Asian Pacific journal of allergy and immunology · 2018
The validation and evaluation of anti-HIV testing algorithm used in mobile clinic setting for men who have sex with men in metropolitan Bangkok, Thailand.
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Pankam Tippawan, Saensiriphan Sarun, Areeyolwattana Suphackok, Barisri Napapat, Pengnonyang Supabhorn, Sirivichayakul Sunee, Phanuphak Nittaya, Phanuphak Praphan
Аннотация
BACKGROUND: Same-day anti-HIV testing algorithm is recommended by Thai National Guidelines. We compared performance characteristics of algorithms used in a mobile clinic and a facility-based clinic for men who have sex with men (MSM) in Bangkok.
METHODS: Mobile clinic samples collected from 4 saunas and 2 spa venues were tested by Alere DetermineTM HIV 1/2, followed by DoubleCheck GoldTM Ultra HIV 1/2 and SD Bioline HIV 1/2 3.0. All samples were re-tested at the Thai Red Cross Anonymous Clinic (TRCAC) by Architect HIV Ag/Ab or Elecsys HIV combi PT, followed by Alere DetermineTM HIV 1/2 and Serodia HIV 1/2. Non-reactive samples were tested by Aptima nucleic acid amplification test (NAAT) and reactive/inconclusive samples were tested by less-sensitive immunoassays (IA) and HIV-1 RNA to detect acute HIV infection (positive NAAT or non-reactive IA/positive HIV-1 RNA).
RESULTS: Of 233 MSM, 36 (15.5%) had HIV infection diagnosed using mobile clinic algorithm. Two additional acute HIV cases (1 positive NAAT and 1 reactive Architect with detectable HIV-1 RNA) were diagnosed using TRCAC algorithm. The mobile clinic algorithm had a sensitivity of 94.9% (95% CI: 82.7, 99.4) and a specificity of 100% (95% CI: 98.1, 100).
CONCLUSION: Use of whole blood on rapid test kits demonstrated satisfactory performance and allowed same-day HIV test result through a mobile clinic model. For populations with high HIV incidence, careful history taking to define the window period is crucial and repeat testing must be encouraged if the testing algorithm does not include 4th generation anti-HIV assay or NAAT.
METHODS: Mobile clinic samples collected from 4 saunas and 2 spa venues were tested by Alere DetermineTM HIV 1/2, followed by DoubleCheck GoldTM Ultra HIV 1/2 and SD Bioline HIV 1/2 3.0. All samples were re-tested at the Thai Red Cross Anonymous Clinic (TRCAC) by Architect HIV Ag/Ab or Elecsys HIV combi PT, followed by Alere DetermineTM HIV 1/2 and Serodia HIV 1/2. Non-reactive samples were tested by Aptima nucleic acid amplification test (NAAT) and reactive/inconclusive samples were tested by less-sensitive immunoassays (IA) and HIV-1 RNA to detect acute HIV infection (positive NAAT or non-reactive IA/positive HIV-1 RNA).
RESULTS: Of 233 MSM, 36 (15.5%) had HIV infection diagnosed using mobile clinic algorithm. Two additional acute HIV cases (1 positive NAAT and 1 reactive Architect with detectable HIV-1 RNA) were diagnosed using TRCAC algorithm. The mobile clinic algorithm had a sensitivity of 94.9% (95% CI: 82.7, 99.4) and a specificity of 100% (95% CI: 98.1, 100).
CONCLUSION: Use of whole blood on rapid test kits demonstrated satisfactory performance and allowed same-day HIV test result through a mobile clinic model. For populations with high HIV incidence, careful history taking to define the window period is crucial and repeat testing must be encouraged if the testing algorithm does not include 4th generation anti-HIV assay or NAAT.