Integration of point-of-care screening for type 2 diabetes mellitus and hypertension into the COVID-19 vaccine programme in Johannesburg, South Africa.

BACKGROUND: South Africa grapples with a substantial burden of non-communicable diseases (NCDs), particularly type 2 diabetes (diabetes) and hypertension. However, these conditions are often underdiagnosed and poorly managed, further exacerbated by the strained primary healthcare (PHC) system and the disruptive impact of the COVID-19 pandemic. Integrating NCD screening with large-scale healthcare initiatives, such as COVID-19 vaccination campaigns, offers a potential solution, especially in low- and middle-income countries (LMICs). We investigated the feasibility and effectiveness of this integration. METHODS: A prospective cohort study was conducted at four government health facilities in Johannesburg, South Africa. NCD screening was incorporated into the COVID-19 vaccination campaign. Participants underwent COVID-19 rapid tests, blood glucose checks, blood pressure assessments, and anthropometric measurements. Those with elevated blood glucose or blood pressure values received referrals for diagnostic confirmation at local PHC centers. RESULTS: Among 1,376 participants screened, the overall diabetes prevalence was 4.1%, combining previously diagnosed cases and newly identified elevated blood glucose levels. Similarly, the hypertension prevalence was 19.4%, comprising pre-existing diagnoses and newly detected elevated blood pressure cases. Notably, 46.1% of participants displayed waist circumferences indicative of metabolic syndrome, more prevalent among females. Impressively, 7.8% of all participants screened were potentially newly diagnosed with diabetes or hypertension. Approximately 50% of individuals with elevated blood glucose or blood pressure successfully linked to follow-up care within four weeks. CONCLUSION: Our study underscores the value of utilizing even brief healthcare interactions as opportunities for screening additional health conditions, thereby aiding the identification of previously undiagnosed cases. Integrating NCD screenings into routine healthcare visits holds promise, especially in resource-constrained settings. Nonetheless, concerted efforts to strengthen care linkage are crucial for holistic NCD management and control. These findings provide actionable insights for addressing the NCD challenge and improving healthcare delivery in LMICs.

Missed opportunities for integrated testing of HIV and tuberculosis on the GeneXpert platform in Lesotho.

Background: Integrated testing, treatment and care are key strategies for addressing the dual burdens of tuberculosis and HIV. The GeneXpert instrument allows simultaneous HIV and tuberculosis testing, but its utilisation for integrated testing remains suboptimal. Objective: The study determined the extent to which tuberculosis testing and HIV early infant detection (EID) were integrated on the GeneXpert platform, or the potential for integration at selected health facilities. Methods: A mixed methods evaluation was conducted using retrospective secondary data analysis of laboratory records from 2017 to 2019, and semi-structured interviews. Data were collected between January 2020 and March 2020 in Lesotho. Results: Forty-four health staff were interviewed across 13 health facilities: one regional, nine district, and three clinic level. Six were government facilities, six were mission hospitals, and one was a non-profit clinic. All facilities selected had at least one GeneXpert instrument used for tuberculosis or HIV testing; none included simultaneous testing for tuberculosis and HIV. In 2017, the average utilisation rate for the GeneXpert instrument for tuberculosis and EID testing was 63% and 24%, while in 2019, the average utilisation rate was 61% for tuberculosis testing and 27% for EID. Conclusion: Except for three sites where the testing rates were high, utilisation rates were sufficiently low that all the HIV EID and tuberculosis tests undertaken in 2017 and 2019 could have been performed using only the instruments currently dedicated to tuberculosis testing. There is a missed opportunity for the integration of testing for tuberculosis and HIV on the GeneXpert instrument. What this study adds: This study adds to the body of evidence on the need for integration of testing and highlights some practical and technical considerations for successful implementation of integrated tuberculosis and HIV testing.

Integration of point-of-care screening for type 2 diabetes mellitus and hypertension with COVID-19 rapid antigen screening in Johannesburg, South Africa.

