Abstract
Rapid antigen tests (RATs) for COVID-19 based on lateral flow immunoassays are useful for rapid diagnosis in a variety of settings. Although many kinds of RATs are available, their respective sensitivity has not been compared. Here, we examined the sensitivity of 27 RATs available in Japan for the detection of the SARS-CoV-2 delta variant. All of the RATs tested detected the delta variant albeit with different sensitivities. Nine RATs (ESPLINE SARS-CoV-2, ALSONIC COVID-19 Ag, COVID-19 and Influenza A+B Antigen Combo Rapid Test, ImmunoArrow SARS-CoV-2, Fuji Dri-chem immuno AG cartridge COVID-19 Ag, 2019-nCoV Ag rapid detection kit, Saliva SARS-CoV-2(2019-nCoV) Antigen Test Kit, and Rabliss SARS-CoV-2 antigen detection kit COVID19 AG) showed superior sensitivity to the isolated delta variant. Although actual clinical specimens were not examined, the detection level of most of the RATs was 7500 pfu, indicating that individuals whose test samples contained less virus than that would be considered negative. Therefore, it is important to bear in mind that RATs may miss individuals shedding low levels of infectious virus.
Highlights
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19)
rapid antigen tests (RATs) were divided into three types based on their format: (i) well format, in which the lysed sample is dropped into the well and the reaction occurs inside a covered plastic body; (ii) test strip format, in which a test strip is soaked in lysis buffer containing the specimen or dipped in the specimen and soaked in the lysis buffer, and the reaction occurs on the strip; or (iii) pen format, in which a test strip is dipped into the specimen and the reaction occurs on the strip. “+ Analyzer” means that these RATs need an analyzer to evaluate the result
We evaluated the sensitivity for the SARS-CoV-2 delta variant of 27 RATs available in Japan in September 2021
Summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). To reduce the burden by SARS-CoV-2, nonpharmaceutical interventions, vaccination, and patient treatment are required. For mitigation of infectious diseases, early and accurate patient diagnosis is essential. For COVID-19 diagnosis, reverse transcription-quantitative PCR (RT-qPCR) using upper respiratory swabs or saliva has become the gold standard [1] because it possesses high sensitivity and specificity against the target agent. RT-qPCR is usually not available in local clinics where patients who suspect they have COVID-19 go first. The collected specimens are transported to sites with RT-qPCR capability, resulting in delayed test results. To obtain results at local clinics, rapid antigen tests (RATs) for COVID-19 have become popular because RATs require just 15–30 min to give results. RATs are helpful as screening tests for asymptomatic individuals since model analyses showed that population screening tests should prioritize frequency and turnaround time over sensitivity [2,3]
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