First external quality assurance of antibody diagnostic for SARS-new coronavirus

Matthias Niedrig; Katrin Leitmeyer; Wilina Lim; Malik Peiris; John S Mackenzie; Maria Zambon

doi:10.1016/j.jcv.2005.01.004

First external quality assurance of antibody diagnostic for SARS-new coronavirus

J Clin Virol. 2005 Sep;34(1):22-5. doi: 10.1016/j.jcv.2005.01.004.

Authors

Matthias Niedrig¹, Katrin Leitmeyer, Wilina Lim, Malik Peiris, John S Mackenzie, Maria Zambon

Affiliation

¹ Robert Koch-Institute, Nordufer 20, 13353 Berlin, Germany. niedrigm@rki.de

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.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Antibodies, Viral / blood*
Humans
Immunologic Tests / standards*
Quality Assurance, Health Care
Reproducibility of Results
Sensitivity and Specificity
Severe Acute Respiratory Syndrome / blood
Severe Acute Respiratory Syndrome / diagnosis*
Severe Acute Respiratory Syndrome / immunology
Severe acute respiratory syndrome-related coronavirus / immunology*

Substances

Antibodies, Viral