Implementation of a new ‘community’ laboratory CD4 service in a rural health district in South Africa extends laboratory services and substantially improves local reporting turnaround time

Background. The CD4 integrated service delivery model (ITSDM) provides for reasonable access to pathology services across South Africa (SA) by offering three new service tiers that extend services into remote, under-serviced areas. ITSDM identified Pixley ka Seme as such an under-serviced district.Objective. To address the poor service delivery in this area, a new ITSDM community (tier 3) laboratory was established in De Aar, SA. Laboratory performance and turnaround time (TAT) were monitored post implementation to assess the impact on local service delivery.Methods. Using the National Health Laboratory Service Corporate Data Warehouse, CD4 data were extracted for the period April 2012 - July 2013 (n=11 964). Total mean TAT (in hours) was calculated and pre-analytical and analytical components assessed. Ongoing testing volumes, as well as external quality assessment performance across ten trials, were used to indicate post implementation success. Data were analysed using Stata 12.Results. Prior to the implementation of CD4 testing at De Aar, the total mean TAT was 20.5 hours. This fell to 8.2 hours post implementation, predominantly as a result of a lower pre-analytical mean TAT reducing from a mean of 18.9 to 1.8 hours. The analytical testing TAT remained unchanged after implementation and monthly test volumes increased by up to 20%. External quality assessment indicated adequate performance. Although subjective, questionnaires sent to facilities reported improved service delivery.Conclusion. Establishing CD4 testing in a remote community laboratory substantially reduces overall TAT. Additional community CD4 laboratories should be established in under-serviced areas, especially where laboratory infrastructure is already in place

Piloting a national laboratory electronic programme status reporting system in Ekurhuleni health district, South Africa

Background. The National Health Laboratory Service (NHLS) performs ~4 million CD4 tests per annum for the public health sector at 61 CD4 testing laboratories across South Africa. Currently, CD4 laboratory data captured do not differentiate between antiretroviral treatment (ART) and pre-ART care.Methods. A cross-sectional study was undertaken to evaluate a redesigned Comprehensive Care, Management and Treatment of HIV and AIDS (CCMT) request form, incorporating a two-tick collection procedure linking the CD4 test request to patient CCMT programme status. Field testing was undertaken at three health facilities, where healthcare personnel were required to capture whether the CD4 count requested was a ‘first-ever CD4’, ‘CD4 taken previously, not yet in ART care’ or ‘in ART care’. All data were extracted from the NHLS Corporate Data Warehouse and analysed using Microsoft Excel and Stata-12.Results. A substantial increase in the number of request forms with a CCMT programme status (28.1% v. 84.4%) was reported pre- and post-implementation. Post-implementation data (N=1 004) revealed that 30.8% patients were ART naive (‘first-ever CD4’), with 7.4% ‘not yet on ART’ (median CD4 counts of 150 and 328 cells/μL, respectively). Patients on ART comprised 61.9% of the study group (median CD4 count ~346 cells/μL). Sixty percent of patients were aged between 30 and 44 years, and females predominated (male/ female ratio 0.7:1).Conclusions. A simple modification to the CCMT request form can successfully facilitate collection of programme status. For national implementation, it would be advantageous to have a unique patient identifier to further enhance laboratory-based programmatic monitoring and evaluation

Documented higher burden of advanced and very advanced HIV disease among patients, especially men, accessing healthcare in a rapidly growing economic and industrial hub in South Africa: A call to action

