第二代化学发光试剂检测乙肝表面抗原的多中心评估
摘要
一.研究背景
根据WHO数据统计,全球乙肝病毒(Hepatitis B Virus, HBV)感染人数高达20亿。我国更是乙型肝炎的高发区,加强对乙型肝炎(以下简称乙肝)的检出能力并及早给予治疗,是保障我国人民健康的重要措施。
与其它包膜病毒相比,HBV具有较强的抵抗外环境灭活的能力。在HBV感染患者的整个病程中,乙肝病毒表面抗原(又称：乙肝表面抗原/Hepatitis B Surface Antigen/HBsAg)是最早出现的血清学标志物,通常在临床症状出现前出现,在肝脏损害和黄疸等生化指标改变前的2到8周便可检测到,并在能痊愈的患者中数月后被机体自动清除,因此被常规作为诊断急慢性HBV感染,血液或器官捐献者的筛查指标,也常用于人群乙肝感染和传播的监测。但是HBV变异发生率较高容易导致漏检,尤其发生在接种乙肝疫苗免疫预防的儿童、肝移植受者和慢性携带者中。a决定簇为HBV颗粒表面突起的双环状结构,在S蛋白亲水基团的124至147位置,是主要的商品化HBsAg检测试剂中乙肝表面抗体(又称：Hepatitis B Surface Antibody/Anti-HBs)的结合位点,所有的HBV基因型都有a决定簇。上述疫苗或药物诱导的变异会引起HBV表面的a决定簇的氨基酸序列替代或变化,导致假阴性结果。为了减少HBV变异导致的乙肝患者漏检事件,降低输血传播乙肝的潜在风险,通过改善检测技术和试剂来提高检测的灵敏度和特异度尤为重要。为提高实验室检测质量,目前国内检验技术从早期的酶联免疫吸附法(英文简称：ELISA)更新为了国际主流使用的化学发光法(英文简称ELCA/ECL),德国罗氏诊断公司更推出的第二代改良型化学发光IIBsAg检测试剂盒。但化学发光检测系统和试剂价格较为昂贵,为了合理高效地利用医疗资源,临床实验室应当客观地了解和评估这些临床检测系统和试剂提高检测乙肝的准确度和灵敏度的程度,在适合的范围内使用。本文就该试剂和现在实验室广泛使用的科华酶联免疫(英文简称：ELISA)试剂以及目前全球公认的金标准----雅培试剂进行多中心评估。
二.研究目的
评估第二代化学发光HBsAg检测试剂的性能,并了解其临床应用价值。
三.研究内容
1.通过中国8家医院的多中心评估,评价在检出HBV突变能力方面做了改进的第二代化学发光试剂的临床检测性能。
2.了解第二代化学发光HBsAg检测试剂的临床应用价值,同时进行小范围的流行病学调查。
四.研究方法
1.收集8家医院212例临床确诊乙肝阳性标本,评估罗氏第二代化学发光试剂,雅培化学发光试剂,科华酶联免疫试剂检测的准确度；6家医院检测13种重组突变株和3种自然突变株,评价试剂检出HBV变异的能力；8家医院检测8组血清转换盘评估试剂的灵敏度；6家医院收集1916例临床标本计算第二代化学发光试剂的灵敏度,特异度和ROC曲线。分析3种试剂对于中国人群标本检测的差异：
·哪一种试剂检出HBV基因突变能力强,准确度高；
·哪一种试剂能最准确,灵敏地反应出患者的血清学转换情况；
·哪一种试剂更早地筛查出患者的HBsAg阳性结果,帮助缩短窗口期。
2.另一方面,使用罗氏第二代HBsAg化学发光检测试剂检测上海市某中心城区三甲医院950例体检人群,探讨第二代化学发光试剂实际临床应用。
五.研究结果
首先,临床确诊的阳性标本验证临床符合率,罗氏化学发光试剂与科华酶联免疫试剂临床阳性符合率为100%；罗氏和雅培化学发光试剂符合率为99.25%(雅培一例为阴性)。且罗氏和科华、雅培的相关趋势总体而言基本保持一致,即罗氏的值越高,相应的科华或者雅培也处于高值,反之亦然,且低值区更符合相关趋势。其次,在HBV突变株检测实验中,3种试剂差异较为明显。13株重组乙肝病毒血清突变株和3株天然变异株比对结果,罗氏的第二代HBsAg检测试剂变异株总检出率为98.1%,雅培的化学发光试剂盒能检出约87.6%的突变株,科华的ELISA试剂盒仅能检出约19.3%的突变株。再次,血清转换盘评估试剂敏感度的实验中,罗氏第二代HBsAg检测试剂和科华ELISA试剂共同参与了5组血清转换盘检测。大多数情况下,罗氏ECL第二代试剂检测结果已经表现出阳性,而科华ELISA试剂时间比较滞后：科华试剂总延迟天数为230天,中位值为39天；罗氏试剂总延迟天数为162天,比科华提早了78天；中位值为19天,比科华提早20天,两者比较结果有统计学显著差异(wilcoxon配对检验,P=0.043<0.05)。