a group of 10 patients with metastatic prostate cancer.

The researchers compared CTC analysis in preserved blood samples and paired fresh samples from the same patients.

There was 92% agreement in the detection of 12 cancer-specific gene transcripts between the fresh and preserved blood samples.

In addition, there was 100% agreement in the detection of a transcript called AR-V7. Recently published studies showed that the presence of AR-V7 mRNA in prostate cancer CTCs predicts resistance to androgen receptor inhibitors, indicating that chemotherapy may be a better option for such patients.

“The ability to preserve the blood for several days and still be able to pick up this clinically relevant biomarker is remarkable,” said study author David Miyamoto, MD, PhD, of MGH Cancer Center.

“This is very exciting for clinicians because AR-V7 mRNA can only be detected using CTCs and not with circulating tumor DNA or other cell-free assays.”

The researchers highlighted the universal nature of their blood preservation approach by pointing to its compatibility with the microfluidic CTC-iChip device, which isolates tumor cells by rapid removal of blood cells. The team said this suggests the potential impact of this work extends beyond cancer detection.

“With exciting breakthroughs in immunotherapy, stem cell transplantation, and regenerative medicine—in which peripheral blood is often the source of cells for functional assays or ex vivo expansion—the ability to preserve live cells will greatly ease logistical timelines and reduce the cost of complex cell-based assays,” Dr Wong said.

Red blood cells

Researchers say they have uncovered a new function of arginine vasopressin (AVP).

It seems this hormone does more than maintain fluid balance for the kidneys.

AVP also stimulates the proliferation and differentiation of red blood cell precursors and improves recovery from anemia, according to the researchers.

The group speculates that drugs targeting an AVP receptor could be used to replenish red blood cells lost due to bleeding or treatment toxicity.

Eva Mezey, MD, PhD, of the National Institutes of Health in Bethesda, Maryland, and her colleagues conducted this research and reported the results in Science Translational Medicine.

The team uncovered the unexpected role for AVP by examining clinical data from 92 patients with central diabetes insipidus, a condition that causes AVP deficiency.

Of those individuals, 87% of males and 51% of females had anemia. In comparison, anemia rates in the US general population range from 1.5% to 6% for men and 4.4% to 12% for women.

The researchers also found that all 3 AVP receptors are present on human and murine hematopoietic stem and progenitor cells.

One of these receptors, AVPR1B, plays a predominant role in red blood cell production.

Further experiments revealed that AVP-deficient rats had delayed recovery from anemia, but treatment with AVP or the AVPR1B agonist d(Leu4Lys8)VP was able to speed up anemia recovery in mice.

The researchers tested AVP and the AVPR1B agonist in mouse models of hemorrhage. Compared to vehicle-treated mice, AVP-treated mice had an increase in hematocrit and reticulocyte numbers by day 2. Mice that received d(Leu4Lys8)VP only had an increase in reticulocytes.

The team also tested mice exposed to sublethal irradiation. When the mice received AVP for 2 days, they saw increases in hematocrit and corrected reticulocyte numbers.

The researchers then tested splenectomized mice subjected to hemorrhage. AVP-treated mice had an increase in hematocrit that was similar to that observed in non-splenectomized mice.

Finally, the researchers found that AVP’s effect on hematocrit is independent of erythropoietin. The team said AVP “appears to jump-start peripheral blood cell replenishment,” but later, erythropoietin seems to take over.

Red blood cells

Researchers say they have uncovered a new function of arginine vasopressin (AVP).

It seems this hormone does more than maintain fluid balance for the kidneys.

AVP also stimulates the proliferation and differentiation of red blood cell precursors and improves recovery from anemia, according to the researchers.

The group speculates that drugs targeting an AVP receptor could be used to replenish red blood cells lost due to bleeding or treatment toxicity.

Eva Mezey, MD, PhD, of the National Institutes of Health in Bethesda, Maryland, and her colleagues conducted this research and reported the results in Science Translational Medicine.

The team uncovered the unexpected role for AVP by examining clinical data from 92 patients with central diabetes insipidus, a condition that causes AVP deficiency.

Of those individuals, 87% of males and 51% of females had anemia. In comparison, anemia rates in the US general population range from 1.5% to 6% for men and 4.4% to 12% for women.

The researchers also found that all 3 AVP receptors are present on human and murine hematopoietic stem and progenitor cells.

One of these receptors, AVPR1B, plays a predominant role in red blood cell production.

Further experiments revealed that AVP-deficient rats had delayed recovery from anemia, but treatment with AVP or the AVPR1B agonist d(Leu4Lys8)VP was able to speed up anemia recovery in mice.

The researchers tested AVP and the AVPR1B agonist in mouse models of hemorrhage. Compared to vehicle-treated mice, AVP-treated mice had an increase in hematocrit and reticulocyte numbers by day 2. Mice that received d(Leu4Lys8)VP only had an increase in reticulocytes.

The team also tested mice exposed to sublethal irradiation. When the mice received AVP for 2 days, they saw increases in hematocrit and corrected reticulocyte numbers.

