Diana Mariani1, Marcelo C V M de Azevedo2, Isabelle Vasconcellos2, Luiz Ribeiro2, Cassia Alves2, Orlando C Ferreira1, Amilcar Tanuri3. 1. Laboratório de Virologia Molecular, Departamento de Genética-IB, Universidade Federal do Rio de Janeiro, Avenida Carlos Chagas Filho, 373. Edifício do Centro de Ciências da Saúde, Bloco A, sala A2-121, Cidade Universitária, CEP: 21.941-902, Rio de Janeiro, RJ, Brazil. 2. Laboratório de Pesquisa em Imunologia e AIDS, Hospital Universitário Gaffrèe e Guinle-UNIRIO, Brazil. 3. Laboratório de Virologia Molecular, Departamento de Genética-IB, Universidade Federal do Rio de Janeiro, Avenida Carlos Chagas Filho, 373. Edifício do Centro de Ciências da Saúde, Bloco A, sala A2-121, Cidade Universitária, CEP: 21.941-902, Rio de Janeiro, RJ, Brazil. Electronic address: atanuri@biologia.ufrj.br.
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 VL 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 VL 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 VL plasma test can determine HIV-1 with concordance of 88.9 % (95 % CI 85.4-91.7) the reference test when 1000 HIV-1 VL threshold was used as WHO cutoff to identify therapy failure. The overall correlation between HIV-1 VL was 0928 (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 VL 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 VL 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.
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 VL 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 patientsHIV-1 failing ARV therapy. STUDY DESIGN: In this study we evaluate the mPIMA HIV-1/2 VL 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 infectedpatients. RESULTS: The results strongly indicate that mPIMA HIV-1/2 VL plasma test can determine HIV-1 with concordance of 88.9 % (95 % CI 85.4-91.7) the reference test when 1000 HIV-1 VL threshold was used as WHO cutoff to identify therapy failure. The overall correlation between HIV-1 VL was 0928 (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 VL 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 VL 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.
Authors: Sarah J Girdwood; Thomas Crompton; Monisha Sharma; Jienchi Dorward; Nigel Garrett; Paul K Drain; Wendy Stevens; Brooke E Nichols Journal: EClinicalMedicine Date: 2020-11-04