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AbstractIntroductionViral load testing is essential to manage HIV disease, especially in infants and children. Early infant diagnosis (EID) is performed using nucleic‐acid testing in children under 18 months. Resource‐limited health systems face severe challenges to scale‐up both viral load and EID to unprecedented levels. Streamlining laboratory systems would be beneficial to improve access to quality testing and to increase efficiency of antiretroviral treatment programmes. We evaluated the performance of viral load testing to serve as an EID assay in children younger than 18 months.MethodsThis study was an observational, prospective study, including children between one and 18 months of age who were born to HIV‐positive mothers in 134 health facilities in Maputo City and Maputo Province, Mozambique. Dried blood spot specimens from heel or toe pricks were collected between January and April 2018, processed using SPEX buffer for both assays, and tested for routine EID and viral load testing using the Roche CAP/CTM HIV‐1 Qualitative v2 and Roche CAP/CTM HIV‐1 Quantitative v2 assays respectively. The sensitivity, specificity and positive and negative predictive values were estimated using the EID results as the reference standard.ResultsA total of 1021 infants were included in the study, of which 47% were female. Over 95% of mothers and children were on antiretroviral treatment or received antiretroviral prophylaxis respectively. The sensitivity and specificity of using the viral load assay to detect infection were 100% (95% CI: 96.2 to 100%) and 99.9% (95% CI: 99.4 to 100%). The positive and negative predictive values were 99.0% (95% CI: 94.3 to 100%) and 100% (95% CI: 99.6 to 100%). The McNemar's test was 1.000 and Cohen's kappa was 0.994.ConclusionsThe comparable performance suggests that viral load assays can be used as an infant diagnostic assay. Infants with either low levels of viraemia or high cycle threshold values should be repeat tested to ensure the result is truly positive prior to treatment initiation, regardless of assay used. Viral load assays could replace traditional EID testing, substantially streamlining molecular laboratory services for children and lowering costs, with the additional advantage of providing baseline viral load results for antiretroviral treatment management.

AbstractIntroductionPoint‐of‐care (POC) early infant diagnosis (EID) testing has been shown to dramatically decrease turnaround times from sample collection to caregiver result receipt and time to ART initiation for HIV‐positive infants compared to centralized laboratory testing. As governments in sub‐Saharan Africa implement POC EID technologies, we report on the feasibility and effectiveness of POC EID testing and the impact of same‐day result delivery on rapid ART initiation within national programmes across six countries.MethodsThis pre‐/post‐evaluation compared centralized laboratory‐based (pre) with POC (post) EID testing in 52 facilities across Cameroon, Democratic Republic of Congo, Ethiopia, Kenya, Senegal and Zimbabwe between April 2017 and October 2019 (country‐dependent). Data were collected retrospectively from routine records at health facilities for all infants tested under two years of age. Hazard ratios and 95% confidence intervals were calculated to compare time‐to‐event outcomes, visualized with Kaplan–Meier curves, and the Somers' D test was used to compare continuous outcomes.ResultsData were collected for 2892 EID tests conducted on centralized laboratory‐based platforms and 4610 EID tests on POC devices with 127 (4%) and 192 (4%) HIV‐positive infants identified, respectively. POC EID significantly reduced the time from sample collection to caregiver result receipt (POC median: 0 days, IQR: 0 to 0 vs. centralized: 35 days, IQR: 26 to 56) and time from sample collection to ART initiation for HIV‐positive infants (POC median: 1 day, IQR: 0 to 7 vs. centralized: 39 days, IQR: 26 to 57). With POC testing, 72% of infants received results on the same day as sample collection; HIV‐positive infants with a same‐day diagnosis had six times the rate of ART initiation compared to those diagnosed one or more days after sample collection (HR: 6.39; 95% CI: 3.44 to 11.85).ConclusionsSame‐day diagnosis and treatment initiation for infants is possible with POC EID within routine government‐led and ‐supported public sector healthcare facilities in resource‐limited settings. Given that POC EID allows for rapid ART initiation, aligning to the World Health Organization's recommendation of ART initiation within seven days, its use in public sector programmes has the potential to reduce overall mortality for infants with HIV through early treatment initiation.

