Objectives: Rapid and accurate identification of persons infected with SARS-CoV-2 which causes COVID-19 is key to managing the pandemic. The urgent need to scale up access to COVID-19 testing in Nigeria has led to the government’s introduction of the use of COVID-19 Ag rapid diagnostic test (RDT) across various settings in the country. However, field performance evaluation of the rapid SARS-CoV-2 antigen detection test is required to be conducted periodically and compared with the gold standard real-time reverse transcription-polymerase chain reaction (RT-PCR) test for diagnosis of COVID-19 cases. Design: A prospective COVID-19 screening and un-blinded verification of the performance of the STANDARD Q COVID-19 Ag test kit. Setting: The rapid SARS-CoV-2 antigen detection test, StandardTM Q COVID-19 Ag kit was compared with the RT-PCR test for detection of SARS-CoV-2 in nasopharyngeal samples for COVID-19 screening from persons and personnel attending a national youth camp orientation exercise during the second wave of the COVID-19 outbreak (January to March 2021) in Ondo state, southwest Nigeria. Participants: Three hundred fifty-one persons and personnel were screened for COVID-19 infection. Results: Of 351 respondents screened, 68 (19.4%) were positive, and 264 (75.2%) were negative for both COVID-19 Ag RDT and RT-PCR assay. The rapid SARS-CoV-2 antigen detection test’s sensitivity and specificity were 78.16% (95% CI = 68.02% - 86.31%) and 100.0% (95% CI = 98.61% - 100.0%), respectively and the diagnostic accuracy was 94.59% (95% CI: 92 - 97). Respondents that were symptomatic had a higher test sensitivity of 78.6% (49.2 - 95.3) compared to those without symptoms 78.1% (66.9 - 86.9) (p < 0.05). Conclusions: Our study shows evidence that StandardTM Q COVID-19 Ag kit can be an appropriate rapid antigen test that could be used to screen for positive COVID-19 tests to guide decision-making for clinical management of persons infected with COVID-19, especially for closed settings and other clinical care settings.
References
[1]
World Health Organization (2020, January 12) Novel Coronavirus—China.
https://www.who.int/emergencies/diseases/novel-coronavirus-2019
[2]
Adhikari, S., Meng, S., Wu, Y.J., Mao, Y., Ye, R., Wang, Q., et al. (2020) Epidemiology, Causes, Clinical Manifestation and Diagnosis, Prevention and Control of Coronavirus Disease (COVID-19) during the Early Outbreak Period: A Scoping Review. Infectious Diseases of Poverty, 9, Article No. 29.
https://doi.org/10.1186/s40249-020-00646-x
[3]
Chaimayo, C., Kaewnaphan, B., Tanlieng, N., Athipanyasilp, N., Sirijatuphat, R., Chayakulkeeree, M., Angkasekwinai, N., et al. (2020) Rapid SARS-CoV-2 Antigen Detection Assay in Comparison with Real-Time RT-PCR Assay for Laboratory Diagnosis of COVID-19 in Thailand. Virology Journal, 17, Article No. 177.
https://doi.org/10.1186/s12985-020-01452-5
[4]
Isere, E.E., Adejugbagbe, A.M., Fagbemi, A.T., Fagbemi S., Famokun A.D., Omoju T.O., et al. (2021) Outcome of Epidemiological Investigation of COVID-19 Outbreak in a Southwest State of Nigeria, March to August 2020. Open Journal of Epidemiology, 11, 163-177. https://doi.org/10.4236/ojepi.2021.112015
[5]
Nigeria Center for Disease Control (NCDC) Guideline for the Use of Approved COVID-19 Ag RDTs in Nigeria for 2021.
https://covid19.ncdc.gov.ng/media/files/Guidance_for_the_use_of_approved_COVID-19_Ag_RDTs_in_Nigeria.pdf
[6]
de Campos-Stairiker, K., Pidathala, A.S., Gill, R.K., Gelimson, I., Varankovich, N., Gill, S.S., et al. (2021) Validation of Microchip RT-PCR COVID-19 Detection System. Journal of Biosciences and Medicines, 9, 8-24.