Background. Lephalale Municipality in Limpopo Province, South Africa, has seen significant economic and industrial development owing to expansion of the coal mining and power generation sectors. This development has coincided with substantial population growth of 65% between 2001 and 2016, attributable to largely (migrant) males living in the area who, overall, outnumbered females by ~121:100. The local HIV prevalence is reported to be higher than national rates.Objectives. Anonymised National Health Laboratory Service CD4+ data were used to document increasing laboratory services workload and to establish the burden of advanced (CD4+ count <200 cells/µL) and very advanced (<100 cells/µL) HIV disease among adult patients accessing public healthcare in Lephalale between 2006 and 2015.Methods. A cross-sectional design was used to analyse CD4+ laboratory data. CD4+ outcomes were categorised by volumes of tests, year, health facility type, age categories (15 - 19, 20 - 24, 25 - 29, 30 - 34, 35 - 39, 40 - 44, 45 - 49 and >49 years), CD4+ test range (≤50, 51 - 100, 101 - 200, 201 - 350, 351 - 500 and ≥501 cells/µL) and gender. Median CD4+ counts were calculated.Results. Extracted Lephalale data comprised 57 490 CD4+ results, with a mean patient age of 34 years. Considerably fewer male than female patients had CD4+ counts reported (male/female ratio 0.45:1). CD4+ test volumes showed a five-fold escalation over the study period, increasing from 1 458 tests in 2006 to 8 239 in 2015. A considerable burden of advanced and very advanced HIV disease (exceeding 50% of all cases) was noted in 2006/2007; by 2015 the proportion had fallen, but was still high at 27%. The overall median CD4+ count in 2006 (192 cells/µL) confirmed a high burden of advanced disease, with modest improvement to 289 cells/µL by 2015. Between 2006 and 2015, the median CD4+ count for females increased from 204 to 405 cells/µL, while that for males increased from 126 to 285 cells/µL. Age analysis further revealed that men aged <20 years or >25 years, and specifically those aged 30 - 45 years, had up to 44% more advanced HIV disease.Conclusions. Lower median CD4+ counts and a dramatic increase in volumes of CD4+ tests performed from 2007 onwards revealed a high burden of advanced and very advanced HIV disease in patients accessing care in Lephalale. Viewed together with Statistics South Africa census documentation of a disproportionately high number of males compared with females living in the area, these figures suggest that improved systems are urgently needed to encourage and accommodate access to HIV care for male (migrant worker) patients living and working in emerging industrial centres

Analysis of HIV disease burden by calculating the percentages of patients with CD4 counts

Background. South Africa (SA)’s Comprehensive HIV and AIDS Care, Management and Treatment (CCMT) programme has reduced new HIV infections and HIV-related deaths. In spite of progress made, 11.2% of South Africans (4.02 million) were living with HIV in 2015.Objective. The National Health Laboratory Service (NHLS) in SA performs CD4 testing in support of the CCMT programme and collates data through the NHLS Corporate Data Warehouse. The objective of this study was to assess the distribution of CD4 counts <100 cells/μL (defining severely immunosuppressed HIV-positive patients) and >500 cells/μL (as an HIV-positive ‘wellness’ indicator).Methods. CD4 data were extracted for the financial years 2010/11 and 2014/15, according to the district where the test was ordered, for predefined CD4 ranges. National and provincial averages of CD4 counts <100 and >500 cells/μL were calculated. Data were analysed using Stata 12 and mapping was done with ArcGIS software, reporting percentages of CD4 counts <100 and >500 cells/μL by district.Results. The national average percentage of patients with CD4 counts <100 cells/μL showed a marked decrease (by 22%) over the 5-year study period, with a concurrent increase in CD4 counts >500 cells/μL (by 57%). District-by-district analysis showed that in 2010/11, 44/52 districts had >10% of CD4 samples with counts <100 cells/μL, decreasing to only 17/52 districts by 2014/15. Overall, districts in the Western Cape and KwaZulu-Natal had the lowest percentages of CD4 counts <100 cells/μL, as well as the highest percentages of counts >500 cells/μL. In contrast, in 2014/15, the highest percentages of CD4 counts <100 cells/μL were noted in the West Rand (Gauteng), Vhembe (Limpopo) and Nelson Mandela Bay (Eastern Cape) districts, where the lowest percentages of counts >500 cells/μL were also noted.Conclusions. The percentages of CD4 counts <100 cells/μL highlighted here reveal districts with positive change suggestive of programmatic improvements, and also highlight districts requiring local interventions to achieve the UNAIDS/SA National Department of Health 90-90-90 HIV treatment goals. The study further underscores the value of using NHLS laboratory data, an underutilised national resource, to leverage laboratory test data to enable a more comprehensive understanding of programme-specific health indicators

Piloting a national laboratory electronic programme status reporting system in Ekurhuleni health district, South Africa

Background. The National Health Laboratory Service (NHLS) performs ~4 million CD4 tests per annum for the public health sector at 61 CD4 testing laboratories across South Africa. Currently, CD4 laboratory data captured do not differentiate between antiretroviral treatment (ART) and pre-ART care.Methods. A cross-sectional study was undertaken to evaluate a redesigned Comprehensive Care, Management and Treatment of HIV and AIDS (CCMT) request form, incorporating a two-tick collection procedure linking the CD4 test request to patient CCMT programme status. Field testing was undertaken at three health facilities, where healthcare personnel were required to capture whether the CD4 count requested was a ‘first-ever CD4’, ‘CD4 taken previously, not yet in ART care’ or ‘in ART care’. All data were extracted from the NHLS Corporate Data Warehouse and analysed using Microsoft Excel and Stata-12.Results. A substantial increase in the number of request forms with a CCMT programme status (28.1% v. 84.4%) was reported pre- and post-implementation. Post-implementation data (N=1 004) revealed that 30.8% patients were ART naive (‘first-ever CD4'), with 7.4% ‘not yet on ART’ (median CD4 counts of 150 and 328 cells/µL, respectively). Patients on ART comprised 61.9% of the study group (median CD4 count ~346 cells/µL). Sixty percent of patients were aged between 30 and 44 years, and females predominated (male/female ratio 0.7:1).Conclusions. A simple modification to the CCMT request form can successfully facilitate collection of programme status. For national implementation, it would be advantageous to have a unique patient identifier to further enhance laboratory-based programmatic monitoring and evaluation

