Evaluation of a new point‐of‐care quantitative reverse transcription polymerase chain test for detecting severe acute respiratory syndrome coronavirus 2

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection is rapidly spreading worldwide, and the resultant disease, coronavirus disease (COVID‐19), has become a global pandemic. Although there are multiple methods for detecting SARS‐CoV‐2, there are some issues with such tests, including long processing time, expense, low sensitivity, complexity, risk of contamination, and user friendly. This study evaluated the reproducibility and usability of a new point‐of‐care test (POCT) using real‐time quantitative reverse transcription polymerase chain reaction (qRT‐PCR) for detecting SARS‐CoV‐2. METHODS: Samples from 96 patients with suspected SARS‐CoV‐2 infection were assessed using the real‐time qRT‐PCR‐based POCT and the conventional real‐time qRT‐PCR method based on the Japanese National Institute of Infectious Diseases guidelines (registration number: jRCT1032200025). RESULTS: The real‐time qRT‐PCR‐based POCT had a positive agreement rate of 90.0% (18/20), a negative agreement rate of 100% (76/76), and a total agreement rate of 97.9% (94/96), and the significantly high score of questionnaire survey (total score p < 0.0001). In the two cases in which real‐time qRT‐PCR‐based POCT results did not match conventional real‐time qRT‐PCR test results, the SARS‐CoV‐2 RNA copy numbers were 8.0 copies per test in one case and below the detection limit in the other case when quantified using conventional real‐time qRT‐PCR. All patients could be triaged within 1 day using the real‐time qRT‐PCR‐based POCT without invalid reports. CONCLUSIONS: The real‐time qRT‐PCR‐based POCT not only had high reproducibility and useability but also allowed rapid patient triage. Therefore, it may be helpful in clinical settings.