AIMS: We sought to evaluate the yield and linkage-to-care for diabetes and hypertension screening alongside a study assessing the use of rapid antigen tests for COVID-19 in taxi ranks in Johannesburg, South Africa. METHODS: Participants were recruited from Germiston taxi rank. We recorded results of blood glucose (BG), blood pressure (BP), waist circumference, smoking status, height, and weight. Participants who had elevated BG (fasting ≥7.0; random ≥11.1mmol/L) and/or BP (diastolic ≥90 and systolic ≥140mmHg) were referred to their clinic and phoned to confirm linkage. RESULTS: 1169 participants were enrolled and screened for elevated BG and elevated BP. Combining participants with a previous diagnosis of diabetes (n = 23, 2.0%; 95% CI:1.3-2.9%) and those that had an elevated BG measurement (n = 60, 5.2%; 95% CI:4.1-6.6%) at study enrollment, we estimated an overall indicative prevalence of diabetes of 7.1% (95% CI:5.7-8.7%). When combining those with known hypertension at study enrollment (n = 124, 10.6%; 95% CI:8.9-12.5%) and those with elevated BP (n = 202; 17.3%; 95% CI:15.2-19.5%), we get an overall prevalence of hypertension of 27.9% (95% CI:25.4-30.1%). Only 30.0% of those with elevated BG and 16.3% of those with elevated BP linked-to-care. CONCLUSION: By opportunistically leveraging existing COVID-19 screening in South Africa to screen for diabetes and hypertension, 22% of participants received a potential new diagnosis. We had poor linkage-to-care following screening. Future research should evaluate options for improving linkage-to-care, and evaluate the large-scale feasibility of this simple screening tool.

Feasibility, Uptake, and Results of COVID-19 Antigen Rapid Diagnostic Tests among Refugees and Migrants in a Pilot Project in North-West Syria.

North-west Syria (NWS) is a conflict-affected and unstable area. Due to its limited health infrastructure, accessing advanced COVID-19 testing services is challenging. COVID-19 antigen rapid diagnostic tests (Ag-RDTs) have the potential to overcome this barrier. A pilot project was implemented to introduce Ag-RDTs in NWS, aiming to determine the feasibility, uptake, and results of Ag-RDTs and identify facilitators and barriers to testing with Ag-RDTs. A cross-sectional study design involving secondary analysis of data collected during the project was employed. A local non-governmental organization implemented 25,000 Ag-RDTs that were conducted cross-border by trained community health workers. In total, 27,888 eligible individuals were enrolled, 24,956 (89.5%) consented to test, and 121 (0.5%) were COVID-19-positive. The highest positivity was observed among those with severe COVID-19 symptoms (12.7%), with respiratory illnesses (2.5%), enrolled at hospitals in Afrin (2.5%), and healthcare workers (1.9%). A non-random sample of 236 individuals underwent confirmatory RT-PCR testing. Observed sensitivity, specificity, and positive and negative predictive values were 80.0%, 96.1%, 91.4%, and 90.3%, respectively. Challenges included obtaining informed consent and conducting confirmatory testing. Ag-RDTs represent a feasible screening/diagnostic tool for COVID-19 infections in NWS, with nearly 90% uptake. Embedding Ag-RDTs into COVID-19 testing and screening strategies would be highly beneficial.

The cost of adding rapid screening for diabetes, hypertension, and COVID-19 to COVID-19 vaccination queues in Johannesburg, South Africa.

