TY - JOUR
T1 - Diagnostic accuracy of point-of-care testing methods for SARS-CoV-2 detection in community quarantine and isolation settings
AU - Lam, Simon Ching
AU - Su, Jing Jing
AU - Tsang, Shun Wa
AU - Wong, Anna On Na
AU - Pang, Vivian Ching Man
AU - Chung, Jessie Yuk Seng
AU - Chan, Shun
AU - Kwan, Rick Yiu Cho
AU - Suen, Lorna Kwai Ping
N1 - This project was supported by Hong Kong Labware Co., Ltd., Hyatt Regency Hong Kong, Shatin, Avalon Biomedical Management Ltd. and Research Matching Grant Scheme, University Grants Committee, The Government of Hong Kong SAR. (Ref: 2022-04-75 RMGS220401).
Publisher Copyright:
© 2025 The Authors. Published by Elsevier Ltd on behalf of The Healthcare Infection Society.
PY - 2025/11/17
Y1 - 2025/11/17
N2 - Reverse
transcriptase polymerase chain reaction (RT-PCR) testing has been
regarded as the gold standard for the diagnosis of coronavirus disease
2019 (COVID-19). In response to the sudden surge in cases that
overwhelmed the healthcare system in Hong Kong, several point-of-care
testing (POCT) methods have been developed for rapid COVID-19 screening.
However, the diagnostic accuracy of these methods remains inadequately
established.
COVID-19–positive
patients and negative control subjects were recruited from a community
isolation centre and individuals under home quarantine. Four nasal swab
samples were collected by trained operators from each subject. Three
swab samples were immediately tested using conventional COVID-19 rapid
antigen test (RAT), fluorescence-based RAT (Fluorescent-RAT) and POCT
quantitative polymerase chain reaction (qPCR). The fourth swab sample
was submitted to a certified laboratory for standard RT-PCR analysis.
The sensitivity and specificity of the three rapid testing methods were
evaluated against the results obtained from the certified
laboratory-based RT-PCR, which served as the reference standard.
The
performance of the three diagnostic methods was assessed in 186 valid
cases, which comprised 86 RT-PCR–confirmed positive cases and 100
negative cases. The participants' age ranged from 3 years to 94 years.
The sensitivity of the Fluorescent-RAT (87.21%, 95% confidence interval
[CI]:80.15%–94.27%) and the POCT qPCR (84.27%, 95% CI:76.71%–91.83%) was
comparable and significantly higher than that of the conventional RAT
(51.69%, 95% CI:41.30%–62.07%). All three methods demonstrated high
specificity. The RAT and POCT qPCR exhibited 100% specificity (95%
CI:100%), and the Fluorescent-RAT showed a specificity of 97.06% (95%
CI:93.78%–100%).
This
study demonstrated that the Fluorescent-RAT and POCT qPCR can serve as
reliable alternatives to RT-PCR for COVID-19 diagnosis, offering
improved performance compared with the conventional RAT.
AB - Reverse
transcriptase polymerase chain reaction (RT-PCR) testing has been
regarded as the gold standard for the diagnosis of coronavirus disease
2019 (COVID-19). In response to the sudden surge in cases that
overwhelmed the healthcare system in Hong Kong, several point-of-care
testing (POCT) methods have been developed for rapid COVID-19 screening.
However, the diagnostic accuracy of these methods remains inadequately
established.
COVID-19–positive
patients and negative control subjects were recruited from a community
isolation centre and individuals under home quarantine. Four nasal swab
samples were collected by trained operators from each subject. Three
swab samples were immediately tested using conventional COVID-19 rapid
antigen test (RAT), fluorescence-based RAT (Fluorescent-RAT) and POCT
quantitative polymerase chain reaction (qPCR). The fourth swab sample
was submitted to a certified laboratory for standard RT-PCR analysis.
The sensitivity and specificity of the three rapid testing methods were
evaluated against the results obtained from the certified
laboratory-based RT-PCR, which served as the reference standard.
The
performance of the three diagnostic methods was assessed in 186 valid
cases, which comprised 86 RT-PCR–confirmed positive cases and 100
negative cases. The participants' age ranged from 3 years to 94 years.
The sensitivity of the Fluorescent-RAT (87.21%, 95% confidence interval
[CI]:80.15%–94.27%) and the POCT qPCR (84.27%, 95% CI:76.71%–91.83%) was
comparable and significantly higher than that of the conventional RAT
(51.69%, 95% CI:41.30%–62.07%). All three methods demonstrated high
specificity. The RAT and POCT qPCR exhibited 100% specificity (95%
CI:100%), and the Fluorescent-RAT showed a specificity of 97.06% (95%
CI:93.78%–100%).
This
study demonstrated that the Fluorescent-RAT and POCT qPCR can serve as
reliable alternatives to RT-PCR for COVID-19 diagnosis, offering
improved performance compared with the conventional RAT.
KW - Community isolation centre
KW - Fluorescence-based rapid antigen test
KW - Home quarantine
KW - Point-of-care testing
KW - Rapid antigen test
KW - Sensitivity and specificity
UR - https://www.scopus.com/pages/publications/105023878413
U2 - 10.1016/j.infpip.2025.100496
DO - 10.1016/j.infpip.2025.100496
M3 - Journal article
AN - SCOPUS:105023878413
SN - 2590-0889
VL - 8
JO - Infection Prevention in Practice
JF - Infection Prevention in Practice
IS - 1
M1 - 100496
ER -
