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HIV-1 tests approved

This article was originally published in The Gray Sheet

Executive Summary

Abbott's RealTime HIV-1 and Roche's Cobas AmpliPrep/Cobas TaqMan HIV-1 tests receive FDA PMA approval May 11. Both tests measure viral load of HIV-I Group M, including non-B subtypes through real-time PCR. The RealTime test is designed for use with Abbott's m2000 automated instrument system while the Roche test works with that firm's Cobas TaqMan automated analyzer. Abbott's m2000 system also is available in Europe, along with the firm's viral tests for HIV-1, hepatitis C, Chlamydia trachomatis (CT), and a combination test for CT/Neisseria gonorrhoeae. Roche notes that its hepatitis B and C tests, for use on the same Roche platform as the HIV-1 test, are under FDA review...
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