Measurement Performance of Reagent Manufacturers by Centers for Disease Control and Prevention/Cholesterol Reference Method Laboratory Network Lipid Standardization Specified for Metabolic Syndrome-Focused Health Checkups Program in Japan
| Autor: | Takashi Shimamoto, Masakazu Nakamura, Masahiko Kiyama, Hiroyasu Iso, Shinichi Sato, Isao Koyama, Masamitsu Konishi, Mitsuyo Okazaki |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Quality Control
medicine.medical_specialty Accuracy improvement chemistry.chemical_compound Japan Reference Values Internal medicine Internal Medicine medicine Humans Lipoprotein cholesterol Metabolic Syndrome business.industry Cholesterol Cholesterol HDL Biochemistry (medical) Reproducibility of Results medicine.disease Lipids Disease control United States Biochemistry chemistry Homogeneous Reagent Calibration Reagent Kits Diagnostic Centers for Disease Control and Prevention U.S Metabolic syndrome Laboratories Cardiology and Cardiovascular Medicine business Blood Chemical Analysis |
| Zdroj: | Journal of Atherosclerosis and Thrombosis. 16:756-763 |
| ISSN: | 1880-3873 1340-3478 |
| Popis: | AIM This study was designed to clarify the current measurement performance of 7 reagent manufacturers for high-density lipoprotein cholesterol (HDLC), low-density lipoprotein cholesterol (LDLC) and triglycerides (TG) specified for the metabolic syndrome (MetS)-focused health checkups program in Japan. METHODS Twenty HDLC, 21 LDLC and 9 TG analytical reagent/instrument/calibrator systems (system), and combinations of reagent lots, instrument models and calibrator lots, underwent Centers for Disease Control and Prevention (CDC)/Cholesterol Reference Method Laboratory Network (CRMLN) lipid standardization. Eighty and 100% systems were requested to achieve an accuracy of within +/-1% and +/-2% of the reference value, so that a clinical laboratory can meet the CDC criteria. RESULTS The CDC performance criteria of HDLC, LDLC and TG require an accuracy of within +/-5%, +/-4% and +/-5%, respectively. For HDLC, all 20 systems met the criteria. Fourteen (70.0%) and 18 (90.0%) systems were within +/-1% and +/-2%, respectively. For LDLC, 14 (66.7%) of 21 systems met the criteria, but 7 (33.3%) failed. Five (23.8%) and 17 (81.0%) systems were within +/-1% and +/-2%, respectively. For TG, 8 of 9 systems met the criteria. Two (22.2%) and 4 (44.4%) systems were within +/-1% and +/-2%, respectively. The minimum and maximum differences of a specified sample among manufacturers were 1.6 and 11.0 mg/dL for HDLC, 7.8 and 33.0 mg/dL for LDLC, and 2.8 and 27.4 mg/dL for TG, respectively. CONCLUSION Homogeneous HDLC methods are acceptable for MetS, but further accuracy improvement of homogeneous LDLC and TG methods will be needed because of their poor performance. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|