一般人群乙型肝炎調(diào)查、試劑評(píng)價(jià)及混合血清法檢測(cè)的初步探討
發(fā)布時(shí)間：2019-06-12 00:02
【摘要】： 目的:(1)調(diào)查江蘇省一般人群乙肝的感染情況。(2)研究并比較常用國(guó)產(chǎn)乙型肝炎表面抗原診斷試劑盒以及國(guó)外相應(yīng)試劑盒的檢測(cè)性能,并對(duì)各個(gè)試劑盒的cutoff值進(jìn)行評(píng)價(jià)。(3)建立二維混合血清法檢測(cè)病毒核酸的數(shù)學(xué)模型,并討論不同陽性率時(shí)最優(yōu)混合樣本數(shù)和對(duì)應(yīng)節(jié)約的檢測(cè)次數(shù)。 研究方法:(1)按照多級(jí)抽樣抽取金壇市、海門市、海安縣、贛榆縣的一般人群,開展一般人群乙肝血清學(xué)指標(biāo)檢測(cè)。(2)采用SAS8.0軟件,對(duì)乙肝的各項(xiàng)檢測(cè)指標(biāo)進(jìn)行比較,并對(duì)乙肝各指標(biāo)的影響因素進(jìn)行Logistic回歸分析。(3)使用國(guó)產(chǎn)和國(guó)外乙型肝炎表面抗原診斷試劑盒對(duì)已知HBsAg陰性和陽性血清、國(guó)家參考品進(jìn)行檢測(cè),比較各試劑盒的檢測(cè)性能。(4)根據(jù)檢測(cè)樣本的OD值,繪制各試劑盒的ROC曲線。根據(jù)ROC曲線獲得最優(yōu)cutoff值,計(jì)算相應(yīng)試劑盒的靈敏度和特異度,并與試劑盒提供的cutoff值得到的靈敏度、特異度進(jìn)行比較。 研究結(jié)果:(1)江蘇省一般人群的HBsAg總陽性率為4.84%,大年齡組的HBsAg陽性的概率高于小年齡組,蘇中和蘇南地區(qū)的HBsAg陽性的概率高于蘇北地區(qū)。女性HBsAg陽性的概率低于男性。HBsAb總陽性率為50.34%,20歲以上各年齡組的陽性概率低于1-5歲組。男性和女性HBsAb陽性的概率未見差異。蘇中HBsAb陽性的概率低于蘇北,而蘇南HBsAb陽性的概率高于蘇北。HBcAb總陽性率為49.83%,年齡越大,HBcAb陽性的概率越大,女性HBcAb陽性的概率高于男性。20歲以上各組HBcAb陽性的概率均高于1-5歲組。與蘇北相比,蘇中和蘇南HBcAb陽性的概率較高。(2)以已知的HBsAg陰性、陽性的血清和國(guó)家參考品為標(biāo)準(zhǔn),意大利索林乙型肝炎表面抗原診斷試劑盒靈敏度高于其他試劑盒。以已知的HBsAg陰性、陽性的血清和國(guó)家參考品為標(biāo)準(zhǔn),不包括中國(guó)藥品生物制品檢定所(NICPBP)的靈敏度參考品,各試劑盒的靈敏度未見差異。單獨(dú)以國(guó)家參考品為標(biāo)準(zhǔn),不包括NICPBP靈敏度參考品,各試劑盒的靈敏度也未見差異。(3)以NICPBP的靈敏度參考品和衛(wèi)生部臨床檢驗(yàn)中心(NCCL)低值陽性參考品為標(biāo)準(zhǔn),國(guó)產(chǎn)四種乙型肝炎表面抗原診斷試劑盒之間的靈敏度未見差異;而意大利索林對(duì)低值陽性參考品檢測(cè)的靈敏度高于所有的國(guó)產(chǎn)試劑盒。(4)以NICPBP和NCCL參考品為標(biāo)準(zhǔn),乙型肝炎表面抗原國(guó)產(chǎn)診斷試劑盒由最優(yōu)cutoff值得到的靈敏度高于說明書給的cutoff值得到的靈敏度,意大利索林的靈敏度前后相同。各試劑盒不同標(biāo)準(zhǔn)下特異度均未見差異。(5)二維混合血清法數(shù)學(xué)模型表明混合血清法可以減少檢測(cè)次數(shù),節(jié)約篩檢費(fèi)用。
[Abstract]:Objective: (1) to investigate the infection of hepatitis B in Jiangsu province. (2) to study and compare the detection performance of domestic hepatitis B surface antigen diagnostic kit and the corresponding foreign kit, and to evaluate the cutoff value of each kit. (3) to establish a mathematical model for the detection of viral nucleic acid by two-dimensional mixed serum method, and to discuss the optimal number of mixed samples and the corresponding saved detection times. Methods: (1) according to the multi-stage sampling, the general population of Jintan City, Haimen City, Haian County and Ganyu County were selected to detect the serological indexes of hepatitis B. (2) the detection indexes of hepatitis B were compared by SAS8.0 software. The influencing factors of hepatitis B indexes were analyzed by Logistic regression analysis. (3) the known HBsAg negative and positive serum and national reference materials were detected by domestic and foreign hepatitis B surface antigen diagnostic kits, and the detection performance of each kit was compared. (4) according to the OD value of the test samples, the ROC curves of each kit were drawn. According to the ROC curve, the optimal cutoff value was obtained, and the sensitivity and specificity of the corresponding kit were calculated, and compared with the sensitivity and specificity obtained by the cutoff value provided by the kit. The results were as follows: (1) the total positive rate of HBsAg in Jiangsu province was 4.84%. The probability of HBsAg positive in older group was higher than that in younger age group, and the probability of HBsAg positive in central and southern Jiangsu was higher than that in northern Jiangsu. The positive probability of HBsAg in women was lower than that in males. The total positive rate of HBsAg was 50.34%. The positive probability of HBsAg in all age groups over 20 years old was lower than that in 1 < 5 years old group. There was no difference in the probability of HBsAb positive between men and women. The probability of HBsAb positive in Jiangsu was lower than that in northern Jiangsu, while the positive probability of HBsAb in southern Jiangsu was 49.83%. The older the age, the greater the probability of HBcAb positive, and the positive probability of HBcAb in women was higher than that in males. The probability of HBcAb positive in each group over 20 years old was higher than that in the group aged 1 to 5 years old. Compared with northern Jiangsu, the probability of HBcAb positive in central and southern Jiangsu is higher. (2) based on the known HBsAg negative, positive serum and national reference materials, the sensitivity of Italian Solin hepatitis B surface antigen diagnostic kit is higher than that of other kits. According to the known HBsAg negative, positive serum and national reference materials, excluding the sensitivity reference materials of (NICPBP) in China Institute of Pharmaceutical and Biological products, there was no difference in the sensitivity of each kit. The sensitivity of each kit was not different according to the national reference material and excluding the NICPBP sensitivity reference material. (3) there was no difference in the sensitivity of the four domestic hepatitis B surface antigen diagnostic kits based on the sensitivity reference of NICPBP and the (NCCL) low value positive reference of the clinical examination center of the Ministry of Health. The sensitivity of Italian Solin to low value positive reference was higher than that of all domestic kits. (4) according to NICPBP and NCCL reference materials, the sensitivity of hepatitis B surface antigen domestic diagnostic kit was higher than that of cutoff value given in specification, and the sensitivity of Italian Solin was the same before and after. There was no difference in the specificity of each kit under different standards. (5) the mathematical model of two-dimensional mixed serum method showed that the mixed serum method could reduce the detection times and save the screening cost.
