First external quality assurance of antibody diagnostic for SARS-new coronavirus. |
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Authors: | Matthias Niedrig Katrin Leitmeyer Wilina Lim Malik Peiris John S Mackenzie Maria Zambon |
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Institution: | Robert Koch-Institute, Nordufer 20, 13353 Berlin, Germany. niedrigm@rki.de |
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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. |
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