Performance verification and sigma metrics of creatinine assays
Journal Title: International Journal of Clinical Biochemistry and Research - Year 2018, Vol 5, Issue 1
Abstract
Introduction: Creatinine enzymatic method is more accurate but its own higher cost is the main reason why the use of Jaffe assays is still in practice. The verification step is performed because assay procedure confirms to the manufacturer’s claims in the end users’ setup. Desirable specification based on biological variation gives Allowable Total Error (ATE) and Sigma metrics provides summative evaluation of method performance. Objectives: Verification of manufacturer’s precision claims. Calculation of bias, Total Analytical Error (TAE) and sigma metrics. Materials and Methods: Modified Jaffe’s (No deproteinization) and enzymatic creatinine Erba XL liquid pack on Erba EM360 fully auto analyser were used. Intra assay and inter assay imprecision done on 20 replicates each. The estimates of bias uses data from precision experiment. Results & Discussion: The performance of jaffe’s and enzymatic serum creatinine is comparable to manufacturer's stated claimed value and are within desirable specification based on biological variation. The bias calculated in both assays is less than allowable bias. Total Analytical Error (TAE) is less than Allowable Total Error (ATE). Both the methods overall showed ATE ≥ bias + 4 SD. Within-run showed ATE ≥ bias + 5 SD complying Six Sigma concepts. Conclusion: Both Jaffe’s and enzymatic creatinine assays gives good performance and better sigma metrics. This makes enzymatic method a better choice due to inherent advantages such as increased accuracy and less interference if cost is neglected.
Authors and Affiliations
Santosh B. Jagtap, Sanjyoti S. Bandebuche, Mamata V. Hegde
Keywords
Related Articles
- EP ID EP472117
- DOI 10.18231/2394-6377.2018.0024
- Views 75
- Downloads 0
Association of serum MDA with Magnesium, Calcium and Zinc levels in thalassemic and healthy children
Introduction: The thalassemias are group of haemoglobin disorders, initially found in 1925 in United States and Italy. It is the genetic disorder which passed down through families. In this disease deficient haemoglobin...
Study of serum nitric oxide (no) in type 2 diabetes mellitus patients having normoalbuminuria and microalbuminuria in Central India
Introduction: Nitric oxide (NO) is known as a mediator in a broad cluster of biological systems. NO is the endothelium-derived relaxing factor, which causes vasodilation by relaxing vascular smooth muscle. This role of N...
Association of high sensitivity C – reactive protein (hs-CRP) with unstable angina: An alarm for vulnerable plaques in CAD patients
Introduction Inflammation plays a crucial role in the development and progression of Coronary Artery Disease HsCRP has been identified as one of the promising inflammatory marker associated with CAD It is synthesized at...
Lipoprotein (a) level and hsCRP as risk markers in Myocardial Ischemia
Cardiovascular diseases are the major cause of death globally Hyperlipidemias and hyperlipoproteinemias are the most important risk factors for atherosclerosis Inflammation plays a major role in atherothrombosis and meas...
Prevalence of High Lipid Profile in Diabetes Meellitus Patients: A Study in a Tertiary Care Centre
Introduction: Diabetes mellitus is a group of metabolic diseases characterized by increased blood glucose levels resulting from defects in insulin secretion, insulin action, or both. It is also associated with interrelat...