Logo-aim
Arch Iran Med. 2020;23(9): 629-632.
doi: 10.34172/aim.2020.75

Scopus ID: 85091812198
  Abstract View: 195
  PDF Download: 197

COVID-19

Original Article

Validity of a Serological Diagnostic Kit for SARS-CoV-2 Available in Iran

Hamid Reza Shamsollahi 1 ORCID logo, Mostafa Amini 2, Shaban Alizadeh 3, Saharnaz Nedjat 4, Ali Akbari-Sari 5, Mehdi Rezaei 6, Seyed Farshad Allameh 7, Akbar Fotouhi 4, Masud Yunesian 1,8,9* ORCID logo

1 Department of Environmental Health Engineering, Tehran University of Medical Sciences, Tehran, Iran
2 Deputy of Treatment Affairs, Tehran University of Medical Sciences, Tehran, Iran
3 Department of Hematology, Tehran University of Medical Sciences, Tehran, Iran
4 Department of Epidemiology and Biostatistics, Tehran University of Medical Sciences, Tehran, Iran
5 Department of Health Management and Economics, Tehran University of Medical Sciences, Tehran, Iran
6 Department of Orthopedics, Tehran University of Medical Sciences, Tehran, Iran
7 Department of Gastroenterology, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran
8 Center for Air Pollution Research (CAPR), Institute for Environmental Research (IER), Tehran University of Medical Sciences, Tehran, Iran
9 Department of Research Methodology and Data Analysis, Institute for Environmental Research (IER), Tehran University of Medical Sciences, Tehran, Iran
*Corresponding Author: Masud Yunesian, MD, PhD.; Address: School of Public Health, Tehran University of Medical Sciences, Tehran, Iran. Tel: +98-21-88954914; Fax: +98-21-88950188; Email: Yunesian@tums.ac.ir

Abstract

Background: The Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemic broke out in December 2019 and is now characterized as a pandemic. Effective control of this infectious disease requires access to diagnostic techniques, for both case finding and epidemic size estimation. The molecular technique is routinely used worldwide. Although it is the “standard” case detection and management method, it has its own shortcomings. Thus, some easy-to-use rapid serological tests have been developed.

Methods: One hundred and fourteen positive RT-PCR-diagnosed patients were tested by VivaDiag Kit, a brand of rapid serological kits available in hospitals affiliated to Tehran University of Medical Sciences (TUMS), Tehran, Iran. Frozen serum specimens taken from healthy people in summer and fall 2019 were also tested as negative controls.

Results: Test sensitivity was 47.9% (95% confidence interval [CI]: 38.8-56.9) for IgM and 47.0% (95% CI: 38.0–56.0) for IgG. There was no difference between IgG and IgM seropositivity except in one case. Specificity was calculated as 99.0% (95% CI: 96.4–99.9) for IgM and of 100.0% (95% CI: 0.98.2–100.0) for IgG. Sensitivity was higher in men and older participants.

Conclusion: This test can be used for epidemiological investigations, especially for the estimation of the level of infection in the community, after it is properly corrected for sensitivity and specificity. The low sensitivity could be attributed to the technical limitations of the kit or low levels of antibodies after infection. The different sensitivity in age and sex groups supports the hypothesis that different people show different immune responses to this virus.

Keywords: Coronavirus, COVID-19, SARS-CoV-2, Sensitivity, Serologic tests
Cite this article as: Shamsollahi HR, Amini M, Alizadeh S, Nedjat S, Akbari-Sari A, Rezaei M, et al. Validity of a serological diagnostic kit for SARS-CoV-2 available in Iran. Arch Iran Med. 2020;23(9):629–632. doi: 10.34172/aim.2020.75.
First Name
 
Last Name
 
Email Address
 
Comments
 
Security code


Abstract View: 195

Your browser does not support the canvas element.


PDF Download: 197

Your browser does not support the canvas element.

Submitted: 25 Apr 2020
Accepted: 29 Jun 2020
ePublished: 01 Sep 2020
EndNote EndNote

(Enw Format - Win & Mac)

BibTeX BibTeX

(Bib Format - Win & Mac)

Bookends Bookends

(Ris Format - Mac only)

EasyBib EasyBib

(Ris Format - Win & Mac)

Medlars Medlars

(Txt Format - Win & Mac)

Mendeley Web Mendeley Web
Mendeley Mendeley

(Ris Format - Win & Mac)

Papers Papers

(Ris Format - Win & Mac)

ProCite ProCite

(Ris Format - Win & Mac)

Reference Manager Reference Manager

(Ris Format - Win only)

Refworks Refworks

(Refworks Format - Win & Mac)

Zotero Zotero

(Ris Format - Firefox Plugin)