INTRODUCTION: Point‐of‐care (POC) early infant diagnosis (EID) testing has been shown to dramatically decrease turnaround times from sample collection to caregiver result receipt and time to ART initiation for HIV‐positive infants compared to centralized laboratory testing. As governments in sub‐Saharan Africa implement POC EID technologies, we report on the feasibility and effectiveness of POC EID testing and the impact of same‐day result delivery on rapid ART initiation within national programmes across six countries. METHODS: This pre‐/post‐evaluation compared centralized laboratory‐based (pre) with POC (post) EID testing in 52 facilities across Cameroon, Democratic Republic of Congo, Ethiopia, Kenya, Senegal and Zimbabwe between April 2017 and October 2019 (country‐dependent). Data were collected retrospectively from routine records at health facilities for all infants tested under two years of age. Hazard ratios and 95% confidence intervals were calculated to compare time‐to‐event outcomes, visualized with Kaplan–Meier curves, and the Somers' D test was used to compare continuous outcomes. RESULTS: Data were collected for 2892 EID tests conducted on centralized laboratory‐based platforms and 4610 EID tests on POC devices with 127 (4%) and 192 (4%) HIV‐positive infants identified, respectively. POC EID significantly reduced the time from sample collection to caregiver result receipt (POC median: 0 days, IQR: 0 to 0 vs. centralized: 35 days, IQR: 26 to 56) and time from sample collection to ART initiation for HIV‐positive infants (POC median: 1 day, IQR: 0 to 7 vs. centralized: 39 days, IQR: 26 to 57). With POC testing, 72% of infants received results on the same day as sample collection; HIV‐positive infants with a same‐day diagnosis had six times the rate of ART initiation compared to those diagnosed one or more days after sample collection (HR: 6.39; 95% CI: 3.44 to 11.85). CONCLUSIONS: Same‐day diagnosis and treatment initiation for infants is possible with POC EID within routine government‐led and ...

AbstractIntroductionIn many low‐ and middle‐income countries, HIV viral load (VL) testing occurs at centralized laboratories and time‐to‐result‐delivery is lengthy, preventing timely monitoring of HIV treatment adherence. Near point‐of‐care (POC) devices, which are placed within health facility laboratories rather than clinics themselves (i.e. "true" POC), can offer VL in conjunction with centralized laboratories to expedite clinical decision making and improve outcomes, especially for patients at high risk of treatment failure. We assessed impacts of near‐POC VL testing on result receipt and clinical action in public sector programmes in Cameroon, Democratic Republic of Congo, Kenya, Malawi, Senegal, Tanzania and Zimbabwe.MethodsRoutine health data were collected retrospectively after introducing near‐POC VL testing at 57 public sector health facilities (2017 to 2019, country‐dependent). Where possible, key indicators were compared to data from patients receiving centralized laboratory testing using hazard ratios and the Somers' D test.ResultsData were collected from 6795 tests conducted on near‐POC and 17614 tests on centralized laboratory‐based platforms. Thirty‐one percent (2062/6694) of near‐POC tests were conducted for high‐risk populations: pregnant and breastfeeding women, children and those with suspected failure. Compared to conventional testing, near‐POC improved the median time from sample collection to return of results to patient [six vs. sixty‐eight days, effect size: −32.2%; 95% CI: −41.0% to −23.4%] and to clinical action for individuals with an elevated HIV VL [three vs. fourty‐nine days, effect size: −35.4%; 95% CI: −46.0% to −24.8%]. Near‐POC VL results were two times more likely to be returned to the patient within 90 days compared to centralized tests [50% (1781/3594) vs. 27% (4172/15271); aHR: 2.22, 95% CI: 2.05 to 2.39]. Thirty‐seven percent (340/925) of patients with an elevated near‐POC HIV VL result had documented clinical follow‐up actions within 30 days compared to 7% (167/2276) for centralized testing.ConclusionsNear‐POC VL testing enabled rapid test result delivery for high‐risk populations and led to significant improvements in the timeliness of patient result receipt compared to centralized testing. While there was some improvement in time‐to‐clinical action with near‐POC VL testing, major gaps remained. Strengthening of systems supporting the utilization of results for patient management are needed to truly capitalize on the benefits of decentralized testing.