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10.1002/jcla.23906

http://scihub22266oqcxt.onion/10.1002/jcla.23906
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34251047!8373346!34251047
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suck abstract from ncbi


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pmid34251047      J+Clin+Lab+Anal 2021 ; 35 (8): e23906
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  • Diagnostic performance of the Elecsys SARS-CoV-2 antigen assay in the clinical routine of a tertiary care hospital: Preliminary results from a single-center evaluation #MMPMID34251047
  • Mueller T; Kompatscher J; La Guardia M
  • J Clin Lab Anal 2021[Aug]; 35 (8): e23906 PMID34251047show ga
  • BACKGROUND: This report describes a manufacturer-independent evaluation of the diagnostic accuracy of the Elecsys SARS-CoV-2 antigen assay from Roche Diagnostics in a tertiary care setting. METHODS: In this single-center study, we used nasopharyngeal swabs from 403 cases from the emergency department and intensive care unit of our hospital. The reference standard for detecting SARS-CoV-2 was the reverse-transcription polymerase chain reaction (RT-PCR) assay. Cycle threshold (Ct) values were recorded for positive RT-PCR assays. The index test was the Elecsys SARS-CoV-2 antigen assay. This electrochemiluminescence immunoassay produces results as cutoff index (COI) values, with values >/=1.00 being reported as positive. RESULTS: Of the 403 cases, 47 showed positive results in RT-PCR assays. Of the 47 RT-PCR-positive cases, 12 showed positive results in the antigen assay. Of the 356 RT-PCR-negative cases, all showed negative results in the antigen assay. Thus, the antigen assay showed a sensitivity of 26% (95% CI, 14%-40%) and specificity of 100% (95% CI, 99%-100%). Analysis of the relationship between Ct values and COI values in the 47 RT-PCR-positive cases showed a correlation coefficient of -0.704 (95% CI, -0.824 to -0.522). The true-positive rate of the antigen assay for Ct values of 15-24.9, 25-29.9, 30-34.9, and 35-39.9 was 100%, 44%, 8%, and 6%, respectively. CONCLUSIONS: The Elecsys SARS-CoV-2 antigen assay has a low sensitivity for detecting SARS-CoV-2 from nasopharyngeal swabs. Hence, we decided to not use this assay in the clinical routine of our hospital.
  • |Antigens, Viral/analysis[MESH]
  • |COVID-19 Nucleic Acid Testing[MESH]
  • |COVID-19 Serological Testing/*methods[MESH]
  • |COVID-19/diagnosis/virology[MESH]
  • |Humans[MESH]
  • |Intensive Care Units[MESH]
  • |Nasopharynx/virology[MESH]
  • |SARS-CoV-2/immunology[MESH]
  • |Sensitivity and Specificity[MESH]
  • |Tertiary Care Centers[MESH]


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