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Updated: Dec 1, 2025
A Rapid, Multiplex Dual Reporter IgG and IgM SARS-CoV-2 Neutralization Assay for a Multiplexed Bead-Based Flow Analysis System
Published on: April 6, 2021
Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2
Gannon Ck Mak1, Stephen Sy Lau1, Kitty Ky Wong1
1All from Microbiology Division, Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, Hong Kong Special Administrative Region, China.
Background:
Numerous rapid antigen detection (RAD) kits for diagnosing COVID-19 patients are available in the market recently.
Objective:
To compare analytical sensitivity and clinical sensitivity for the three commercially available RAD kits.
Study Design:
Analytical sensitivity for the detection of SARS-CoV-2 virus was determined by limit of detection (LOD) using RT-PCR as a reference method. Clinical sensitivity was evaluated by using respiratory specimens collected from confirmed COVID-19 patients.
Results:
The LOD results showed that the three RAD kits varied from 102-105 fold less sensitive than RT-PCR. Clinical sensitivity of RAD kits ranged from 22.9 %-71.4 % for detecting specimens from COVID-19 patients.
Conclusions:
Although RAD kits were less sensitive than RT-PCR, understanding the clinical characteristics of different RAD kits can guide us to obtain suitable specimens for testing. The likelihood of positive results for RAD kits will be higher.
