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All 101 samples with a subgenomic RNA positive result had a Lumipulse assay’s antigen positive result, whereas only 54 (58.1%) of remaining 93 samples had a Lumipulse assay’s antigen positive result. PPAs dropped to 55.6, 20.0, or 41.7% for samples with Ct values of 25–<30, respectively. Additional testing of RT-PCR positive samples for SARS-CoV-2 subgenomic RNA showed that, by three groups, PPA was 63.8% (44/69), 62.3% (33/53), or 33.3% (24/72), respectively. With a limit of detection of 1.2 × 10 4 SARS-CoV-2 RNA copies/mL, Lumipulse showed positive percent agreement (PPA) of 79.9% (155/194) and negative percent agreement of 99.3% (397/400), whereas PPAs were 100% for samples with Ct values of <18 or 18–<25 and 92.5% for samples with Ct values of 25–<30.

RT-PCR positive samples were assigned to diagnostic, screening, or monitoring groups of testing. We tested 594 nasopharyngeal swab samples from individuals with COVID-19 (RT-PCR cycle threshold values ≤ 40) or non-COVID-19 (Ct values >40) diagnoses. Compared to RT-PCR, lower performance of antigen detection assays, including the Lumipulse G SARS-CoV-2 Ag assay, may depend on specific testing scenarios.

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