The researchers then tested splenectomized mice subjected to hemorrhage. AVP-treated mice had an increase in hematocrit that was similar to that observed in non-splenectomized mice.

Finally, the researchers found that AVP’s effect on hematocrit is independent of erythropoietin. The team said AVP “appears to jump-start peripheral blood cell replenishment,” but later, erythropoietin seems to take over.

Red blood cells

Researchers say they have uncovered a new function of arginine vasopressin (AVP).

It seems this hormone does more than maintain fluid balance for the kidneys.

AVP also stimulates the proliferation and differentiation of red blood cell precursors and improves recovery from anemia, according to the researchers.

The group speculates that drugs targeting an AVP receptor could be used to replenish red blood cells lost due to bleeding or treatment toxicity.

Eva Mezey, MD, PhD, of the National Institutes of Health in Bethesda, Maryland, and her colleagues conducted this research and reported the results in Science Translational Medicine.

The team uncovered the unexpected role for AVP by examining clinical data from 92 patients with central diabetes insipidus, a condition that causes AVP deficiency.

Of those individuals, 87% of males and 51% of females had anemia. In comparison, anemia rates in the US general population range from 1.5% to 6% for men and 4.4% to 12% for women.

The researchers also found that all 3 AVP receptors are present on human and murine hematopoietic stem and progenitor cells.

One of these receptors, AVPR1B, plays a predominant role in red blood cell production.

Further experiments revealed that AVP-deficient rats had delayed recovery from anemia, but treatment with AVP or the AVPR1B agonist d(Leu4Lys8)VP was able to speed up anemia recovery in mice.

The researchers tested AVP and the AVPR1B agonist in mouse models of hemorrhage. Compared to vehicle-treated mice, AVP-treated mice had an increase in hematocrit and reticulocyte numbers by day 2. Mice that received d(Leu4Lys8)VP only had an increase in reticulocytes.

The team also tested mice exposed to sublethal irradiation. When the mice received AVP for 2 days, they saw increases in hematocrit and corrected reticulocyte numbers.

The researchers then tested splenectomized mice subjected to hemorrhage. AVP-treated mice had an increase in hematocrit that was similar to that observed in non-splenectomized mice.

Finally, the researchers found that AVP’s effect on hematocrit is independent of erythropoietin. The team said AVP “appears to jump-start peripheral blood cell replenishment,” but later, erythropoietin seems to take over.

Photo by Elise Amendola

ANAHEIM, CA—Results of a large study suggest a restrictive transfusion strategy is safe for moderate- to high-risk patients undergoing cardiac surgery.

Researchers found that patients had similar rates of various outcomes—death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis—whether they received red blood cell (RBC) transfusions according to a restrictive strategy or a liberal one.

C. David Mazer, MD, of St. Michael’s Hospital in Toronto, Ontario, Canada, presented these results at the American Heart Association’s Scientific Sessions 2017.

Results were simultaneously published in NEJM.

Dr Mazer and his colleagues studied 5243 adults undergoing cardiac surgery. They all had a European System for Cardiac Operative Risk Evaluation I score of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery).

Patients were randomized to receive RBC transfusions according to a restrictive strategy or a liberal one.

With the restrictive strategy, patients received transfusions if their hemoglobin level was below 7.5 g/dL, starting from induction of anesthesia.

With the liberal strategy, patients were transfused if their hemoglobin level was less than 9.5 g/dL in the operating room or intensive care unit (ICU) or was less than 8.5 g/dL in the non-ICU ward.

Results

There were 4860 patients in the per-protocol analysis—2430 in each transfusion group. Baseline characteristics were similar between the groups.

The rate of RBC transfusion was 52.3% in the restrictive group and 72.6% in the liberal group. The odds ratio (OR) was 0.41 (95% confidence interval [CI], 0.37 to 0.47).

Transfused patients received a median of 2 RBC units (interquartile range [IQR], 1 to 4) in the restrictive group and 3 units (IQR, 2 to 5) in the liberal group.

The study’s primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first.

This outcome occurred in 11.4% of patients in the restrictive group and 12.5% of those in the liberal group. The absolute risk difference was −1.11 percentage points (95% CI, −2.93 to 0.72), and the odds ratio was 0.90 (95% CI, 0.76 to 1.07; P<0.001 for noninferiority).

There were no significant differences between the groups when it came to the individual components of the composite outcome.

“We have shown that this [restrictive] approach to transfusion is safe in moderate- to high-risk patients undergoing cardiac surgery,” Dr Mazer said.

“Such practices can also reduce the number of patients transfused, the amount of blood transfused, the impact on blood supply, and costs to the healthcare system.”

Photo by Elise Amendola

ANAHEIM, CA—Results of a large study suggest a restrictive transfusion strategy is safe for moderate- to high-risk patients undergoing cardiac surgery.

Researchers found that patients had similar rates of various outcomes—death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis—whether they received red blood cell (RBC) transfusions according to a restrictive strategy or a liberal one.

