Methodological Evaluation Of Heart-Type Fatty Acid-binding Protein Detection Kit And Clinical Study For Early Risk Stratification And Prognosis In ACS Patients

Objective:Evaluation the equivalence and compliance of clinical diagnosis of H-FABPELISA detection kit produccted by LanZhou biological research institute with theapproved kit and determine the performance of acceptability.Methods:Samples were the plasma or serum of suspected ACS patients hospitalized inGeneral Hospital of PLA and health examination personnel from The305thHospital ofPLA.240samples were enrolled according to inclusion criteria and exclusion criteria.Lanzhou H-FABP reagent kit and Holland H-FABP kit were detected by the standard ofparallel and controlled trails. Correlation of the two kits was evaluated and the precisiontest, recovery test, interference test and stability test of Lanzhou H-FABP kit for wereperformed to evaluate the clinical performance. SPSS13.0was used for statisticaldescription and analysis of obtained data. McNamara’s Test was used for paired dataand Kappa test was used to see the consistency in the results of two products. P<0.05was considered statistically significant while using two-sided test.Results:Correlation experiment: After detecting H-FABP by Lanzhou and Holland kitrespectively, correlation coefficient R=0.96and the two kits showed a good correlation(P<0.001). Precision test: For H-FABP detection, coefficient of variation within groupwas5.7%~8.2%, and coefficient of variation between groups was3.9%~4.1%.Recovery test: In the use of Lanzhou Kit, recovery rate was93.0%-105.7%for H-FABP detection. Anti-interference test: the effects of different concentrations of TBIL onnormal levels of H-FABP was in-9.57%~2.39%and on the abnormal levels of H-FABPin-20.71~7.43%. Effects of different concentrations of TG on normal levels of H-FABPwas in-7.33%~10.13%and on the abnormal levels of H-FABP in5.07~10.93%. Effectsof different concentration of hemolysis hemoglobin on normal levels of H-FABP was in-9.18%~8.16%and on abnormal levels of H-FABP was in-9.27%~9.83%. Thesensitivity of H-FABP diagnosis of ACS detection Lanzhou kit was91.8%, thespecificity was88.7%, the total diagnostic rate was90.42%. The sensitivity of H-FABPdiagnosis of ACS detection Holland kit was90.3%, the specificity was86.8%, the totaldiagnostic rate was88.75%. Paired McNamara ’s test chi-square test results showed thattwo kinds of products results in no statistically difference (P=0.668,>0.05). UsingKappa test, the results showed a good consistency of the two kinds of products(Kappa=0.726, P<0.01).Conclusions:1. H-FABP ELISA detection kit produccted by LanZhou biological researchinstitute has a well correlation with H-FABP detection kit produccted by HBT companyof Holland.2. The sensitivity, specificity and consistency rate of Lanzhou H-FABP kit for thediagnosis of ACS slightly higher than the Holland H-FABP detection kit, but the twogroups showed no significant difference. The two products were equivalent and have agood clinical compliance.3. H-FABP ELISA detection kit produccted by LanZhou biological researchinstitute has potential value in clinical application. Objective:To study the correlation between the incidence of adverse cardiovascular events inacute coronary syndrome (ACS) patients and the H-FABP detected by the ELISA kitproduccted by LanZhou biological research institute combined with NT-proBNP, CRPand cTnT. To explore the clinical value of combined detection for the prognosticassessment of patients with ACS.Methods:From2010March to2012March232patients with ACS were enrolled from286patients with acute chest pain suspected with ACS in the General Hospital of PLA,including unstable angina (UA), non ST segmnt elevation myocardial infarction(NSTEMI) and ST segment elevation myocardial infarction (STEMI). All the clinicaltreatment and follow-up data of the patients were complete and excluding of renaldysfunction, heart failure, chronic obstructive pulmonary disease and the variousconnective tissue diseases, infections, trauma, malignancy. Symptoms to12of detectionof ACS in patients with H-FABP, NT-proBNP, CRP and cTnT levels were detectedwithin12hours after the symptoms. Data were grouped according to the four percentileand using the receiver operator characteristic (ROC) curve to compare the value of thefour kinds of marker for accessing prognosis in ACS patients as well as the values ofcombined detection of four kinds of marker for prognosis and risk stratification in ACSpatients. Results:The average H-FABP level in ACS patients was20.98±11.39; area of ROC curvewas0.807and the value of prediction of cardiovascular events was40.97ng/ml. TheROC curve of NT-proBNP, CRP and cTnT in the area under slightly low, but all werehigher than0.7, therefore they had good prediction effect on cardiovascular events inACS patients. Levels of the four markers in patients with cardiovascular events weresignificantly