FDA Approves New Automated HIV Screening Test
On September 21, the Food and Drug Administration (FDA) approved a new fully automated HIV screening test, manufactured by Abbott Laboratories. The new test, called Abbott Prism HIV O Plus, allows lab professionals to screen blood and organ donors for antibodies to HIV.
Antibodies are protein molecules manufactured by the body’s immune system to mark and neutralize pathogens in the body for destruction. Pathogens are agents such as bacteria, fungi, and viruses that cause disease.
Unlike current tests such as the enzyme-linked immunosorbent assay, the fully automated Abbott Prism system can run up to 160 samples per hour. If a positive result is received from the test, verification of the results is required from other tests. The efficiency of the new test allows lab professionals to quickly test many samples of blood at a given time, which is important when labs are required to screen every sample of donated blood for infectious diseases.
The Abbott Prism HIV O Plus is unique in that it can detect both HIV-1 and HIV-2. HIV-1 contains several subgroups; two of the most common are group M and group O. The M subgroup is most common in the United States, whereas the O subgroup is most common in West Africa. HIV type 2 is most commonly found in West Africa as well.
This new test completes Abbott’s Prism system, which includes other tests for hepatitis B, hepatitis C, and the human T- lymphotropic virus.
For more information, please see the Reuters press release.