Performance of the Diasorin SARS-CoV-2 antigen detection assay on the LIAISON XL

N Van der Moeren; V F Zwart; G Goderski; G T Rijkers; W van den Bijllaardt; J Veenemans; J A J W Kluytmans; S D Pas; A Meijer; J J Verweij; J L A N Murk; J J J M Stohr

doi:10.1016/j.jcv.2021.104909

Performance of the Diasorin SARS-CoV-2 antigen detection assay on the LIAISON XL

J Clin Virol. 2021 Aug:141:104909. doi: 10.1016/j.jcv.2021.104909. Epub 2021 Jul 8.

Authors

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

Affiliations

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.

Keywords: Antigen detection assay; Evaluation; SARS-CoV-2.

MeSH terms

COVID-19*
Humans
Nasopharynx
SARS-CoV-2*
Sensitivity and Specificity