The Lumipulse ® G SARS-CoV-2 Ag assay performance was evaluated on prospectively collected saliva and nasopharyngeal swabs (NPS) of recently ill in- and outpatients and according to the estimated viral load. Performances were calculated using RT-PCR positive NPS from patients with symptoms ≤ 7 days and RT-PCR negative NPS as gold standard. In addition, non-selected positive NPS were analyzed to assess the performances on various viral loads. This assay yielded a sensitivity of 93.1% on NPS and 71.4% on saliva for recently ill patients. For NPS with a viral load > 10 3 RNA copies/mL, sensitivity was 96.4%. A model established on our daily routine showed fluctuations of the performances depending on the epidemic trends but an overall good negative predictive value. Lumipulse ® G SARS-CoV-2 assay yielded good performance for an automated antigen detection assay on NPS. Using it for the detection of recently ill patients or to screen high-risk patients could be an interesting alternative to the more expensive RT-PCR.
【저자키워드】 COVID-19, SARS-CoV-2, Test, diagnostic, Model, assay, 【초록키워드】 Saliva, Symptom, RT-PCR, RNA, Nasopharyngeal swab, sensitivity, Viral load, Patient, automated, antigen detection, performance, Outpatient, Negative predictive value, gold standard, viral loads, positive, NPs, high-risk patient, the epidemic, fluctuation, analyzed, collected, addition, evaluated, calculated, ill patient, ill patients, 【제목키워드】 Population, target, trend, performance, Sample, Type,