Performance evaluation of SARS-CoV-2 rapid diagnostic tests in Nigeria: A cross-sectional study.

Autor:	Omonkhua AA; Centre of Excellence in Reproductive Health Innovation (CERHI), University of Benin, Benin City, Nigeria.; Department of Medical Biochemistry, University of Benin, Benin City, Nigeria., Faneye A; Department of Virology, College of Medicine, University of Ibadan, Ibadan, Nigeria., Akinwande KS; Department of Chemical Pathology and Immunology, Federal Medical Centre Abeokuta, Abeokuta, Nigeria., Evaezi O; International Research Centre of Excellence, Institute of Human Virology, Abuja, Nigeria., Shehu NY; West African Center for Emerging Infectious Diseases (WAC-EID), Jos University Teaching Hospital, Jos, Nigeria., Onayade A; Institute of Public Health, Obafemi Awolowo University, Ile-Ife, Nigeria., Ochu CL; Nigeria Centre for Disease Control & Prevention, Abuja Nigeria.; Nigeria COVID-19 Research Coalition, Abuja, Nigeria., Popoola M; Nigeria COVID-19 Research Coalition, Abuja, Nigeria.; Tertiary Education Trust Fund, Abuja, Nigeria., Emmanuel N; Plateau State University, Bokkos, Plateau State, Nigeria., Ojo T; Institute of Public Health, Obafemi Awolowo University, Ile-Ife, Nigeria., Ohonsi C; Nigeria Centre for Disease Control & Prevention, Abuja Nigeria.; Nigeria COVID-19 Research Coalition, Abuja, Nigeria., Abubakar A; International Research Centre of Excellence, Institute of Human Virology, Abuja, Nigeria., Odeh E; Federal University Teaching Hospital, Abakiliki, Ebonyi State, Nigeria., Akinduti P; Department of Microbiology, Covenant University, Ota, Ogun State, Nigeria., Folarin O; African Centre of Excellence for Genomics of Infectious Diseases, Redeemers University, Ede, Nigeria., Bimba JS; Zankli Research Centre, Bingham University, Karu, Nigeria., Igumbor E; Nigeria COVID-19 Research Coalition, Abuja, Nigeria.; Centre for Infectious Disease Research, Nigerian Institute of Medical Research, Lagos, Nigeria.; School of Health Systems and Public Health, University of Pretoria, Pretoria, South Africa.; Department of Public Health, Walter Sisulu University, Mthatha, South Africa., Elimian K; Department of Microbiology, Faculty of Life Sciences, University of Benin, Benin City, Edo State, Nigeria., Edem VF; Department of Immunology, University of Ibadan, Ibadan, Nigeria., Pam D L; National Veterinary Research Institute (NVRI), Vom, Plateau State, Nigeria., Olusola T; Department of Virology, College of Medicine, University of Ibadan, Ibadan, Nigeria., Ntoimo L; Centre of Excellence in Reproductive Health Innovation (CERHI), University of Benin, Benin City, Nigeria.; Department of Demography and Social Statistics, Federal University, Oye-Ekiti, Ekiti State, Nigeria., Olugbile M; The World, Bank, Abuja, Nigeria., Opayele AV; Department of Virology, College of Medicine, University of Ibadan, Ibadan, Nigeria., Kida I; University of Maiduguri Teaching Hospital, Maiduguri, Borno State, Nigeria., David S; West African Center for Emerging Infectious Diseases (WAC-EID), Jos University Teaching Hospital, Jos, Nigeria., Onyeaghala A; Department of Chemical Pathology, University College Hospital, Ibadan, Nigeria., Igbarumah I; Molecular Virology Laboratory, University of Benin Teaching Hospital, Benin City, Nigeria., Maduka O; University of Port Harcourt, Port Harcourt, Rivers State, Nigeria., Mahmoud MA; Faculty of Science, Ahmadu Bello University, Zaria, Nigeria., El-Fulatty AR; Faculty of Science, Ahmadu Bello University, Zaria, Nigeria., Olaleye DO; Department of Virology, College of Medicine, University of Ibadan, Ibadan, Nigeria., Simon O; University of Jos, Jos, Plateau State, Nigeria., Osaigbovo II; Department of Medical Microbiology, School of Medicine, College of Medical Sciences, University of Benin, Benin City, Nigeria., Obaseki DE; Office of the Chief Medical Director, University of Benin Teaching Hospital, Benin City, Nigeria., Tolulupe A; University of Jos, Jos, Plateau State, Nigeria., Happi C; African Centre of Excellence for Genomics