Background: Non-communicable diseases (NCDs) are responsible for 51% of total mortality in South Africa, with a rising burden of hypertension (HTN) and diabetes mellitus (DM). Incorporating NCD and COVID-19 screening into mass activities such as COVID-19 vaccination programs could offer significant long-term benefits for early detection interventions. However, there is limited knowledge of the associated costs and resources required. We evaluated the cost of integrating NCD screening and COVID-19 antigen rapid diagnostic testing (Ag-RDT) into a COVID-19 vaccination program. Methods: We conducted a prospective cost analysis at three public sector primary healthcare clinics and one academic hospital in Johannesburg, South Africa, conducting vaccinations. Participants were assessed for eligibility and recruited during May-Dec 2022. Costs were estimated from the provider perspective using a bottom-up micro-costing approach and reported in 2022 USD. Results: Of the 1,376 enrolled participants, 240 opted in to undergo a COVID-19 Ag-RDT, and none tested positive for COVID-19. 138 (10.1%) had elevated blood pressure, with 96 (70%) having no prior HTN diagnosis. 22 (1.6%) were screen-positive for DM, with 12 (55%) having no prior diagnosis. The mean and median costs per person screened for NCDs were $2.53 (SD: 3.62) and $1.70 (IQR: $1.38-$2.49), respectively. The average provider cost per person found to have elevated blood glucose levels and blood pressure was $157.99 and $25.19, respectively. Finding a new case of DM and HTN was $289.65 and $36.21, respectively. For DM and DM + HTN screen-positive participants, diagnostic tests were the main cost driver, while staff costs were the main cost driver for - and HTN screen-positive and screen-negative participants. The mean and median cost per Ag-RDT was $6.13 (SD: 0.87) and $5.95 (IQR: $5.55-$6.25), with costs driven mainly by test kit costs. Conclusions: We show the cost of finding new cases of DM and HTN in a vaccine queue, which is an essential first step in understanding the feasibility and resource requirements for such initiatives. However, there is a need for comparative economic analyses that include linkage to care and retention data to fully understand this cost and determine whether opportunistic screening should be added to general mass health activities.

Contexts for developing of national essential diagnostics lists. Lessons from a mixed-methods study of existing documents, stakeholders and decision making on tier-specific essential in-vitro diagnostics in African countries.

Since 2019, the WHO recommends the development and implementation of National Essential Diagnostics List (NEDL) to facilitate availability of In-Vitro Diagnostics (IVDs) across the various tiers of the healthcare pyramid, facilities with or without a laboratory on-site. To be effective, the development of NEDL should take into consideration the challenges and opportunities associated with current modalities for organization of tier specific testing services in-country. We conducted a mixed-methods analysis set out to explore available national policies, guidelines and decision-making processes that affect accessibility of diagnostics in African countries; 307 documents from 48 African countries were reviewed and 28 in-depth (group) interviews with 43 key-informants in seven countries were conducted between June and July 2022. Of the 48 countries, Nigeria was the only one with formal NEDL. Twenty-five countries had national test menus (63% outdated, from 2015 or earlier) all specifying tests by laboratory tier (5 including the "community tier"), with additional details on equipment (20), consumables (12), and personnel requirements (11). The most popular criteria to select essential IVDs in the quantitative analysis relate to specificities of the tests, whereas in the qualitative study most mentioned were health care and laboratory contextual factors. Quality assurance and waste management for tests at "community tier" were highlighted as concerns by all the respondents. Additional barriers to implementation included the low decision-making power of Laboratory Directorates within the Ministry of Health, as well as the chronic budgetary gaps for clinical laboratory services and policy and strategic plan development outside of vertical programmes. Four countries out of seven would rather revise their test menus by updating them and add ''community tier", than developing a separate NEDL, the former being considered more operational. This study provides a unique set of practical recommendations to the process of development and effective implementation on NEDL in Africa.

Optimizing diagnostic networks to increase patient access to TB diagnostic services: Development of the diagnostic network optimization (DNO) approach and learnings from its application in Kenya, India and the Philippines.

