The Asian project for collaborative derivation of reference intervals: (1) strategy and major results of standardized analytes
Articolo
Data di Pubblicazione:
2013
Citazione:
The Asian project for collaborative derivation of reference intervals: (1) strategy and major results of standardized analytes / K. Ichihara, F. Ceriotti, T. Huu Tam, S. Sueyoshi, P.M.K. Poon, M. Ling Thong, Y. Higashiuesato, X. Wang, H. Kataoka, A. Matsubara, S.C. Shiesh, D. Muliaty, J.H. Kim, M. Watanabe, C.W.K. Lam, L. Siekmann, J.B. Lopez, M. Panteghini. - In: CLINICAL CHEMISTRY AND LABORATORY MEDICINE. - ISSN 1434-6621. - 51:7(2013), pp. 1429-1442. [10.1515/cclm-2012-0421]
Abstract:
Background : A multicenter study conducted in Southeast
Asia to derive reference intervals (RIs) for 72 commonly
measured analytes (general chemistry, inflammatory
markers, hormones, etc.) featured centralized measurement
to clearly detect regionality in test results. The
results of 31 standardized analytes are reported, with the
remaining analytes presented in the next report.
Method : The study included 63 clinical laboratories from
South Korea, China, Vietnam, Malaysia, Indonesia, and
seven areas in Japan. A total of 3541 healthy individuals
aged 20 – 65 years (Japan 2082, others 1459) were recruited
mostly from hospital workers using a well-defined common
protocol. All serum specimens were transported to Tokyo
at − 80 ° C and collectively measured using reagents from
four manufacturers. Three-level nested ANOVA was used
to quantitate variation (SD) of test results due to region,
sex, and age. A ratio of SD for a given factor over residual
SD (representing net between-individual variations) (SDR)
exceeding 0.3 was considered significant. Traceability of
RIs was ensured by recalibration using value-assigned reference
materials. RIs were derived parametrically.
Results : SDRs for sex and age were significant for 19 and
16 analytes, respectively. Regional difference was significant
for 11 analytes, including high density lipoprotein
(HDL)-cholesterol and inflammatory markers. However,
when the data were limited to those from Japan, regionality
was not observed in any of the analytes. Accordingly,
RIs were derived with or without partition by sex and
region.
Conclusions : RIs applicable to a wide area in Asia were
established for the majority of analytes with traceability to
reference measuring systems, whereas regional partitioning
was required for RIs of the other analytes.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
common reference interval; multicenter study; nested ANOVA; regionality; standardization
Elenco autori:
K. Ichihara, F. Ceriotti, T. Huu Tam, S. Sueyoshi, P.M.K. Poon, M. Ling Thong, Y. Higashiuesato, X. Wang, H. Kataoka, A. Matsubara, S.C. Shiesh, D. Muliaty, J.H. Kim, M. Watanabe, C.W.K. Lam, L. Siekmann, J.B. Lopez, M. Panteghini
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