Xpert HIV-1 Qual is a qualitative in vitro diagnostic test designed to detect Human Immunodeficiency Virus Type 1 (HIV-1) total nucleic acids using human whole blood (WB) and dried blood spot (DBS) specimens from individuals suspected of HIV-1 infection.

Manufacturer: Cepheid AB (Sunnyvale, CA, United States)

Instrument Compatibility: GeneXpert Dx, GeneXpert Infinity-48s and GeneXpert Infinity-80

Detects: HIV-1

Quality Standards: WHO PQ; CE marked 

WHO PQ Number: PQ Dx 0259-070-00

WHO Listing Date: 13 June 2016

One systematic review has been published (Agutu et al 2019) which includes data from  five studies that have assessed the performance of Xpert HIV-1 Qual Assay as compared with current reference standards. The assay performed well across the studies with high sensitivities (range: 93.3-100%) and high specificities (range: 99.5-100%).