C. David Mazer, MD, of St. Michael’s Hospital in Toronto, Ontario, Canada, presented these results at the American Heart Association’s Scientific Sessions 2017.

Results were simultaneously published in NEJM.

Dr Mazer and his colleagues studied 5243 adults undergoing cardiac surgery. They all had a European System for Cardiac Operative Risk Evaluation I score of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery).

Patients were randomized to receive RBC transfusions according to a restrictive strategy or a liberal one.

With the restrictive strategy, patients received transfusions if their hemoglobin level was below 7.5 g/dL, starting from induction of anesthesia.

With the liberal strategy, patients were transfused if their hemoglobin level was less than 9.5 g/dL in the operating room or intensive care unit (ICU) or was less than 8.5 g/dL in the non-ICU ward.

Results

There were 4860 patients in the per-protocol analysis—2430 in each transfusion group. Baseline characteristics were similar between the groups.

The rate of RBC transfusion was 52.3% in the restrictive group and 72.6% in the liberal group. The odds ratio (OR) was 0.41 (95% confidence interval [CI], 0.37 to 0.47).

Transfused patients received a median of 2 RBC units (interquartile range [IQR], 1 to 4) in the restrictive group and 3 units (IQR, 2 to 5) in the liberal group.

The study’s primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first.

This outcome occurred in 11.4% of patients in the restrictive group and 12.5% of those in the liberal group. The absolute risk difference was −1.11 percentage points (95% CI, −2.93 to 0.72), and the odds ratio was 0.90 (95% CI, 0.76 to 1.07; P<0.001 for noninferiority).

There were no significant differences between the groups when it came to the individual components of the composite outcome.

“We have shown that this [restrictive] approach to transfusion is safe in moderate- to high-risk patients undergoing cardiac surgery,” Dr Mazer said.

“Such practices can also reduce the number of patients transfused, the amount of blood transfused, the impact on blood supply, and costs to the healthcare system.”

Photo by Elise Amendola

ANAHEIM, CA—Results of a large study suggest a restrictive transfusion strategy is safe for moderate- to high-risk patients undergoing cardiac surgery.

Researchers found that patients had similar rates of various outcomes—death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis—whether they received red blood cell (RBC) transfusions according to a restrictive strategy or a liberal one.

C. David Mazer, MD, of St. Michael’s Hospital in Toronto, Ontario, Canada, presented these results at the American Heart Association’s Scientific Sessions 2017.

Results were simultaneously published in NEJM.

Dr Mazer and his colleagues studied 5243 adults undergoing cardiac surgery. They all had a European System for Cardiac Operative Risk Evaluation I score of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery).

Patients were randomized to receive RBC transfusions according to a restrictive strategy or a liberal one.

With the restrictive strategy, patients received transfusions if their hemoglobin level was below 7.5 g/dL, starting from induction of anesthesia.

With the liberal strategy, patients were transfused if their hemoglobin level was less than 9.5 g/dL in the operating room or intensive care unit (ICU) or was less than 8.5 g/dL in the non-ICU ward.

Results

There were 4860 patients in the per-protocol analysis—2430 in each transfusion group. Baseline characteristics were similar between the groups.

The rate of RBC transfusion was 52.3% in the restrictive group and 72.6% in the liberal group. The odds ratio (OR) was 0.41 (95% confidence interval [CI], 0.37 to 0.47).

Transfused patients received a median of 2 RBC units (interquartile range [IQR], 1 to 4) in the restrictive group and 3 units (IQR, 2 to 5) in the liberal group.

The study’s primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first.

This outcome occurred in 11.4% of patients in the restrictive group and 12.5% of those in the liberal group. The absolute risk difference was −1.11 percentage points (95% CI, −2.93 to 0.72), and the odds ratio was 0.90 (95% CI, 0.76 to 1.07; P<0.001 for noninferiority).

There were no significant differences between the groups when it came to the individual components of the composite outcome.

“We have shown that this [restrictive] approach to transfusion is safe in moderate- to high-risk patients undergoing cardiac surgery,” Dr Mazer said.

“Such practices can also reduce the number of patients transfused, the amount of blood transfused, the impact on blood supply, and costs to the healthcare system.”

Ortho Clinical Diagnostics

The China Food and Drug Administration has approved Ortho Clinical Diagnostics’ ORTHO VISION® Platform of fully automated blood analyzers for transfusion medicine laboratories.

The platform consists of ORTHO VISION and ORTHO VISION Max.

ORTHO VISION is a blood analyzer designed for small- to mid-sized transfusion labs, and ORTHO VISION Max is an analyzer developed for mid- to high-volume labs.

According to Ortho Clinical Diagnostics, the ORTHO VISION Platform automates more tests than ever before and takes less time to perform those tests.

The platform supports complex immunohematology testing such as serial dilutions for titration studies, reflex tests, and selected cell antibody identification.

The ORTHO VISION Platform also has scheduling intelligence, which allows a transfusion medicine department to process routine samples and STAT orders as they are received, rather than waiting for a complete batch before running the instrument.

