Accepted for/Published in: JMIR Public Health and Surveillance
Date Submitted: Apr 11, 2023
Date Accepted: Oct 17, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Quickly screening people for COVID-19 with the Pluslife SARS-CoV-2 nucleic acid rapid test kit: A multicenter prospective cohort study
ABSTRACT
Background:
In response to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemic, a convenient, rapid and sensitive diagnostic method for coronavirus disease 2019 (COVID-19) is crucial for patient control and timely treatment.
Objective:
This study aimed to validate the detection of SARS-CoV-2 with the Pluslife SARS-CoV-2 rapid test kit developed based on a novel thermostatic amplification technique (RNase hybridization-assisted amplification (RHAM)).
Methods:
From November 25 to December 8, 2022, suspected or confirmed COVID-19 candidates, close contacts and health care workers at high risk of exposure were recruited from three hospitals and one university. Respiratory specimens were collected for the Pluslife SARS-CoV-2 rapid test and compared with reverse transcription-quantitative polymerase chain reaction (RT‒qPCR) and antigen (Wondfo) assays. Samples were obtained from 1447 cases from three “ready-to-test” scenarios in which samples were collected on site and tested immediately and 503 cases from the “freeze‒thaw test” scenario in which samples were collected and then frozen and thawed for testing.
Results:
The Pluslife SARS-CoV-2 rapid test for the “ready-to-test” scenario was validated to be accurate (overall sensitivity and specificity of 98.26% and 99.32%, respectively) and diagnostically useful (positive and negative likelihood ratios of 145.45 and 0.02, respectively). The Pluslife SARS-CoV-2 rapid test for the “freeze‒thaw test” scenario was validated as accurate (overall sensitivity and specificity of 71.18% and 98.60%, respectively) and diagnostically useful (positive and negative likelihood ratios of 51.01 and 0.67, respectively).This means that the time efficiency and accuracy of the results in a “ready-to-test” scenario achieved the best results. The time required from sample preparation to the result of the Pluslife SARS-CoV-2 rapid test was less than 10 to 38 minutes, which was substantially shorter than that of RT‒qPCR (at least 90 minutes). In addition, the diagnostic efficacy of the Pluslife SARS-CoV-2 rapid test was better than that of the antigen (Wondfo) test.
Conclusions:
Thus, the developed RHAM assay provided rapid, sensitive and convenient detection of SARS-CoV-2 infection and may be useful for enhanced detection of COVID-19 in homes, high-risk industries and hospitals.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.