Development of HIV-1 Dried Tube Specimen Prototype as Quality Control Samples for HIV Viral Load Testing

Abstract

HIV viral load is an important parameter in monitoring effectiveness of antiretroviral therapy for HIV-infected individuals. Quality control (QC) for HIV viral load testing is essential to achieve accuracy and precision of the assay. Currently, QC sample is in a form of liquid prepa- ration (plasma) from HIV infected specimen that requires cold-chain condition for storage and transportation. To circumvent the usage of a cold-chain dependent system, a QC sample using dried tube sample (DTS) that can be shipped and stored at ambient temperature was developed and evaluated. A laboratory strain of HIV-1 NP1525 was propagated co-cultured with peripheral blood mononuclear cells (PBMCs), measured for HIV RNA, aliquoted and air-dried at room temperature for 18 - 24 hours. No significant difference of HIV viral load was observed between DTS and culture fluid specimen at the same concentration (P ≥ 0.05, t test). The stability of DTS was testedand found stable at -70°C, 4°C, and 45°C for at least 8 weeks. The study suggested that DTSquality control sample could be used as a routine quality control for HIV viral load testing and for external quality assessment program, thus supporting the 5-95-95 target to end the AIDS epidemic by the year 2030.