Implementation of the COVID-19 laboratory testing certification program (CoLTeP), Zimbabwe, 2021.

The Africa Union (AU) Trusted Travel Initiative was introduced in 2021 to support Africa Union member states enhance their current health screening systems. Trusted Travel offers an online digital platform for the verification and authentication of COVID-19 results based on a collaborative effort across a network of participating COVID-19 testing laboratories. In this paper, we describe the certification process of laboratories to qualify for listing on the AU Trusted Travel platform as approved and recognized COVID-19 testing facilities. A checklist prepared from the ISO15189: 2012, ISO15190: 2020 and World Health Organization Laboratory Safety Manual, 4th edition was used to audit laboratories. Approved auditors completed the audit checklist through reviewing laboratory documents and records, observing laboratory operations whilst asking open-ended questions to clarify documentation seen and observations made. A laboratory was recommended for certification after scoring at least 90%. Between May and September 2021, a total of 26 (19%) of the 134 medical laboratories authorized for SARS-CoV-2 testing had been audited for CoLTeP certification in Zimbabwe. The majority 16 (62%) attained 5 stars rating with 10 (38%) attaining 0-4 stars. Performance was highest in the area of test result and data management (mean score 93%, SD 9.1). The least performance of the laboratories was on the laboratory biosafety and biosecurity (mean score 73%, SD 17.0) and Quality Control and Assurance (mean score 71%, SD 15.0). There is need for laboratories to commit their resources to quality assurance programs and training of laboratory personnel in biosafety and biosecurity as part of continuous quality improvement.

An analysis of the COVID-19 laboratory dataset at AiBST Laboratory in Harare, Zimbabwe, 2020.

INTRODUCTION: coronavirus disease 2019 (COVID-19) has become a major public health problem and has spread rapidly around the globe since its first identification in Wuhan, China, in December 2019. Zimbabwe reported its first case on the 20th March 2020, and since then the disease has spread to almost every part of the country. Laboratory testing is important in controlling this pandemic. However, few studies have focused on assessing trends of SARS-CoV-2 laboratory data. We described SARS-CoV-2 data from African Institute of Biomedical Science and Technology (AiBST) Laboratory in Harare, Zimbabwe. METHODS: a retrospective record review of secondary SARS-CoV-2 data from AiBST Laboratory in Harare between May to September 2020 was done. Epi Info TM 7.2.2.6 was used to generate frequencies, proportions and conduct bivariate analysis. RESULTS: a total of 6,535 SARS-CoV-2 laboratory records were analysed. The median age of the patients was 36 years and 55% (3594/6535) were males. There was an increase in average analytical turn-around time (TAT) of SARS-CoV-2 results from May to August 2020. Analytical and preanalytical TAT remained above 2 days from August to September. Males were 1.18 times at risk of being SARS-CoV-2 infected than females (p<0.05). The risk of being SARS-CoV-2 infected increased with age from 1.06 in the 11-20 age group to 1.45 in the 41-50 age group. CONCLUSION: COVID-19 poses a greater threat to the older age groups and to men. The delayed TAT of SARS-CoV-2 results limits the efforts to control the pandemic. Decentralization of testing to provincial and district level would help improve result TAT.

Comparison of Real-Q 2019-nCoV and DaAn Gene 2019-nCoV polymerase chain reaction assays for the detection of SARS-CoV-2.

BACKGROUND: Various nucleic acid amplification assays for the diagnosis of SARS-CoV-2 infection have been developed, and there is a need to assess their test performance relative to one another. The aim of this study was to compare the performance characteristics of the Biosewoom Real-Q 2019-nCoV assay targeting the E and RdRP genes to DaAn Gene 2019-nCoV kit targeting the N gene and ORF1ab in the diagnosis of SARS-CoV-2. METHODS: We performed a diagnostic comparison study by testing nasopharyngeal samples for SARS-CoV-2 using the two reverse transcription polymerase chain reaction (RT-PCR) assays. Assay agreement was assessed by overall percent agreement, negative percent agreement, positive percent agreement, and Cohen's kappa coefficient. RESULTS: A total of 48 nasopharyngeal samples were tested using the two assays. One sample was invalid, and three showed inconclusive results with Real-Q; hence, 44 were included for the comparative analysis. Overall, percent agreement between the assays was 93.2% (95% CI 81.3%-98.6%), Positive percent agreement (PPA) was 86.4% (95% CI 65.1%-97.1%) and negative percent agreement (NPA) was 100% (95% CI 84.6%-100%). The kappa coefficient was 0.86 (95% CI 0.72-1.01). Three samples (6.8%) were positive with DaAn gene kit and negative with Real-Q. The fluorescence intensity for Real-Q reporter dyes was low. CONCLUSION: The two kits showed high levels of concordance in their detection of SARS-CoV-2 despite having different gene targets. The Biosewoom kit can be improved through addressing the fluorescence intensity of the target dyes, and feedback was given to the manufacturer.