Evaluation of Turbidometric hsCRP Kits Commercially Available in India for Cardiovascular Risks Estimation

Abstract

The aim of the present study is to evaluate four turbidimetric assays, available in India, suited for Clinical chemistry analyzers; the analytical performances were measured with in the concentration range 0.32–7.5 mg/L, which has been proposed for cardiovascular risk assessment. Our study is comprised of four internationally accepted brands of immunoturbidimetric kits used for High Sensitive C- Reactive Protein (hs-CRP) estimation. Twenty different concentrations were analyzed over a period of 6 days to study the standard deviation (SD) and Coefficient of Variation (CV), using automated analyzer Miura. Significantly higher SD and CV% was observed in the lower concentrations of samples and lower SD were more or less the same over the period of 6 days. The sensitivity of Roche kit was found to be better with a low SD and CV%, in the low concentration samples. The study shows that there is a difference in the sensitivity and detection capacity of kits, the repeatability and the variation is also seen varying from lower to higher concentration, the variation is more marked in the case of low concentration samples when compared to the variation in the high concentration samples