| Enzyme-linked immunosorbent assay for high-throughput(ELISA) testing is most commonly used in clinical laboratories to detect hepatitis B virus(HBV) serology markers method with high sensitivity and specificity, low price advantage, but at the same time and there are poor repeatability and accuracy operation, affecting the reliability of the resμLts. In this study, our high-throughput instrument ADDCAER1100 automatic ELISA workstation including precision pipette sample performance evaluation measure, washout of residual microplate measurement and incubation temperature measurements as well as ancillary reagents; the Architect I2000 methodological comparison automated chemiluminescence immunoassay analyzer(the Architect I2000) as the reference method, ADDCAER1100 automatic ELISA workstation(referred ADDCAER1100) of HBV serological markers, as well as repetitive tests ADDCAER1100 to complete its qualitative performance evaluation tests, to ensure standardized systematic ELISA test. collecting different methods of Chongqing main city and county of four hospitals to detect HBV serological markers and the basic information in 2013.6-2014.6.Establishment of Chongqing hepatitis B virus specimen bank informationthe and Chongqing Hepatitis B virus epidemiology analysis of the resμLts of the study are as follows1. ADDCARE 1100 hardware has a total of 12 samples, each sample is repeated 10 times, the number of measurements for the 12 × 10 = 120 times. Pipette accuracy of 12 channels are within 100 ± 2μ L, repetitive line with national standards CV≤0.75%. Three washers have reached an average of the resμ Lts of each hole remaining amount required ≤2μ L; 32 measurements microplate meets a temperature T = 37 ℃ ± 0.5 at different times twice.2. Methodology comparison: Hepatitis B virus surface antigen(HBs Ag), hepatitis B surface antibody(HBs Ab), hepatitis B virus E antigen(HBe Ag), hepatitis E virus antibody(HBe Ab), hepatitis B virus core antibody(HBc Ab) of total coincidence rates were 99.0%, 99.5%, 99.5%, 98.0%, 100.0%; positive coincidence rates were 98.0%, 100.0%, 99.0%, 97.0%, 100.0%; negative coincidence rate was 100.0%, 99.0%, 100.0%, 99.0%, 100.0%; Kappa test coefficient K are 0.98,0.99,0.99,0.96, 1.00.3. Repeatability test: HBs Ag, HBs Ab, HBe Ag, HBe Ab, HBc Ab ± 20% of the threshold concentration of samples positive(negative) of the rate of ≥95%.95% confidence interval, respectively: 96.6%-99.5%, 97.6%-99.5% 97.6%-99.5% 94.7%-99.5% 98.6%-99.5%.4. The epidemiologicalfindings: 2013.6-2014.6 Daping Hospital,Nanchuan District People’s Hospital, Qianjiang Central Hospital, Hechuan District hospital laboratories were detected HBV serological markers(HBs Ag, HBs Ab, HBe Ag, HBe Ab, HBc Ab) 149762. Specimens were obtained 31 kinds of serological combined mode; HBs Ab(+), HBs Ab(+) HBc Ab(+), markers whole negative, mainly three modes, accounting for the number of detected of 18.02%, 17.55%, 15.46%5. HBs Ag positive gender distribution of the popμLation : Male HBs Ag positive rate was16%; Female HBs Ag positive rate was 9.82%6. HBs Ag positive and HBs Ab positive four ages of the distribution: HBs Ag lowest positive rate of ages 5-14 years,was 3.48%;the highest HBs Ag positive rate of the 15-59 age group for 14.15%; Four ages HBs Ag positive rate were significantly different, P <0.01; HBs Ab highest positive rate of 0-4 age group was 65.38%; HBs Ab lowest positive rate of 5-14 years was 48.48%; Four ages HBs Ab positive were significant differences in the distribution, P <0.01.7. The main city and counties of HBs Ag positive distribution; Five hospitals participated in the detection of HBV serological 。The main city of HBs Ag(+) positive rate was 10.23%, and four county hospitals HBs Ag(+) positive rate was 13.78%, the main city and county of HBs Ag(+) positive rate were significantly different P <0.01.To sum up: ADDCAER1100 automated ELISA workstations and Architect I2000 chemiluminescence analyzer test resμLts of HBV serological markers are strong consistency; ADDCAER1100 detection of hepatitis B virus serological markers within ± 20% of the critical value of concentration to get stable resμLts. The instrument detection ELISA test system meets the requirements for standardized operations require high accuracy and reproducibility of clinical and ELISA detection system can be used for the detection of clinical laboratory specimens.The overall survey of Chongqing epidemiology of hepatitis B virus in line with the national reports of national epidemiological survey in 2006,provides important clinical evidence for prevalence of hepatitis B virus in Chongqing basic characteristics and prognosis of outcome, etc., And to provide a reliable scientific basis for the prevention and treatment of hepatitis B virus. |
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