Data di Pubblicazione:
2016
Citazione:
Verification of the harmonization of human epididymis protein 4 assays / S. Ferraro, S. Borille, A. Carnevale, E. Frusciante, N.P. Bassani, M. Panteghini. - In: CLINICAL CHEMISTRY AND LABORATORY MEDICINE. - ISSN 1434-6621. - 54:10(2016), pp. 1635-1643. [10.1515/cclm-2015-1142]
Abstract:
Background: Serum human epididymis protein 4 (HE4) has
gained relevance as an ovarian cancer (OC) biomarker and
new automated methods have replaced the first released
manual EIA by tracing results to it. We verified agreement
and bias of automated methods vs. EIA as well as possible
effects on patients’ management.
Methods: One hundred and fifteen serum samples were
measured by Abbott Architect i2000, Fujirebio Lumipulse
G1200, Roche Modular E170, and Fujirebio EIA. PassingBablok
regression was used to compare automated assays
to EIA and agreement between methods was estimated by
Lin’s concordance correlation coefficient (CCC). The bias
vs. EIA was estimated and compared to specifications
derived from HE4 biological variation.
Results: Median (25th–75th percentiles) HE4 concentrations
(pmol/L) were 84.5 (60.1–148.8) for EIA, 82.7 (50.3–153.9) for
Abbott, 89.1 (55.2–154.9) for Roche, and 112.2 (67.8–194.2)
for Fujirebio. Estimated regressions and agreements (95%
confidence interval) were: Abbott = 1.01(0.98–1.03) EIA–
4.8(–7.5/–2.6), CCC = 0.99(0.99–1.00); Roche = 0.91(0.89–0.93)
EIA+5.7(4.2/8.0), CCC = 0.98(0.98–0.99); Fujirebio = 1.20(1.17–
1.24) EIA+ 2.4(–0.6/4.9), CCC = 0.97(0.96–0.98). The average
bias vs. EIA resulted within the desirable goal for Abbott
[–3.3% (–6.1/–0.5)] and Roche [–0.2% (–3.0/2.5)]. However, while for Abbott the bias was constant and acceptable
along the measurement concentration range, Roche bias
increased up to –28% for HE4 values > 250 pmol/L. Lumipulse
showed a markedly positive bias [25.3% (21.8/28.8)].
Conclusions: Abbott and Roche assays exhibited a good
comparability in the range of HE4 values around the previously
recommended 140 pmol/L cut-off. For patient
monitoring, however, the assay used for determining
serial HE4 must not be changed as results from different
systems in lower and higher concentration ranges can
markedly differ.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
assay; bias; comparison; harmonization; ovarian cancer.
Elenco autori:
S. Ferraro, S. Borille, A. Carnevale, E. Frusciante, N.P. Bassani, M. Panteghini
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