A Medical Device Daily
The FDA has just cleared the first fully automated HIV screening test in the U.S., which is designed to check the blood supply used for transfusions. It reduces time to screen a blood sample from two hours to less than 30 minutes.
Abbott's (Abbott Park, Illinois) Abbott Prism HIV O Plus test is intended for use by labs to screen individual donors of blood and plasma for antibodies to HIV type 1 Groups M and O (anti-HIV-1) and type 2 (anti-HIV-2), and as an aid in the diagnosis of HIV-1/HIV-2 infection.
"From a lab efficiency standpoint, it reduces hands-on labor required," Mark Mathieson, marketing manager, Infectious Disease Products, told Medical Device Daily. "The instrument has reagent bar coding and scanning and on-board refrigeration capabilities. The blood sample remains in the original sample rack and the operator isn't required to move the test tubes around unlike some manual microplate methods. It requires less time from the operator.
"We're talking about multi-fold improvements," he said, adding that, "Facilities can reallocate their resources. They can reallocate full-time equivalents and reconfigure shifts. The efficiency gives people greater flexibility."
The assay runs on the Abbott Prism system, which can handle 160 samples per hour, or 1,200 samples in an eight-hour shift, according to the company. Mathieson said there are approximately 100 Prism systems in place across the U.S.
The American Association of Blood Banks (AABB) reports that 9.5 million volunteers donate about 16 million units of whole blood each year in the U.S., each of which must be tested for infectious diseases. Abbott now offers a complete panel of hepatitis and retrovirus tests on the Abbott Prism system which includes: hepatitis B core test; hepatitis B surface antigen test; hepatitis C test; and a human T-lymphotropic virus test.
Abbott's HIV test has been available outside of the U.S. for more than a decade.
"The U.S. is the only country that differentiates between diagnostic and screening tests," Mathieson pointed out. "Outside the U.S. it can be used for either, with no differentiation. Outside the U.S. a lot of technology has shifted away from solely looking at antibody testing to antigen and antibody testing simultaneously. The U.S. hasn't gone in that direction yet."
The science behind Abbott's Prism HIV O Plus test is similar to existing assays.
"Where we believe that this assay has some differentiators is in the group O detection; not every assay detects group O," he said. "But what's really different about Prism when you're testing blood for blood supply is that it's important to have process control so you know what's going to happen and when, and your instrument keeps track of this for you. With Prism, all the steps are automated with an audit trail to see all those steps."
Mathieson said that Prism can identify what reagent lot was used based on bar codes, provide verification on how pumps are performing. All processes are tracked and documented so that it provides control to insure the sample hasn't been tampered with and that results are verifiable.
Abbott data indicates that the test has 100% sensitivity from a study of 1,524 samples tested from known HIV-positive people. Regarding specificity, the initial reactive rate is .06%, meaning that from 6,284 known negative samples, four of those were positive.
Abbott was the first company to launch an HIV test in the U.S. in 1985. In addition to its work to develop tests, the company also is involved in disease surveillance.
"Abbott is proud of two programs," he said. "We have an HIV surveillance program in Africa where we work to identify emerging viral strains and we use that knowledge in the development of our next generation assays. Second, we recently signed an agreement with University of California San Francisco for a viral discovery program to help us stay on the forefront on new emerging viruses." n
Lynn Yoffee, 770-361-4789;