The ORTHO VISION Platform offers dynamic workflow and lab standardization across instrumentation, technology, procedures, and training. These features are intended to help labs keep pace with growing industry pressure to increase productivity while remaining operationally efficient.

ORTHO VISION and ORTHO VISION Max are commercially available in countries other than China as well, including the US, Japan, and European countries.

“Around the world, transfusion medicine labs are facing increasing pressure to perform more tests with fewer resources, and yet their work in ensuring that all patients receive safe and appropriate blood remains critically important,” said Robert Yates, chief operating officer of Ortho Clinical Diagnostics.

“Ortho is committed to helping labs become more efficient while continuing to perform precise, accurate testing.” 

Ortho Clinical Diagnostics

The China Food and Drug Administration has approved Ortho Clinical Diagnostics’ ORTHO VISION® Platform of fully automated blood analyzers for transfusion medicine laboratories.

The platform consists of ORTHO VISION and ORTHO VISION Max.

ORTHO VISION is a blood analyzer designed for small- to mid-sized transfusion labs, and ORTHO VISION Max is an analyzer developed for mid- to high-volume labs.

According to Ortho Clinical Diagnostics, the ORTHO VISION Platform automates more tests than ever before and takes less time to perform those tests.

The platform supports complex immunohematology testing such as serial dilutions for titration studies, reflex tests, and selected cell antibody identification.

The ORTHO VISION Platform also has scheduling intelligence, which allows a transfusion medicine department to process routine samples and STAT orders as they are received, rather than waiting for a complete batch before running the instrument.

The ORTHO VISION Platform offers dynamic workflow and lab standardization across instrumentation, technology, procedures, and training. These features are intended to help labs keep pace with growing industry pressure to increase productivity while remaining operationally efficient.

ORTHO VISION and ORTHO VISION Max are commercially available in countries other than China as well, including the US, Japan, and European countries.

“Around the world, transfusion medicine labs are facing increasing pressure to perform more tests with fewer resources, and yet their work in ensuring that all patients receive safe and appropriate blood remains critically important,” said Robert Yates, chief operating officer of Ortho Clinical Diagnostics.

“Ortho is committed to helping labs become more efficient while continuing to perform precise, accurate testing.” 

Ortho Clinical Diagnostics

The China Food and Drug Administration has approved Ortho Clinical Diagnostics’ ORTHO VISION® Platform of fully automated blood analyzers for transfusion medicine laboratories.

The platform consists of ORTHO VISION and ORTHO VISION Max.

ORTHO VISION is a blood analyzer designed for small- to mid-sized transfusion labs, and ORTHO VISION Max is an analyzer developed for mid- to high-volume labs.

According to Ortho Clinical Diagnostics, the ORTHO VISION Platform automates more tests than ever before and takes less time to perform those tests.

The platform supports complex immunohematology testing such as serial dilutions for titration studies, reflex tests, and selected cell antibody identification.

The ORTHO VISION Platform also has scheduling intelligence, which allows a transfusion medicine department to process routine samples and STAT orders as they are received, rather than waiting for a complete batch before running the instrument.

The ORTHO VISION Platform offers dynamic workflow and lab standardization across instrumentation, technology, procedures, and training. These features are intended to help labs keep pace with growing industry pressure to increase productivity while remaining operationally efficient.

ORTHO VISION and ORTHO VISION Max are commercially available in countries other than China as well, including the US, Japan, and European countries.

“Around the world, transfusion medicine labs are facing increasing pressure to perform more tests with fewer resources, and yet their work in ensuring that all patients receive safe and appropriate blood remains critically important,” said Robert Yates, chief operating officer of Ortho Clinical Diagnostics.

“Ortho is committed to helping labs become more efficient while continuing to perform precise, accurate testing.” 

Photo from UAB Hospital

Early blood transfusion is associated with improved survival among people with severe trauma sustained during combat, according to research published in JAMA.

Researchers studied medically evacuated US military personnel fighting in Afghanistan and found that patients who received blood products prior to hospitalization or within 15 minutes of medical evacuation were more likely to be alive at 24 hours and 30 days, when compared to patients who had delayed transfusions or did not receive transfusions.

Stacy A. Shackelford, MD, of Ft. Sam Houston in San Antonio, Texas, and her colleagues conducted this study to examine the association of prehospital transfusion and time to initial transfusion with injury survival.

The study included US military combat casualties in Afghanistan between April 1, 2012, and August 7, 2015. Eligible patients were rescued alive by medical evacuation from the point of injury with either:

• A traumatic limb amputation at or above the knee or elbow
• Shock, defined as a systolic blood pressure of less than 90 mm Hg or a heart rate greater than 120 beats per minute.

The study included 502, mostly male (98%), patients with a median age of 25 (range, 22 to 29). There were 55 patients who received prehospital transfusions (of red blood cells and/or plasma) and 447 who did not.