Diagnostic network optimization (DNO) is an analytical approach that enables use of available country data to inform evidence-based decision-making to optimize access to diagnostic services. A DNO methodology was developed using available data sources and a commercial supply chain optimization software. In collaboration with Ministries of Health and partners, the approach was applied in Kenya, India and the Philippines to map TB diagnostic networks, identify misalignments, and determine optimal network design to increase patient access to TB diagnostic services and improve device utilization. The DNO analysis was successfully applied to evaluate and inform TB diagnostic services in Kenya, India and the Philippines as part of national strategic planning for TB. The analysis was tailored to each country's specific objectives and allowed evaluation of factors such as the number and placement of different TB diagnostics, design of sample referral networks and integration of early infant diagnosis for HIV at national and sub-national levels and across public and private sectors. Our work demonstrates the value of DNO as an innovative approach to analysing and modelling diagnostic networks, particularly suited for use in low-resource settings, as an open-access approach that can be applied to optimize networks for any disease.

Correction: Two-test algorithms for infectious disease diagnosis: Implications for COVID-19.

[This corrects the article DOI: 10.1371/journal.pgph.0000293.].

Use of Physical Accessibility Modelling in Diagnostic Network Optimization: A Review.

Diagnostic networks are complex systems that include both laboratory-tested and community-based diagnostics, as well as a specimen referral system that links health tiers. Since diagnostics are the first step before accessing appropriate care, diagnostic network optimization (DNO) is crucial to improving the overall healthcare system. The aim of our review was to understand whether the field of DNO, and especially route optimization, has benefited from the recent advances in geospatial modeling, and notably physical accessibility modeling, that have been used in numerous health systems assessment and strengthening studies. All publications published in English between the journal's inception and 12 August 2021 that dealt with DNO, geographical accessibility and optimization, were systematically searched for in Web of Science and PubMed, this search was complemented by a snowball search. Studies from any country were considered. Seven relevant publications were selected and charted, with a variety of geospatial approaches used for optimization. This paucity of publications calls for exploring the linkage of DNO procedures with realistic accessibility modeling framework. The potential benefits could be notably better-informed travel times of either the specimens or population, better estimates of the demand for diagnostics through realistic population catchments, and innovative ways of considering disease epidemiology to inform DNO.

Two-test algorithms for infectious disease diagnosis: Implications for COVID-19.

Diagnostic assays for various infectious diseases, including COVID-19, have been challenged for their utility as standalone point-of-care diagnostic tests due to suboptimal accuracy, complexity, high cost or long turnaround times for results. It is therefore critical to optimise their use to meet the needs of users. We used a simulation approach to estimate diagnostic outcomes, number of tests required and average turnaround time of using two-test algorithms compared with singular testing; the two tests were reverse transcription polymerase chain reaction (RT-PCR) and an antigen-based rapid diagnostic test (Ag-RDT). A web-based application of the model was developed to visualise and compare diagnostic outcomes for different disease prevalence and test performance characteristics (sensitivity and specificity). We tested the model using hypothetical prevalence data for COVID-19, representing low- and high-prevalence contexts and performance characteristics of RT-PCR and Ag-RDTs. The two-test algorithm when RT-PCR was applied to samples negative by Ag-RDT predicted gains in sensitivity of 27% and 7%, respectively, compared with Ag-RDT and RT-PCR alone. Similarly, when RT-PCR was applied to samples positive by Ag-RDT, specificity gains of 2.9% and 1.9%, respectively, were predicted. The algorithm using Ag-RDT followed by RT-PCR as a confirmatory test for positive patients limited the requirement of RT-PCR testing resources to 16,400 and 3,034 tests when testing a population of 100,000 with an infection prevalence of 20% and 0.05%, respectively. A two-test algorithm comprising a rapid screening test followed by confirmatory laboratory testing can reduce false positive rate, produce rapid results and conserve laboratory resources, but can lead to large number of missed cases in high prevalence setting. The web application of the model can identify the best testing strategies, tailored to specific use cases and we also present some examples how it was used as part of the Access to Covid-19 Tools (ACT) Accelerator Diagnostics Pillar.

Designing an optimized diagnostic network to improve access to TB diagnosis and treatment in Lesotho.

