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Clinical Research : The Impact of Creatinine Standardization on the Identification of Patients with Kidney Disease in Mexico

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Name: Alfonso M. Cueto-Manzano

Hospital / Affiliation: Hospital de Especialidades, CMNO, IMSS

Home Country: Mexico

Host Country: Mexico

Year: 2015

Status of your program: IN PROGRESS


Title of the project: 

The Impact of Creatinine Standardization on the Identification of Patients with Kidney Disease in Mexico


Chronic Kidney Disease 


Short description of the project or abstract:

Patients and physicians routinely rely upon the results they generate for making decisions on the diagnosis and management of disease. In the case of creatinine, there is high variability in its measurement as most of current techniques overestimate its real value; moreover, results show inter- and intra-laboratory, and intra-individual variations, with several important implications. The impact of laboratory error is better exemplified when decisions in evidence-based guidelines are triggered on the basis of a laboratory test result: if the test result is inaccurate, some patients will be treated unnecessarily while others that should be treated will not be. The uniform application of such guidelines requires that all laboratories operating under the guideline utilize testing methods that have been standardized to produce uniformly accurate test results. In Mexico, there is no widespread standardization of creatinine measurement and the impact of such adjustment has not been evaluated yet.
The study will examine the testing error associated with the measurement of creatinine. Detailed information form each participating laboratory, including the method currently being used, will be collected. Each laboratory will be shipped 3 sets of human serum samples (matrix insensitive, commutable, each set to consist of 3 samples) for a total of nine samples.

Concentration of creatinine will cover the clinical range of interest for diagnosis of CKD stage 3. Creatinine target values will be assigned using an isotope dilution gas chromatograph mass spectrometry (ID|GC|MS) Reference Method approved by the IFCC Joint Committee on Traceability in Laboratory Medicine. Laboratories will be asked to measure creatinine in these samples 3 times on each of 3 days and to submit test results to the study coordinating office. Such results will be used to calculate precision , bias and total error (TE) for the measurement of creatinine in each of the participating laboratories.
In addition, each laboratory will be asked to provide a list of creatinine results that they reported the preceding 2 months, including the patient’s age and gender. Assignation of values by the IDMS reference method will be performed by a reference laboratory (HealthMetrx, Vancouver), responsible for sending samples, collecting information, and evaluating laboratories’ performance. Laboratory testing performance will be assessed on the basis of the assigned target value and a fixed TE limit. Patient data will be used to provide an estimation of the number of test results that the laboratory produces for creatinine measurement, and will be subsequently used to calculate eGFR. The number of patients with an eGFR <60 ml/min/1.73m2 will be determined before and after post-analytical standardization of the creatinine results. These data will then be used to determine the rate of eGFR miss-classification in each laboratory. The costs of the treatment of kidney disease can then be used as an estimation of health care costs associated with false positive/false negative rates of miss-classification.


Learning or Research objectives:

To evaluate the accuracy of laboratories in measuring serum creatinine, and to establish their respective correction factor after standardization with an ideal methodology (IDMS). Additionally, we will evaluate the impact of creatinine standardization on identifying individuals who could be diagnosed with CKD on the basis of an estimated GFR.


Additional Info

  • Year: 2015
  • Status: In progress
  • Partners: ISN only
  • Region: Latin America and the Caribbean
  • Country: Mexico
  • Topics: CKD
Read 7438 times Last modified on Friday, 17 February 2017 12:24

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