The Establishment Of A Fully Autometic Myeloperoxidase Quantified Measuring Method And Its Clinical Significance Studies

Acute coronary syndrome is caused by coronary artery plaque rupture andthrombosis. It leads to acute or subacute myocardial ischemia clinical syndrome.Inflammation is associating with plaque formation and development. Myeloperoxidaseis a heme protein, when the inflammation happened, neutrophil released MPO into thecirculatory system. The quantitative determination of content of MPO can reflect thecondition and severity of the inflammatory response. It can be used in ACS`s auxiliarydiagnosis.Particle-enhanced immunoturbidimetric assay, developed from the immuneagglutination test, is an high sensitive rapid and easy-use assay which is used inautomatic biochemical analyzer. PEITA breaked the limitation of the originalimmunoturbidimetric assay. The targe material`s molecular weight and content is toosmall to test. Because of its high specificity, high sensitivity, wide linear range, it iswidely used in highly automated clinical laboratory.Select anti-MPO monoclonal antibodies from different companies, the optimumdouble-antibody combination was picked out by the method of each monoclonalantibody crosslink latex particle and one by one match. The suitable latex(203nm) andreaction concentration were analyzed， according to MPO`s concentration.Finally,Choosing optimize antibodies and latex concentration, buffer systems, standardoperating procedure, it could be ensured toproduct high quality and traceability of MPOreagent kit.According to the guildline of EP5-A2,EP6-A and EP9-A2The results showed thatthe sensitivity: LoB=1.0ng/ml，LoD=3.9ng/ml，LoQ=4.7ng/ml, the within-run and interday-run coefficients of variation(CV) were:1.28%and1.85%, and the meanrecovery rate was100.0%±1.2%, reference range was:54-266ng/ml; linear range up20-1300ng/ml, virtually unaffected by endogenous interferences, MPO assay has highspecificity, linearity and sensitivity. It can be used in the automatic biochemicalanalyzer easily.Significant MPO differences were found between control groups, unstable anginapectoris(UAP) and acute myocardial infarction(AMI).MPO has a low positivecorrelation with CVD factors(P<0.05). The UAP group has a ROC curve(A=0.795，P=0.000). The best cut-off point for MPO was identified as≥149.2ng/ml using the ROCcurve of AMI(A=0.911，P=0.000). Kappa value (P=0.000) showed that the twodiagnostic methods were in good agreement． Logistic regression identified significantdifferences in MPO，LDH,HCY,IMA and AGE between control group and AMIgroup(R2=0.922)．A predictive model of AMI was established using these variables andthe total correct rate of MPO in predicting AMI reached96.80%．MPO can effectivelypredict ACS occur and diagnose acute myocardial infarction.According to the China Food and Drug Administration regulations, MPO reagent kitcompleted all relevant technical document and accepted product registration card.Completed product standards traceability test, It can ensure that the results havetraceability and comparality.Through the above research and experimentation, particle enhanced turbidimetricimmunoassay testing MPO with high sensitivity, good stability, simply operation showsa better application to predict and diagnose cardiovascular diseases. Results of clinicaltrials, MPO can predict the occurrence of acute coronary syndrome, and can serve as ahierarchical index of ACS, on the AMI diagnosed with high accuracy.