Quantitative plasma viral load (VL) at 1000 copies /mL was recommended as the threshold to confirm antiretroviral therapy (ART) failure by the World Health Organization (WHO). Because of ongoing challenges of using plasma for VL testing in resource-limited settings (RLS), especially for children, this study collected 717 DBS and paired plasma samples from children receiving ART ≥1 year in Mozambique and compared the performance of DBS using Abbott’s VL test with a paired plasma sample using Roche’s VL test. At a cut-off of 1000 copies/mL, sensitivity of DBS using Abbott DBS VL test was 79.9%, better than 71.0% and 63.9% at 3000 and 5000 copies/mL, respectively. Specificities were 97.6%, 98.8%, 99.3% at 1000, 3000, and 5000 copies/mL, respectively. The Kappa value at 1000 copies/mL, 0.80 (95% CI: 0.73, 0.87), was higher than 0.73 (95% CI: 0.66, 0.80) and 0.66 (95% CI: 0.59, 0.73) at 3000, 5000 copies/mL, respectively, also indicating better agreement. The mean difference between the DBS and plasma VL tests with 95% limits of agreement by Bland-Altman was 0.311 (-0.908, 1.530). Among 73 children with plasma VL between 1000 to 5000 copies/mL, the DBS results were undetectable in 53 at the 1000 copies/mL threshold. While one DBS sample in the Abbott DBS VL test may be an alternative method to confirm ART failure at 1000 copies/mL threshold when a plasma sample is not an option for treatment monitoring, because of sensitivity concerns between 1,000 and 5,000 copies/ml, two DBS samples may be preferred accompanied by careful patient monitoring and repeat testing.
HIV viral suppression through antiretroviral (ARV) treatment has public health benefits in potentially reducing the risk of subsequent HIV transmissions. Mozambique has adopted the World Health Organization (WHO) “Test and Start” strategy, which assumes that all people who test positive for HIV start ARV treatment immediately. In order that treatment is guided by the respective HIV viral load (VL) test results, the MOH expanded the network of VL testing laboratories. About 26 VL testing instruments are now operational in the country. Although the increase in testing platforms increased VL tests performed, problems associated with errors, failures in user maintenance, and equipment malfunctions occur frequently. Delays in resolving equipment malfunctions contributed to lower laboratory productivity in certain periods of 2018. Therefore, the MOH, in coordination with the American Society for Clinical Pathology (ASCP) and VL testing instrument manufacturers, provided targeted training for VL laboratory Super Users (SUs). The SUs are primarily composed of laboratory technicians representing all VL laboratories. Training focused on equipment maintenance, software configuration, and troubleshooting the most common instrument-related problems and errors. Following this training, the SUs worked as in-laboratory equipment supervisors, helping laboratory staff to better perform equipment maintenance procedures. Furthermore, they worked remotely with representatives and field technicians of the instrument manufacturers to resolve small problems, such as accessory replacement and adding new users to the systems, in their own laboratories. This has led to a reduction in the overall time to equipment repair, less reliance on external field technicians, and correspondingly increased overall lab productivity and workforce capacity building for VL laboratory SU.
Following the WHO 2013 recommendations for routine HIV viral load (VL) testing as the tool to monitor antiretroviral therapy, countries have prepared for massive testing scale-up. However, developing countries that also bear the highest HIV prevalence often lack qualified human resources and basic infrastructure. Mozambique has established 13 VL laboratories, including 2 in the province with the highest overall HIV prevalence, Gaza. The challenges to VL testing implementation and this rapid scale-up demand an urgent investment toward laboratory accreditation to ensure accurate and reliable VL results. To identify gaps and areas for improvement where additional resources may be needed to provide high-quality VL testing services, the CDC developed a VL and Early Infant Diagnosis (EID) scorecard (106 points; 5 levels). The scorecard evaluates 9 key areas, including (1) Personnel, (2) Facility/Environment, (3) Safety, (4) Procurement/Inventory, (5) Sample Management, (6) Equipment, (7) Process Control, (8) M&E Documents and Records, and (9) Internal Quality Audits/Quality Indicators. These 9 essential areas cover the pretesting, testing, and posttesting phases along the continuum of care for HIV patients. Baseline assessments in the two VL and EID laboratories in Gaza Province, Carmelo Molecular Laboratory and Xai-Xai Molecular Laboratory, were recently conducted. Personnel standards and M&E documentation represented strengths across both laboratories, with over 70% of the master list of M&E documents having been developed and in use. The overall gaps identified included poor segregation and prioritization of higher VL results (>1,000 cp/mL), lack of internal audits, and no follow-up of nonconformities. Both laboratories scored in the level 2 range, with a total of 68 points (Carmelo) and 78 points (Xai-Xai). Considering this is a baseline assessment, we conclude that both labs are on an excellent path toward accreditation; however, additional laboratory quality mentorship is needed in order to reach accreditation standards.
Objectives In response to the urgent need for high-quality HIV viral load (VL) testing scale-up to reach the UNAIDS goal of 90% of HIV+ patients on ART treatment and 90% of these patients reaching viral suppression worldwide, the American Society for Clinical Pathology (ASCP) has directed a VL mentorship program across six provinces in Mozambique. Methods Through this program, three in-country consultants with advanced molecular biology and quality management system skills have mentored nine molecular biology laboratories conducting VL testing (four new laboratories, five established laboratories) through both in-person and remote mentorship methods. Using external audit evaluations conducted by CDC and Ministry of Health using the CDC VL Scorecard (scored 1-5), mentors have directed targeted interventions to address laboratory needs including (but not limited to) the following: biosafety, document control, quality control, corrective actions, assay troubleshooting, and codevelopment of key technical and quality-based SOPs and job aids with local laboratory management. In-person mentorship visits also focus on skills building of laboratory staff and management. Results Excluding two new laboratories with only baseline assessments available, the majority of mentored laboratories (six of seven; 85%) showed improvement at follow-up audits compared to baseline assessment scores, with only one laboratory showing a one-level backslide between sequential audits. Potential reasons for this backslide include more limited in-person mentorship during the time period or interevaluator scoring variability. Conclusion These data suggest that mentorship focused on test methodology and quality management is an effective way to promote laboratory quality while scaling up services; however, additional efforts, including integration of methods for improved remote mentorship to in-laboratory mentors and management, are needed in order to sustain high laboratory quality in the absence of an external mentor.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.