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[Development, manufacture and sales of products for diagnosis of disease]
1Kainos Laboratories, Inc., Bunkyo-ku, Tokyo.
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.
Abstract:
Final version of "Chronic kidney disease (CKD) Practice Guide" book is displayed on the Japanese Society of Nephrology (JSN) homepage in April, 2007. JSN epidemiology working-group finally approved the glomerular filtration rate (GFR) estimation equation for Japanese. Serum creatinine (Cr) should be measured by enzyme method. The modified the abbreviated MDRD Study equation for Japanese is already printed in the "CKD practice guide". GFR = 175 x Cr(-1.154) x Age (-0.203) x 0.741 (if women 0.742) The limit of detection of enzymatic method of serum creatinine is at least 0.02 mg/dL to evaluate GFR accurately. Moreover, Japanese Government will assume decreasing the number of the prevalence and reserve of the lifestyle related disease up to present 25% to be a policy objective by 2015. And, it obligated the checkup and the health guidance specially provided to the employee of 40 years or more who worked in each corporation to be executed on April 1, 2008. The spread of the automatic clinical analyzer reduces a necessary amount of the specimen and the amount of the reagent, and has reduced time and the cost of clinical chemistry test greatly. The environment of the clinical examination will change in the future, and useful information for the patient and the doctor change again like this. To offer information suitable for needs in the changing age, the researcher who works at the site of the clinical examination and the researcher who works at the site of the reagent development should cooperate mutually, and continue study and the effort.
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