Mylan HIV Self Test

Sensitivity

(ability to correctly identify HIV positive samples)

Specificity

(ability to correctly identify HIV negative samples)

World's 1st integrated blood based HIV self-test device that offers users, simple at-home HIV screening test with result in just 15 minutes.

Video Overlay Content

Approved by multiple regulatory authorities

CE

Conformité Européenne

WHO

World Health Organisation

References

1. Data on file: MHST-OA-011 Mylan HIV ST IFU English (WHO Version). Rev 6.
2. Data on file: EC Design-Examination Certificate, Directive 98/79/EC on In Vitro Diagnostic Medical Devices, Annex IV Section 4, 28 June 2019.
3. WHO PQ Public Report, July 2021, version 3.0; Available at: https://extranet.who.int/pqweb/sites/default/files/PQDx_0320-090-00_MylanHIV-SelfTest_V3.0.pdf; Accessed on 17 April 2023.