| Objective To verify the performance of automatic chemiluminescence analyzer. 1426 Healthy Han participants of Kunming area were involved in this study to evaluated the 25(OH)D status by Chemiluminescence and risk factors were analyzed. To further explore whether the international reference standard is appropriated to local people. and then establish a reference interval for the Han population in Kunming, to evaluate the reference interval at the same time.Methods1. The linearity, imprecision, accuracy and interferencesused by chemiluminescence were verified according to the CLSI EP15-A2,CLSI EP6-A, CLSI EP9-A2 and CLSIEP7-A2.2. The 25(OH)D status of Kunming healthy Han population was evaluated by 1426 participants and risk factors which make 25(OH)D decrease were anylysed.3. Assess the suitability of the international recommended reference interval for the local population.Established the 25(OH)D reference interval of Han population in Kunming according to CLSI C28-A3.4. To verified the reference interval which established above 38 healthy Han population in Kunming with bone densitometry and PTH examination in normal.Results1. Our date showed that a good imprecision,linearity,accuracy and interference.Repeatability of high level of 25(OH)D sample reached 1.15%, total imprecision CV was 1.38%, repeatability of low level was 7.23%, total imprecision CV was 9.33%; linear range experimental results are shown in 10-380nmol/L, with the linear equation:Y=0.999X1-0,044, R2=0.999; chemiluminescence and liquid chromatography tandem mass spectrometry detection of 25(OH)D showed a linear correlation (linear regression equation is Y=0.1013X-0.218, R2=0.998); the interference test shows that this method is not susceptible to interference of chyle, hemoglobin, serum bilirubin.2. The level of 25(OH)D in healthy Han population in Kunming was generally unoptimism, the number of 25(OH)D optimism, insufficient,deficiency was 365 661,400, the proportion of the study population were 25.59%,46.35%,28.05%, respectively, the low level of vitamin D (lack and deficiency) accounted for 74.04% of the total population.3. The logistics regression analysis of single factor shows that 25(OH)D level was lower in healthy Han population in Kunming related with age, gender, drinking history and seasons (P<0.05); multiple logistics regression analysis showed that gender, age, and drinking history are the factors which make the low level of 25(OH)D (P<0.05), the higher the age, the higher the risk of vitamin D lower, the risk of 25(OH)D levels in the history of alcohol drinking was higher than that of the non-drinking history, compared with men, women has higher risk of 25(OH)D level lower.4. The 25(OH)D’s reference range of healthy Han population in Kunming:the overall reference interval is 27.4-102.94nmol/L; reference interval for women is 24.19-97.0nmol/L; reference interval for men is 33.02-111.35nmol/L. Reference range for total reference interval and season variations:spring 28.1-93.6nmol/L, summer 44.06-119.8nmol/L, autumn 34.1-102.23nmol/L, winter 22.36～80.0nmol/L. Age related reference intervals:≥60,26.5～90.0nmol/L;<60, 24.7～103.Onmol/L. Reference interval related to age and gender:≥60 male, 35.3～111.5nmol/L,≥60 female 23.7-89.77nmol/L,<60 male 32.78～111.18nmol/L,<60 female 24.04-97.05nmol/L.5. Using the established reference interval,25(OH)D status of 38 normal population of bone densitometry and PTH examination showed that no one was in a low state.Conclusions:A good analytical performance was found in chemiluminescence method to evaluate the serum totle 25(OH)D. The 25(OH)D status of kunming Han population was unsatisfactory. Interval reference recommended by American Endocrine Society was not so adequeted for local pupolation... |
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