higher than those in patients without cardiovascular events after a12-month follow-up. Detected levels of the four markers were divided into four groupsaccording to the four percentile from low to high. It was found that incidence ofcardiovascular events in patients with high value was far higher than that with low value.The survival time of patients with high value was obviously lower than that with lowvalue. Cox analysis of single factor of four cardiac markers in patients with ACS wassignificantly related to cardiovascular events. Using the cutoff value of the four markersas the positive standard, in a total of there were16cases with the four markers were allpositive in which cardiovascular events all occurred. Cardiovascular events occurred in62.5%of patients with H-FABP positive and other two markers positive. Incidence ofcardiovascular events was decrease in patients with H-FABP positive and one of theother markers positive, but still above30%. The incidence of cardiovascular events inpatients only with H-FABP positive was23.1%, but still higher than patients that fourmarkers were all negative which incidence of cardiovascular events was only4.6%.Using age, gender, hypertension, smoking, diabetes, the number of diseased vessels andH-FABP, NT-proBNP, CRP and cTnT as variables, adverse cardiovascular events after12months follow-up as the dependent variable, the results of Cox regression analysisshowed H-FABP, NT-proBNP, CRP and cTnT were independent risk factors ofcardiovascular adverse events in patients with ACS.Conclusions:1. Levels of H-FABP, NT-proBNP, CRP and cTnT are closely related withcardiovascular events in ACS patients, which are independent prognostic factors inpatients with ACS. 2. Domestic kit for detection of H-FABP and combined with NT-proBNP, CRPand cTnT detection can be better on patient with ACS in early risk stratification andprognosis. Objective:To explore the application value of H-FABP for risk stratification and prognosis inearly cTnT negative ACS patients.Methods:From2010March to2012March,55patients with early cTnT negative wereselected from232patients with ACS diagnosed with ACS in the General Hospital ofPLA. Levels of cTnT and H-FABP were detected within6hours from onset ofsymptoms. H-FABP and cTnT12,24,48hours from onset of symptoms werecontinuously detected to investigate the dynamic changes of H-FABP and cTnT and thecorresponding prognosis. ROC curve of H-FABP for early prediction of evolution ofmyocardial infarction in cTnT negative patients was drawn and the area under the curvewas calculated and the specificity and sensitivity of predict early evolution ofmyocardial infarction was evaluated. The cTnT negative ACS patients were followed upfor12months and divided into2groups according to the presence of cardiovascularevents and level of H-FABP of early onset between patients in2groups was compared.ROC curve is adopted to observe within6hours of onset detection of H-FABP levelspredict cardiovascular events in patients with ACS. Patients were divided into highH-FABP value group and the low value group according to the cutoff value of ROCcurve. Patients with cardiovascular events and no cardiovascular events survival in the2groups were observed. Results:Detection levels of cTnT in early cTnT negative ACS patients within6hours fromonset of symptoms gradually increased with the disease progress and reached the peakvalue at12h after onset of symptoms and then decreased, but still maintain a certainlevel and decreased by about50%at the48h. Detection levels of H-FABP reached thepeak within6h from onset of symptoms and decreased slightly (12.82%) at12h andthen decreased rapidly48h can be decreased by about79%. In55patients,24casesevolved to acute myocardial infarction during hospitalization. Detection of H-FABPlevel within6hours from onset of symptoms has a good predictive value in the earlycTnT negative ACS patients evolved to myocardial infarction. Area under ROC curvewas0.946and the cutoff value was15.47ng/ml. The predicted sensitivity was87.5%,specificity90.33%. During12months follow-up,11patients were found to havecardiovascular events. Levels of H-FABP in patients with cardiovascular events weresignificantly higher than that without cardiovascular events. ROC curve analysisshowed that the area under the curve was0.772and the prediction cutoff value ofcardiovascular events was44.71ng/ml. Patients were divided into high value and lowvalue group according to the cutoff value. Results showed in the high values groupincidence of cardiovascular events was54.5%, while in the low value group was only11.4%and the difference was significant. Survival without cardiovascular events of thepatients in the high-risk group was significantly lower than that in the low risk group(8.55±1.08VS11.23±1.39).Conclusions:For the ACS patients with early negative detection of cTnT, H-FABP is a goodindex for early risk stratification and prognosis.