The rate of death within 24 hours of medical evacuation was 5% (3/55) among prehospital transfusion recipients and 19% (85/447) among nonrecipients (P=0.01). The rate of death by day 30 was 11% (6/55) and 23% (102/447), respectively (P=0.04).

The researchers also matched nonrecipients and recipients of prehospital transfusion by mechanism of injury, prehospital shock, severity of limb amputation, head injury, and torso hemorrhage. And the team adjusted their analyses for patient age, injury year, transport team, tourniquet use, and time to medical evacuation.

There were 386 matched patients with complete covariate data. Among these patients, the association of survival with prehospital transfusion remained significant at 24 hours and 30 days.

At 24 hours, the adjusted hazard ratio (aHR) for mortality was 0.26 (P=0.02). There were 3 deaths among the 54 prehospital transfusion recipients and 67 deaths among the 332 matched nonrecipients.

At 30 days, the aHR was 0.39 (P=0.03). There were 6 deaths among the 54 prehospital transfusion recipients and 76 deaths among the 332 matched nonrecipients.

The researchers also found that shorter time to initial transfusion, whether it occurred prior to or during hospitalization, was associated with reduced 24-hour mortality.

Transfusions occurring within 15 minutes of medical evacuation (a median of 36 minutes after injury) were associated with reduced mortality at 24 hours.

The aHR was 0.17 (P=0.02). There were 2 deaths among the 62 patients who received a transfusion within 15 minutes of medical evacuation and 68 deaths among the 324 patients who received delayed transfusions or did not receive transfusions.

When the researchers eliminated patients who did not receive transfusions, the aHR was 0.23 (P=0.04). There were 47 deaths among the 303 patients who received delayed transfusions (compared to 2 deaths among the 62 patients who received a transfusion within 15 minutes of medical evacuation).

Photo from UAB Hospital

Early blood transfusion is associated with improved survival among people with severe trauma sustained during combat, according to research published in JAMA.

Researchers studied medically evacuated US military personnel fighting in Afghanistan and found that patients who received blood products prior to hospitalization or within 15 minutes of medical evacuation were more likely to be alive at 24 hours and 30 days, when compared to patients who had delayed transfusions or did not receive transfusions.

Stacy A. Shackelford, MD, of Ft. Sam Houston in San Antonio, Texas, and her colleagues conducted this study to examine the association of prehospital transfusion and time to initial transfusion with injury survival.

The study included US military combat casualties in Afghanistan between April 1, 2012, and August 7, 2015. Eligible patients were rescued alive by medical evacuation from the point of injury with either:

• A traumatic limb amputation at or above the knee or elbow
• Shock, defined as a systolic blood pressure of less than 90 mm Hg or a heart rate greater than 120 beats per minute.

The study included 502, mostly male (98%), patients with a median age of 25 (range, 22 to 29). There were 55 patients who received prehospital transfusions (of red blood cells and/or plasma) and 447 who did not.

The rate of death within 24 hours of medical evacuation was 5% (3/55) among prehospital transfusion recipients and 19% (85/447) among nonrecipients (P=0.01). The rate of death by day 30 was 11% (6/55) and 23% (102/447), respectively (P=0.04).

The researchers also matched nonrecipients and recipients of prehospital transfusion by mechanism of injury, prehospital shock, severity of limb amputation, head injury, and torso hemorrhage. And the team adjusted their analyses for patient age, injury year, transport team, tourniquet use, and time to medical evacuation.

There were 386 matched patients with complete covariate data. Among these patients, the association of survival with prehospital transfusion remained significant at 24 hours and 30 days.

At 24 hours, the adjusted hazard ratio (aHR) for mortality was 0.26 (P=0.02). There were 3 deaths among the 54 prehospital transfusion recipients and 67 deaths among the 332 matched nonrecipients.

At 30 days, the aHR was 0.39 (P=0.03). There were 6 deaths among the 54 prehospital transfusion recipients and 76 deaths among the 332 matched nonrecipients.

The researchers also found that shorter time to initial transfusion, whether it occurred prior to or during hospitalization, was associated with reduced 24-hour mortality.

Transfusions occurring within 15 minutes of medical evacuation (a median of 36 minutes after injury) were associated with reduced mortality at 24 hours.

The aHR was 0.17 (P=0.02). There were 2 deaths among the 62 patients who received a transfusion within 15 minutes of medical evacuation and 68 deaths among the 324 patients who received delayed transfusions or did not receive transfusions.

When the researchers eliminated patients who did not receive transfusions, the aHR was 0.23 (P=0.04). There were 47 deaths among the 303 patients who received delayed transfusions (compared to 2 deaths among the 62 patients who received a transfusion within 15 minutes of medical evacuation).

Photo from UAB Hospital

Early blood transfusion is associated with improved survival among people with severe trauma sustained during combat, according to research published in JAMA.

Researchers studied medically evacuated US military personnel fighting in Afghanistan and found that patients who received blood products prior to hospitalization or within 15 minutes of medical evacuation were more likely to be alive at 24 hours and 30 days, when compared to patients who had delayed transfusions or did not receive transfusions.

