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. 2022 Oct 26;61(2):323-331.
doi: 10.1515/cclm-2022-0849. Print 2023 Jan 27.

New insights into SARS-CoV-2 Lumipulse G salivary antigen testing: accuracy, safety and short TAT enhance surveillance

Ada Aita  1 , Filippo Navaglia  2 , Stefania Moz  2 , Nicole Contran  2 , Francesco Barbaro  3 , Anna Maria Cattelan  3 , Andrea Padoan  1   2 , Chiara Cosma  2 , Diego Faggian  2 , Mario Plebani  1 , Daniela Basso  1   2
Affiliations

New insights into SARS-CoV-2 Lumipulse G salivary antigen testing: accuracy, safety and short TAT enhance surveillance

Ada Aita et al. Clin Chem Lab Med. .

Abstract

Objectives: The rapid, accurate and safe detection of SARS-CoV-2 is the key to improving surveillance and infection containment. The aim of the present study was to ascertain whether, after heat/chemical inactivation, SARS-CoV-2 N antigen chemiluminescence (CLEIA) assay in saliva remains a valid alternative to molecular testing.

Methods: In 2022, 139 COVID-19 inpatients and 467 healthcare workers were enrolled. In 606 self-collected saliva samples (Salivette), SARS-CoV-2 was detected by molecular (TaqPath rRT-PCR) and chemiluminescent Ag assays (Lumipulse G). The effect of sample pre-treatment (extraction solution-ES or heating) on antigen recovery was verified.

Results: Salivary SARS-CoV-2 antigen assay was highly accurate (AUC=0.959, 95% CI: 0.943-0.974), with 90% sensitivity and 92% specificity. Of the 254 antigen positive samples, 29 were false positives. We demonstrated that heterophilic antibodies could be a cause of false positive results. A significant antigen concentration decrease was observed after ES treatment (p=0.0026), with misclassification of 43 samples. Heat had a minimal impact, after treatment the correct classification of cases was maintained.

Conclusions: CLEIA SARS-CoV-2 salivary antigen provides accurate, timely and high-throughput results that remain accurate also after heat inactivation, thus ensuring a safer work environment. This supports the use of salivary antigen detection by CLEIA in surveillance programs.

Keywords: Lumipulse; N-antigen; SARS-CoV-2; chemiluminescence (CLEIA); saliva.

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