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Comparative Assessment of Diagnostic Performance of RT-PCR and Rapid Diagnostic Test (RDT) Kits for the Detection of SARS-CoV-2
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Volume 8, 2020
Issue 2 (June)
Pages: 7-14   |   Vol. 8, No. 2, June 2020   |   Follow on         
Paper in PDF Downloads: 5   Since Dec. 10, 2020 Views: 147   Since Dec. 10, 2020
Omisakin Ibukun Akinsola, Department of Haematology and Blood Transfusion, State Specialist Hospital, Abeokuta, Nigeria.
Iyevhobu Kenneth Oshiokhayamhe, Department of Medical Laboratory Science, Ambrose Alli University, Ekpoma, Nigeria.
Obodo Basil Nnaemeka, Department of Medical Laboratory Science, Ambrose Alli University, Ekpoma, Nigeria.
Salako Risquat Oluremi, Department of Public Health, Ogun State Ministry of Health, Oke-Mosan Abeokuta, Nigeria.
Okobi Tobechukwu Joseph, Biology Department, Georgetown University, Washington D.C., USA.
Festus Oloruntoba Okojie, Department of Medical Laboratory Science, Ambrose Alli University, Ekpoma, Nigeria.
Ajayi Folake Olubunmi, Nigeria Field Epidemiology and Laboratory Training Program, Abuja, Nigeria.
Uhomoibhi Oserefuamen Trinitas, Department of Social Science and Mathematics, University of the District of Columbia, Maryland, DC., USA.
Bisiriyu Adebiyi Hakeem, Nigeria Field Epidemiology and Laboratory Training Program, Abuja, Nigeria.
Turay Ahmadu Adjin, Department of Medical Laboratory Science, Ambrose Alli University, Ekpoma, Nigeria.
Omolumen Lucky Eromosele, Department of Medical Laboratory Science, Ambrose Alli University, Ekpoma, Nigeria.
Animasahun Olawale Sunday, Nigeria Field Epidemiology and Laboratory Training Program, Abuja, Nigeria.
Usoro Edidiong Raphael, Department of Biomedical Sciences, Augusta University, Augusta Georgia, USA.
Amaechi Rose Akubueziuka, Department of Medical Laboratory Science, Ambrose Alli University, Ekpoma, Nigeria.
Ogundare Stephen Olusegun, Morbid Anatomy and Histopathology Department, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria.
COVID-19 is an infectious respiratory disease that is caused by the SARS-CoV-2 virus. The outcome of this pandemic stemmed the interest for the development and validation of rapid diagnostic tests. This study assessed the diagnostic performance of real time (RT)-PCR and rapid diagnostic test (RDT) kit for the detection of SARS-Cov2 in Respiratory Samples. A total of one hundred (100) suspected Covid-19 patients who visited Sagamu Health Zone in Ogun State were recruited for this study. Nasopharyngeal (NP) and oropharyngeal (OP) swabs were collected from the patients in a universal transport medium and then analysed using the RT-PCR. Blood samples were also collected from the patients and analysed using diagnostic kit for 2019-Novel Coronavirus 2019-nCoV Antibody test. Diagnostic performance was determined by comparing the results obtained by Rapid Diagnostic Test RDT to Real Time Polymerase Chain Reaction (RT-PCR.). The results of this study revealed that out of a total hundred (100) suspected cases of Covid-19 recruited, sixty four (64) were RT-PCR positive and thirty six (36) were RT-PCR negative. The mean age of the patients was 36.54±12.06 while the median age was 37.5 years. The overall sensitivity and specificity were 64.5% (CI 95%; 60.5–70.6) and 70.7% (CI 95%; 65.7–74.6) respectively with diagnostic accuracy of 61.4%. Female patients had higher cases of SARS-Cov2 (65.5%) with a sensitivity of 68.2% and specificity of 71.4% while male patients had lower cases (63.4%) with a sensitivity of 60.7% and specificity of 70.0%. The results of this study revealed that the antigen-based RDT showed low to moderate sensitivity and specificity in the samples obtained from the patients in contrast to the high sensitivity and specificity obtained from RT-PCR. This study revealed that RT-PCR is an important tool for the early detection and diagnosis of SARS-CoV-2 and hence should still remain the gold standard for diagnosis of SARS-CoV-2 in order to prevent misdiagnosis and further guide the clinicians effectively.
Diagnostic Performance, Coronavirus, SARS-CoV-2, COVID-19, Rapid Diagnostic Test
Huang, C., Wang, Y., Li, X., Ren, L., Zhao, J. and Hu, Y. (2020). Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet; 395: 497-506.
Li, Q., Guan, X., Wu, P., Wang, X., Zhou, L. and Tong, Y. (2020). Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med; 382: 1199-1207.
WHO (World Health Organisation) (2020a). A coordinated Global Research Roadmap. https://www.who.int/who-documents-detail/a-coordinated-global-research-roadmap, (accessed 15 May 2020).