Implementation of a new ‘community’ laboratory CD4 service in a rural health district in South Africa extends laboratory services and substantially improves local reporting turnaround time

Background. The CD4 integrated service delivery model (ITSDM) provides for reasonable access to pathology services across South Africa (SA) by offering three new service tiers that extend services into remote, under-serviced areas. ITSDM identified Pixley ka Seme as such an under-serviced district.Objective. To address the poor service delivery in this area, a new ITSDM community (tier 3) laboratory was established in De Aar, SA. Laboratory performance and turnaround time (TAT) were monitored post implementation to assess the impact on local service delivery. Methods. Using the National Health Laboratory Service Corporate Data Warehouse, CD4 data were extracted for the period April 2012 - July 2013 (n=11 964). Total mean TAT (in hours) was calculated and pre-analytical and analytical components assessed. Ongoing testing volumes, as well as external quality assessment performance across ten trials, were used to indicate post-implementation success. Data were analysed using Stata 12. Results. Prior to the implementation of CD4 testing at De Aar, the total mean TAT was 20.5 hours. This fell to 8.2 hours post implementation, predominantly as a result of a lower pre-analytical mean TAT reducing from a mean of 18.9 to 1.8 hours. The analytical testing TAT remained unchanged after implementation and monthly test volumes increased by up to 20%. External quality assessment indicated adequate performance. Although subjective, questionnaires sent to facilities reported improved service delivery. Conclusion. Establishing CD4 testing in a remote community laboratory substantially reduces overall TAT. Additional community CD4 laboratories should be established in under-serviced areas, especially where laboratory infrastructure is already in place.

Sentinel seroprevalence of SARS-CoV-2 in Gauteng Province, South Africa, August - October 2020

Background. Estimates of prevalence of anti-SARS-CoV-2 antibody positivity (seroprevalence) for tracking the COVID-19 epidemic are lacking for most African countries.Objectives. To determine the prevalence of antibodies against SARS-CoV-2 in a sentinel cohort of patient samples received for routine testing at tertiary laboratories in Johannesburg, South Africa.Methods. This sentinel study was conducted using remnant serum samples received at three National Health Laboratory Service laboratories in the City of Johannesburg (CoJ) district. Collection was from 1 August to 31 October 2020. We extracted accompanying laboratory results for glycated haemoglobin (HbA1c), creatinine, HIV, viral load and CD4 T-cell count. An anti-SARS-CoV-2 targeting the nucleocapsid (N) protein of the coronavirus with higher affinity for IgM and IgG antibodies was used. We reported crude as well as population-weighted and test-adjusted seroprevalence. Multivariate logistic regression analysis was used to determine whether age, sex, HIV and diabetic status were associated with increased risk for seropositivity.Results. A total of 6 477 samples were analysed, the majority (n=5 290) from the CoJ region. After excluding samples with no age or sex stated, the model population-weighted and test-adjusted seroprevalence for the CoJ (n=4 393) was 27.0% (95% confidence interval (CI) 25.4 - 28.6). Seroprevalence was highest in those aged 45 - 49 years (29.8%; 95% CI 25.5 - 35.0) and in those from the most densely populated areas of the CoJ. Risk for seropositivity was highest in those aged 18 - 49 years (adjusted odds ratio (aOR) 1.52; 95% CI 1.13 - 2.13; p=0.0005) and in samples from diabetics (aOR 1.36; 95% CI 1.13 - 1.63; p=0.001).Conclusions. Our study conducted between the first and second waves of the pandemic shows high levels of current infection among patients attending public health facilities in Gauteng Province

Utility of WIfI foot assessment tool in a Sri Lankan setting; an initial experience

