Point-of-care testing of cholesterol and triglycerides for epidemiologic studies: evaluation of the multicare-in system.

Cardiovascular disease is the leading cause of death in the world with 80% of cardiovascular events that occur in low- and middle-income countries. Reliable data on the prevalence of risk factors in developing countries can be obtained in door-to-door epidemiologic studies with the use of automatic instruments. This study was performed to assess the sensitivity and specificity of a low-cost and manageable point-of-care testing (POCT) instrument (HPS MultiCare-in, Italy) for cholesterol and triglyceride assays. Plasma blood samples were obtained from consecutive subjects referred to our clinic for diagnostic evaluation. The analyzer currently used in our central laboratory (ADVIA 2400; Siemens, Deerfield, Ill) was used as comparison method. The inter-assay imprecision (expressed as variation coefficient) of the MultiCare POCT system was 4.51% (range, 2.38%-8.54%) and was 3.29% (range, 1.06%-7.45%) for cholesterol and triglycerides systems, respectively. The mean percent bias for capillary samples was 3.5 +/- 4.3% for total cholesterol and -2.4 +/- 4.9% for triglycerides. The difference in results obtained by nonprofessionals compared with professionals (practicability testing) was 0.28 +/- 7.61% and 1.26 +/- 9.86%, respectively (P value was nonsignificant for both). Sensitivity and specificity measurements were 95.7% and 61.9% (threshold value of cholesterol 190 mg/dL) and 98% and 93.5% (threshold value of triglycerides 170 mg/dL), respectively. POCT instruments are essential to perform epidemiologic studies while avoiding transportation and storage of biologic material. The characteristics of sensitivity and specificity as well as diagnostic accuracy make the POCT instrument useful for obtaining an accurate stratification of a study population.

[1]  D. Altman,et al.  STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENT , 1986, The Lancet.

[2]  G. Ronquist,et al.  Multicentre evaluation of a non-wipe system for the rapid determination of total cholesterol in capillary blood, Accutrend Cholesterol on Accutrend GC. , 1995, European journal of clinical chemistry and clinical biochemistry : journal of the Forum of European Clinical Chemistry Societies.

[3]  W. Bablok,et al.  A New Biometrical Procedure for Testing the Equality of Measurements from Two Different Analytical Methods. Application of linear regression procedures for method comparison studies in Clinical Chemistry, Part I , 1983, Journal of clinical chemistry and clinical biochemistry. Zeitschrift fur klinische Chemie und klinische Biochemie.

[4]  C. Carlsson,et al.  Inaccuracy of lipid measurements with the portable Cholestech L.D.X analyzer in patients with hypercholesterolemia. , 2002, Clinical chemistry.

[5]  E. Bruck,et al.  National Committee for Clinical Laboratory Standards. , 1980, Pediatrics.

[6]  S. Yusuf,et al.  Global burden of cardiovascular diseases: part I: general considerations, the epidemiologic transition, risk factors, and impact of urbanization. , 2001, Circulation.

[7]  J. Ubbink,et al.  Analytical quality of near-patient blood cholesterol and glucose determinations. , 2000, Clinical chemistry.

[8]  Jan S Krouwer,et al.  Setting performance goals and evaluating total analytical error for diagnostic assays. , 2002, Clinical chemistry.

[9]  M. Shephard,et al.  Comparative performance of two point-of-care analysers for lipid testing. , 2007, Clinical laboratory.

[10]  Stephen Jan,et al.  Global inequalities in access to cardiovascular health care: our greatest challenge. , 2008, Journal of the American College of Cardiology.

[11]  James R. Taylor,et al.  Cholesterol: Point-of-Care Testing , 2004, The Annals of pharmacotherapy.

[12]  Claude Lenfant,et al.  Definition of Metabolic Syndrome: Report of the National Heart, Lung, and Blood Institute/American Heart Association Conference on Scientific Issues Related to Definition , 2004, Arteriosclerosis, thrombosis, and vascular biology.

[13]  R. Christenson,et al.  Eight compact analysis systems evaluated for measuring total cholesterol. , 1994, Clinical chemistry.

[14]  R. Heine,et al.  Point-of-care testing of triglycerides: evaluation of the Accutrend triglycerides system. , 2000, Clinical chemistry.

[15]  G. Boran,et al.  Validation of a point of care lipid analyser using a hospital based reference laboratory , 2006, Irish journal of medical science.

[16]  K. Reddy,et al.  Cardiovascular disease in non-Western countries. , 2004, The New England journal of medicine.

[17]  M. Shephard.  Analytical Goals for Point-of-Care Testing Used for Diabetes Management in Australian Health Care Settings Outside The Laboratory , 2006 .

[18]  Alan D. Lopez,et al.  Alternative projections of mortality and disability by cause 1990–2020: Global Burden of Disease Study , 1997, The Lancet.

[19]  J. Mckenney,et al.  Analytic and Clinical Performance of Two Compact Cholesterol‐Testing Devices , 1998, Pharmacotherapy.

[20]  C. Mathers,et al.  Projections of Global Mortality and Burden of Disease from 2002 to 2030 , 2006, PLoS medicine.

[21]  N. Rifai,et al.  Impact of the third cholesterol report from the adult treatment panel of the national cholesterol education program on the clinical laboratory. , 2002, Clinical chemistry.

[22]  Neil J Stone,et al.  Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines , 2004, Circulation.