Healthy Life Laboratories announced today that it has been selected to present their new method development and validation data for the determination of high-sensitivity C-Reactive Protein (hs-CRP) in a capillary blood sample at the annual meeting of the American Association of Clinical Chemistry (AACC) in Anaheim, California. With so much publicized about CRP as an independent risk factor for heart disease, stroke, and diminished mental acuity, Healthy Life Labs believes their research and develop has created a timely and innovative methodology which is expected to have great appeal to the scientific community when presented on July 24, 2010.
Originally developed to serve the professional dental community in detecting underlying sources of inflammation responsible for periodontal disease, the Healthy Life Labs’ method for determining CRP, a generalized marker for inflammation, has been identified as a new weapon in assessing those at risk for cardiovascular maladies, as well as decreased cognitive skills and early dementia.
A brief excerpt from their accepted abstract appears below.
Background: Much press has been given to the “oral-systemic connection”, and the importance of good oral health to maintaining good overall health. One of the evident markers of oral inflammation is the acute phase reactant, C-Reactive Protein (CRP), which becomes elevated in the bloodstream during periodontal maladies. CRP may thus be used as both a marker of oral inflammation, and a tool to assess the effectiveness of periodontal therapies. Dental professionals have looked to the clinical laboratory community to provide a simple, accurate, and sensitive means to determine CRP in a dental office setting. Since dental offices are not staffed to perform moderately complex laboratory testing, and venipuncture is not practical in dental offices, our objective was to develop a CRP laboratory method for a fingernick blood sample which could be collected chairside in a dental setting.
Methods: The Roche Integra hs-CRP method was adapted for the Roche Diagnostics Integra 400 System to measure CRP in extracted capillary DBS samples. Test method validation included assessment of precision, analytical accuracy, sensitivity, linearity, and hemoglobin interference. The accuracy of the system was assessed by comparing CRP results from DBS samples as determined by the modified Roche Integra method, to CRP in paired plasma samples as determined using the standard Roche Integra hs-CRP assay.
Results: Within-run precision coefficients of variation (CV’s) (n=20) at CRP levels of 1.0 and 3.9 mg/L were 7.7% and 5.8%, respectively. The minimum detectable concentration of DBS CRP was determined to be 0.40 mg/L, (n = 20). Assay linearity was demonstrated between 0.6 and 20.0 mg/L). Regression analysis comparing plasma and DBS levels of CRP (n=55, range 0.4 – 19.8 mg/L) yielded a correlation coefficient (R2) of 0.98, y = 0.9995x + 0.008. No influence from any degree of hemolysis was apparent across the analytical range for CRP.
Conclusions: The Roche Integra hs-CRP assay modified by Healthy Life Laboratories for DBS analysis was shown to provide a strong correlation with the Roche plasma method, with suitable precision and sensitivity for use in a dental setting to assess oral inflammation. Dental professionals have begun incorporating CRP testing as part of their periodontal assessment and treatment protocols, and have successfully demonstrated that the collection of a fingernick sample using the provided single-use, self retracting, and minimally invasive lancet is within their accepted scope of patient care services.