Comparison of the effect of reporting cytoplasmic patterns as anti-nuclear antibody positive and anti-nuclear antibody negative on reflex test ordering

Abstract

Abstract Objective Anti-nuclear antibody (ANA) patterns are classified as nuclear, cytoplasmic or mitotic. The International Consensus on ANA patterns (ICAP) suggests three parameters for ANA reporting – assay type, results and advice for reflex testing – but has not yet reached a consensus on the reporting of cytoplasmic/mitotic patterns as ANA-negative or positive. We investigated the effect of ICAP’s two proposals for reporting cytoplasmic patterns as ANA-positive and negative with a view to the recommendation for reflex testing in a country that has no national reimbursement policies for automatic reflex testing. Methods This non-interventional descriptive study included 1241 patients with positive cytoplasmic ANA patterns. 442 patients were reported as ANA-negative and 799 as ANA-positive. Patients were followed up for a two-year period to determine testing recommendations based upon nuclear and cytoplasmic patterns. For statistical analysis, the t-test was used, with a significance threshold of p-value<0.05. Results Appropriate reflex orders were seen more commonly with cytoplasmic patterns reported as ANA-positive (27.30%) than with those reported as ANA-negative (5.51%, p-value<0.05). However, ANA-positive reports led to higher ordering of nuclear pattern reflex tests (12.97%) compared with ANA-negative reports (1.10%, p-value<0.05). A large group of patients (59.73% ANA-positive, 93.39% ANA-negative) did not receive reflex testing. Conclusion Reporting cytoplasmic patterns as ANA-positive was considered more significant, but reading the result report without considering the pattern and recommendation notes could lead to inappropriate reflex testing. Besides reaching a consensus for reporting cytoplasmic patterns as ANA-negative or positive, it is important to consider solutions to reimbursement policies for automatic reflex testing to decrease the impediments in reporting cytoplasmic ANA patterns.