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10.1093/labmed/lmab033

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33928384!8135470!33928384
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suck abstract from ncbi


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pmid33928384      Lab+Med 2021 ; 52 (6): e154-e158
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  • Utility of Antigen-Based Rapid Diagnostic Test for Detection of SARS-CoV-2 Virus in Routine Hospital Settings #MMPMID33928384
  • Thakur P; Saxena S; Manchanda V; Rana N; Goel R; Arora R
  • Lab Med 2021[Nov]; 52 (6): e154-e158 PMID33928384show ga
  • OBJECTIVE: This study aims to evaluate the performance of an antigen-based rapid diagnostic test (RDT) for the detection of the SARS-CoV-2 virus. METHODS: A cross-sectional study was conducted on 677 patients. Two nasopharyngeal swabs and 1 oropharyngeal swab were collected from patients. The RDT was performed onsite by a commercially available immune-chromatographic assay on the nasopharyngeal swab. The nasopharyngeal and oropharyngeal swabs were examined for SARS-CoV-2 RNA by real-time reverse-transcription quantitative polymerase chain reaction (RT-qPCR) assay. RESULTS: The overall sensitivity of the SARS-CoV-2 RDT was 34.5% and the specificity was 99.8%. The positive predictive value and negative predictive value of the test were 96.6% and 91.5%, respectively. The detection rate of RDT in RT-qPCR positive results was high (45%) for cycle threshold values <25. CONCLUSION: The utility of RDT is in diagnosing symptomatic patients and may not be particularly suited as a screening tool for patients with low viral load. The low sensitivity of RDT does not qualify its use as a single test in patients who test negative; RT-qPCR continues to be the gold standard test.
  • |Adolescent[MESH]
  • |Aged[MESH]
  • |Aged, 80 and over[MESH]
  • |Antigens, Viral/*genetics[MESH]
  • |Automation, Laboratory[MESH]
  • |COVID-19 Serological Testing/methods/*standards[MESH]
  • |COVID-19/*diagnosis/immunology/virology[MESH]
  • |Chromatography, Affinity/*methods[MESH]
  • |Cross-Sectional Studies[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Nasopharynx/virology[MESH]
  • |Oropharynx/virology[MESH]
  • |RNA, Viral/*genetics[MESH]
  • |Reagent Kits, Diagnostic[MESH]
  • |Reverse Transcriptase Polymerase Chain Reaction/methods[MESH]
  • |SARS-CoV-2/*genetics/immunology[MESH]
  • |Sensitivity and Specificity[MESH]


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