The performance of a new point-of-care HIV virus load technology to identify patients failing antiretroviral treatment

Abstract Background A new point-of-care (POC) HIV virus load technology has been recently developed and designed to be utilized in decentralized settings. Alere Technologies GmbH*, Germany, developed the mPIMA HIV-1/2 V L plasma test which uses real time PCR technology with 50 μl and a turnaround time of one hour. Objective Analyze the performance of mPIMA to detect and quantify HIV-1 and HIV-2 and compare with Abbott M2000 assay fooling patients HIV-1 failing ARV therapy. Study design In this study we evaluate the mPIMA HIV-1/2 V L plasma test using 413 specimens from 270 patients failing ARV therapy, and compared its performance with Abbott RealTime HIV-1 Viral Load assay on the m2000 system. In addition, were determined VL in plasma specimens obtained from HIV-2 infected patients. Results The results strongly indicate that mPIMA HIV-1/2 V L plasma test can determine HIV-1 with concordance of 88.9% (95% CI 85.4-91.7) the reference test when 1,000 HIV-1 VL threshold was used as WHO cutoff to identify therapy failure. The overall correlation between HIV-1 VL was 0,928 (Pearson correlation coefficient of Linear regression) and the Bland-Altman showed a mean difference of -0.20 Log cp/mL between the two technology. mPIMA HIV-1/2 V L plasma test was also able to measure HIV-2 viral load in 16 specimens from Guinea-Bissau HIV-1/HIV-2 positive samples. Conclusions These data support the use of mPIMA HIV-1/2 V L plasma test to follow up patients and select patients failing ART, guiding immediate clinical decisions such as adherence counseling or ART regimen switch during the patient consultation.