[Development, manufacture and sales of products for diagnosis of disease]

Shigekazu Yamamoto1

  • 1Kainos Laboratories, Inc., Bunkyo-ku, Tokyo.

Rinsho Byori. the Japanese Journal of Clinical Pathology
|March 6, 2008
PubMed

Insights

The Japanese Society of Nephrology approved a new equation for estimating glomerular filtration rate (GFR) in Japanese individuals using serum creatinine measured by enzyme methods for better chronic kidney disease (CKD) management.

Area of Science:

  • Nephrology
  • Clinical Chemistry
  • Epidemiology

Context:

  • The Japanese Society of Nephrology (JSN) released its "CKD Practice Guide" in April 2007.
  • The JSN epidemiology working group approved a specific glomerular filtration rate (GFR) estimation equation for the Japanese population.
  • Serum creatinine (Cr) measurement should utilize enzymatic methods for accuracy.

Purpose:

  • To introduce and implement an updated GFR estimation equation for Japanese individuals.
  • To standardize the measurement of serum creatinine using enzymatic methods.
  • To support the Japanese government's objective of reducing lifestyle-related diseases by 25% by 2015.

Summary:

  • A modified abbreviated MDRD Study equation for Japanese is presented: GFR = 175 x Cr(-1.154) x Age(-0.203) x 0.741 (or 0.742 for women).
  • Accurate GFR estimation requires enzymatic serum creatinine assays with a limit of detection of at least 0.02 mg/dL.
  • Mandatory health checkups for employees aged 40+ were implemented in April 2008 to address lifestyle-related diseases.

Impact:

  • Advancements in automatic clinical analyzers reduce specimen and reagent volumes, decreasing test time and cost.
  • The evolving clinical examination environment necessitates continuous collaboration between clinical and reagent development researchers.
  • This ensures the provision of timely and relevant information for both patients and physicians in a changing healthcare landscape.

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