Is Alere Determine a fourth generation test?

Third generation RDT-negative samples were tested with the fourth generation FDA-approved Alere™ Determine™ HIV-1/2 Ag/Ab Combo rapid test (Alere North America, Waltham, MA) and the CE-Marked Alere™ HIV Combo Rapid Test (Alere Medical Co.

Which HIV test is 4th generation?

Combined antigen/antibody tests (also called fourth generation HIV tests) Fourth generation tests look for HIV antibodies as well as something called p24 antigens. The p24 antigens are part of HIV itself. You will have a lot of these in your blood in the first few weeks after infection.

What test follows a positive p24 antigen test?

An antibody-antigen blood test checks for levels of both HIV antibodies and the p24 antigen. This test can detect the virus as early as 3 weeks after getting infected. A follow-up test is also called a confirmatory test. It is usually done when the screening test is positive.

Why is the p24 antigen test a more accurate screening test?

High levels of p24 are present in the blood during the short period between HIV infection and seroconversion, before fading away. Since p24 antigen is usually detectable a few days before HIV antibodies, a diagnostic test that can detect p24 has a slightly shorter window period than a test that only detects antibodies.

How accurate is Alere Determine?

The sensitivity for detecting HIV infection among the panel samples was 95\% (95\%CI 88–98\%) for the Alere Determine HIV-1/2 Combo and for the SD Combo 91\% (95\%CI 83–96\%). Both assays showed an overall specificity of 100\% (95\%CI 90–100\%).

What type of test is alere?

The Alere Determine® HIV-1/2 is an In Vitro, visually read, qualitative immunoassay for the detection of antibodies to HIV-1 and HIV-2 in human serum, plasma or whole blood. The test is intended as an aid to detect antibodies to HIV-1/HIV-2 from infected individuals.

What is Alere Determine?

Alere Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of Human Immunodeficiency Virus Type 1 (HIV-1) p24 antigen (Ag) and antibodies (Ab) to HIV Type 1 and Type 2 (HIV-1 and HIV-2) in human serum, plasma, capillary (fingerstick) whole blood or …

When does the p24 antigen become detectable?

However, the p24 test is generally only positive from about two to three weeks after infection with HIV. The p24 protein cannot be detected until about a week after infection with HIV because it generally takes that long for the virus to become established and multiply to sufficient numbers that they can be detected.

How soon can p24 antigen be detected?

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