Clinical Research Of The MPO Varying From Different Reference Interval Of Test Samples

Background:MPO (myeloperoxidase, MPO) is an important iron-containing lysosomes,it exists in myeloid cells (mainly neutrophils and monocytes) azurophil particles,it’s specific marker of myeloid,it’s neutrophils,monocytes and macrophages of certain tissues secrete the protease-containing hemoglobin prosthetic group of heme, and one of the heme peroxidase superfamily members. When the body becomes inflammatory, MPO is released into the circulation system from neutrophils. It catalytic substrate of hydrogen peroxide and chloride ions to generate product hypochlorous acid, participate in the oxidation and absorption process of inflammatory reaction. MPO promote the formation of atherosclerosis, and affect the stability of the plaque, participate in the evolution of atherosclerotic plaque development by enhancing oxidative stress and oxidative modification of pro-inflammatory role. At present, more and more evidences indicate that plasma MPO levels have special significance in the early diagnosis and prognosis evaluation of cardiovascular diseases. And the current domestic MPO reference interval is no consistent view. Reference interval is clinical judgment people healthy or not, only establish a reasonable reference intervals in order to guide the clinical efficacy for patients. Given the importance of the reference interval, the establishment of the MPO reference interval is particularly important, the experimental study on the establishment of MPO reference interval. EDTA anticoagulant reference interval was(male 44-579.5ng/ml,female 40.5-517.0ng/ml), heparin reference sample interval was(male109-599nl/ml,female 118-434ng/ml), no anticoagulant serum samples reference interval was(male 149-795ng/ml,female 110-901ng/ml);Three types of different blood samples were no obvious difference between different age groups (Z = 0.348,1.001,0.914, P>0.05),but the differences are between different genders(Z= 0.012,0.049,0.008, P<0.05).Objective:To study the latex-enhanced immunoturbidimetric assay myeloperoxidase blood samples between different types of reference intervals, establish a suitable reference interval for MPO in the healthy population in different types of samples in the laboratory; Evaluation of the current commonly used different venous blood samples on the same research object MPO content influence, and at the same time to provide performance evaluation kit manufacturers.Provide valuable laboratory data for the clinical application of MPO.Methods:Through the inclusion and exclusion criteria, screened the conditions of the healthy people, and according to different sample types, different gender and age groups; According to current standards, which according to the US Committee for Standardization of Clinical Laboratory (CLSI) to develop《Defining, Establishing, and Verifying reference Intervals in the clinical laboratory; Approved Guideline-Third Edition》(C28-A3) and China’s 《Development of clinical laboratory test reference period (WS/T 402-2012)》 method files provided, to have already developed the latex enhanced turbidimetric immunoassay determination of MPO between different sample types of reference intervals comparison research and statistical analysis, to investigate the relationship between serum,EDTA-K2 plasma, and heparin plasma samples with different reference limits, and clinical compliance analysis, for these sample types of MPO test provide references for the clinical application.Results:At OLYMPUS AU5421 automatic biochemical analyzer of Beijing JiuQiang Biotechnology Co., Ltd. to provide the latex enhanced turbidimetric immunoassay determination of myeloperoxidase detection system, the performance evaluation is good.High concentration repeatability precision CV% was 1.47,total indoor precision CV% was 1.67;The low concentration repeatability precision CV% was 2.38 and the total indoor precision CV% was 3.13; Accuracy validation results and target values relative bias between 1.16%-4.14%; Detection System MPO analytical measurement range of 29.91～862.61ng/ml; The added concentration of bilirubin less than 684 umol/L, hemoglobin concentration below add 5000 mg/L, chylomicron adding concentration is less than 20.0% level under the condition of is not observed interference;Conclusion:There were significant differences in MPO levels among 3 different types of blood samples of healthy adults; and among the three types of sample differences were statistically significant (P<0.05); And there was no significant difference between the different age groups, but there were significant differences among the different gender groups; Different genders, different test samples should establish reference intervals, respectivesly.