title: Scaling up HIV rapid testing in developing countries: comprehensive approach for implementing quality assurance.
abstract: In the last few years, the use of HIV rapid testing has expanded worldwide in response to the call for universal access to prevention, care, and treatment by UNAIDS and the World Health Organization. HIV rapid testing is performed by people with varied skills in laboratory and nonlaboratory settings. Accurate HIV diagnostic testing is the first step to identifying infected persons for follow-up referral and care. However, there are several challenges related to test kit quality, test selection, testing algorithms, training, quality assurance (QA), quality of new lots, and postmarket performance. We highlight various issues that impact the quality of HIV rapid testing and provide solutions to monitor and improve test accuracy, especially in resource-limited settings. These include the use of validated kits, training with emphasis on QA, use of a standardized log book, dried-tube specimen-based proficiency testing, new kit lot verification, and postmarket surveillance. Systematic implementation of these tools should greatly enhance the quality of HIV rapid testing.
authors.affiliation: Serology/Incidence and Diagnostics Team, GAP International Laboratory Branch, 1600 Clifton Rd, MS-G19, Bldg 15/2611, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
authors.forename: Bharat S
authors.initials: BS
authors.lastname: Parekh
authors.forename: Mireille B
authors.initials: MB
authors.lastname: Kalou
authors.forename: George
authors.initials: G
authors.lastname: Alemnji
authors.forename: Chin-Yih
authors.initials: CY
authors.lastname: Ou
authors.forename: Guy-Michel
authors.initials: GM
authors.lastname: Gershy-Damet
authors.forename: John N
authors.initials: JN
authors.lastname: Nkengasong
mesh_terms: D003150:Community Health Workers / Q000193:education; D003906:Developing Countries; D015658:HIV Infections / Q000175:diagnosis* / Q000453:epidemiology; D019095:Point-of-Care Systems / Q000592:standards; D011358:Product Surveillance, Postmarketing; D011785:Quality Assurance, Health Care; D011933:Reagent Kits, Diagnostic / Q000592:standards*
chemical_list: D011933:Reagent Kits, Diagnostic