FDA approves new rapid HIV-1 test

The FDA has approved a new single-use, rapid test for the detection of antibodies to HIV-1 in human venipuncture whole blood, finger-prick blood or plasma specimens, according to an FDA press release.

The INSTI HIV-1 antibody test — manufactured by bioLytical Laboratories Inc., in Richmond British Columbia, Canada — delivers results in as little as 1 minute, in contrast to the 10 to 20 minutes it takes for the six previously approved rapid HIV tests to deliver results.

The new test may be used in clinical laboratories, in public health laboratories and in point-of-care settings and is classified as moderate complexity under Clinical Laboratory Improvements Amendments.

According to the press release, the overall sensitivity of the test is 99.8% (95% CI, 99.3%-99.9%) in finger-prick whole blood; 99.9% (95% CI, 99.5%-100%) in venipuncture whole blood; and 99.9% (95% CI, 99.5%-100%) in plasma.

Overall specificity for the different types is 99.5% (95% CI, 99.0%-99.8%) in finger-prick whole blood; 100% (95% CI, 99.7-100) in venipuncture whole blood; and 100% (95% CI, 99.7-100) in plasma for the detection of antibodies to HIV-1.

The test is not recommended to be used for screening of blood donors.

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The FDA has approved a new single-use, rapid test for the detection of antibodies to HIV-1 in human venipuncture whole blood, finger-prick blood or plasma specimens, according to an FDA press release.

The INSTI HIV-1 antibody test — manufactured by bioLytical Laboratories Inc., in Richmond British Columbia, Canada — delivers results in as little as 1 minute, in contrast to the 10 to 20 minutes it takes for the six previously approved rapid HIV tests to deliver results.

The new test may be used in clinical laboratories, in public health laboratories and in point-of-care settings and is classified as moderate complexity under Clinical Laboratory Improvements Amendments.

According to the press release, the overall sensitivity of the test is 99.8% (95% CI, 99.3%-99.9%) in finger-prick whole blood; 99.9% (95% CI, 99.5%-100%) in venipuncture whole blood; and 99.9% (95% CI, 99.5%-100%) in plasma.

Overall specificity for the different types is 99.5% (95% CI, 99.0%-99.8%) in finger-prick whole blood; 100% (95% CI, 99.7-100) in venipuncture whole blood; and 100% (95% CI, 99.7-100) in plasma for the detection of antibodies to HIV-1.

The test is not recommended to be used for screening of blood donors.

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