Exploration Of Clinical Diagnosis Significance Of CMIA Technology In Detection Of HBcAb

Objective:To explore the range of S/CO values with a clinical significance for chemiluminescent immunoassay(CMIA)in detection of hepatitis B virus(HBV)core antibody(HBcAb).Methods1.According to HBcAb-positive specimens measured by CMIA,they were divided into the ELISA-positive group and ELISA-negative group by using ELISA 1:30 fold dilution method.The results of two sets of data were described by using quartile.The differences in S/CO values of HBcAb were observed and analyzed between the ELISA-positive group and ELISA-negative group.2.According to the level of S/CO values measured by CMIA,HBcAb specimens were divided into the low value group(1.00-3.99),median value group(4.00-6.99)and high value(7.00-9.99)group.ELISA retest of HBcAb specimens was observed in each group.3.Binary Logistic Regression was used for analysis of the correlation between three sets of data of low,medium and high values and HBcAb-positive results by ELISA.The diagnostic sensitivity and specificity of S/CO values in HBcAb specimens were evaluated by using ROC curve analysis of HBcAb specimens measured by CMIA.4.The fluorescence quantitative PCR(FQ-PCR)method was used for detection of the specimens in the ELISA-positive group and observation of HBV-DNA detection.5.CMIA and ELISA were used for parallel analysis of HBcAb in specimens with low replication level of HBV-DNA(X.XX × 103 IU/ml).Results1.There were 104 patients in the ELISA-positive group and 550 patients in the ELISA-negative group.The quartile of S/CO values in HBcAb specimens measured by CMIA were respectively P508.26(7.77,8.59)and P505.07(3.22,7.02)in two groups,and P50 in the positive group was higher than the negative group.2.The partial regression coefficient(B)in the low value group was lower than the median value group,both of which were lower than the high value group,P<0.05.Thus,the high value group was the main factor affecting the results of ELISA.3.The area under the ROC curve of HBcAb S/CO value was 0.922,with a significant difference,P<0.05.The S/CO value of 7.79 was considered as the critical point for discrimination of CMIA in detection of clinically significant HBcAb,with the sensitivity of 79.2%and specificity of 93.1%.4.The median S/CO value(M)of HBcAb was 8.05 in HBV-DNA specimens with low replication levels measured by CMIA.The HBV-DNA specimens with low replication levels by 1:30 fold dilution method were all positive by ELISA.ConclusionCMIA method used for detection of S/CO value with HBcAb?7.79 had a certain reference value for clinical diagnosis.