Abstract 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. We assessed a new point‐of‐care test that uses the quantitative reverse transcription polymerase chain reaction (qRT‐PCR). This test reduces the extra RNA purification step, allowing much faster results. We compared the results of this test to those of the traditional qRT‐PCR test.
【저자키워드】 COVID‐19, SARS‐CoV‐2, POCT, qRT‐PCR, quenching probe, 【초록키워드】 coronavirus disease, coronavirus, Infection, risk, Infectious disease, COVID‐19, SARS‐CoV‐2, global pandemic, sensitivity, Contamination, Patient, reverse transcription, Japanese, disease, Quantitative, questionnaire, Detection limit, acute respiratory syndrome, patient triage, clinical settings, total score, SARS‐CoV‐2 infection, reproducibility, positive, RNA purification, polymerase chain, Result, Sample, significantly, evaluated, faster, reduce, quantified, multiple method, point‐of‐care test, RNA copy number, were assessed, 【제목키워드】 coronavirus, reverse transcription, Quantitative, acute respiratory syndrome, point‐of‐care, polymerase chain,