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Int J Infect Dis ; 2022 Apr 12.
Article in English | MEDLINE | ID: covidwho-1783424


OBJECTIVES: To conduct a diagnostic validation study of SARS-CoV-2 diagnostic kits. METHODOLOGY: We compared SARS-CoV-2 diagnostic test results from three RT-PCR assays used by the Zambian government between Nov 2020 to Feb 2021 (the Panther Fusion® assay, Da An Gene's 2019-nCoV RNA kit and Maccura's PCR Kit) with the Altona RealStar RT-PCR kit which served as the gold standard. We also evaluated results from rapid antigen testing, and whether co-morbidities were linked with increased odds of infection. RESULTS: We recruited 244 participants, 61% (149/244) were positive by at least one PCR assay. Da An Gene, Maccura and Panther Fusion assays had sensitivities of 0.0% (95%CI 0-41%), 27.1% (95%CI 15-42%) and 76% (95%CI 65-85%) respectively but specificity was low (<85% for all three assays). HIV and TB were not associated with SARS-CoV-2, whereas female sex (OR 0.5 (0.3-0.9), p = 0.026) and Chronic Pulmonary Disease (0.1 (0.0-0.8), p = 0.031), were associated with lower odds of SARS-CoV-2 infection. 84% of 44 samples sequenced were Beta variant. CONCLUSIONS: The RT-PCR assays evaluated did not meet WHO recommended minimum sensitivity of 80%. Local diagnostic validation studies should be embedded within preparedness plans for future outbreaks to improve the public health response.

BMJ ; 372: n457, 2021 02 19.
Article in English | MEDLINE | ID: covidwho-1090955