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10.1515/cclm-2021-0182

http://scihub22266oqcxt.onion/10.1515/cclm-2021-0182
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suck abstract from ncbi


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pmid33823089      Clin+Chem+Lab+Med 2021 ; 59 (8): 1468-1476
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  • Lumipulse G SARS-CoV-2 Ag assay evaluation using clinical samples from different testing groups #MMPMID33823089
  • Menchinelli G; Bordi L; Liotti FM; Palucci I; Capobianchi MR; Sberna G; Lalle E; Romano L; De Angelis G; Marchetti S; Sanguinetti M; Cattani P; Posteraro B
  • Clin Chem Lab Med 2021[Jul]; 59 (8): 1468-1476 PMID33823089show ga
  • 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) diagnoses. RT-PCR positive samples were assigned to diagnostic, screening, or monitoring groups of testing. RESULTS: With a limit of detection of 1.2 x 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. 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.
  • |COVID-19 Nucleic Acid Testing[MESH]
  • |COVID-19/*diagnosis/virology[MESH]
  • |Humans[MESH]
  • |Limit of Detection[MESH]
  • |Nasopharynx/virology[MESH]
  • |RNA, Viral/*analysis[MESH]
  • |Reagent Kits, Diagnostic[MESH]
  • |Reverse Transcriptase Polymerase Chain Reaction/*methods[MESH]
  • |SARS-CoV-2/*genetics/isolation & purification[MESH]


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