• P-ISSN 0974-6846 E-ISSN 0974-5645

Indian Journal of Science and Technology


Indian Journal of Science and Technology

Year: 2020, Volume: 13, Issue: 34, Pages: 3510-3514

Original Article

Utility of serological VivaDiag IgM/IgG rapid test kits for COVID-19 screening, during disease progression and following recovery

Received Date:02 September 2020, Accepted Date:09 September 2020, Published Date:15 September 2020


Objectives: This study evaluated VivaDiag IgM/IgG Rapid Test (VDtest) for covid-19 screening, during disease progression and following recovery. Methods: Prospectively, 969 patients RT-PCR positive for SARS-CoV-2 virus were compared to VDtest in 166 individuals upon airport arrival; 62 active inpatient COVID-19 cases ranging 2-23 days; 741 recovered COVID-19 patients from diagnosis date (median 24-days). Findings: Screening; VDtest assay sensitivity 7.6% (95% CI 2.8–15.8%), specificity 94.3% (95% CI 87.1–98.1%). Active disease patients, positive IgG rate 27.4% and IgM positivity 0 of 62 patients. Recovery phase patients: positive rates of IgM and IgG were 0.7% and 1.2%, respectively, within 14-days of diagnosis date, increasing to 25.9% and 43.4%, respectively 14-days after diagnosis. Novelty: VDtest kit showed poor sensitivity and identification of COVID-19 infection for screening, moreover,need for larger sample study to confirm our findings.

Keywords: COVID19; SARSCoV2; RTPCR; serological testing; rapid test


  1. Li Z, Yi Y, Luo X, Xiong N, Liu Y, Li S. Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis. Journal of medical virology. 2020. Available from: https://doi.org/10.1002/jmv.25727
  2. Petherick A. Developing antibody tests for SARS-CoV-2. The Lancet. 2020;395(10230):1101–1102. Available from: https://dx.doi.org/10.1016/s0140-6736(20)30788-1
  3. Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX. Clinical Characteristics of Coronavirus Disease 2019 in China. The New England journal of medicine. 2020;382(18):1708–1720. Available from: https://doi.org/10.1056/NEJMoa2002032
  4. Marca AL, Capuzzo M, Paglia T, Roli L, Trenti T, Nelson SM. Testing for SARS-CoV-2 (COVID-19): a systematic review and clinical guide to molecular and serological in-vitro diagnostic assays. Reproductive biomedicine online. 2020. Available from: https://doi.org/10.1016/j.rbmo.2020.06.001
  5. Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2020. Available from: https://doi.org/10.1093/cid/ciaa344
  6. Okba NMA, Müller MA, Li W, Wang C, Geurtsvankessel CH, Corman VM, et al. Severe Acute Respiratory Syndrome Coronavirus 2-Specific Antibody Responses in Coronavirus Disease. Patients. Emerging infectious diseases. 2019;26(7). Available from: https://doi.org/10.3201/eid2607.200841
  7. Lauer AS, Grantz HK, BIQ, Jones KF, Zheng Q, Meredith RH, et al. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Annals of Internal Medicine. 2020;172(9):577–582. Available from: https://dx.doi.org/10.7326/m20-0504
  8. Nishiura H, Kobayashi T, Miyama T, Suzuki A, Jung Sm, Hayashi K, et al. Estimation of the asymptomatic ratio of novel coronavirus infections (COVID-19) International Journal of Infectious Diseases. 2020;94:154–155. Available from: https://dx.doi.org/10.1016/j.ijid.2020.03.020
  9. Cassaniti I, Novazzi F, Giardina F, Salinaro F, Sachs M, Perlini S, et al. Performance of VivaDiag COVID‐19 IgM/IgG Rapid Test is inadequate for diagnosis of COVID‐19 in acute patients referring to emergency room department. Journal of Medical Virology. 2020. Available from: https://dx.doi.org/10.1002/jmv.25800
  10. Pan Y, Li X, Yang G, Fan J, Tang Y, Zhao J, et al. Serological immunochromatographic approach in diagnosis with SARS-CoV-2 infected COVID-19 patients. The Journal of infection. 2020. Available from: https://doi.org/10.1016/j.jinf.2020.03.051
  11. Zhang W, Du RH, Li B, Zheng XS, Yang XL, Hu B. Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerging microbes & infections. 2020;9:386–389. Available from: https://doi.org/10.1080/22221751.2020.1729071
  12. Lu S. Timely development of vaccines against SARS-CoV-2. Emerging microbes & infections. 2020;9(1):542–544. Available from: https://doi.org/10.1080/22221751.2020.1737580
  13. Capello F, Cipolla M, Cosco L, Gnasso A, Mancini R, Nichelatti M, et al. The VivaDiag COVID-19 lgM/IgG Rapid Test for the Screening and Early Diagnosis of COVID-19 in Patients with No Clinical Signs of the Disease. International Journal of Endocrinology and Metabolic Disorders. 2020;6(1). Available from: https://dx.doi.org/10.16966/2380-548x.167
  14. Paradiso AV, Silvestris N, Tommasi S, Tufaro A, Palma D, Larocca G, et al. Rapid serological tests have a role in asymptomatic health workers COVID-19 screening. medRxiv. 2020. Available from: https://doi.org/10.1101/2020.04.15.20057786


© 2020 Alarabi et al.This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Published By Indian Society for Education and Environment (iSee).


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