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10.1016/S1473-3099(21)00132-8

http://scihub22266oqcxt.onion/10.1016/S1473-3099(21)00132-8
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33773618!7993929!33773618
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suck abstract from ncbi


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pmid33773618      Lancet+Infect+Dis 2021 ; 21 (8): 1089-1096
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  • Performance and operational feasibility of antigen and antibody rapid diagnostic tests for COVID-19 in symptomatic and asymptomatic patients in Cameroon: a clinical, prospective, diagnostic accuracy study #MMPMID33773618
  • Boum Y; Fai KN; Nikolay B; Mboringong AB; Bebell LM; Ndifon M; Abbah A; Essaka R; Eteki L; Luquero F; Langendorf C; Mbarga NF; Essomba RG; Buri BD; Corine TM; Kameni BT; Mandeng N; Fanne M; Bisseck AZ; Ndongmo CB; Eyangoh S; Hamadou A; Ouamba JP; Koku MT; Njouom R; Claire OM; Esso L; Epee E; Mballa GAE
  • Lancet Infect Dis 2021[Aug]; 21 (8): 1089-1096 PMID33773618show ga
  • BACKGROUND: Real-time PCR is recommended to detect SARS-CoV-2 infection. However, PCR availability is restricted in most countries. Rapid diagnostic tests are considered acceptable alternatives, but data are lacking on their performance. We assessed the performance of four antibody-based rapid diagnostic tests and one antigen-based rapid diagnostic test for detecting SARS-CoV-2 infection in the community in Cameroon. METHODS: In this clinical, prospective, diagnostic accuracy study, we enrolled individuals aged at least 21 years who were either symptomatic and suspected of having COVID-19 or asymptomatic and presented for screening. We tested peripheral blood for SARS-CoV-2 antibodies using the Innovita (Biological Technology; Beijing, China), Wondfo (Guangzhou Wondfo Biotech; Guangzhou, China), SD Biosensor (SD Biosensor; Gyeonggi-do, South Korea), and Runkun tests (Runkun Pharmaceutical; Hunan, China), and nasopharyngeal swabs for SARS-CoV-2 antigen using the SD Biosensor test. Antigen rapid diagnostic tests were compared with Abbott PCR testing (Abbott; Abbott Park, IL, USA), and antibody rapid diagnostic tests were compared with Biomerieux immunoassays (Biomerieux; Marcy l'Etoile, France). We retrospectively tested two diagnostic algorithms that incorporated rapid diagnostic tests for symptomatic and asymptomatic patients using simulation modelling. FINDINGS: 1195 participants were enrolled in the study. 347 (29%) tested SARS-CoV-2 PCR-positive, 223 (19%) rapid diagnostic test antigen-positive, and 478 (40%) rapid diagnostic test antibody-positive. Antigen-based rapid diagnostic test sensitivity was 80.0% (95% CI 71.0-88.0) in the first 7 days after symptom onset, but antibody-based rapid diagnostic tests had only 26.8% sensitivity (18.3-36.8). Antibody rapid diagnostic test sensitivity increased to 76.4% (70.1-82.0) 14 days after symptom onset. Among asymptomatic participants, the sensitivity of antigen-based and antibody-based rapid diagnostic tests were 37.0% (27.0-48.0) and 50.7% (42.2-59.1), respectively. Cohen's kappa showed substantial agreement between Wondfo antibody rapid diagnostic test and gold-standard ELISA (kappa=0.76; sensitivity 0.98) and between Biosensor and ELISA (kappa=0.60; sensitivity 0.94). Innovita (kappa=0.47; sensitivity 0.93) and Runkun (kappa=0.43; sensitivity 0.76) showed moderate agreement. An antigen-based retrospective algorithm applied to symptomatic patients showed 94.0% sensitivity and 91.0% specificity in the first 7 days after symptom onset. For asymptomatic participants, the algorithm showed a sensitivity of 34% (95% CI 23.0-44.0) and a specificity of 92.0% (88.0-96.0). INTERPRETATION: Rapid diagnostic tests had good overall sensitivity for diagnosing SARS-CoV-2 infection. Rapid diagnostic tests could be incorporated into efficient testing algorithms as an alternative to PCR to decrease diagnostic delays and onward viral transmission. FUNDING: Medecins Sans Frontieres WACA and Medecins Sans Frontieres OCG. TRANSLATIONS: For the French and Spanish translations of the abstract see Supplementary Materials section.
  • |*Asymptomatic Infections[MESH]
  • |*COVID-19 Serological Testing[MESH]
  • |Antibodies, Viral/*blood[MESH]
  • |Antigens, Viral/*analysis[MESH]
  • |COVID-19/*diagnosis[MESH]
  • |Feasibility Studies[MESH]
  • |Humans[MESH]
  • |Prospective Studies[MESH]
  • |SARS-CoV-2/*immunology[MESH]


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