BACKGROUND: To reach WHO End tuberculosis (TB) targets, countries need a quality-assured laboratory network equipped with rapid diagnostics for tuberculosis diagnosis and drug susceptibility testing. Diagnostic network analysis aims to inform instrument placement, sample referral, staffing, geographical prioritization, integration of testing enabling targeted investments and programming to meet priority needs. METHODS: Supply chain modelling and optimization software was used to map Lesotho's TB diagnostic network using available data sources, including laboratory and programme reports and health and demographic surveys. Various scenarios were analysed, including current network configuration and inclusion of additional GeneXpert and/or point of care instruments. Different levels of estimated demand for testing services were modelled (current [30,000 tests/year], intermediate [41,000 tests/year] and total demand needed to find all TB cases [88,000 tests/year]). RESULTS: Lesotho's GeneXpert capacity is largely well-located but under-utilized (19/24 sites use under 50% capacity). The network has sufficient capacity to meet current and near-future demand and 70% of estimated total demand. Relocation of 13 existing instruments would deliver equivalent access to services, maintain turnaround time and reduce costs compared with planned procurement of 7 more instruments. Gaps exist in linking people with positive symptom screens to testing; closing this gap would require extra 11,000 tests per year and result in 1000 additional TB patients being treated. Closing the gap in linking diagnosed patients to treatment would result in a further 629 patients being treated. Scale up of capacity to meet total demand will be best achieved using a point-of-care platform in addition to the existing GeneXpert footprint. CONCLUSIONS: Analysis of TB diagnostic networks highlighted key gaps and opportunities to optimize services. Network mapping and optimization should be considered an integral part of strategic planning. By building efficient and patient-centred diagnostic networks, countries will be better equipped to meet End TB targets.

Bringing Data Analytics to the Design of Optimized Diagnostic Networks in Low- and Middle-Income Countries: Process, Terms and Definitions.

Diagnostics services are an essential component of healthcare systems, advancing universal health coverage and ensuring global health security, but are often unavailable or under-resourced in low- and middle-income (LMIC) countries. Typically, diagnostics are delivered at various tiers of the laboratory network based on population needs, and resource and infrastructure constraints. A diagnostic network additionally incorporates screening and includes point-of-care testing that may occur outside of a laboratory in the community and clinic settings; it also emphasizes the importance of supportive network elements, including specimen referral systems, as being critical for the functioning of the diagnostic network. To date, design and planning of diagnostic networks in LMICs has largely been driven by infectious diseases such as TB and HIV, relying on manual methods and expert consensus, with a limited application of data analytics. Recently, there have been efforts to improve diagnostic network planning, including diagnostic network optimization (DNO). The DNO process involves the collection, mapping, and spatial analysis of baseline data; selection and development of scenarios to model and optimize; and lastly, implementing changes and measuring impact. This review outlines the goals of DNO and steps in the process, and provides clarity on commonly used terms.

Situating trade-offs: Stakeholder perspectives on overtreatment versus missed diagnosis in transition to Xpert MTB/RIF Ultra in Kenya and Swaziland.

Implementing new diagnostics in public health programs can involve difficult trade-off decisions between individual patient benefits and public health considerations. Such decision-making processes are often not documented and may not include engagement of affected communities. This paper examines the perspectives of stakeholders on the trade-off between over-treatment and missed diagnosis captured during decision-making workshops on the transition from use of Xpert MTB/RIF to diagnose tuberculosis to Xpert MTB/RIF Ultra in Kenya and Swaziland. Xpert MTB/RIF Ultra has an overall increase in sensitivity but a decrease in specificity when compared to its predecessor. We conducted a qualitative study using four focus group discussions with a total of 47 participants and non-participant observation. The analysis reveals how participants deemed Xpert MTB/RIF Ultra's reduced specificity vis-à-vis its increased sensitivity to be an acceptable trade-off. The way participants assessed this trade-off was shaped by their experiences with the general uncertainty of all diagnostic tests, alternative testing options, historical evolution of diagnostic practices, epidemiological factors and resource constraints. In assessing the trade-off community and individual benefit and harm was frequently discussed together. Qualitative research on stakeholder engagement activities for diagnostic development and implementation can identify everyday experiences and situate assessments and perspectives of key stakeholders and as such aid in decision-making, improving implementation as well as patient outcomes. Further research is needed on the intended and unintended consequences of such engagement activities, how findings are being incorporated by decision-makers, and the impact on programmatic implementation.