Stacy A. Shackelford, MD, of Ft. Sam Houston in San Antonio, Texas, and her colleagues conducted this study to examine the association of prehospital transfusion and time to initial transfusion with injury survival.

The study included US military combat casualties in Afghanistan between April 1, 2012, and August 7, 2015. Eligible patients were rescued alive by medical evacuation from the point of injury with either:

• A traumatic limb amputation at or above the knee or elbow
• Shock, defined as a systolic blood pressure of less than 90 mm Hg or a heart rate greater than 120 beats per minute.

The study included 502, mostly male (98%), patients with a median age of 25 (range, 22 to 29). There were 55 patients who received prehospital transfusions (of red blood cells and/or plasma) and 447 who did not.

The rate of death within 24 hours of medical evacuation was 5% (3/55) among prehospital transfusion recipients and 19% (85/447) among nonrecipients (P=0.01). The rate of death by day 30 was 11% (6/55) and 23% (102/447), respectively (P=0.04).

The researchers also matched nonrecipients and recipients of prehospital transfusion by mechanism of injury, prehospital shock, severity of limb amputation, head injury, and torso hemorrhage. And the team adjusted their analyses for patient age, injury year, transport team, tourniquet use, and time to medical evacuation.

There were 386 matched patients with complete covariate data. Among these patients, the association of survival with prehospital transfusion remained significant at 24 hours and 30 days.

At 24 hours, the adjusted hazard ratio (aHR) for mortality was 0.26 (P=0.02). There were 3 deaths among the 54 prehospital transfusion recipients and 67 deaths among the 332 matched nonrecipients.

At 30 days, the aHR was 0.39 (P=0.03). There were 6 deaths among the 54 prehospital transfusion recipients and 76 deaths among the 332 matched nonrecipients.

The researchers also found that shorter time to initial transfusion, whether it occurred prior to or during hospitalization, was associated with reduced 24-hour mortality.

Transfusions occurring within 15 minutes of medical evacuation (a median of 36 minutes after injury) were associated with reduced mortality at 24 hours.

The aHR was 0.17 (P=0.02). There were 2 deaths among the 62 patients who received a transfusion within 15 minutes of medical evacuation and 68 deaths among the 324 patients who received delayed transfusions or did not receive transfusions.

When the researchers eliminated patients who did not receive transfusions, the aHR was 0.23 (P=0.04). There were 47 deaths among the 303 patients who received delayed transfusions (compared to 2 deaths among the 62 patients who received a transfusion within 15 minutes of medical evacuation).

Photo by Nina Matthews

In a large study, men who received blood from women with a history of pregnancy had an increased risk of death after transfusion.

However, receiving blood from a woman who was never pregnant did not carry the same risk.

And female recipients of blood transfusions had a similar risk of death whether they received blood from women with or without a history of pregnancy.

Rutger A. Middelburg, PhD, of Sanquin Research in Leiden, Netherlands, and his colleagues reported these results in JAMA.

The researchers noted that the most common cause of transfusion-related mortality is transfusion-related acute lung injury, which has been associated with transfusions from female donors, specifically those with a history of pregnancy.

Therefore, Dr Middleburg and his colleagues set out to determine whether an increased risk of mortality after red blood cell transfusions could depend on the donor’s history of pregnancy.

The team studied first-time transfusion recipients at 6 major Dutch hospitals.

When the researchers looked only at patients who received blood from a single type of donor (male/female with pregnancy history/female without), there was a significantly higher risk of death among men who received blood from females with a history of pregnancy.

Male recipients

There were 1722 deaths among the 12,212 males who only received blood from male donors (hazard ratio [HR]=1.00).

There were 1873 deaths among the 13,669 males who only received blood from females with a history of pregnancy (HR=1.13, P=0.03).

And there were 1831 deaths among the 13,538 men who only received blood from females without a history of pregnancy (HR=0.93, P=0.29).

Female recipients

There were 1752 deaths among the 13,332 females who only received blood from male donors (HR=1.00).

There were 1871 deaths among the 14,770 females who only received blood from females with a history of pregnancy (HR=0.99, P=0.92).

And there were 1868 deaths among the 14,685 females who only received blood from females with no history of pregnancy (HR=1.01, P=0.92).

Role of age

The researchers also found the association between donor pregnancy history and recipient death was only observed for men younger than 51.

There were 107 deaths among the 2251 males ages 0 to 17 who received blood from male donors (HR=1.00). And there were 124 deaths among the 2556 males ages 0 to 17 who received blood from females with a history of pregnancy (HR=1.63, P=0.04).

There were 84 deaths among the 1170 males ages 18 to 50 who received blood from male donors (HR=1.00). And there were 94 deaths among the 1296 males ages 18 to 50 who received blood from females with a history of pregnancy (HR=1.50, P=0.06).

There were 598 deaths among the 4292 males ages 51 to 70 who received blood from male donors (HR=1.00). And there were 645 deaths among the 4775 males ages 51 to 70 who received blood from females with a history of pregnancy (HR=1.10, P=0.31).

