title: Evaluation of the Whole-Blood Alere Q NAT Point-of-Care RNA Assay for HIV-1 Viral Load Monitoring in a Primary Health Care Setting in Mozambique.
abstract: Viral load testing is the WHO-recommended monitoring assay for patients on HIV antiretroviral therapy (ART). Point-of-care (POC) assays may help improve access to viral load testing in resource-limited settings. We compared the performance of the Alere Q NAT POC viral load technology (Alere Technologies, Jena, Germany), measuring total HIV RNA using finger prick capillary whole-blood samples collected in a periurban health center, with that of a laboratory-based plasma RNA test (Roche Cobas Ampliprep/Cobas TaqMan v2) conducted on matched venous blood samples. The whole-blood Alere Q NAT POC assay produced results with a bias of 0.8593 log copy/ml compared to the laboratory-based plasma assay. However, at above 10,000 copies/ml, the bias was 0.07 log copy/ml. Using the WHO-recommended threshold to determine ART failure of 1,000 copies/ml, the sensitivity and specificity of the whole-blood Alere Q NAT POC assay were 96.83% and 47.80%, respectively. A cutoff of 10,000 copies/ml of whole blood with the Alere Q NAT POC assay appears to be a better predictor of ART failure threshold (1,000 copies/ml of plasma), with a sensitivity of 84.0% and specificity of 90.3%. The precision of the whole-blood Alere Q NAT POC assay was comparable to that observed with the laboratory technology (5.4% versus 7.5%) between detectable paired samples. HIV POC viral load testing is feasible at the primary health care level. Further research on the value of whole-blood viral load to monitor antiretroviral therapy is warranted.
authors.affiliation: Instituto Nacional da Saúde, Maputo, Mozambique ilesh.jani@gmail.com.
authors.forename: Ilesh V
authors.initials: IV
authors.lastname: Jani
authors.affiliation: Instituto Nacional da Saúde, Maputo, Mozambique.
authors.forename: Bindiya
authors.initials: B
authors.lastname: Meggi
authors.affiliation: Instituto Nacional da Saúde, Maputo, Mozambique.
authors.forename: Adolfo
authors.initials: A
authors.lastname: Vubil
authors.affiliation: Instituto Nacional da Saúde, Maputo, Mozambique.
authors.forename: Nádia E
authors.initials: NE
authors.lastname: Sitoe
authors.affiliation: Instituto Nacional da Saúde, Maputo, Mozambique.
authors.forename: Nilesh
authors.initials: N
authors.lastname: Bhatt
authors.affiliation: Clinton Health Access Initiative, Maputo, Mozambique.
authors.forename: Ocean
authors.initials: O
authors.lastname: Tobaiwa
authors.affiliation: Clinton Health Access Initiative, Maputo, Mozambique.
authors.forename: Jorge I
authors.initials: JI
authors.lastname: Quevedo
authors.affiliation: Department of Mathematics and Informatics, Universidade Eduardo Mondlane, Maputo, Mozambique.
authors.forename: Osvaldo
authors.initials: O
authors.lastname: Loquiha
authors.affiliation: Clinton Health Access Initiative, Maputo, Mozambique.
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Lehe
authors.affiliation: Clinton Health Access Initiative, Maputo, Mozambique.
authors.forename: Lara
authors.initials: L
authors.lastname: Vojnov
authors.affiliation: Clinton Health Access Initiative, Maputo, Mozambique.
authors.forename: Trevor F
authors.initials: TF
authors.lastname: Peter
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D003430:Cross-Sectional Studies; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D005858:Germany; D015658:HIV Infections / Q000188:drug therapy / Q000821:virology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009073:Mozambique; D019095:Point-of-Care Systems; D011320:Primary Health Care / Q000379:methods*; D012367:RNA, Viral / Q000097:blood*; D012680:Sensitivity and Specificity; D019562:Viral Load / Q000379:methods*; D055815:Young Adult
chemical_list: D012367:RNA, Viral