Implementation of the ANA HEp-2 consensus guidelines in Brazilian clinical laboratories

Abstract

ABSTRACT Introduction: The detection of autoantibodies in HEp-2 cells represents a relevant tool for the diagnosis of autoimmune diseases, especially rheumatic autoimmune diseases. As a result of the methodological advances, the technique gradually increased the sensitivity, as well as the need for standardization. Objective: To evaluate the implementation of the Brazilian Consensus recommendations for autoantibody determination in HEp-2 cells. Methods: A structured form in a virtual platform was filled in by experts in clinical laboratories that carry out the methodology across the country. The questionnaire addressed the adoption of the Brazilian Consensus guidelines, detailing the technical aspects, quality control, the strategy for reading slides and the release of reports. Results: The study included 53 laboratories responsible for more than 300,000 antinuclear antibody (ANA) tests/month; more than half (58.5%) reported fully adopting the recommendations of the Brazilian Consensus. The majority (83.1%) used the 1:80 for screening dilution, and 75.5% of laboratories, perform education and quality control programs. Only 39.6% reported using more than one kit brand to perform the test, and 32.1% did not report observing all phases of the cell cycle during slide reading. The study also detected some heterogeneity among participants in the identification of patterns. Conclusion: The results confirm the adoption of the Brazilian Consensus recommendations by most of participating laboratories, although with variable extent. There is need for improvement in some aspects, especially those related to the quality control.

Keywords

• indirect fluorescent-antibody technique
• autoantibodies