Cobas ampliprep cobas taqman real time hiv 1 rna assay

HIV-1 uninfected participants attended monthly and HIV-1 infected partners attended quarterly visits for up to 36 months. Follow up visits included standardized interviews about sexual behavior in the last 30 days, medical history, and assessment of clinical and laboratory safety. Male circumcision status was determined by physical examination at the time of study enrollment and each annual follow up visit and reported as fully circumcised, partially circumcised or not circumcised. HIV-1 uninfected partners underwent HIV-1 testing and were dispensed study medication. For HIV-1 infected partners, CD4 counts were quantified every 6 months using standard flow cytometry and plasma HIV-1 RNA levels were quantified using the COBAS Ampliprep/COBAS TaqMan real-time HIV-1 RNA assay, version 1.0 (Roche Diagnostics, Indianapolis, IN), with a lower limit of quantification of 240 copies/mL.

Plasma and endocervical swab samples were collected every six months, irrespective of ART initiation, and included in this analysis if they were collected after ART initiation. The samples were linked to the contraceptive method reported as being used at the sample collection visit. Plasma and genital viral detection was conducted using COBAS AmpliPrep/COBAS TaqMan Real-Time HIV-1 RNA assay (Roche Diagnostics, Indianapolis, IN) for Partners in Prevention and Couples Observational Studies and Abbott RealTime HIV-1 assay (Abbott Laboratories, Des Plains, IL) for Partners PrEP Study, as previously detailed.^{11 (link),18} The lower limits of quantification for HIV-1 RNA assays in both undiluted plasma and endocervical samples were 40–48 copies/mL of fluid tested. Plasma viral suppression was considered <400 copies/mL and genital shedding as any detectable genital viral RNA. We defined isolated genital shedding as any detectable genital viral RNA in the setting of plasma viral suppression at the same visit.