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suck abstract from ncbi


10.1136/bmj.m4262

http://scihub22266oqcxt.onion/10.1136/bmj.m4262
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33177070!7656121!33177070
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suck abstract from ncbi


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pmid33177070      BMJ 2020 ; 371 (ä): m4262
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  • Accuracy of UK Rapid Test Consortium (UK-RTC) "AbC-19 Rapid Test" for detection of previous SARS-CoV-2 infection in key workers: test accuracy study #MMPMID33177070
  • Mulchandani R; Jones HE; Taylor-Phillips S; Shute J; Perry K; Jamarani S; Brooks T; Charlett A; Hickman M; Oliver I; Kaptoge S; Danesh J; Di Angelantonio E; Ades AE; Wyllie DH
  • BMJ 2020[Nov]; 371 (ä): m4262 PMID33177070show ga
  • OBJECTIVE: To assess the accuracy of the AbC-19 Rapid Test lateral flow immunoassay for the detection of previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. DESIGN: Test accuracy study. SETTING: Laboratory based evaluation. PARTICIPANTS: 2847 key workers (healthcare staff, fire and rescue officers, and police officers) in England in June 2020 (268 with a previous polymerase chain reaction (PCR) positive result (median 63 days previously), 2579 with unknown previous infection status); and 1995 pre-pandemic blood donors. MAIN OUTCOME MEASURES: AbC-19 sensitivity and specificity, estimated using known negative (pre-pandemic) and known positive (PCR confirmed) samples as reference standards and secondly using the Roche Elecsys anti-nucleoprotein assay, a highly sensitive laboratory immunoassay, as a reference standard in samples from key workers. RESULTS: Test result bands were often weak, with positive/negative discordance by three trained laboratory staff for 3.9% of devices. Using consensus readings, for known positive and negative samples sensitivity was 92.5% (95% confidence interval 88.8% to 95.1%) and specificity was 97.9% (97.2% to 98.4%). Using an immunoassay reference standard, sensitivity was 94.2% (90.7% to 96.5%) among PCR confirmed cases but 84.7% (80.6% to 88.1%) among other people with antibodies. This is consistent with AbC-19 being more sensitive when antibody concentrations are higher, as people with PCR confirmation tended to have more severe disease whereas only 62% (218/354) of seropositive participants had had symptoms. If 1 million key workers were tested with AbC-19 and 10% had actually been previously infected, 84 700 true positive and 18 900 false positive results would be projected. The probability that a positive result was correct would be 81.7% (76.8% to 85.8%). CONCLUSIONS: AbC-19 sensitivity was lower among unselected populations than among PCR confirmed cases of SARS-CoV-2, highlighting the scope for overestimation of assay performance in studies involving only PCR confirmed cases, owing to "spectrum bias." Assuming that 10% of the tested population have had SARS-CoV-2 infection, around one in five key workers testing positive with AbC-19 would be false positives. STUDY REGISTRATION: ISRCTN 56609224.
  • |Betacoronavirus[MESH]
  • |COVID-19[MESH]
  • |COVID-19 Testing[MESH]
  • |Clinical Laboratory Techniques/*standards[MESH]
  • |Coronavirus Infections/*diagnosis[MESH]
  • |Female[MESH]
  • |Firefighters[MESH]
  • |Health Personnel[MESH]
  • |Humans[MESH]
  • |Immunoassay/*standards[MESH]
  • |Male[MESH]
  • |Pandemics[MESH]
  • |Pneumonia, Viral/*diagnosis[MESH]
  • |Police[MESH]
  • |Predictive Value of Tests[MESH]
  • |Reagent Kits, Diagnostic/standards[MESH]
  • |SARS-CoV-2[MESH]
  • |Sensitivity and Specificity[MESH]


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