https://doi.org/10.4236/jbm.2021.99002
[7]
Brummer, L.E., Katzenschlager, S., Gaeddert, M., Erdmann, C., Schmitz, S., Bota, M., et al. (2021) Accuracy of Novel Antigen Rapid Diagnostics for SARS-CoV-2: A Living Systematic Review and Meta-Analysis. PLOS Medicine, 18, e1003735.
https://doi.org/10.1371/journal.pmed.1003735
[8]
Thommes, L., Burkert, F.R., Öttl, K.W., Goldin, D., Loacker, L., Lanser, L., et al. (2021) Comparative Evaluation of Four SARS-CoV-2 Antigen Tests in Hospitalized Patients. International Journal of Infectious Diseases, 105, 144-146.
https://doi.org/10.1016/j.ijid.2021.02.052
[9]
Landaas, E.T., Storm, M.L., Tollånes, M.C., Barlinn, R., Bakken Kran, A.B., Bragstad, K., et al. (2021) Diagnostic Performance of a SARS-CoV-2 Rapid Antigen Test in a Large, Norwegian Cohort. Journal of Clinical Virology, 137, Article ID: 104789.
https://doi.org/10.1016/j.jcv.2021.104789
[10]
National Population Commission (NPC) [Nigeria] and ICF International (2014) Nigeria Demographic and Health Survey 2013. NPC and ICF International, Abuja and Rockville, 1-2.
[11]
Igbalajobi, O., Fatuase, A.I. and Ajibefun, I. (2013) Determinants of Poverty Incidence among Rural Farmers in Ondo State, Nigeria. American Journal of Rural Development, 1, 131-137.
[12]
National Population Commission. The Nigeria Population Census, 2006.
https://nigeria.opendataforafrica.org/ifpbxbd/state-population-2006
[13]
Amos, T.T. (2007) An Analysis of Productivity and Technical Efficiency of Smallholder Cocoa Farmers in Nigeria. Journal of Social Sciences, 15, 127-133.
https://doi.org/10.1080/09718923.2007.11892573
[14]
Otu, A., Ebenso, B., Okuzu, O. and Osifo-Dawodu, E. (2016) Using a mHealth Tutorial Application to Change Knowledge and Attitude of Frontline Health Workers to Ebola Virus Disease in Nigeria: A Before-and-After Study. Human Resources for Health, 14, Article No. 5. https://doi.org/10.1186/s12960-016-0100-4
[15]
NCDC Guideline on 2020 National Youth Corp Orientation Camp Activities.
https://covid19.ncdc.gov.ng/media/files/Guidelines_on_2020_National_Youth_Service_Corps_NYSC_Orientation_Camp_activities.pdf
[16]
Odega, C.C. and Mofolorunsho, K.C. (2020) Prevalence of Ailments in a Youth Camp in Southern Nigeria. Central African Journal of Public Health, 6, 346-350.
https://doi.org/10.11648/j.cajph.20200606.15
[17]
Osaigbovo, I.I., Igbarumah, I.O., Muoebonam, E.B. and Obaseki, D.E. (2021) Setting up a Molecular Diagnostic Laboratory for SARS-CoV-2 Testing: Experience of a Single Centre in a Resource-Constrained Setting. African Journal of Laboratory Medicine, 10, Article No. 1326. https://doi.org/10.4102/ajlm.v10i1.1326
[18]
Nalumansia,, A., Lutaloa, T., John Kayiwaa, J., Wateraa, C., Balinandia, S., Kiconcoa, J., et al. (2021) Field Evaluation of the Performance of a SARS-CoV-2 Antigen Rapid Diagnostic Test in Uganda Using Nasopharyngeal Samples. International Journal of Infectious Diseases, 104, 282-286. https://doi.org/10.1016/j.ijid.2020.10.073
[19]
Schoonjans, F. (2020) MedCalc’s Diagnostic Test Evaluation Calculator. MedCalc. MedCalc Software. https://www.medcalc.org/calc/diagnostictest.php
[20]
Arinze, S.A. (2019) Entrepreneurship Education on Entrepreneurial Intention of Fresh Graduates: A Study of NYSC Orientation Camp, Umunya. IJAAS, 5, 1-10.
