Background: Since December 2019, there had been an outbreak of COVID-19 in Wuhan, China. At present, diagnosis COVID-19 were based on real-time RT-PCR, which have to be performed in biosafe laboratory and is unsatisfactory for suspect case screening. Therefore, there is an urgent need for rapid diagnostic test for COVID-19.
Objective: To evaluate the diagnostic performance and clinical utility of the colloidal gold immunochromatography assay for SARS-Cov-2 specific IgM/IgG anti-body detection in suspected COVID-19 cases.
Methods: In the prospective cohort, 150 patients with fever or respiratory symptoms were enrolled in Taizhou Public Health Medical Center, Taizhou Hospital, Zhejiang province, China, between January 20 to February 2, 2020. All patients were tested by the colloidal gold immunochromatography assay for COVID-19. At least two samples of each patient were collected for RT-PCR assay analysis, and the PCR results were performed as the reference standard of diagnosis. Meanwhile 26 heathy blood donor were recruited. The sensitivity and specificity of the immunochromatography assay test were evaluated. Subgroup analysis were performed with respect to age, sex, period from symptom onset and clinical severity.
Results: The immunochromatography assay test had 69 positive result in the 97 PCR-positive cases, achieving sensitivity 71.1% [95% CI 0.609-0.797], and had 2 positive result in the 53 PCR-negative cases, achieving specificity 96.2% [95% CI 0.859-0.993]. In 26 healthy donor blood samples, the immunochromatography assay had 0 positive result. In subgroup analysis, the sensitivity was significantly higher in patients with symptoms more than 14 days 95.2% [95% CI 0.741-0.998] and patients with severe clinical condition 86.0% [95% CI 0.640-0.970].
Conclusions: The colloidal gold immunochromatography assay for SARS-Cov-2 specific IgM/IgG anti-body had 71.1% sensitivity and 96.2% specificity in this population, showing the potential for a useful rapid diagnosis test for COVID-19. Further investigations should be done to evaluate this assay in variety of clinical settings and populations.
Keywords: COVID-19; immunoglobulin M/immunoglobulin G; rapid diagnosis.
AJTR Copyright © 2020.
Conflict of interest statement
[Effect of heat inactivation of blood samples on the efficacy of three detection methods of SARS-CoV-2 antibodies].Nan Fang Yi Ke Da Xue Xue Bao. 2020 Mar 30;40(3):316-320. doi: 10.12122/j.issn.1673-4254.2020.03.03. Nan Fang Yi Ke Da Xue Xue Bao. 2020. PMID: 32376571 Free PMC article. Chinese.
Diagnostic performance of immunochromatography assay for rapid detection of IgM and IgG in coronavirus disease 2019.J Med Virol. 2020 May 26. doi: 10.1002/jmv.26060. Online ahead of print. J Med Virol. 2020. PMID: 32458479
Antibody Detection and Dynamic Characteristics in Patients with COVID-19.Clin Infect Dis. 2020 Apr 19:ciaa461. doi: 10.1093/cid/ciaa461. Online ahead of print. Clin Infect Dis. 2020. PMID: 32306047 Free PMC article.
Diagnostic performance of COVID-19 serology assays.Malays J Pathol. 2020 Apr;42(1):13-21. Malays J Pathol. 2020. PMID: 32342927 Review.
Features, Evaluation and Treatment Coronavirus (COVID-19).2020 Apr 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan–. StatPearls. 2020 Jan–. PMID: 32150360 Free Books & Documents. Review.