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Roche’s Anti-SARS-CoV-2 serology assay was tested between 5 and 7 May by the PHE diagnostic support group,2 which used 93 serum samples from convalescent patients and 472 negative samples Sheila Bird, formerly programme leader at the MRC Biostatistics Unit at the University of Cambridge and current member of the Royal Statistical Society’s Covid-19 Taskforce, told The BMJ, “PHE’s evaluation does not meet the standards that would be expected for confirmation that these tests meet the criteria set by UK’s Medicines and Healthcare Products Regulatory Authority for accreditation as point-of-care tests ” BMJ 2020;369: m2000 10 1136/bmj m2000 32423976 2 Evaluation of Roche Elecsys Anti- SARS-CoV-2 serology assay for the detection of anti-SARS-CoV-2 antibodies https://assets publishing service gov uk/government/uploads/system/uploads/attachment_data/file/886159/PHE_Evaluation_of_Roche_Elecsys_anti_SARS_CoV_2 pdf
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Covid-19: Two antibody tests are “highly specific” but vary in sensitivity, evaluations find
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