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Objective: To determine sensitivity and specificity of Roche SARs-cov-2 antibodies assay using real time poly-marase chain reaction (RT-PCR) Covid-19 as standard in Pakistani population.
Methodology: It was a cross-sectional study conducted in Rehman Medical Institute Peshawar from 1st January 2021 till 15th February 2021. This study include 192 suspected Covid-19 patients. Serum samples set consisted of 122 symptomatic RT-PCR positive patients and 70 negative RT-PCR were used for qualitative detection of Antibodies (CoVID-19 IgG, IgM). Overall and period wise (Post RT-PCR) diagnostic accuracy was determined by comparing results of antibodies assay to Rt-PCR. Chi square test was applied to assess the correlation between post-PCR duration and Anti-SARS-Cov-2. A p-value of <0.05 was considered significant.
Results: On post-PCR duration and Anti-SARS-Cov-2 analysis, it was evident that the sensitivity of detection increased steadily with increase in duration after viral detection reaching a value of 94.5% after 20 days. Overall sensitivity was 86.9% with PPV of 97.3%. There was a significant level (X2= 6.846, p =.033) of correlation between detection probability of Antibodies and post-PCR duration at 95% Cl. Anti-SARS-Cov-2 showed a specificity of 95.7% and a NPV of 81.7%.
Conclusion: Our study demonstrated that in middle and later stages of disease antibodies to SARS-CoV-2 can be detected. This testing strategy can be utilized complementary to molecular-based testing of CoVID-19 diagnosis. Also, this can help in determining the seroprevalence of CoVID-19 in the community.
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Mahase E. Covid-19: WHO declares pandemic because of “alarming levels” of spread, severity, and inaction. BMJ. 2020; 368.
World Health Organization (WHO). WHO Coronavirus Disease (COVID-19) Dash¬board 2021. [Cited 2021 May 12]. Avi¬alable from: URL: https://covid19.who. int/
Govt of Pakistan. Pakistan cases details [online] 2021. [cited 2021 Nov 21]. Avi¬alable from: URL: https:// covid.gov.pk/ stats/pakistan.
Chan JFW, Yuan S, Kok KH, To KKW, Chu H, Yang J, et al. A familial clus¬ter of pneumonia associated with the 2019 novel coronavirus indicating per¬son-to-person transmission: a study of a family cluster. Lancet. 2020; 395(10223):514-23.
Bajema KL, Oster AM, McGovern OL, Lindstrom S, Stenger MR, Anderson TC, et al. Persons evaluated for 2019 novel coronavirus—United States, January 2020. Morb Mortal Wkly Rep. 2020; 69(6):166.
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel coronavi¬rus in Wuhan, China. Lancet. 2020; 395(10223):497-506.
Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, et al. Epidemiological and clini¬cal characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wu¬han, China: a descriptive study. Lancet. 2020; 395(10223):507-13.
Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus–infected pneumo¬nia in Wuhan, China. Jama. 2020; 323(11):1061-9.
Liu K, Fang Y-Y, Deng Y, Liu W, Wang M-F, Ma J-P, et al. Clinical characteris¬tics of novel coronavirus cases in ter¬tiary hospitals in Hubei Province. Chin Med J. 2020; 133(9):1025-31.
Yang X, Yu Y, Xu J, Shu H, Liu H, Wu Y, et al. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a sin¬gle-centered, retrospective, observa¬tional study. Lancet Respir Med. 2020; 8(5):475-81.
ECDC. An overview of the rapid test situation for COVID-19 diagnosis in the EU/EEA. 2020.
Vashist SKJD. In vitro diagnostic assays for COVID-19: recent advances and emerging trends. Diagnostics. 2020; 10(4):202.
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(9):1518-24.
Duggan J, Brooks T, Migchelsen S. Evaluation of Roche Elecsys Anti-SARS-CoV-2 serology assay for the detection of anti-SARS-CoV-2 antibodies. Public Health England. 2020.
Chauhan DS, Prasad R, Srivastava R, Jaggi M, Chauhan SC, Yallapu MM. Comprehensive review on current inter¬ventions, diagnostics, and nanotechnol¬ogy perspectives against SARS-CoV-2. Bioconjugate Chem. 2020; 31(9):2021- 45.
Lau CS, Hoo SP, Yew SF, Ong SK, Lum LT, Heng PY, et al. Evaluation Of The Roche Elecsys Anti-Sars-Cov-2 Assay. Medrxiv. 2020.
Bryan A, Pepper G, Wener MH, Fink SL, Morishima C, Chaudhary A, et al. Per¬formance characteristics of the Abbott Architect SARS-CoV-2 IgG assay and seroprevalence in Boise, Idaho. J Clin Microbiol. 2020; 58(8).
Riester E, Krieter B, Findeisen P, Laimighofer M, Schoenfeld K, Laengin T, et al. Performance of an automat¬ed anti-SARS-CoV-2 immunoassay in prepandemic cohorts. Medrxiv. 2020.
Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, et al. Antibody responses to SARS-CoV-2 in patients with novel coronavi¬rus disease 2019. Clin Infect Dis. 2020; 71(16):2027-34.
Herroelen PH, Martens GA, De Smet D, Swaerts K, Decavele AS. Humoral Im¬mune Response to SARS-CoV-2: Com¬parative Clinical Performance of Seven Commercial Serology Tests. Am J Clin Pathol. 2020; 154(5):610-9.
Bajema KL, Wiegand RE, Cuffe K, Pa¬tel SV, Iachan R, Lim T, et al. Estimated SARS-CoV-2 Seroprevalence in the US as of September 2020. JAMA Internal Med 2021; 181(4):450-60.