【學(xué)位授予單位】：東南大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2006
【分類號(hào)】：R181.3
本文編號(hào)：2497560
[Abstract]:Objective: (1) to investigate the infection of hepatitis B in Jiangsu province. (2) to study and compare the detection performance of domestic hepatitis B surface antigen diagnostic kit and the corresponding foreign kit, and to evaluate the cutoff value of each kit. (3) to establish a mathematical model for the detection of viral nucleic acid by two-dimensional mixed serum method, and to discuss the optimal number of mixed samples and the corresponding saved detection times. Methods: (1) according to the multi-stage sampling, the general population of Jintan City, Haimen City, Haian County and Ganyu County were selected to detect the serological indexes of hepatitis B. (2) the detection indexes of hepatitis B were compared by SAS8.0 software. The influencing factors of hepatitis B indexes were analyzed by Logistic regression analysis. (3) the known HBsAg negative and positive serum and national reference materials were detected by domestic and foreign hepatitis B surface antigen diagnostic kits, and the detection performance of each kit was compared. (4) according to the OD value of the test samples, the ROC curves of each kit were drawn. According to the ROC curve, the optimal cutoff value was obtained, and the sensitivity and specificity of the corresponding kit were calculated, and compared with the sensitivity and specificity obtained by the cutoff value provided by the kit. The results were as follows: (1) the total positive rate of HBsAg in Jiangsu province was 4.84%. The probability of HBsAg positive in older group was higher than that in younger age group, and the probability of HBsAg positive in central and southern Jiangsu was higher than that in northern Jiangsu. The positive probability of HBsAg in women was lower than that in males. The total positive rate of HBsAg was 50.34%. The positive probability of HBsAg in all age groups over 20 years old was lower than that in 1 < 5 years old group. There was no difference in the probability of HBsAb positive between men and women. The probability of HBsAb positive in Jiangsu was lower than that in northern Jiangsu, while the positive probability of HBsAb in southern Jiangsu was 49.83%. The older the age, the greater the probability of HBcAb positive, and the positive probability of HBcAb in women was higher than that in males. The probability of HBcAb positive in each group over 20 years old was higher than that in the group aged 1 to 5 years old. Compared with northern Jiangsu, the probability of HBcAb positive in central and southern Jiangsu is higher. (2) based on the known HBsAg negative, positive serum and national reference materials, the sensitivity of Italian Solin hepatitis B surface antigen diagnostic kit is higher than that of other kits. According to the known HBsAg negative, positive serum and national reference materials, excluding the sensitivity reference materials of (NICPBP) in China Institute of Pharmaceutical and Biological products, there was no difference in the sensitivity of each kit. The sensitivity of each kit was not different according to the national reference material and excluding the NICPBP sensitivity reference material. (3) there was no difference in the sensitivity of the four domestic hepatitis B surface antigen diagnostic kits based on the sensitivity reference of NICPBP and the (NCCL) low value positive reference of the clinical examination center of the Ministry of Health. The sensitivity of Italian Solin to low value positive reference was higher than that of all domestic kits. (4) according to NICPBP and NCCL reference materials, the sensitivity of hepatitis B surface antigen domestic diagnostic kit was higher than that of cutoff value given in specification, and the sensitivity of Italian Solin was the same before and after. There was no difference in the specificity of each kit under different standards. (5) the mathematical model of two-dimensional mixed serum method showed that the mixed serum method could reduce the detection times and save the screening cost.
【學(xué)位授予單位】：東南大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2006
【分類號(hào)】：R181.3
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