ArticleJournal of clinical laboratory analysis2025
Soluble C5b-9 (sC5b-9) in Pediatrics-A Clinical Assessment.
Article in Journal of clinical laboratory analysis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThe soluble C5b-9 (sC5b-9) is a soluble form of the Terminal Complement Complex (TCC) that is released into the circulation with elevated levels, associated with increased morbidity and mortality in patients with complement-mediated inflammatory conditions. With the advent of eculizumab and ravulizumab, proper testing for diagnoses and therapeutic monitoring is warranted.
methodsWe evaluated both the analytical and clinical performance of the Quidel Microvue sC5b-9 Plus enzyme immunoassay. Analytical performance was evaluated with precision, linearity, interference studies, and correlation with a reference laboratory. Reference intervals were established using control donor samples [n = 26; median age 18.5 years (range 2-59)]. Clinical performance of the assay was assessed using plasma samples of patients who (i) developed transplant-associated thrombotic microangiopathy [n = 10; median age 14 years (range 3-19)], (ii) had reduced ADAMTS13 activity [n = 6; median age 16 years (range 9-18)], and (iii) developed acquired Von-Willebrand disease [n = 10; median age 18.5 years (range 0.5-18)].
resultsThe assay showed acceptable intra and inter-precision at both low and high levels. Linearity ranged from 12.6 to 160.66 ng/mL, while accuracy and method correlation studies with a reference laboratory yielded a correlation coefficient (R) of 0.96. The reference range in control donors was established at ≤ 268.0 ng/mL. Clinical performance of the assay in patients' plasma revealed elevated sC5b-9 levels suggesting complement activation in these patient cohorts compared with control levels.
conclusionThe Quidel Microvue sC5b-9 plus EIA assay demonstrated acceptable analytical performance and clinical utility for monitoring complement activation in patients. Further studies are needed to correlate sC5b-9 levels with existing markers of complement activation.
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