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10.1016/j.jiac.2021.07.006

http://scihub22266oqcxt.onion/10.1016/j.jiac.2021.07.006
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suck abstract from ncbi


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pmid34294528      J+Infect+Chemother 2021 ; 27 (10): 1493-1497
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  • The evaluation of a novel digital immunochromatographic assay with silver amplification to detect SARS-CoV-2 #MMPMID34294528
  • Kurihara Y; Kiyasu Y; Akashi Y; Takeuchi Y; Narahara K; Mori S; Takeshige T; Notake S; Ueda A; Nakamura K; Ishikawa H; Suzuki H
  • J Infect Chemother 2021[Oct]; 27 (10): 1493-1497 PMID34294528show ga
  • INTRODUCTION: Rapid antigen tests are convenient for diagnosing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); however, they have lower sensitivities than nucleic acid amplification tests. In this study, we evaluated the diagnostic performance of Quick Chaser((R)) Auto SARS-CoV-2, a novel digital immunochromatographic assay that is expected to have higher sensitivity than conventional antigen tests. METHODS: A prospective observational study was conducted between February 8 and March 24, 2021. We simultaneously obtained two nasopharyngeal samples, one for evaluation with the QuickChaser((R)) Auto SARS-CoV-2 antigen test and the other for assessment with reverse transcription PCR (RT-PCR), considered the gold-standard reference test. The limit of detection (LOD) of the new antigen test was compared with those of four other commercially available rapid antigen tests. RESULTS: A total of 1401 samples were analyzed. SARS-CoV-2 was detected by reference RT-PCR in 83 (5.9%) samples, of which 36 (43.4%) were collected from symptomatic patients. The sensitivity, specificity, positive predictive value, and negative predictive value were 74.7% (95% confidence interval (CI): 64.0-83.6%), 99.8% (95% CI: 99.5-100%), 96.9% (95% CI: 89.2-99.6%), and 98.4% (95% CI: 97.6-99.0%), respectively. When limited to samples with a cycle threshold (Ct) < 30 or those from symptomatic patients, the sensitivity increased to 98.3% and 88.9%, respectively. The QuickChaser((R)) Auto SARS-CoV-2 detected 34-120 copies/test, which indicated greater sensitivity than the other rapid antigen tests. CONCLUSIONS: QuickChaser((R)) Auto SARS-CoV-2 showed sufficient sensitivity and specificity in clinical samples of symptomatic patients. The sensitivity was comparable to RT-PCR in samples with Ct < 30.
  • |*COVID-19[MESH]
  • |*SARS-CoV-2[MESH]
  • |Antigens, Viral[MESH]
  • |Humans[MESH]
  • |Immunoassay[MESH]
  • |Sensitivity and Specificity[MESH]


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