Proficiency testing for the detection of anti-citrullinated protein antibody in China

Abstract Background Anti-citrullinated protein antibodies (ACPAs) are important for the detection of rheumatoid arthritis (RA). There are many laboratories to detect it in their routine work, but their performance is not displayed in China. To examine the performance of ACPA assays from all laboratories, it is necessary to organize a laboratory proficiency test (PT). Methods A panel of 5 samples, including 4 positive and 1 negative, was produced by the National Center for Clinical Laboratories, using serum derived from patients, then distributed to 271 clinical laboratories. Quantitative and qualitative results reported by the participating laboratories were compared. Results Overall, 80.97% (200/247) of the laboratories had eligible PT scores. Of the kits used, most ELISA and chemiluminescence kits had a high sensitivity and specificity. Regarding intra-assay discrepancy, the Roche and Abbott kit had a better variable coefficient. The ratios of the quantitative results to the kit-specific cut-off values were similar. Conclusion Performance varied between laboratories. Reagents and methods are the most important factors. Other factors may affect the intra-assay discrepancy. The similar mean of ratios of the quantitative results to the kit-assigned cut-offs suggests that a national criterion is requisite. It is necessary to organize a PT to identify performances of different laboratories.