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Updated: Sep 4, 2025

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Evaluation Protocol for SARS-CoV-2 Serological Assays.

Maemu P Gededzha1,2, Sarika Jugwanth3,4, Nakampe Mampeule3,4

  • 1Department of Immunology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Maemu.gededzha@nhls.ac.za.

Methods in Molecular Biology (Clifton, N.J.)
|July 15, 2022
PubMed
Summary
This summary is machine-generated.

This study evaluates serological antibody tests for detecting SARS-CoV-2, the virus causing COVID-19. The protocol details methods for assessing automated platforms and lateral flow immunoassays for accurate COVID-19 diagnosis.

Keywords:
Automated serology PlatformLateral flow immunoassayPrecisionSARS-CoV-2 serology test

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Area of Science:

  • Virology
  • Immunology
  • Diagnostic Medicine

Background:

  • Severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) causes COVID-19, necessitating accurate detection for patient management and transmission control.
  • Polymerase chain reaction (PCR) is the standard for acute infection diagnosis but cannot detect past infections or maintain sensitivity beyond 14 days post-symptom onset.
  • Serological antibody tests offer a complementary diagnostic approach, with various high-throughput platforms and lateral flow immunoassays available.

Purpose of the Study:

  • To describe a protocol for evaluating serological antibody testing for SARS-CoV-2.
  • To optimize the diagnostic algorithm for SARS-CoV-2 by assessing diverse serology platforms.
  • To ensure serological tests meet local regulatory acceptance criteria for performance.

Main Methods:

  • Evaluation of various automated serology platforms and lateral flow immunoassays for SARS-CoV-2 antibody detection.
  • Protocol includes sample preparation, procedural steps, and data analysis for serological testing.
  • Testing was performed on both serum and plasma samples.

Main Results:

  • The protocol provides a framework for assessing the performance of different SARS-CoV-2 serological assays.
  • Demonstrated adaptability of the protocol for various serological testing methodologies.
  • Detailed procedures for sample handling and data interpretation were established.

Conclusions:

  • The described protocol enables comprehensive evaluation of serological tests for SARS-CoV-2 antibodies.
  • This systematic approach aids in selecting appropriate diagnostic tools for COVID-19.
  • The protocol can be adapted for evaluating serological tests for other infectious agents.