Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar

Date Icon Publish Date
  • Jesha Mundodan
    Public Health Department, Ministry of Public Health, Doha, Qatar.
  • Samina Hasnain
    Public Health Department, Ministry of Public Health, Doha, Qatar.
    https://orcid.org/0000-0003-0832-810X
  • Hayat Khogali
    Vaccination section / National COVID Track ‘n Trace Team, Public Health Department, Ministry of Public Health, Doha, Qatar.
  • Soha Shawqi Al Bayat
    Vaccination section / National COVID Track ‘n Trace Team, Public Health Department, Ministry of Public Health, Doha, Qatar.
  • Dina Ali
    Primary Health Care Corporation, Doha, Qatar.
  • Saif Alateeg
    Contact tracing, Health Protection and Communicable Diseases Control (HP-CDC), Public Health Department, Ministry of Public Health, Doha, Qatar.
  • Hamad Al-Romaihi
    Director of Health Protection and Communicable Diseases (HP-CDC), Public Health Department, Ministry of Public Health, Doha, Qatar.
  • Mohammed Hamad J. Al-Thani
    Public Health Department, Ministry of Public Health, Doha, Qatar.

ABSTRACT

Background: In response to the growing coronavirus disease 2019 (COVID-19) pandemic and the shortage of laboratory based molecular testing capacity and reagents, multiple diagnostic test manufacturers have developed rapid and easy to use devices to facilitate testing outside laboratory settings. These kits are either based on detection of proteins from SARS-CoV-2 virus or detection of antigen or human antibodies generated in response to the infection. However, it is important to understand their performance characteristics and they must be validated in the local population setting.
Design and Methods: The objective is to assess the validity of the rapid test for IgG and IgM immunoglobulins compared to the current gold standard reverse transcription polymerase chain reaction (RT-PCR) test. A total of 16951 asymptomatic individuals were tested by the Ministry of Public Health track-and-trace team using both rapid immunodiagnostic test and RT-PCR as part of screening across various random settings with potential risk of community interaction prior to gradual lifting of restrictions in Qatar.  Rapid test was considered to be posiive if both IgG and IgM are positive, while only IgG/IgM positive was considered as rapid test negative. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated.
Results: The sensitivity of rapid test kit was found to be 0.9%, whereas the specificity was found to be 97.8%. the PPV was found to be 0.3% whereas the NPV was found to be 99.4%.
Conclusion: Based on the outcome and results of the study, it appears that the sensitivity and PPV of the rapid antibody test are low. As such, this test is not recommended for use to assist in taking clinic-based decisions or decisions related to quarantine/isolation.

REFERENCES

Long C, Xu H, Shen Q, et al. Diagnosis of the Coronavirus disease (COVID-19): rRT-PCR or CT? Eur J Radiol 2020;126:108961. DOI: https://doi.org/10.1016/j.ejrad.2020.108961

Cassaniti I, Novazzi F, Giardina F, 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. J Med Virol 2020;92:1724-7. DOI: https://doi.org/10.1002/jmv.25800

Lee HK, Lee BH, Seok SH, et al. Production of specific antibodies against SARS‐coronavirus nucleocapsid protein without cross reactivity with human coronaviruses 229E and OC43. J Vet Sci 2010;11:165‐67. DOI: https://doi.org/10.4142/jvs.2010.11.2.165

Wan ZY, Zhang X, Yan XG. IFA in testing specific antibody of SARS coronavirus. South China J Prev Med 2003;29:36‐7.

Deeks JJ, Dinnes J, Takwoingi Y, et al. Antibody tests for identification of current and past infection with SARS-CoV-2. Cochrane Database Syst Rev 2020;6:CD013652. DOI: https://doi.org/10.1002/14651858.CD013652

Biomedomics [Internet]. COVID-19 IgM/IgG Rapid Test. Accessed on: 29 Dec 2020. Available from: https://www.biomedomics.com/products/infectious-disease/covid-19-rt/

Döhla M, Boesecke C, Schulte B, et al. Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity. Public Health 2020;182:170-2. DOI: https://doi.org/10.1016/j.puhe.2020.04.009

Li Z, Yi Y, Luo X, 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. DOI: https://doi.org/10.1002/jmv.25727

Shen B, Zheng Y, Zhang X, et al. Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG. Am J Transl Res 2020;12:1348–54.

Prazuck T, Colin M, Giachè S, et al. Evaluation of performance of two SARS-CoV-2 Rapid IgM-IgG combined antibody tests on capillary whole blood samples from the fingertip. PLoS One 2020;15:e0237694. DOI: https://doi.org/10.1371/journal.pone.0237694

Wan WY, Lim SH, Seng EH. Cross-reaction of sera from COVID-19 patients with SARS-CoV assays. Ann Acad Med Singap 2020;49:523-6. DOI: https://doi.org/10.47102/annals-acadmedsg.2020120

World Health Organization. Advice on the use of point of care immunodiagnostic tests for COVID-19: scientific brief. 8 April 2020. Available from: https://apps.who.int/iris/handle/10665/331713

Our most popular topics on Journal of Public Health Research

Leave a Reply

Your email address will not be published.