European Journal of Biomedical and Pharmaceutical Sciences

AN INDIGENEOUS METHOD TO ESTABLISH DETECTION LIMIT AND QUANTIFICATION LIMIT FOR FOUR BASIC BIOCHEMICAL PARAMETERS

Natarajan K., Selvam V. and Swaminathan S.*

ABSTRACT

Laboratory diagnosis is an integral part of healthcare delivery systems. There has been rapid improvement in laboratory diagnosis due to the availability of a wide range of sophisticated state of art fully automated discrete selective analysers to use. All clinical laboratories are now employing reagent kits supplied by reputed companies for the measurements of almost all analytes. Accreditation by NABL has given an awareness to improve standardized and reliable laboratory reports for the correct diagnosis. However, only very few laboratories check certain indicators mentioned in the kit leaflets, among which DL and QL are the most important. NABL too has stressed the importance of checking the detection limit and linearity atleast for some analytes, if not for all. This research paper presents the DL and QL check done for four analytes viz Glucose, Urea, Creatinine and Calcium. The DL obtained for the above analytes are better than those mentioned in the kit leaflets. Glucose 1.0 mg/dL, Urea 0.73 mg/dL, Creatinine 0.04 mg/dL and Calcium 0.53 mg/dL against Glucose 6.04 mg/dL, Urea 3 mg/dL , Creatinine 0.29 mg/dL and Calcium 0.36 mg/dL given in the kit leaflets. The QL obtained for the above parameters are Glucose 600.8 mg/dL, Urea 300 mg/dL, Creatinine 32.5 mg/dL and Calcium 23.05 mg/dL against Glucose 614 mg/dL, Urea 303 mg/dL, Creatinine 32.5 mg/dL and Calcum 17.24 mg/dL provided in the kit leaflets. This study will be a guide for other laboratories to do such experiments to establish their own DL and QL and to fulfill NABL criteria.

Keywords: DL, QL, CLIA, Validation, Glucose, Urea, Creatinine, Calcium.