Multidisease testing for HIV and TB using the GeneXpert platform: A feasibility study in rural Zimbabwe.

BACKGROUND: HIV Viral Load and Early Infant Diagnosis technologies in many high burden settings are restricted to centralized laboratory testing, leading to long result turnaround times and patient attrition. GeneXpert (Cepheid, CA, USA) is a polyvalent near point-of-care platform and is widely implemented for Xpert MTB/RIF diagnosis. This study sought to evaluate the operational feasibility of integrated HIV VL, EID and MTB/RIF testing in new GeneXpert platforms. METHODS: Whole blood samples were collected from consenting patients due for routine HIV VL testing and DBS samples from infants due for EID testing, at three rural health facilities in Zimbabwe. Sputum samples were collected from all individuals suspected of TB. GeneXpert testing was reserved for all EID, all TB suspects and priority HIV VL at each site. Blood samples were further sent to centralized laboratories for confirmatory testing. GeneXpert polyvalent testing results and patient outcomes, including infrastructural and logistical requirements are reported. The study was conducted over a 10-month period. RESULTS: The fully automated GeneXpert testing device, required minimal training and biosafety considerations. A total of 1,302 HIV VL, 277 EID and 1,581 MTB/RIF samples were tested on a four module GeneXpert platform in each study site. Xpert HIV-1 VL testing was prioritized for patients who presented with advanced HIV disease, pregnant women, adolescents and suspected ART failures patients. On average, the study sites had a GeneXpert utilization rate of 50.4% (Gutu Mission Hospital), 63.5% (Murambinda Mission Hospital) and 17.5% (Chimombe Rural Health Centre) per month. GeneXpert polyvalent testing error rates remained lower than 4% in all sites. Decentralized EID and VL testing on Xpert had shorter overall median TAT (1 day [IQR: 0-4] and 1 day [IQR: 0-1] respectively) compared to centralized testing (17 days [IQR: 13-21] and 26 days [IQR: 23-32] respectively). Among patients with VL >1000 copies/ml (73/640; 11.4%) at GMH health facility, median time to enhanced adherence counselling was 8 days and majority of those with documented outcomes had re-suppressed VL (20/32; 62.5%). Median time to ART initiation among Xpert EID positive infants at GMH was 1 day [IQR: 0-1]. CONCLUSION: Implementation of near point-of-care GeneXpert platform for integrated multi-disease testing within district and sub-district healthcare settings is feasible and will increase access to VL, and EID testing to priority populations. Quality management systems including monitoring of performance indicators, together with regular on-site supervision are crucial, and near-POC test results must be promptly actioned-on by clinicians for patient management.

Developing a customised approach for strengthening tuberculosis laboratory quality management systems toward accreditation.

BACKGROUND: Quality-assured tuberculosis laboratory services are critical to achieve global and national goals for tuberculosis prevention and care. Implementation of a quality management system (QMS) in laboratories leads to improved quality of diagnostic tests and better patient care. The Strengthening Laboratory Management Toward Accreditation (SLMTA) programme has led to measurable improvements in the QMS of clinical laboratories. However, progress in tuberculosis laboratories has been slower, which may be attributed to the need for a structured tuberculosis-specific approach to implementing QMS. We describe the development and early implementation of the Strengthening Tuberculosis Laboratory Management Toward Accreditation (TB SLMTA) programme. DEVELOPMENT: The TB SLMTA curriculum was developed by customizing the SLMTA curriculum to include specific tools, job aids and supplementary materials specific to the tuberculosis laboratory. The TB SLMTA Harmonized Checklist was developed from the World Health Organisation Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation checklist, and incorporated tuberculosis-specific requirements from the Global Laboratory Initiative Stepwise Process Towards Tuberculosis Laboratory Accreditation online tool. IMPLEMENTATION: Four regional training-of-trainers workshops have been conducted since 2013. The TB SLMTA programme has been rolled out in 37 tuberculosis laboratories in 10 countries using the Workshop approach in 32 laboratories in five countries and the Facility-based approach in five tuberculosis laboratories in five countries. CONCLUSION: Lessons learnt from early implementation of TB SLMTA suggest that a structured training and mentoring programme can build a foundation towards further quality improvement in tuberculosis laboratories. Structured mentoring, and institutionalisation of QMS into country programmes, is needed to support tuberculosis laboratories to achieve accreditation.