[21]
Maori, L., Jimoh, A., Shittu, A.N., Raji, A.A., Eigege, E, Anaryu, J.J., et al. (2017) Prevalence of Malaria Parasite among NYSC Corps Members, Staff, Military and Paramilitary Who Reported at NYSC Orientation Camp Amada in Gombe State. Greener Journal of Epidemiology and Public Health, 5, 6-10.
https://doi.org/10.15580/GJEPH.2017.2.031317035
[22]
Alemany, A., Baro, B., Ouchi, D., Rodó, P., Ubals, M., Corbacho-Monné, M., et al. (2021) Analytical and Clinical Performance of the Panbio COVID-19 Antigen-Detecting Rapid Diagnostic Test. Journal of Infection, 82, 186-230.
https://doi.org/10.1016/j.jinf.2020.12.033
[23]
Albert, E., Torres, I., Bueno, F., Huntley, D., Molla, E., Fernández-Fuentes, M.A., et al. (2020) Field Evaluation of a Rapid Antigen Test (PanbioTM COVID-19 Ag Rapid Test Device) for COVID-19 Diagnosis in Primary Healthcare Centres. Clinical Microbiology and Infection, 27, 472.e7-472.e10.
https://doi.org/10.1101/2020.10.16.20213850
[24]
Linares, M., Perez-Tanoira, R., Carrero, A., Romanyk, J., Pérez-García, F., Gómez-Herruz P., et al. (2020) Panbio Antigen Rapid Test Is Reliable to Diagnose SARS-CoV-2 Infection in the First 7 Days after the Onset of Symptoms. Journal of Clinical Virology, 133, Article ID: 104659. https://doi.org/10.1016/j.jcv.2020.104659
[25]
Fenollar, F., Bouam, A., Ballouche, M., Fuster, L., Prudent, E., Colson, P., et al. (2020) Evaluation of the Panbio Covid-19 Rapid Antigen Detection Test Device for the Screening of Patients with Covid-19. Journal of Clinical Microbiology, 59, e02589-20. https://doi.org/10.1128/JCM.02589-20
[26]
Tang, X., Wu, C., Li, X., Song, Y., Yao, X., Wu, X., et al. (2020) On the Origin and Continuing Evolution of SARS-CoV-2. National Science Review, 7, 1012-1023.
https://doi.org/10.1093/nsr/nwaa036
[27]
Ceraolo, C. and Giorgi, F.M. (2020) Genomic Variance of the 2019-nCoV Coronavirus. Journal of Medical Virology, 92, 522-528. https://doi.org/10.1002/jmv.25700
[28]
Treggiari, D., Piubelli, C., Caldrer, S., Mistretta, M., Ragusa, A., Orza, P., et al. (2021) SARS-CoV-2 Rapid Antigen Test in Comparison to RT-PCR Targeting Different Genes: A Real-Life Evaluation among Unselected Patients in a Regional Hospital of Italy. Journal of Medical Virology, 94, 1190-1195.
https://doi.org/10.1002/jmv.27378
[29]
Bulilete, O., Lorente, P., Leiva, A., Carandell, E., Oliver, A., Rojo, E., et al. (2020) Evaluation of the Panbio? Rapid Antigen Test for SARS-CoV-2 in Primary Health Care Centers and Test Sites. https://doi.org/10.1101/2020.11.13.20231316
[30]
Masiá, M., Fernández-González, M., Sánchez. M., Carvajal, M., García, J.A., Gonzalo-Jiménez, N., et al. (2021) Nasopharyngeal Panbio COVID-19 Antigen Performed at Point-of-Care Has a High Sensitivity in Symptomatic and Asymptomatic Patients with Higher Risk for Transmission and Older Age. Open Forum Infectious Diseases, 8, ofab059. https://doi.org/10.1093/ofid/ofab059
[31]
Dinnes, J., Deeks, J.J., Adriano, A., Berhane, S., Davenport, C., Dittrich, S., et al. (2020) Rapid, Point-of-Care Antigen and Molecular-Based Tests for Diagnosis of SARS-CoV-2 Infection. Cochrane Database of Systematic Reviews, 8, CD013705.
https://doi.org/10.1002/14651858.CD013705
