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A Multicenter Reference Intervals Study for Specific Proteins in China.

Xuzhen Qin1, Guodong Tang, Ling Qiu

  • 1From the Department of Clinical Laboratory, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing (XQ, LQ, PL, LX, SY, XC, JH, LH); Beijing Hospital of the Ministry of Health (GT); Department of Clinical Laboratory, Third Affiliated Hospital of Third Military Medical University, Chongqing (MC); Department of Clinical Laboratory, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou (ZT); Department of Clinical Laboratory, The First Affiliated Hospital of Dalian Medical University, Dalian (SL); Department of Clinical Laboratory, The first Affiliated Hospital, Sun Yat-sen University, Guangzhou (ML); Department of Clinical Laboratory, Xinjiang Medical University, Urumuqi (LW); Department of Clinical Laboratory, Hospital of Beijing Prison Administration Bureau Qinghe Branch, China (SG); and Faculty of Health Sciences, Yamaguchi University Graduate School of Medicine, Ube, Japan (KI).

Medicine
|December 15, 2015
PubMed
Summary
This summary is machine-generated.

This study established reference intervals for seven serum proteins across China, finding no regional variations but identifying age and sex as key factors for specific proteins like IgM, C3, C4, CRP, and hsCRP.

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Area of Science:

  • Clinical Chemistry
  • Immunology
  • Biostatistics

Background:

  • Establishing accurate reference intervals (RIs) for serum proteins is crucial for clinical diagnostics.
  • Inter-laboratory and inter-platform variability can impact the reliability of diagnostic test results.
  • Understanding sources of variation (age, sex, region, etc.) is essential for defining population-specific RIs.

Purpose of the Study:

  • To identify sources of variation for seven serum-specific proteins.
  • To establish reliable reference intervals (RIs) for these proteins in a healthy Chinese population.
  • To compare results obtained from two different automation platforms.

Main Methods:

  • A multicenter study enrolled 3148 healthy subjects aged 19-64 across 6 Chinese cities.
  • Serum samples were analyzed on Beckman AU5800 and Immage 800 analytical systems.
  • Statistical methods including ANOVA, multiple regression, and the Latent Abnormal Value Exclusion (LAVE) method were employed.

Main Results:

  • No significant regional variations were observed for any of the seven immunoassays in China.
  • Sex was a significant source of variation for Immunoglobulin M (IgM).
  • Results for C-reactive protein (CRP) and high-sensitivity C-reactive protein (hsCRP) differed between turbidimetry and nephelometry methods.
  • Age-related inflection points were noted for C3, C4, and IgM, necessitating age-specific RIs.

Conclusions:

  • Nationwide RIs for C3, Immunoglobulin G (IgG), Immunoglobulin A (IgA), and IgM are applicable to the entire Chinese population due to lack of regional differences.
  • Separate RIs are recommended for C4, CRP, and hsCRP due to platform-specific variations.
  • Gender-specific RIs are necessary for IgM, and age-specific RIs are recommended for C3, C4, and IgM.