Diagnostic Accuracy Index of The Baiya Rapid COVID-19 IgM/IgG Test Kit in Preoperative Gynecologic Cancer Surgery Compared with Cured COVID-19 Patients

Main Article Content

Watcharin Chirdchim
Pipat Kongsap

Abstract

BACKGROUND: With the rapid and severe outbreak of COVID-19, diagnostic tools are needed. Rapid antibody test kits are convenient and fast, and the price is not high, suitable for screening patients. In addition, the diagnostic accuracy index compared to the gold standard, RT-PCR, is required for further clinical use.


OBJECTIVES: To study the accuracy of the Baiya Rapid Covid-19 IgM/IgG test kit.


METHODS: Cross-sectional studies were collected between 1 May 2020 and 30 January 2021 at the Department of Obstetrics and Gynaecology, Prapokklao Hospital. Blood was taken from the fingertips to analyze to detect IgM/IgG antibodies in 23 preoperative gynecological cancer patients (control group) compared with 27 women with COVID-19 infection sent home from field hospitals after 14-day quarantine (case group).


RESULTS: For the preoperative 23 cases, 0 were positive PCR, and 1 case of the positive rapid antibody test. Of the 27 patients from field hospitals, 27 cases were positive PCR, 27 cases were positive rapid antibody tests, the sensitivity was 100.0%, specificity 95.6%, and accuracy 98%


CONCLUSIONS: Diagnostic accuracy index of the Baiya Rapid Covid-19 IgM/IgG test kit is very high. It can be for clinical use.

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References

Sun P, Lu X, Xu C, Sun W, Pan B. Understanding of COVID-19 based on current evidence. J Med Virol 2020;92:548-51.

Bai Y, Yao L, Wei T, Tian F, Jin DY, Chen L, et al. Presumed asymptomatic carrier transmission of COVID-19. JAMA 2020;323:1406-7.

Rattanapisit K, Shanmugaraj B, Manopwisedjaroen S, Purwono PB, Siriwattananon K, Khorattanakulchai N, et al. Rapid production of SARS-CoV-2 receptor binding domain (RBD) and spike specific monoclonal antibody CR3022 in Nicotiana benthamiana. Sci Rep [Internet]. 2020 [cited 2021 Sep 15];10(1):17698. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7573609/pdf/41598_2020_Article_74904.pdf

Li Z, Yi Y, Luo X, Xiong N, Liu Y, Li S, et al. Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis. J Med Virol 2020;92: 1518-24.

Haynes RB. Sackett D, Guyatt GH, Tugwell P. Clinical epidemiology: how to do clinical practice research. 3rd ed. Philadelphia: Lippincott William & Wilkins 2006.

Uwins C, Bhandoria GP, Shylasree TS, Butler-Manuel S, Ellis P, Chatterjee J, et al. A COVID-19 and gynecological cancer: a review of the published guidelines. Int J Gynecol Cancer 2020;30: 1424-33.

de Santiago J, Yelo C, F Chereguini M, Conde A, Galipienzo J, Salvatierra D, et al. COVID-19: gynecologic cancer surgery at a single center in Madrid. Int J Gynecol Cancer 2020;30:1108-12.

Kang K, Huang L, Ouyang C, Du J, Yang B, Chi Y, et al. Development, performance evaluation, and clinical application of a Rapid SARS- CoV-2 IgM and IgG Test Kit based on automated fluorescence immunoassay. J Med Virol 2021;93:2838-47.

Rashid ZZ, Othman SN, Abdul Samat MN, Ali UK, Wong KK. Diagnostic performance of COVID-19 serology assays. Malays J Pathol 2020;42:13-21.

Uwamino Y, Wakui M, Aoki W, Kurafuji T, Yanagita E, Morita M, et al. Evaluation of the usability of various rapid antibody tests in the diagnostic application for COVID-19. Ann Clin Biochem 2021;58:174-80.

Jacobs J, Kühne V, Lunguya O, Affolabi D, Hardy L, Vandenberg O. Implementing COVID-19 (SARS-CoV-2) rapid diagnostic tests in Sub-Saharan Africa: a review. Front Med (Lausanne) [Internet]. 2020 [cited 2021 Sep 15];7:557797. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7662157/pdf/fmed-07-557797.pdf

Akyala AI, Awayimbo JR, Ogo AC, Chima NJ, Billyrose OMA, Engom AOG. Clinical diagnostic performance evaluation of five immunoassays for antibodies to SARS- CoV-2 diagnosis in a real-life routine care setting. Pan Afr Med J [Internet]. 2021 [cited 2021 Sep 30];39:3. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8197056/pdf/PAMJ-39-3.pdf

Maya V, Kaviyil JE, Ponnambath DK, Nair RP, Bhatt A, Pilankatta R, et al. Evaluation of diagnostic accuracy of developed rapid SARS-COV-2 IgG antibody test kit using novel diluent system. Virusdisease 2021;32:78-84.