Monitoring of HIV viral load in low and middle income settings is limited by high cost of the commercial assays. Therefore, we developed a novel RT-PCR quantitative assay was developed. This assay targets the HIV-1 pol integrase gene (INT). Subsequently, the performance of the INT assay, described previously as a Long Terminal Repeat (LTR) assay and a combined INT/LTR dual target RT-PCR assay was compared. The LTR-assay was found to be sensitive and cost-effective (50-70% cheaper than commercial assays) with the lowest coefficient of variation (%CV). Introduction of an internal standard further improved assay reliability. Therefore, this LTR assay was implemented in West Java, Indonesia. Linearity and precision of the LTR assay were good: %CV ranged from 1.0% to 10.4%. The limit of quantitation was 616copies/ml. Performance was comparable with the commercial assay (Abbott assay) (r2=0.01), although on average the viral loads were 0.39log10copies/ml lower. In clinical practice, it had excellent capability for monitoring treatment failure, the positive predictive value was 99% and the negative predictive value was 93%. In conclusion, the implementation of the improved HIV-1 viral load LTR-assay for routine diagnosis in resource poor settings can be a good alternative when commercial assays are unaffordable.

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Journal of Virological Methods
Department of Virology

Fibriani, A., Farah, N., Kusumadewi, I., Pas, S., van Crevel, R., van der Ven, A., … Schutten, M. (2012). Low cost HIV-1 quantitative RT-PCR assay in resource-limited settings: Improvement and implementation. Journal of Virological Methods, 185(1), 118–123. doi:10.1016/j.jviromet.2012.06.015