title: Development of a high sensitivity C-reactive protein immunoassay and comparison with a commercial kit.
abstract: C-reactive protein (CRP) is intricately sensitive marker of inflammation, infection, and tissue damage. Role in the prognosis of heart diseases has been recently discovered. 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, and 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.
authors.affiliation: a National Health Research Complex , Shaikh Zayed Hospital , Lahore , Pakistan.
authors.forename: Saima
authors.initials: S
authors.lastname: Naz
authors.affiliation: a National Health Research Complex , Shaikh Zayed Hospital , Lahore , Pakistan.
authors.forename: Farkhanda
authors.initials: F
authors.lastname: Ghafoor
authors.affiliation: b Department of Cardiology , Shaikh Zayed Hospital , Lahore , Pakistan.
authors.forename: Imran Akhtar
authors.initials: IA
authors.lastname: Iqbal
authors.affiliation: c PMAS , University of Arid Agriculture , Rawalpindi , Pakistan.
authors.forename: S M
authors.initials: SM
authors.lastname: Saqlan Naqvi
mesh_terms: D002097:C-Reactive Protein / Q000032:analysis*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods* / Q000592:standards; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic / Q000592:standards
chemical_list: D011933:Reagent Kits, Diagnostic; D002097:C-Reactive Protein
keywords: C-reactive protein; acute coronary syndrome; cardiovascular risk assessment; cost effective; high sensitivity C-reactive protein assay; inflammation