Diagnostic accuracy of Rapid Antigen Test in detecting Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) Infection. chronic kidney disease pediatric patients: a randomized controlled study
Jill J Jaime | Raymundo W Lo | Farrah Kristine F Santiago
Discipline: medicine by specialism
Abstract:
BACKGROUND: Improving the means to detect SARS-COV-2 infection is important in the
ongoing battle against the COVID-19 pandemic. STANDARDTM Q COVID-19 Ag Test offers
an easy to use, cheap and rapid way of testing that must be evaluated first to optimize its utility.
OBJECTIVES: This study aims to evaluate the diagnostic accuracy of this test kit compared
with Reverse Transcription Polymerase Chain Reaction (RT-PCR) for SARS-COV-2 diagnosis.
METHODS: Using retrospective cross-sectional study, seventy seven (77) nasopharyngeal
swabs in viral transport media were used to determine the sensitivity, specificity, positive
predictive value and negative predictive value of STANDARDTM Q COVID-19 Ag Test
compared with the reference method, RT-PCR.
RESULTS: Among all participants, the rapid antigen test has a sensitivity of 9.86%, specificity
of 100%, positive predictive value of 100%, and negative predictive value of 8.57%. The
sensitivity increases among symptomatic participants and when Ct value is less than 20 to
25.00% and 31.58%, respectively.
CONCLUSION: Despite the low sensitivity, STANDARDTM Q COVID-19 Ag Test has a high
specificity and positive predictive value and could be a cheap and efficient test in the proper
clinical context. Its use in conjunction with RT-PCR for those who tested negative initially
should be emphasized in the implementation of the existing policies.
References:
- WHO. Laboratory Testing for Coronavirus Disease. Interim Guidance March 2020.; 2020. https://apps.who.int/iris/bitstream/handle/10665/331329/WHO-COVID-19-laboratory-2020.4-eng.pdf.
- Tang Y-W, Schmitz JE, Persing DH, Stratton CW. Laboratory Diagnosis of COVID-19: Current Issues and Challenges. McAdam AJ, ed. J Clin Microbiol. 2020;58(6). doi:10.1128/JCM.00512-20
- SD Biosensor. Products - Standard Q COVID 19 Ag. http://sdbiosensor.com/xe/product/772
- Administration D of H-F and D. SC-COVID-19-2020-314 SpecialCertification for Standard Q Rapid Antigen Test.
- Loeffelholz MJ, Tang Y-W. Laboratory diagnosis of emerging human coronavirus infections – the state of the art. Emerg Microbes Infect.2020;9(1):747-756. doi:10.1080/22221751.2020.1745095
- Mak GC, Cheng PK, Lau SS, et al.Evaluation of rapid antigen test for detection of SARS-CoV-2 virus. J Clin Virol. 2020;129:104500. doi:10.1016/j.jcv.2020.104500
- Scohy A, Anantharajah A, Bodéus M, Kabamba-Mukadi B, Verroken A, Rodriguez-Villalobos H. Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis. J Clin Virol.2020;129:104455. doi:10.1016/j.jcv.2020.104455
- Van Honacker E, Van Vaerenbergh K, Boel A, De Beenhouwer H, Leroux-Roels I, Cattoir L. Comparison of five SARS-CoV-2 rapid antigen tests in a hospital setting and performance of one antigen assay in routine practice. A useful tool to guide isolation precautions? J Hosp Infect. Published online March 2021.doi:10.1016/j.jhin.2021.03.021
- McPherson, RA; Pincus M. Henry’s Clinical Diagnosis and Management by Laboratory Methods. 23rd ed. Saunders Elsevier; 2016.
- Jong HL. In-House Clinical Trial (Unpublished). Published online 2020.
- Tavora P. Clinical Evaluation Interim Report “Standard Q COVID-19 Antigen Test” (Unpublished). Published online 2020.
- (FIND) F for IND. FIND Evaluation of SD Biosensor, Inc. STANDARD Q COVID-19 Ag Test External Report Version 1.0, 18 September 2020. Published 2020. https://www.finddx.org/wp-content/uploads/2020/09/SDQ-Ag-Public-Report_20200918.pdf
- Kim J-H. SARS-CoV-2 in Extraction Buffer Inactivation Report (Unpublished). Published online 2020.
- Trevethan R. Sensitivity, Specificity, and Predictive Values: Foundations, Pliabilities, and Pitfalls in Research and Practice. Front Public Heal. 2017;5. doi:10.3389/fpubh.2017.00307
- Šimundić A-M. Measures of Diagnostic Accuracy: Basic 85 The PCMC Journal, COVID-19 Special Edition Volume 18, No.1 Definitions. EJIFCC. 2009;19(4):203-211.http://www.ncbi.nlm.nih.gov/pubmed/27683318
- Department of Health Philippines. Department of Health - nCOV tracker. Published 2020. Accessed September 18, 2020. https://ncovtracker.doh.gov.ph/
- Department Memorandum 2020-0468 Supplemental Guidance on the Use of Rapid Antigen Test Kits. Department of Health, Philippines
- Department Memorandum 2021-0169 Interim Guidelines on Rapid Antigen Test Reporting for the NCR Plus Bubble. Department of Health, Philippines
- DOH Health Technology Assessment Unit B et al. (2020). Rapid Review: Use of Rapid Antigen Test Kits for the Diagnosis of COVID-19. https://drive.google.com/file/d/1cb5v 0PKGIwriGnhibZNIhp9pIzQVeVz9/view
- Research Institute for Tropical Medicine (RITM). EVALUATION OF RAPID Ag TEST KITS. Published 2021. Accessed August 8, 2021. https://ritm.gov.ph/covid-19-kit-evaluation/completed-evaluations/sars-cov-2-rapid-antigen-ag-test/
ISSN 2704-3665 (Online)
ISSN 0117-3774 (Print)