Introduction: Potential for limb salvage and wound healing in a lower limb ulcer depends on degreeof ischemia, wound grade and superadded foot infection.Objectives: Our objective was to assess the feasibility of applying WIfI classification system to stratifypatients presenting with limb ulceration according to risk of undergoing amputation and benefit ofrevascularization.Methods: Fifty four consecutive patients with ulcerated limbs presenting over two months to theUniversity unit at the National Hospital were staged according to the Society for Vascular Surgery(SVS)Wound, Ischemia, and Foot Infection (WIfI) classification system.Results: The median age was 64 (39-93), and 42 (79%) patients were males. Diabetes (87%),hypertension (53%), ischemic heart disease (14%), cerebrovascular disease (13%), chronic renal disease(13%) were identified risk factors. Smoking was reported among 35%. Median Anterior TibialArtery(ATA), Posterior Tibial Artery(PTA), Toe pressures, Ankle Brachial Index, Pole test values ofthe affected side lower limbs were 114.5mmHg, 107.5mmHg, 41mmHg, 0.87 and 85cm respectively.Values for the contralateral limb were 140mmHg, 120mmHg, 74mmHg, 1.0 and 85cm respectively.84% of ATA and 90 % of PTA pulses were not palpable on the affected side. Grades of ischemia were;none (23.3%), mild (27.9%), moderate (18.6%), severe (30.2%), grades of infection were none (20.9%),mild (37.2%), moderate (39.5%), severe (2.3%), and wound grades were 0(0%), 1(20%.9), 2(39.5%),3(39.5%). Estimated risk of amputation were high (65.1%), moderate (11.6%), low (11.6%), very low(11.6%) and estimated benefit of revascularization were high (46.5%) moderate (23.3%), low (7.0%),very low (23.3%).Conclusions: Application of WIfI system was useful to prioritize patients with eminent limb loss forurgent intervention. Toe pressure assessment for diabetic foot ulcer stratification should become acommon practice

Expectations versus reality in chronic venous ulceration; a quality of life assessment study

Introduction: Chronic venous ulceration is a common problem worldwide with a significant effect onQuality of Life (QoL).Objectives: Our objective was to assess Sri Lankan patients’ perspective with regard to this scenario.Methods: We involved 141 consenting patients presenting to the OPD, National Hospital with a venousulcer lasting one month or more. Data was collected using an interviewer administered questionnaire, aclinical interview and a lower limb duplex scan. Short form 36 questionnaire was used for QoLassessment.Results: The majority were elderly (median age 53 years) men (n=9[69.5%]). Fifty four (38.3%) wereunemployed at the time of the study and 28 (19.9%) directly attributed the ulcer as the cause forunemployment. Median duration of ulcer was 10[1-360] months and mean Venous Clinical SeverityScore (VCSS) was 13.85(4-24). Family history (44[31.2%]), previous limb trauma or non-venoussurgery (24[17.0%]), smoking among men (57 [58.2%]) and history of pregnancy among females(34[79.1%]) were identified as risk factors. Role limitation due to physical health (28.4[SD 42.8]) androle emotional problems (40.9 [SD 46.7]) had a mean SF 36 score below 50. Factors such as pain,duration of ulcer, older age and higher BMI significantly affected many domains of QoL (p<0.05). Sixtysix (46.8%) patients continue to have ulcers despite having had surgical treatment for varicose veins.Conclusions: Venous ulcers have a considerable impact on the quality of life in Sri Lankan patientswith venous ulcer. The need for providing preventive and rapid healing methods together with socialsupport must be emphasized

The potential for quality assurance systems to save costs and lives:the case of early infant diagnosis of HIV

OBJECTIVES: Scaling up of point-of-care testing (POCT) for early infant diagnosis of HIV (EID) could reduce the large gap in infant testing. However, suboptimal POCT EID could have limited impact and potentially high avoidable costs. This study models the cost-effectiveness of a quality assurance system to address testing performance and screening interruptions, due to, for example, supply stockouts, in Kenya, Senegal, South Africa, Uganda and Zimbabwe, with varying HIV epidemics and different health systems. METHODS: We modelled a quality assurance system-raised EID quality from suboptimal levels: that is, from misdiagnosis rates of 5%, 10% and 20% and EID testing interruptions in months, to uninterrupted optimal performance (98.5% sensitivity, 99.9% specificity). For each country, we estimated the 1-year impact and cost-effectiveness (US$/DALY averted) of improved scenarios in averting missed HIV infections and unneeded HIV treatment costs for false-positive diagnoses. RESULTS: The modelled 1-year costs of a national POCT quality assurance system range from US$ 69 359 in South Africa to US$334 341 in Zimbabwe. At the country level, quality assurance systems could potentially avert between 36 and 711 missed infections (i.e. false negatives) per year and unneeded treatment costs between US$ 5808 and US$ 739 030. CONCLUSIONS: The model estimates adding effective quality assurance systems are cost-saving in four of the five countries within the first year. Starting EQA requires an initial investment but will provide a positive return on investment within five years by averting the costs of misdiagnoses and would be even more efficient if implemented across multiple applications of POCT