Primary health clinic nurses generated accurate results for CD4(+) T-cell counts, liver enzymes and hemoglobin using simple POC devices on finger prick samples at decentralized antiretroviral therapy (ART) clinics. POC diagnostics to monitor ART at primary healthcare level is technically feasible and should be utilized in efforts to decentralize HIV care and treatment.

Primary health care nurses accurately performed POC NAT EID testing within primary health care clinics. On-site nucleic acid-based EID testing is technically feasible in clinic settings and could be used in efforts to improve access to pediatric HIV antiretroviral treatment.

POC infant HIV testing enabled clinics to more rapidly diagnose and provide treatment to HIV-infected infants. This reduced opportunities for pretreatment loss to follow-up and enabled a larger proportion of infants to receive test results and initiate antiretroviral therapy. The benefits of faster HIV diagnosis and antiretroviral treatment may also improve early retention in care.

Background: The World Health Organization (WHO)'s "3 × 5 program" has spurred efforts to place 3 million people on combination antiretroviral therapy (ART) for treatment of AIDS in resource-limited countries. Paradoxically, the cost of CD4 + T-lymphocyte count essential for decision-making to commence HIV positive adults on ART as well as for monitoring responses to ART remains unaffordable in most resource-limited countries. Thus, low-cost methods for enumerating CD4 + T-lymphocyte are urgently needed.

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. The World Health Organization strongly recommends the use of viral load testing as the primary tool for HIV antiretroviral treatment (ART) monitoring in its 2015 consolidated ART guidelines (1). The Joint United Nations Programme on HIV/AIDS (UNAIDS) has also highlighted the importance of viral load testing in its new 90-90-90 HIV targets and has launched a global initiative to increase access to viral load and other HIV diagnostic tests (2, 3). However, many resource-limited countries face challenges in implementing HIV viral load testing within their public health programs due to limited laboratory infrastructure, capacity, and skills. Emerging point-of-care (POC) technologies offer the opportunity to decentralize diagnostic testing and greatly expand access to quality health care (4).Plasma-based RNA constitutes the conventional gold standard specimen type and biomarker for HIV viral load measurement. Currently, however, plasma-based testing requires venipuncture and processing of blood specimens using centrifugation to separate plasma, which require some laboratory infrastructure. The use of finger or heel prick capillary blood samples increases the ease of use of POC tests and enables both sample collection and viral load testing to be decentralized to locations that lack laboratories, required infrastructure, or skilled technicians.The use of whole blood, although operationally advantageous, presents a technical problem, since both intracellular and extracellular RNA and DNA are present in the specimen and mig...