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10.1016/j.jcv.2021.104782

http://scihub22266oqcxt.onion/10.1016/j.jcv.2021.104782
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suck abstract from ncbi


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pmid33711691      J+Clin+Virol 2021 ; 137 (ä): 104782
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  • Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR #MMPMID33711691
  • Olearo F; Norz D; Heinrich F; Sutter JP; Roedl K; Schultze A; Wiesch JSZ; Braun P; Oestereich L; Kreuels B; Wichmann D; Aepfelbacher M; Pfefferle S; Lutgehetmann M
  • J Clin Virol 2021[Apr]; 137 (ä): 104782 PMID33711691show ga
  • BACKGROUND: SARS-CoV-2 molecular diagnostics is facing material shortages and long turnaround times due to exponential increase of testing demand. OBJECTIVE: We evaluated the analytic performance and handling of four rapid Antigen Point of Care Tests (AgPOCTs) I-IV (Distributors: (I) Roche, (II) Abbott, (III) MEDsan and (IV) Siemens). METHODS: 100 RT-PCR negative and 84 RT-PCR positive oropharyngeal swabs were prospectively collected and used to determine performance and accuracy of these AgPOCTs. Handling was evaluated by 10 healthcare workers/users through a questionnaire. RESULTS: The median duration from symptom onset to sampling was 6 days (IQR 2-12 days). The overall respective sensitivity were 49.4 % (CI95 %: 38.9-59.9), 44.6 % (CI95 %: 34.3-55.3), 45.8 % (CI95 %: 35.5-56.5) and 54.9 % (CI95 %: 43.4-65.9) for tests I, II, III and IV, respectively. In the high viral load subgroup (containing >10(6) copies of SARS-CoV-2 /swab, n = 26), AgPOCTs reached sensitivities of 92.3 % or more (range 92.3 %-100 %). Specificity was 100 % for tests I, II (CI95 %: 96.3-100 for both tests) and IV (CI95 %: 96.3-100) and 97 % (CI95 %: 91.5-98.9) for test III. Regarding handling, test I obtained the overall highest scores, while test II was considered to have the most convenient components. Of note, users considered all assays, with the exception of test I, to pose a significant risk for contamination by drips or spills. DISCUSSION: Besides some differences in sensitivity and handling, all four AgPOCTs showed acceptable performance in high viral load samples. However, due to the significantly lower sensitivity compared to RT-qPCR, a careful consideration of pro and cons of AgPOCT has to be taken into account before clinical implementation.
  • |Antigens, Viral/*analysis[MESH]
  • |COVID-19 Nucleic Acid Testing/*methods[MESH]
  • |COVID-19 Testing/*methods[MESH]
  • |COVID-19/*diagnosis/immunology/virology[MESH]
  • |Humans[MESH]
  • |Nasopharynx/virology[MESH]
  • |Oropharynx/virology[MESH]
  • |Point-of-Care Testing[MESH]
  • |SARS-CoV-2/genetics/immunology/*isolation & purification[MESH]
  • |Sensitivity and Specificity[MESH]
  • |Serologic Tests/methods[MESH]
  • |Specimen Handling/methods[MESH]


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