Implementation of quality management systems and progress towards accreditation of National Tuberculosis Reference Laboratories in Africa.

BACKGROUND: Laboratory services are essential at all stages of the tuberculosis care cascade, from diagnosis and drug resistance testing to monitoring response to treatment. Enabling access to quality services is a challenge in low-resource settings. Implementation of a strong quality management system (QMS) and laboratory accreditation are key to improving patient care. OBJECTIVES: The study objective was to determine the status of QMS implementation and progress towards accreditation of National Tuberculosis Reference Laboratories (NTRLs) in the African Region. METHOD: An online questionnaire was administered to NTRL managers in 47 World Health Organization Regional Office for Africa member states in the region, between February and April 2015, regarding the knowledge of QMS tools and progress toward implementation to inform strategies for tuberculosis diagnostic services strengthening in the region. RESULTS: A total of 21 laboratories (43.0%) had received SLMTA/TB-SLMTA training, of which 10 had also used the Global Laboratory Initiative accreditation tool. However, only 36.7% of NTRLs had received a laboratory audit, a first step in quality improvement. Most NTRLs participated in acid-fast bacilli microscopy external quality assurance (95.8%), although external quality assurance for other techniques was lower (60.4% for first-line drug susceptibility testing, 25.0% for second-line drug susceptibility testing, and 22.9% for molecular testing). Barriers to accreditation included lack of training and accreditation programmes. Only 28.6% of NTRLs had developed strategic plans and budgets which included accreditation. CONCLUSION: Good foundations are in place on the continent from which to scale up accreditation efforts. Laboratory audits should be conducted as a first step in developing quality improvement action plans. Political commitment and strong leadership are needed to drive accreditation efforts; advocacy will require clear evidence of patient impact and cost-benefit.

Antituberculosis Drug Resistance Survey in Lesotho, 2008-2009: Lessons Learned.

SETTING: Drug resistance is an increasing threat to tuberculosis (TB) control worldwide. The World Health Organization advises monitoring for drug resistance, with either ongoing surveillance or periodic surveys. METHODS: The antituberculosis drug resistance survey was conducted in Lesotho in 2008-2009. Basic demographic and TB history information was collected from individuals with positive sputum smear results at 17 diagnostic facilities. Additional sputum sample was sent to the national TB reference laboratory for culture and drug susceptibility testing. RESULTS: Among 3441 eligible smear-positive persons, 1121 (32.6%) were not requested to submit sputum for culture. Among 2320 persons submitted sputum, 1164 (50.2%) were not asked for clinical information or did not have valid sputum samples for testing. In addition, 445/2320 (19.2%) were excluded from analysis because of other laboratory or data management reasons. Among 984/3441 (28.6%) persons who had data available for analysis, MDR-TB was present in 24/773 (3.1%) of new and 25/195 (12.8%) of retreatment TB cases. Logistical, operational and data management challenges affected survey results. CONCLUSION: MDR-TB is prevalent in Lesotho, but limitations reduced the reliability of our findings. Multiple lessons learned during this survey can be applied to improve the next drug resistance survey in Lesotho and other resource constrained countries may learn how to avoid these bottlenecks.