There were 933 deaths among the 4499 males ages 71 and older who received blood from male donors (HR=1.00). And there were 1010 deaths among the 5042 males ages 71 and older who received blood from females with a history of pregnancy (HR=1.06, P=0.47).

The researchers said more work is required to replicate these findings, determine their clinical significance, and identify the underlying mechanism.

Photo by Nina Matthews

In a large study, men who received blood from women with a history of pregnancy had an increased risk of death after transfusion.

However, receiving blood from a woman who was never pregnant did not carry the same risk.

And female recipients of blood transfusions had a similar risk of death whether they received blood from women with or without a history of pregnancy.

Rutger A. Middelburg, PhD, of Sanquin Research in Leiden, Netherlands, and his colleagues reported these results in JAMA.

The researchers noted that the most common cause of transfusion-related mortality is transfusion-related acute lung injury, which has been associated with transfusions from female donors, specifically those with a history of pregnancy.

Therefore, Dr Middleburg and his colleagues set out to determine whether an increased risk of mortality after red blood cell transfusions could depend on the donor’s history of pregnancy.

The team studied first-time transfusion recipients at 6 major Dutch hospitals.

When the researchers looked only at patients who received blood from a single type of donor (male/female with pregnancy history/female without), there was a significantly higher risk of death among men who received blood from females with a history of pregnancy.

Male recipients

There were 1722 deaths among the 12,212 males who only received blood from male donors (hazard ratio [HR]=1.00).

There were 1873 deaths among the 13,669 males who only received blood from females with a history of pregnancy (HR=1.13, P=0.03).

And there were 1831 deaths among the 13,538 men who only received blood from females without a history of pregnancy (HR=0.93, P=0.29).

Female recipients

There were 1752 deaths among the 13,332 females who only received blood from male donors (HR=1.00).

There were 1871 deaths among the 14,770 females who only received blood from females with a history of pregnancy (HR=0.99, P=0.92).

And there were 1868 deaths among the 14,685 females who only received blood from females with no history of pregnancy (HR=1.01, P=0.92).

Role of age

The researchers also found the association between donor pregnancy history and recipient death was only observed for men younger than 51.

There were 107 deaths among the 2251 males ages 0 to 17 who received blood from male donors (HR=1.00). And there were 124 deaths among the 2556 males ages 0 to 17 who received blood from females with a history of pregnancy (HR=1.63, P=0.04).

There were 84 deaths among the 1170 males ages 18 to 50 who received blood from male donors (HR=1.00). And there were 94 deaths among the 1296 males ages 18 to 50 who received blood from females with a history of pregnancy (HR=1.50, P=0.06).

There were 598 deaths among the 4292 males ages 51 to 70 who received blood from male donors (HR=1.00). And there were 645 deaths among the 4775 males ages 51 to 70 who received blood from females with a history of pregnancy (HR=1.10, P=0.31).

There were 933 deaths among the 4499 males ages 71 and older who received blood from male donors (HR=1.00). And there were 1010 deaths among the 5042 males ages 71 and older who received blood from females with a history of pregnancy (HR=1.06, P=0.47).

The researchers said more work is required to replicate these findings, determine their clinical significance, and identify the underlying mechanism.

Photo by Nina Matthews

In a large study, men who received blood from women with a history of pregnancy had an increased risk of death after transfusion.

However, receiving blood from a woman who was never pregnant did not carry the same risk.

And female recipients of blood transfusions had a similar risk of death whether they received blood from women with or without a history of pregnancy.

Rutger A. Middelburg, PhD, of Sanquin Research in Leiden, Netherlands, and his colleagues reported these results in JAMA.

The researchers noted that the most common cause of transfusion-related mortality is transfusion-related acute lung injury, which has been associated with transfusions from female donors, specifically those with a history of pregnancy.

Therefore, Dr Middleburg and his colleagues set out to determine whether an increased risk of mortality after red blood cell transfusions could depend on the donor’s history of pregnancy.

The team studied first-time transfusion recipients at 6 major Dutch hospitals.

When the researchers looked only at patients who received blood from a single type of donor (male/female with pregnancy history/female without), there was a significantly higher risk of death among men who received blood from females with a history of pregnancy.

Male recipients

There were 1722 deaths among the 12,212 males who only received blood from male donors (hazard ratio [HR]=1.00).

There were 1873 deaths among the 13,669 males who only received blood from females with a history of pregnancy (HR=1.13, P=0.03).

And there were 1831 deaths among the 13,538 men who only received blood from females without a history of pregnancy (HR=0.93, P=0.29).

Female recipients

There were 1752 deaths among the 13,332 females who only received blood from male donors (HR=1.00).

There were 1871 deaths among the 14,770 females who only received blood from females with a history of pregnancy (HR=0.99, P=0.92).

And there were 1868 deaths among the 14,685 females who only received blood from females with no history of pregnancy (HR=1.01, P=0.92).

Role of age

The researchers also found the association between donor pregnancy history and recipient death was only observed for men younger than 51.

