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<p>Method validation procedures are essential for the testing laboratories to ensure that the analytical procedures used as a test method is capable and suitable for incurring all the specific needs. Method validation is required for reducing the uncertainty in diagnostic measurements of diseases and establishing quality healthcare system. Method validation documents are needed by the clinical chemistry laboratory for acquiring and maintaining national and international accreditations. For enhanced credibility and accuracy of test results produced by the laboratory they could adopt the method validation procedures explained in the present study which involves the estimation of various parameters such as accuracy, total error and biasness, repeatability precision, intermediate precision, reproducibility, measurement of uncertainty, performance testing, linearity and range. In the present study, all the above-mentioned parameters have been evaluated for one year and found within the specified limits as per the Clinical Laboratory Standards Institute guidelines. The coefficient of variance (C.V.) as well as standard deviation (S.D.) of the above-mentioned parameters have been evaluated and statistically analyzed and found within specified limits. This analysis established the accuracy and precision of the test method along with the equipment in use. After applying the student’s t-test the <i>p</i> values obtained for all the parameters were found &gt; 0.05 which supports the hypothesis that there is no significant difference between values obtained for variance over one year. The protocols were guided by the statistical tools and capable of validating the performance of the laboratory and maintaining the NABL accreditation status since 2014.</p>

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Establishment of Method Validation Criteria and Internal Quality Control System for Measurement of Glucose in Accredited Laboratory

  • 期刊论文

  • 发表日期：

    2026年1月16日

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  • Swati Shalini,
  • Amreen Fatima,
  • Beulah Gowri,
  • Harish Chander,
  • Anup Anvikar,
  • Varun Singh

摘要

Method validation procedures are essential for the testing laboratories to ensure that the analytical procedures used as a test method is capable and suitable for incurring all the specific needs. Method validation is required for reducing the uncertainty in diagnostic measurements of diseases and establishing quality healthcare system. Method validation documents are needed by the clinical chemistry laboratory for acquiring and maintaining national and international accreditations. For enhanced credibility and accuracy of test results produced by the laboratory they could adopt the method validation procedures explained in the present study which involves the estimation of various parameters such as accuracy, total error and biasness, repeatability precision, intermediate precision, reproducibility, measurement of uncertainty, performance testing, linearity and range. In the present study, all the above-mentioned parameters have been evaluated for one year and found within the specified limits as per the Clinical Laboratory Standards Institute guidelines. The coefficient of variance (C.V.) as well as standard deviation (S.D.) of the above-mentioned parameters have been evaluated and statistically analyzed and found within specified limits. This analysis established the accuracy and precision of the test method along with the equipment in use. After applying the student’s t-test the p values obtained for all the parameters were found > 0.05 which supports the hypothesis that there is no significant difference between values obtained for variance over one year. The protocols were guided by the statistical tools and capable of validating the performance of the laboratory and maintaining the NABL accreditation status since 2014.