We aimed to evaluate the LIAISON ® SARS-CoV-2 antigen assay (DiaSorin), comparing its performance to real-time polymerase chain reaction (RT-PCR) for the detection of SARS-CoV-2 RNA. 182 (110 PCR-positive and 72 PCR-negative) nasopharyngeal swab samples were taken for the detection of SARS-CoV-2. RT-PCR and antigen assay were performed using the same material. The sensitivity and specificity of the antigen assay were calculated for different cut-offs, with RT-PCR serving as the reference method. Stored clinical samples that were positive for other respiratory viruses were tested to evaluate cross-reactivity. One third (33/110, 30%) were falsely classified as negative, while no false positives were found using the 200 TCID 50 /mL cut-off for the SARS-CoV-2 antigen as proposed by the manufacturer. This corresponded to a sensitivity of 70% (60–78%) and a specificity of 100% (94–100%). Lowering the cut-off for positivity of the antigen assay to 22.79 or 57.68 TCID 50 /mL increased the sensitivity of the method, reaching a sensitivity of 92% (85–96%) vs. 79% (70–86%) and a specificity of 81% (69–89%) vs. 99% (91–100%), respectively. The antigen assay reliably detected samples with high SARS-CoV-2 viral loads (≥10 6 copies SARS-CoV-2/mL), while it cannot differentiate between negative and low positive samples. Cross-reactivity toward other respiratory viruses was not detected.
【저자키워드】 COVID-19, SARS-CoV-2, RT-PCR, Antigen, LIAISON® SARS-CoV-2 antigen assay, 【초록키워드】 cross-reactivity, sensitivity, specificity, Sensitivity and specificity, SARS-CoV-2 RNA, SARS-CoV-2 antigen, False positive, LIAISON, DiaSorin, PCR-positive, SARS-CoV-2 viral load, lowering, cut-off, positive, reference method, PCR-negative, nasopharyngeal swab sample, cut-offs, TCID, polymerase chain, clinical sample, tested, performed, evaluate, calculated, other respiratory virus, the SARS-CoV-2, 【제목키워드】 performance, LIAISON,