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10.1093/clinchem/hvab138

http://scihub22266oqcxt.onion/10.1093/clinchem/hvab138
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34240163!ä!34240163

suck abstract from ncbi


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pmid34240163      Clin+Chem 2021 ; 67 (11): 1545-1553
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  • Analytical Sensitivity and Specificity of Four Point of Care Rapid Antigen Diagnostic Tests for SARS-CoV-2 Using Real-Time Quantitative PCR, Quantitative Droplet Digital PCR, and a Mass Spectrometric Antigen Assay as Comparator Methods #MMPMID34240163
  • Karon BS; Donato LJ; Bridgeman AR; Blommel JH; Kipp B; Maus A; Renuse S; Kemp J; Madugundu AK; Vanderboom PM; Chavan S; Dasari S; Singh RJ; Grebe SK; Pandey A
  • Clin Chem 2021[Nov]; 67 (11): 1545-1553 PMID34240163show ga
  • BACKGROUND: We evaluated the analytical sensitivity and specificity of 4 rapid antigen diagnostic tests (Ag RDTs) for severe acute respiratory syndrome coronavirus 2, using reverse transcription quantitative PCR (RT-qPCR) as the reference method and further characterizing samples using droplet digital quantitative PCR (ddPCR) and a mass spectrometric antigen test. METHODS: Three hundred fifty (150 negative and 200 RT-qPCR positive) residual PBS samples were tested for antigen using the BD Veritor lateral flow (LF), ACON LF, ACON fluorescence immunoassay (FIA), and LumiraDx FIA. ddPCR was performed on RT-qPCR-positive samples to quantitate the viral load in copies/mL applied to each Ag RDT. Mass spectrometric antigen testing was performed on PBS samples to obtain a set of RT-qPCR-positive, antigen-positive samples for further analysis. RESULTS: All Ag RDTs had nearly 100% specificity compared to RT-qPCR. Overall analytical sensitivity varied from 66.5% to 88.3%. All methods detected antigen in samples with viral load >1 500 000 copies/mL RNA, and detected >/=75% of samples with viral load of 500 000 to 1 500 000 copies/mL. The BD Veritor LF detected only 25% of samples with viral load between 50 000 to 500 000 copies/mL, compared to 75% for the ACON LF device and >80% for LumiraDx and ACON FIA. The ACON FIA detected significantly more samples with viral load <50 000 copies/mL compared to the BD Veritor. Among samples with detectable antigen and viral load <50 000 copies/mL, sensitivity of the Ag RDT varied between 13.0% (BD Veritor) and 78.3% (ACON FIA). CONCLUSIONS: Ag RDTs differ significantly in analytical sensitivity, particularly at viral load <500 000 copies/mL.
  • |*Point-of-Care Testing[MESH]
  • |Antigens, Viral/*analysis[MESH]
  • |COVID-19 Testing/*methods[MESH]
  • |Humans[MESH]
  • |Mass Spectrometry[MESH]
  • |Real-Time Polymerase Chain Reaction/methods[MESH]
  • |SARS-CoV-2/immunology[MESH]
  • |Sensitivity and Specificity[MESH]


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