Evaluating diagnostic accuracy and analytical performance of HELIOS in detecting autoimmune disorders using external...

ObjectiveTo assess the analytical performance and diagnostic accuracy of an automated analyzer HELIOS in external proficiency testing for diagnosing autoimmune disorders based on antinuclear antibody (ANA) images and titer values.MethodsTotal 09 CAP shipments over the period of 03 years were included in our study, comprising 05 samples in each shipment making a total of 45 samples. All samples were analyzed on HELIOS by the technique of Indirect Immunofluorescence (IFA) having built-in library for ANA image comparison and end-point titer estimation.ResultsThe data showed that there was 100% agreement with the positivity and negativity of the PT samples in detecting autoimmune disorders; however, for ANA pattern agreement, it was an average of 90.3% compared to peer mean. The most frequent ANA pattern in all 3 years was nuclear homogenous (40%) followed by nuclear speckled (32%). However, for end-point titer, there is a marked difference of mutual agreement with the PT peer group showing the lowest harmony of 35.3% in 2022 which was reported with titer of 5120; however, peer group reported titer was ≤640. Thus, the analyzer has a limitation in evaluating end-point titer and it should always be critically evaluated by the pathologist before final approval.Conclusion HELIOS has an acceptable performance in detecting autoimmune disorders and ANA pattern identification; however, for end-point titer, there were many variations for which manual dilutions should be done in routine for accurate analysis of results.