Abstract
Background: The current reference standard to diagnose a SARS-CoV-2 infection is real-time reverse transcriptase polymerase chain reaction (RT-PCR). This test poses substantial challenges for large-scale community testing, especially with respect to the long turnaround times. SARS-CoV-2 antigen tests are an alternative, but typically use a lateral flow assay format rendering them less suitable for analysis of large numbers of samples.
Methods: We conducted an evaluation of the Diasorin SARS-CoV-2 antigen detection assay (DAA) compared to real-time RT-PCR (Abbott). The study was performed on 248 (74 qRT-PCR positive, 174 qRT-PCR negative) clinical combined oro-nasopharyngeal samples of individuals with COVID-19-like symptoms obtained at a Municipal Health Service test centre. In addition, we evaluated the analytical performance of DAA with a 10-fold dilution series of SARS-CoV-2 containing culture supernatant and compared it with the lateral flow assay SARS-CoV-2 Roche/SD Biosensor Rapid Antigen test (RRA).
Results: The DAA had an overall specificity of 100% (95%CI 97.9%-100%) and sensitivity of 73% (95%CI 61.3%-82.7%) for the clinical samples. Sensitivity was 86% (CI95% 74.6%-93.3%) for samples with Ct-value below 30. Both the DAA and RRA detected SARS-CoV-2 up to a dilution containing 5.2 × 10 2 fifty-percent-tissue-culture-infective-dose (TCID50)/ml.
Discussion: The DAA performed adequately for clinical samples with a Ct-value below 30. Test performance may be further optimised by lowering the relative light unit (RLU) threshold for positivity assuming the in this study used pre-analytical protocol . The test has potential for use as a diagnostic assay for symptomatic community-dwelling individuals early after disease onset in the context of disease control.
Keywords: Antigen detection assay; Evaluation; SARS-CoV-2.
【저자키워드】 SARS-CoV-2, Evaluation, Antigen detection assay, 【초록키워드】 SARS-CoV-2, protocol, SARS-COV-2 infection, qRT-PCR, Test, diagnostic, Symptom, RT-PCR, lateral flow, biosensor, polymerase chain reaction, clinical samples, sensitivity, specificity, Reverse transcriptase polymerase chain reaction, Culture, symptomatic, disease control, Rapid, Community, Ct-value, SARS-CoV-2 antigen, real-time RT-PCR, threshold, disease, reference standard, diagnose, Analysis, disease onset, Abbott, Dilution, reverse transcriptase, Chain Reaction, Real-time reverse transcriptase polymerase chain reaction, 95%CI, tissue, alternative, individual, culture supernatant, positive, turnaround times, service, polymerase chain, real-time reverse transcriptase, clinical sample, performed, addition, evaluated, conducted, was performed, dilution sery, less suitable, RLU, 【제목키워드】 SARS-CoV-2 antigen, performance, LIAISON,