Alere has a 3rd generation rapid HIV test, 3rd generation meaning it only detects antibodies. Here are the information:
Intended use:
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.
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.
With its simple one-step procedure for serum/plasma or two-step procedure for whole blood, the Alere Determine™ HIV-1/2 is quick and easy to use, delivering clear, dependable results in just 15 minutes.
Certification: WHO
Made in Japan
In this limited performance evaluation using a panel of 1079 biological specimens, we
observed aninitial (sensitivity (95% CI) of 100% (99.1% – 100%) and an initial specificity (95%
CI) of 97.87% (96.4% – 98.8%) compared to the reference assays. The final sensitivity (95% CI)
was 100% (99.1% – 100%) and the final specificity (95% CI) was 98.93% (97.8% – 99.6%)
compared to the reference assays. In this study, 0.3% of the overall results were recorded as
indeterminate. Results were interpreted independently by three technicians; the interreader
variability was 1.4%. The invalid rate was 0.3% for initial testing and 0.1% for repeat
testing.
Results in 15 minutes
Usage Guide
