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Public Health England assessed COVID-19 serological assay laboratory tests
Public Health England has carried out a number of rapid evaluations of commercial serological tests for their suitability for detecting the production of COVID-19 antibodies. Abbott SARS-CoV-2 IgG assay and the Roche Elecsys Anti-SARS-CoV-2 serology assay were evaluated by Public Health England.
Public Health England came to the following conclusion regarding Abbott SARS-CoV-2 IgG for the detection of anti-SARS-CoV-2 antibodies:
- Abbott SARS-CoV-2 is a highly specific test with a specificity of 99.73%. This is in line with the manufacturer's reported specificity of 99.63%
- Overall, the sensitivity of the assay was found to be 92.71% for all positive samples tested. The sensitivity of the assay for the samples collected < 14 days after the onset of the symptom was 85.71%, which was consistent with the sensitivity of the manufacturer to 86.36% early collected samples. However, for samples collected 14 days after the onset of the symptom, Public Health England found that the sensitivity of the assay was 93.90% lower than the sensitivity of 100% reported by the manufacturer. The sensitivity of the assay at ≥ 21 days after the onset of the symptom is 93.40% and 87.5% at > 40 days after the onset of the symptom
Public Health England came to the following conclusion regarding Roche Elecsys Anti-SARS-CoV-2 serology assay for the detection of anti-SARS-CoV-2 antibodies:
- the Elecsys Anti-SARS-CoV-2 assay is a very highly specific assay with a 100% specificity
- The sensitivity of the test ranged over time, rising from 75% for a period of ≤ 20 days to 100% sensitivity > 40 days after the onset of the symptom. The assay 's sensitivity from the onset of 21 days after the symptom is 87.7%. The assay 's overall sensitivity is 83.87%
- That is in line with the sensitivity data supplied by the manufacturer. The cut-off used by
- the manufacturer was found to be on the high side and could be reduced with very little
- loss in specificity
See the full details here.
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