Google Translate
Mylan HIV Self Test
The Mylan HIV Self Test is a single-use, immunochromatographic, rapid in-vitro diagnostic test for the detection of HIV-1 and HIV-2 antibodies in whole blood.
Manufacturer: Atomo Diagnostics Pty Ltd (Leichardt, Australia; Muizenberg, South Africa)
Detects: HIV-1 and HIV-2
Quality Standards: WHO PQ
WHO PQ Number: PQDx 0320-090-00
WHO Listing Dates: 3 July 2019
Two systematic reviews and meta-analyses comparing HIV self-testing to standard HIV testing services have been published. Johnson et al (2017) found that HIV self-testing is associated with increased uptake and frequency of testing, while Figueroa et al (2018) found that self-testers can reliably and accurately conduct HIV rapid diagnostic tests, as compared with trained healthcare workers.
Summary of WHO PQ product performance evaluation |
|
|---|---|
Reference standard | Murex HIV Ag/Ab Combination (DiaSorin S.p.A) and Genscreen ULTRA HIV Ag-Ab (Biorad Laboratories) |
Sample type | Capillary blood |
Number of specimens | 1013 |
Evaluator | WHO at National Health Laboratory Quality Assurance and Training Centre (Dar el Salaam, Tanzania) |
Evaluation Period | 1st and 2nd quarters of 2018 |
Performance characteristics in comparison with an agreed reference standard |
|
|---|---|
Sensitivity % (95% CI) | 99.8% (98.7% – 100%) |
Specificity % (95% CI) | 99.8% (99.1% – 100%) |
Invalid rate % | 0% |
Inter-reader variability % | 0% |