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Evaluation of A Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 Infection: Single Italian Center Study

Katia Margiotti1, Marina Cupellaro1, Sabrina Emili1, Alvaro Mesoraca1 and Claudio Giorlandino2
  • 1 Altamedica Main Centre, Italy
  • 2 Fetal-Maternal Medical Centre, Italy

Abstract

The need for timely establishment of diagnostic assays of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is demanded in laboratories worldwide. We evaluated the performance of a flow immunoassay which can detect IgM an IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15 min. Among the 132 positive novel Coronavirus Disease 19 (COVID-19) cases, 126 tests were consistent with previous quantitative Real Time PCR (qRT-PCR) assays. Among the 62 negative cases, 60 were consistent with qRT-PCR assays except for 2 cases. In this study, 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device showed 95.5% sensitivity and 96.8% specificity. In conclusion, Rapid IgM-IgG Combined Antibody Test showed high detection consistency among all analysed samples. Suggesting that could be used for the rapid screening of SARS-CoV-2 carriers, either symptomatic or asymptomatic.

American Journal of Infectious Diseases
Volume 16 No. 2, 2020, 85-88

DOI: https://doi.org/10.3844/ajidsp.2020.85.88

Submitted On: 1 April 2020 Published On: 22 June 2020

How to Cite: Margiotti, K., Cupellaro, M., Emili, S., Mesoraca, A. & Giorlandino, C. (2020). Evaluation of A Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 Infection: Single Italian Center Study. American Journal of Infectious Diseases, 16(2), 85-88. https://doi.org/10.3844/ajidsp.2020.85.88

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Keywords

  • Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
  • Rapid IgM-IgG Combined Antibody Test
  • Novel Coronavirus Disease 19 (COVID-19)