title: First external quality assurance of antibody diagnostic for SARS-new coronavirus.
abstract: To confirm an infection with the new coronavirus (SARS-CoV) causing the severe acute respiratory syndrome (SARS) diagnostic assays for detection of SARS-CoV specific antibody are necessary. To evaluate the diagnostic performance of laboratories an external quality assurance (EQA) study was performed in 2004. Participating laboratories (9/20) correctly detected anti-SARS antibodies in serum samples without false positive results in an immunofluorescence assay. In contrast, only 4/13 laboratories detected most of the anti-SARS antibody positive samples without false positive results using enzyme immunoassays (EIA) and/or immunoblot. The overall results clearly demonstrate that serological diagnosis of SARS-CoV remains at an early stage of development, with further technical improvements required, particularly with respect to the use of SARS specific EIAs.
authors.affiliation: Robert Koch-Institute, Nordufer 20, 13353 Berlin, Germany. niedrigm@rki.de
authors.forename: Matthias
authors.initials: M
authors.lastname: Niedrig
authors.forename: Katrin
authors.initials: K
authors.lastname: Leitmeyer
authors.forename: Wilina
authors.initials: W
authors.lastname: Lim
authors.forename: Malik
authors.initials: M
authors.lastname: Peiris
authors.forename: John S
authors.initials: JS
authors.lastname: Mackenzie
authors.forename: Maria
authors.initials: M
authors.lastname: Zambon
mesh_terms: D000914:Antibodies, Viral / Q000097:blood*; D006801:Humans; D007159:Immunologic Tests / Q000592:standards*; D011785:Quality Assurance, Health Care; D015203:Reproducibility of Results; D045473:Severe acute respiratory syndrome-related coronavirus / Q000276:immunology*; D012680:Sensitivity and Specificity; D045169:Severe Acute Respiratory Syndrome / Q000097:blood / Q000175:diagnosis* / Q000276:immunology
chemical_list: D000914:Antibodies, Viral