Background Clinical laboratories in Botswana have relied entirely on the reference intervals for normal immunohaematological values provided by manufacturers' kits and textbooks. Objectives The aim of this study was to determine the means, medians, 2.5th and 97.5th percentile reference intervals, for normal immunohaematological values in healthy adults in Botswana. Method A total of 261 healthy participants comprising 126 men (48%) and 135 (52%) women were enrolled in the southern part of Botswana, and immunological and haematological laboratory parameters were measured. Results The mean age was 28.8 (95% Confidence Interval [CI] 27.7–29.8) years, with a median of 27 years and a range 18–66 years. The mean haemoglobin level was significantly lower for women (12.4 g/dL; 95% CI 12.1% – 12.7%) than men (15.1 g/dL; 95% CI 14.9% – 15.3%). The women's haemoglobin reference values (9.0 g/dL – 15.0 g/dL) levels were lower than observed in predominantly White populations (12.0 g/dL – 16.0 g/dL), but comparable with regional consensus reference intervals (9.5 g/dL – 15.8 g/dL) recently defined for East and Southern Africa. Conclusion The established values provide an important tool for patient management and could influence decisions on inclusion of participants and adverse events in clinical trials conducted locally.

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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-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.

Background

Objectives: Near-point-of-care (POC) testing for early infant diagnosis (EID) and viral load expedites clinical action and improves outcomes but requires capital investment. We assessed whether excess capacity on existing near-POC devices used for TB diagnosis could be leveraged to increase near-POC HIV molecular testing, termed integrated testing, without compromising TB services. Design: Preimplementation/postimplementation studies in 10 health facilities in Malawi and 8 in Zimbabwe.Methods: Timeliness of EID and viral load test results and clinical action were compared between centralized and near-POC testing using Somers' D tests (continuous indicators) and risk ratios (RR, binary indicators); TB testing/treatment rates and timeliness were analyzed preintegration/postintegration.Results: With integration, average device utilization increased but did not exceed 55%. Despite the addition of HIV testing, TB test volumes, timeliness, and treatment initiations were maintained. Although few HIV-positive infants were identified, near-POC EID testing improved treatment initiation within 1 month by 57% compared with centralized EID [Malawi RR: 1.57, 95% confidence interval (CI) 0.98-2.52], and near-POC viral load testing significantly increased the proportion of patients with elevated viral load receiving clinical action within 1 month (

Background Nucleoside reverse-transcriptase inhibitors (NRTIs) are a major component of combination antiretroviral therapy (cART) worldwide but they have been associated with mitochondrial toxicities, with one of the most significant being lactic acidosis. In southern Africa, being female and overweight (BMI > 25) as well as receiving d4T and/or ddI-based cART are risk factors for the development of this potentially life-threatening complication. It is challenging in many resource-limited settings to obtain reliable serum lactate measurements while screening for the presence of lactic acidosis. Point-of-care devices, however, are now available that provide simple, accurate measurements of serum lactate levels at relatively low cost. The objective of this study was to assess the agreement of the portable (Accutrend™ handheld) lactate analyzer to the conventional laboratory system for obtaining serum lactate. Methods Eighty two “at-risk” cART-treated adults were evaluated, having their lactate levels tested in parallel using both modalities. Results The mean (range) lactate level for the portable device was 2.28 (0.9-5.0) compared to 1.96 (0.7-5.4) using the conventional method. There was a strong correlation (p<0.05) between the portable device and the conventional means with a Pearson correlation coefficient of 0.92 [95% CI: 0.88-0.95]. The mean bias was 0.33 [95% CI: -0.39-1.04], with the portable device having slightly higher values. Conclusion The use of a portable lactate device provides an accurate and user-friendly means of screening at-risk patients for the presence of lactic acidosis in resource-limited settings with limited laboratory capacity.

Objectives:Assess whether near-point-of-care (POC) viral load testing at the first antenatal care visit (ANC1) increased the proportion of women taking antiretroviral therapy who were virally suppressed at delivery through expedited clinical action.Design:Difference-in-difference analysis.Methods:At 20 public sector facilities in Zimbabwe, 10 implemented near-POC viral load testing at ANC1 (August 2019 to November 2020) and 10 used centralized viral load testing at ANC1. Study endpoints included time to result received, clinical action, and unsuppressed viral load (UVL; >1000 copies/ml) at delivery.Results:Of 1782 women, only 46% came for ANC1 before their third trimester. Preimplementation, 28% of women received viral load testing at ANC1, increasing to 86% during implementation. In the near-POC viral load arm, women were more likely to receive their result within 30 days of ANC1 sample collection compared with the centralized laboratory arm [54 versus 14%, relative risk (RR): 4.17, 95% confidence interval (CI) 1.82–9.55], as well as receive clinical action among those with UVL (63 versus 8%, RR 7.88; 95% CI 1.53–40.47). However, we did not observe significant changes in risk of UVL at delivery with near-POC viral load (RR 1.02, 95% CI 0.95–1.10).Conclusion:ANC1 viral load coverage was initially low. Near-POC viral load testing at ANC1 dramatically improved the timeliness of result receipt by patients and clinical action for those with an UVL. Although we did not observe a significant impact of provision of near-POC viral load at ANC1 on re-suppression at delivery, potentially because of late presentation for ANC1, continued near-POC viral load testing during pregnancy and delivery may reduce UVL and mother-to-child transmission risk.

Background Since 2010, point-of-care (POC) CD4 testing platforms have been introduced in both urban and rural settings to expand access to testing by bringing diagnostic services closer to patients. We conducted an analysis of routinely collected CD4 testing data to determine the invalid result rates associated with POC CD4 testing. Methods We analyzed 981,152 CD4 testing records collected from Alere Pima Analyzers between January 2011 and December 2016 across five countries in sub-Saharan Africa. Routinely collected data and programmatic records were used to determine the rate of invalid test results per month, by facility type, and by operator based on cumulative usage during the study period. In addition, frequency of invalid test types and utilization of control beads were assessed. Results Across the five countries, 75,530 invalid messages were returned, resulting in an overall invalid result rate of 7.7%. The invalid result rate by country ranged from 6.6% to 11.2%. Invalid result rates were consistent across facility types. Invalid result rates were inversely correlated with operator usage: low volume operators (<50 tests over study period) experienced an invalid result rate of 10.2%, while high volume operators (>500 tests over study period) experienced an invalid result rate of 5.5%. Two invalid result types (exposure position control and reagent control) accounted for nearly 50% of invalid results. Routine data showed that control beads were run on 88.3% of days that the device was used. Conclusions Our analysis found that the rate of invalid results was consistent across all types of health facilities, indicating that decentralization of POC CD4 testing to lower level health facilities did not exhibit high invalid result rates or increase cartridge wastage. Additionally, invalid result rates were inversely correlated to operator usage, with high-volume operators experiencing lower invalid result rates than low-volume operators. POC CD4 testing can, therefore, be performed in decentralized national testing programs; however, adequate training, quality assurance, routine monitoring, and ongoing mentorship should also be implemented for success.