Authors
Nayab Zehra, Asif Loya, Hiba Asif, Mudassar Hussain, Hina Maqbool, Umer Nisar
Published in
Annals of clinical biochemistry. Pages 45632261488247. Sep 01, 2026. Epub Sep 01, 2026.
Abstract
To 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.
Total 09 CAP shipments over the period of 03 years were included in our study, comprising of 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.
The 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 huge 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.
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.
Autoimmune disorders, External Proficiency testing, HELIOS, Analytical Performance.
PMID:
42678385
Bibliographic data and abstract were imported from PubMed on 01 Sep 2026.
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