by Keith Loria

More than 3.6 million Americans receive blood transfusions each year and assuring the safety of the blood supply is a high-tech process requiring at least nine specific tests; proper processing, labeling, and storage; as well as vigilant quality control.

With developing technology and new information about the transmission of infectious diseases becoming available, FDA's Center for Biologics Evaluation and Research issues written guidance to all blood establishments. This guidance sets the standard for the industry and is incorporated into standard operating procedures for all blood facilities.

According to the American Association of Blood Banks, last year eight million
Note: This report originally appeared in the May 2008 edition of DOTmed Business News. A list of registered users that provide sales & service can be found at the end.

Americans donated approximately 15 million units of blood, which were then processed into 25-30 million blood products.

Before a blood donation can enter the blood supply, it is tested for evidence of exposure to viruses that might cause disease. This screening process involves numerous assays, multiple test instruments and many manual steps.




"There are really only two major players in the field, Ortho-Clinical Diagnostics and Abbott Laboratories," says Fred Stallone, technical director of Blood Systems Laboratories in Tempe AZ, one of the two regional labs of Blood Systems Incorporated. "They offer the newest technology available for infectious disease testing."

Last year Abbott introduced the PRISM, which has been rumored to be coming out for more than a decade, but finally met FDA approval in 2006.

"Abbott has a strong history and commitment to ensuring the safety of the world's blood supply. Now, the PRISM system's advanced screening technology will be available to U.S. blood banks for hepatitis core screening, helping to make America's blood supply as safe as possible," said Joseph M. Nemmers, senior vice president, Diagnostic Operations, Abbott, on release of the product. Since its release, the PRISM now has four of the required six donor screening tests available.

The Abbott PRISM instrument consolidates much of this testing into a single automated system, reducing the number of times a blood sample is handled and improving operating safety and efficiency for blood and plasma centers. It's samples in and results out.

"The real benefit of the PRISM analyzer is that the operator loads samples and reagent on the instrument and the PRISM performs the entire process for you," says Stallone, who estimated that they test more than 1.6 million samples each year at the Tempe facility. "It basically pipettes the samples for multiple donor screening tests and automatically performs all required processing steps. Upon completion of processing, the donor results will be reported, only if all quality control checks are acceptable."

This reduces the risk of human error and performs the task with fewer employees. At a cost of about $400,000 per machine, the PRISM system can process 160 samples per hour for four different screening tests.

Ortho-Clinical Diagnostics, a Johnson & Johnson company, is a leading provider of high-value diagnostic solutions for the global health care community. Over the past six years, the Ortho Summit Processor (OSP) has been used by blood banks to automate all screening assays, and has flexibility for adding new tests as required. Designed for mid- to high-volume screening, the OSP is proven in 22 countries and is currently screening over 15 million units of blood annually at a cost of about $250,000 per machine.




With the OSP system, sample pipetting is performed on a different instrument. The pipetted sample plates are loaded onto the OSP to complete the required processing steps. The OSP with prompt the operator to load sample plates and reagent as needed. Upon completion of processing, the donor results will be reported, only if all quality control checks are acceptable." Stallone says. "The real difference between the two systems, is with the PRISM you load samples on the machine and you get results out the other end. Where as the OSP requires off line sample pipetting and then the analyzer performs the rest of the steps."

According to Johnson & Johnson News, one new assay that met approval in March of this year is a new diagnostic assay for the detection of antibodies to Human Immunodeficiency Virus types 1 and/or 2 (anti-HIV-1 and anti-HIV-2). The new VITROS Anti-HIV 1+2 assay 1 can be run in a fully automated, random access format on the VITROS ECi/ECiQ Immunodiagnostic System, with results readily available in less than 50 minutes. This FDA approval and availability to laboratories in the U.S., Puerto Rico and U.S. territories marks the first anti-HIV 1+2 test capable of being run in full random access with other tests and providing immediate result reporting capability upon test completion.

The downside on the PRISM is that they are not yet licensed to perform all the tests that are required and won't be for at least another year. The manufacturer of the OSP is eliminating some of the required tests as part of the donor screening profile, so this equipment is not enough either. Smaller blood banks will now be forced to send out their blood samples for testing because they won't be able to afford both systems.

"The small laboratories are getting to a point where it is difficult to test these infectious diseases in a cost effective manner," Stallone says.

Both machines have greatly improved the way that blood is analyzed and can ensure up to 99.9 percent that the blood is safe of viruses.

"With each new generation of screening test, the goal is to make the test more sensitive, Stallone adds. "More sensitive tests allow us to detect lower levels of the virus earlier in the infectious process."

This story originally appeared in the May 2008 issue of DOTmed Business News.

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DOTmed registered users contributing to this story were:
Dick Slade, BIS Technologies, AZ
DOTmed Certified/ 100
Rob Rankin, Rankin Biomedical Corporation, MI
DOTmed Certified

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