of Infectious Diseases, Redeemers University, Ede, Nigeria., Jibrin YB; Abubakar Tafawa Balewa University Teaching Hospital (ATBUTH), Bauchi, Nigeria., Okonofua F; Centre of Excellence in Reproductive Health Innovation (CERHI), University of Benin, Benin City, Nigeria.; Department of Obstetrics and Gynaecology, University of Benin, Benin City, Nigeria., Eliya T; Zankli Research Centre, Bingham University, Karu, Nigeria., Simji G; University of Jos, Jos, Plateau State, Nigeria., Abi IJ; West African Center for Emerging Infectious Diseases (WAC-EID), Jos University Teaching Hospital, Jos, Nigeria., Ameh E; West African Center for Emerging Infectious Diseases (WAC-EID), Jos University Teaching Hospital, Jos, Nigeria., Maigari IM; Abubakar Tafawa Balewa University Teaching Hospital (ATBUTH), Bauchi, Nigeria., Alhaji S; Abubakar Tafawa Balewa University Teaching Hospital (ATBUTH), Bauchi, Nigeria., Adetifa I; Nigeria Centre for Disease Control & Prevention, Abuja Nigeria.; Nigeria COVID-19 Research Coalition, Abuja, Nigeria., Salako B; Nigeria COVID-19 Research Coalition, Abuja, Nigeria.; Nigerian Institute of Medical Research, Lagos, Nigeria., Bogoro S; Nigeria COVID-19 Research Coalition, Abuja, Nigeria.; Tertiary Education Trust Fund, Abuja, Nigeria., Ihekweazu C; Nigeria COVID-19 Research Coalition, Abuja, Nigeria.; World Health Organization Hub for Pandemic and Epidemic Intelligence, Berlin, Germany., Odaibo GN; Department of Virology, College of Medicine, University of Ibadan, Ibadan, Nigeria.
Jazyk:	angličtina
Zdroj:	PLOS global public health [PLOS Glob Public Health] 2024 Jul 15; Vol. 4 (7), pp. e0003371. Date of Electronic Publication: 2024 Jul 15 (Print Publication: 2024).
DOI:	10.1371/journal.pgph.0003371
Abstrakt:	The COVID-19 pandemic challenged health systems globally. Reverse transcription polymerase chain reaction (RT-PCR) is the gold standard for detecting the presence of SARS-CoV-2 in clinical samples. Rapid diagnostic test (RDT) kits for COVID-19 have been widely used in Nigeria. This has greatly improved test turnover rates and significantly decreased the high technical demands of RT-PCR. However, there is currently no nationally representative evaluation of the performance characteristics and reliability of these kits. This study assessed the sensitivity, specificity, and predictive values of ten RDT kits used for COVID-19 testing in Nigeria. This large multi-centred cross-sectional study was conducted across the 6 geo-political zones of Nigeria over four months. Ten antigen (Ag) and antibody (Ab) RDT kits were evaluated, and the results were compared with RT-PCR. One thousand, three hundred and ten (1,310) consenting adults comprising 767 (58.5%) males and 543 (41.5%) females participated in the study. The highest proportion, 757 (57.7%), were in the 20-39 years' age group. In terms of diagnostic performance, Lumira Dx (61.4, 95% CI: 52.4-69.9) had the highest sensitivity while MP SARS and Panbio (98.5, 95% CI: 96.6-99.5) had the highest specificity. For predictive values, Panbio (90.7, 95% CI: 79.7-96.9) and Lumira Dx (81.2, 95% CI: 75.9-85.7) recorded the highest PPV and NPV respectively. Ag-RDTs had better performance characteristics compared with Ab-RDTs; however, the sensitivities of all RDTs in this study were generally low. The relatively high specificity of Ag-RDTs makes them useful for the diagnosis of infection in COVID-19 suspected cases where positive RDT may not require confirmation by molecular testing. There is therefore the need to develop RDTs in-country that will take into consideration the unique environmental factors, interactions with other infectious agents, and strains of the virus circulating locally. This may enhance the precision of rapid and accurate diagnosis of COVID-19 in Nigeria. Competing Interests: The authors have declared that no competing interests exist. (Copyright: © 2024 Omonkhua et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze:	MEDLINE
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