Development of a high sensitivity C-reactive protein immunoassay and comparison with a commercial kit.

This study aimed to develop a cost effective and high sensitivity CRP immunoassay for use in cardiac risk assessment. Assay was optimized for coating, blocking of capturing antibody, dilution & reaction time of the conjugate and sample volume. For normal reference range, CRP was determined in serum samples from apparently healthy volunteers. For clinical validation, CRP was determined in samples of acute coronary syndrome patients by in-house and commercial assays. The lower detection limit of in-house assay was 0.16 µg/L. Intra and inter assay imprecision was 4.39%, 4.6% and 8.6%, 9.3%, respectively. The correlation between the CRP levels by the two assays was r = 0.861. Sensitivity, specificity, predictive value for a positive test and a negative test of in-house assay was 95.3%, 92.8%, 95.3% and 92.8%, respectively. At lower end CRP levels of both kits correlated very well but showed variation at upper end In-house assay showed high sensitivity and reliability at lower end and it is hoped that will help to evaluate cardiac risk assessment (after improvement at upper end) in clinically poor settings. PMID: 27366878 [PubMed - as supplied by publisher]
Source: Journal of Immunoassay and Immunochemistry - Category: Biochemistry Tags: J Immunoassay Immunochem Source Type: research