Accepted for/Published in: JMIR Public Health and Surveillance
Date Submitted: Apr 11, 2023
Date Accepted: Oct 17, 2023
Trial of the Pluslife SARS-CoV-2 nucleic acid rapid test kit: A 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 assays of Wondfo. 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 assays of Wondfo.
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.
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