Journal
TRANSLATIONAL RESEARCH
Volume 153, Issue 2, Pages 71-76Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.trsl.2008.11.010
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Funding
- Ministero dell'Universita a della Ricerca
- Direzione Generale per le strategic a to sviluppo dell'intemazionalizzazione della ricerca scientifica a tecnologica
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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, III) 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. (Translational Research 2009;153:71-76)
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