There were 107 deaths among the 2251 males ages 0 to 17 who received blood from male donors (HR=1.00). And there were 124 deaths among the 2556 males ages 0 to 17 who received blood from females with a history of pregnancy (HR=1.63, P=0.04).

There were 84 deaths among the 1170 males ages 18 to 50 who received blood from male donors (HR=1.00). And there were 94 deaths among the 1296 males ages 18 to 50 who received blood from females with a history of pregnancy (HR=1.50, P=0.06).

There were 598 deaths among the 4292 males ages 51 to 70 who received blood from male donors (HR=1.00). And there were 645 deaths among the 4775 males ages 51 to 70 who received blood from females with a history of pregnancy (HR=1.10, P=0.31).

There were 933 deaths among the 4499 males ages 71 and older who received blood from male donors (HR=1.00). And there were 1010 deaths among the 5042 males ages 71 and older who received blood from females with a history of pregnancy (HR=1.06, P=0.47).

The researchers said more work is required to replicate these findings, determine their clinical significance, and identify the underlying mechanism.

The US Food and Drug Administration (FDA) has approved the first test designed to screen blood donations for Zika virus.

The cobas Zika test is a qualitative nucleic acid test that can detect Zika virus RNA in individual plasma specimens obtained from donors of whole blood and blood components and from living organ donors.

The test is not intended for the individual diagnosis of Zika virus infection.

The cobas Zika test is intended for use on the fully automated cobas 6800 and cobas 8800 systems. These systems and the test are manufactured by Roche Molecular Systems, Inc.

“Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“Screening blood donations for the Zika virus is critical to preventing infected donations from entering the US blood supply. Today’s approval is the result of a commitment by the manufacturer to work rapidly and collaboratively with the FDA and the blood collection industry to respond to a public health crisis and ensure the safety of blood in the US and its territories.”

In August 2016, the FDA issued a guidance document recommending that all states and territories screen individual units of whole blood and blood components with an investigational blood screening test available under an investigational new drug (IND) application, or use an approved test when available.

Several blood collection establishments have used the cobas Zika test under an IND. The data collected from this testing and additional studies performed by the manufacturer demonstrated that the test is effective in screening blood donors for Zika virus infection, according to the FDA.

The test’s clinical specificity was evaluated by testing individual samples from blood donations at 5 external laboratory sites, and the specificity exceeded 99%.

The US Food and Drug Administration (FDA) has approved the first test designed to screen blood donations for Zika virus.

The cobas Zika test is a qualitative nucleic acid test that can detect Zika virus RNA in individual plasma specimens obtained from donors of whole blood and blood components and from living organ donors.

The test is not intended for the individual diagnosis of Zika virus infection.

The cobas Zika test is intended for use on the fully automated cobas 6800 and cobas 8800 systems. These systems and the test are manufactured by Roche Molecular Systems, Inc.

“Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“Screening blood donations for the Zika virus is critical to preventing infected donations from entering the US blood supply. Today’s approval is the result of a commitment by the manufacturer to work rapidly and collaboratively with the FDA and the blood collection industry to respond to a public health crisis and ensure the safety of blood in the US and its territories.”

In August 2016, the FDA issued a guidance document recommending that all states and territories screen individual units of whole blood and blood components with an investigational blood screening test available under an investigational new drug (IND) application, or use an approved test when available.

Several blood collection establishments have used the cobas Zika test under an IND. The data collected from this testing and additional studies performed by the manufacturer demonstrated that the test is effective in screening blood donors for Zika virus infection, according to the FDA.

The test’s clinical specificity was evaluated by testing individual samples from blood donations at 5 external laboratory sites, and the specificity exceeded 99%.

The US Food and Drug Administration (FDA) has approved the first test designed to screen blood donations for Zika virus.

The cobas Zika test is a qualitative nucleic acid test that can detect Zika virus RNA in individual plasma specimens obtained from donors of whole blood and blood components and from living organ donors.

The test is not intended for the individual diagnosis of Zika virus infection.

The cobas Zika test is intended for use on the fully automated cobas 6800 and cobas 8800 systems. These systems and the test are manufactured by Roche Molecular Systems, Inc.

“Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

“Screening blood donations for the Zika virus is critical to preventing infected donations from entering the US blood supply. Today’s approval is the result of a commitment by the manufacturer to work rapidly and collaboratively with the FDA and the blood collection industry to respond to a public health crisis and ensure the safety of blood in the US and its territories.”

In August 2016, the FDA issued a guidance document recommending that all states and territories screen individual units of whole blood and blood components with an investigational blood screening test available under an investigational new drug (IND) application, or use an approved test when available.

Several blood collection establishments have used the cobas Zika test under an IND. The data collected from this testing and additional studies performed by the manufacturer demonstrated that the test is effective in screening blood donors for Zika virus infection, according to the FDA.

The test’s clinical specificity was evaluated by testing individual samples from blood donations at 5 external laboratory sites, and the specificity exceeded 99%.