Rothan, H. A. and Byrareddy, S. N. (2020). The epidemiology and pathogenesis of coronavirus disease 344 (COVID-19) outbreak. Journal of Autoimmunity. 109: 102433. 345 doi: 10.1016/j.jaut.2020.102433
Prazuck, T., Colin, M., Giachè, S., Gubavu, C., Seve, A., Rzepecki, V., et al., (2020) Evaluation of performance of two SARS-CoV-2 Rapid whole-blood finger-stick IgM-IgG 4 Combined Antibody Tests, Pp. 1-15. doi: https://doi.org/10.1101/2020.05.27.20112888
Nguyen, T., Duong Bang, D. and Wolff, A. (2020). 2019 Novel Coronavirus Disease (COVID-19): Paving the Road for Rapid Detection and Point-of-Care Diagnostics. Micromachines (Basel) 2020; 11. pii: E306.
Wang, J., Zhou, M. and Liu, F. (2020). Exploring the reasons for healthcare workers infected with novel coronavirus disease 2019 (COVID-19) in China. J Hosp Infect; doi10.1016/j.jhin.2020.03.002.
Corman, V. M., Landt, O., Kaiser, M. Molenkamp, R., Meijer, A. and Chu, D. K. W. (2020). Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill; 25 (3). doi: 10.2807/1560-7917. ES. 2020. 25. 3. 2000045.
CDC (Centers for Disease Control and Prevention), (2020). Respiratory Viruses Branch, Division of Viral Diseases. Real-Time RT-PCR Panel for Detection 2019-Novel Coronavirus. Instructions for Use. 04 Feb 2020. https://www.cdc.gov/coronavirus/2019-ncov/lab/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Flab%2Frt-pcr-detection-instructions.html, 2020 (accessed 15 May 2020)
FIND (Foundation for Innovative New Diagnostics) (2020). SARS-CoV-2 diagnostic pipeline. 2020 (continuously updated). https://www.finddx.org/covid-19/pipeline, 2020 (accessed 15 May 2020).
WHO (World Health Organisation) (2020b). Laboratory testing for 2019 novel 309 coronavirus (2019-nCoV) in suspected human cases. Interim guidance. 19 March 2020. https://www.who.int/publications-detail/laboratory-testing-for-2019-novel-coronavirusin-suspected-human-cases-20200117, (accessed 15 May 2020).
WHO (World Health Organisation) (2020c). Laboratory testing strategy recommendations for COVID-19. Interim guidance. 22 March 2020. https://apps.who.int/iris/bitstream/handle/10665/331509/WHO-COVID-19-lab_testing-2020.1-eng.pdf, (accessed 15 May 2020).
ECDC (2020). Coronavirus disease 2019 (COVID-19) pandemic: increased transmission in the EU/EEA and the UK – seventh update, 25 March 2020. Stockholm: 2020.
Patel, R., Babady, E., Theel, E. S., Storch, G. A., Pinsky, B. A. and St George, K. (2020). Report from the American Society for Microbiology COVID-19 International Summit, 23 March 2020: Value of Diagnostic Testing for SARS-CoV-2/COVID-19. mBio 2020;11. pii: e00722-20.
CLSI, (2008). User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline-Second Edition. CLSI document EP12-A2. Wayne, PA: Clinical and Laboratory Standards institute; 2008.
Liu, Y., Liu, Y., Diao, B., Ren, F., Wang, Y., Ding, J., et al. (2020). Diagnostic Indexes of a Rapid 365 IgG/IgM Combined Antibody Test for SARS-CoV-2. Infectious Diseases (except 366 HIV/AIDS); doi: 10.1101/2020.03.26.20044883 367.
Pan, Y., Li, X., Yang, G., Fan, J., Tang, Y., Zhao, J., et al. (2020). Serological immunochromatographic 368 approach in diagnosis with SARS-CoV-2 infected COVID-19 patients. Journal of Infection. doi: 10.1016/j.jinf.2020.03.051
Diao, B., Wen, K., Chen, J., Liu, Y., Yuan, Z., Han, C., et al. (2020). Diagnosis of acute respiratory syndrome coronavirus 2 infection by detection of nucleocapsid protein. Preprint at https://www.medrxiv.org/content/10.1101/2020.03.07.20032524v2 (2020).
Laferi, H., Kandel, K and Pichler, H. (1997). False positive dipstick test for malaria. New Engl. J. Med., 337: 1635-1636.
Grobusch, M. P., Alpermann, U., Schwenke, S., Jelinek, T. and Warhurst, D. C. (1999). False-positive rapid tests for malaria in patients with rheumatoid factor. Lancet, 353: 297-297.
Chiodini, P. L., Bowers, K., Jorgensen, P., Barnwell. J. W., Grady, K. K., et al., (2007). The heat stability of Plasmodium lactate dehydrogenase-based and histidine-rich protein 2-based malaria rapid diagnostic tests. Trans. Royal Soc. Trop. Med. Hygiene, 101: 331-337.
Miller, R., (2006). Comparison of performance characteristics of the Binax NOW Malaria test using venous and fingerstick samples. Proceedings of Abstract 533 of the 55th Annual Meeting of the American Society of Tropical Medicine and Hygiene, November 12-16, 2006, Atlanta, Georgia, USA.
Lorena, P., Paulette, L., Valeska, V., Ximena, A., Jos´e, M., Rafael, A., et al., (2020). Evaluation of novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples International Journal of Infectious Diseases S1201-9712 (20) 30405-7 https://doi.org/10.1016/j.ijid.2020.05.098.
Chen, L., Liu, W. and Zhang, Q., et al. (2020) RNA based mNGS approach identifies a novel human coronavirus from two individual pneumonia cases in 2019 Wuhan outbreak. Emerg Microbes Infect; 9: 313–319.
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