N Van der Moeren1, V F Zwart2, G Goderski3, G T Rijkers4, W van den Bijllaardt5, J Veenemans6, J A J W Kluytmans7, S D Pas5, A Meijer3, J J Verweij8, J L A N Murk8, J J J M Stohr2. 1. St. Elisabeth-Tweesteden Hospital, Hilvarenbeekse Weg 60, Tilburg, the Netherlands; Amphia Hospital, Molengracht 21, 4818 CK Breda, the Netherlands. Electronic address: n.vdmoeren@gmail.com. 2. St. Elisabeth-Tweesteden Hospital, Hilvarenbeekse Weg 60, Tilburg, the Netherlands; Amphia Hospital, Molengracht 21, 4818 CK Breda, the Netherlands. 3. National Institute for Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, 3721 MA Bilthoven, the Netherlands. 4. St. Elisabeth-Tweesteden Hospital, Hilvarenbeekse Weg 60, Tilburg, the Netherlands; Admiral De Ruyter Hospital, 's-Gravenpolderseweg 114, 4462 RA Goes, the Netherlands. 5. Amphia Hospital, Molengracht 21, 4818 CK Breda, the Netherlands. 6. Admiral De Ruyter Hospital, 's-Gravenpolderseweg 114, 4462 RA Goes, the Netherlands. 7. Amphia Hospital, Molengracht 21, 4818 CK Breda, the Netherlands; Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Heidelberglaan 100, 3584 CX Utrecht University, the Netherlands. 8. St. Elisabeth-Tweesteden Hospital, Hilvarenbeekse Weg 60, Tilburg, the Netherlands.
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 × 102 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.
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 DiasorinSARS-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 × 102 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.
Authors: Gema Fernández-Rivas; Jaume Barallat; Victoria Gonzalez; Silvia Martinez; Antoni E Bordoy; Laura Jimenez; Cristina Casañ; Ignacio Blanco Journal: Front Public Health Date: 2022-01-07