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. 2021 Apr 7;59(8):1468-1476.
doi: 10.1515/cclm-2021-0182. Print 2021 Jul 27.

Lumipulse G SARS-CoV-2 Ag assay evaluation using clinical samples from different testing groups

Giulia Menchinelli  1   2 , Licia Bordi  3 , Flora Marzia Liotti  1   2 , Ivana Palucci  1   2 , Maria Rosaria Capobianchi  3 , Giuseppe Sberna  3 , Eleonora Lalle  3 , Lucio Romano  2 , Giulia De Angelis  1   2 , Simona Marchetti  2 , Maurizio Sanguinetti  1   2 , Paola Cattani  1   2 , Brunella Posteraro  1   4
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Free article

Lumipulse G SARS-CoV-2 Ag assay evaluation using clinical samples from different testing groups

Giulia Menchinelli et al. Clin Chem Lab Med. .
Free article

Abstract

Objectives: 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.

Methods: We tested 594 nasopharyngeal swab samples from individuals with COVID-19 (RT-PCR cycle threshold [Ct] values ≤ 40) or non-COVID-19 (Ct values >40) diagnoses. RT-PCR positive samples were assigned to diagnostic, screening, or monitoring groups of testing.

Results: With a limit of detection of 1.2 × 104 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. By three groups, Lumipulse showed PPA of 87.0% (60/69), 81.1% (43/53), or 72.2% (52/72), respectively, whereas PPA was 100% for samples with Ct values of <18 or 18-<25, and was 94.4, 80.0, or 100% 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. PPAs dropped to 55.6, 20.0, or 41.7% for samples with Ct values of 25-<30, respectively. 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.

Conclusions: Lumipulse assay was highly sensitive in samples with low RT-PCR Ct values, implying repeated testing to reduce consequences of false-negative results.

Keywords: SARS-CoV-2; antigen detection; lumipulse assay; nasopharyngeal swab; testing group.

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