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 generation is Alere Determine?
The first 4th generation rapid test – Alere Determine HIV-1/2 Combo test, disappointedly, gave rarely positive p24-antigen results in acute or early infections. To improve the sensitivity, a new test was developed: Alere HIV Combo test.
How accurate is Alere HIV test kit?
After testing 120 samples from participants, the researchers found that the Alere HIV Combo Rapid Test had 91% sensitivity and 100% specificity for p24 antigen detection (Fitzgerald et al., 2016).
What is the window period for Alere Determine HIV-1 2?
Timeframe for Alere Determine™ HIV-1/2 Ag/Ab Combo ONLY: Antigen can be detected 14-15 days after infection (Acute Infection). Antigen and antibodies can both be detected 21-28 days after infection (Early Infection).
What is determine test?
By detecting all known subtypes of HIV, Alere Determine™ HIV-1/2 will help healthcare workers across the world diagnose individual infection, prevent mother-to-child transmission, monitor HIV prevalence and screen blood donations.
How accurate is Alere Determine?
It is highly sensitive and is able to detect 99.9% of infections with HIV at 90 days after exposure. The Alere combination HIV test tests for HIV 1 & 2 antibodies as well as P24: an enzyme that rises early in HIV infection.
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.
How accurate is alere?
Results. Reference testing yielded 97 positives for HIV infection and 36 negative samples. Sensitivity of the Alere test was 95% (88–98%), while the SD Bioline sensitivity was 91% (83–96%). Both assays showed 100% (90–100%) specificity.
Which one is a confirmatory test?
Confirmatory tests for blood include identification of blood cells under a microscope [Shaler, 2002], crystal tests such as the Teichman and Takayama tests [Shaler, 2002; Spalding, 2003], and ultraviolet absorption tests [Gaensslen, 1983].
What does see confirmatory test mean?
Confirmatory tests are the tests required to confirm the analysis. Confirmatory tests cost more than simpler presumptive tests so presumptive tests are often done to see if confirmatory tests are necessary.
What are the four types of presumptive tests?
Luminol, leuchomalachite green, phenolphthalein, Hemastix, Hemident, and Bluestar are all used as presumptive tests for blood.