罗氏和雅培两个化学发光试剂的8组血清转换盘比较,罗氏总延迟天数179天,中位值15. 5天,雅培总延迟天数164天,提早了15天,中位值为16天,两者结果无统计学显著性差异(wilcoxon配对检验,P=0.553>0.05)。试剂的临床灵敏度用敏度指数(假阴性样本数/检测总样本数,越接近于“0”说明临床灵敏度越高)表示,罗氏为0.49,雅培为0.55,科华为0.90。最后,利用6家医院1916例门诊常规患者标本结果计算罗氏ECL第二代化学发光试剂的特异度和敏感度,结果为灵敏度99.7%,假阴性率0.3%,特异度99.0%,假阳性率1.0%,约登指数0.987,阳性预期值98.5%,阴性预期值99.8%, ROC曲线下面积为0.994,标准误0.002,95%可信区间为0.990到0.998。
另外,罗氏ECL第二代化学发光HBsAg检测试剂临床应用实验共选取上海某中心城区医院随机采样的950例体检标本,男女之比约1.081：1,年龄均值为48.06±12.85岁,年龄范围在19岁～88岁之间。总阳性率为8.32%,男性阳性率为9.02%,女性7.21%,男性略高于女性,性别之间差异无统计学意义(X2=0.973,自由度=948,P=0.324>0.05)；HBsAg阳性者年龄主要分布在45±11岁,不同年龄阳性率无统计学显著差异(X2=5.556,P值为0.592>0.05)。
上述一系列实验表明,罗氏ECL第二代化学发光检测试剂在检测突变的能力和敏感度方面明显优于国产的ELISA试剂,略优于第一代雅培化学发光试剂,能更早更灵敏准确地检出阳性结果,缩短窗口期。使用在临床小规模体检以及流行病学调查时,没有出现明显的高阳性率,基本与之前文献报道相符合,很适合临床应用于常规患者样本检测和流行病学调查,是目前较为理想的实验室检测工具。
1. Backgroud
According to WHO statistics, Hepatitis B virus (Abbreviate:HBV) infection is a global health problem that two billion people have been infected worldwide. It is even much more serious in China. So what we should do is to improve the detection ability of HBV and give early treatment. It is a significant case to maintain chineses'health.
HBV has strong capacity resistant to abominable environment. Hepatitis B surface antigen(Abbreviate:HBsAg) is one of the first serum markers to appear during the course of HBV infection and can be detected 2 to 8 weeks before biochemical evidence of liver dysfunction and the onset of jaundice. HBsAg is cleared within a few months in self-limiting illness. So HBsAg is the established serological marker used routinely for the diagnosis of acute or chronic HBV infection, the screening of blood or organ donors, and the surveillance of persons at risk of acquiring or transmitting. But HBV antigenic variation occurs frequently, especially S gene mutations has been detected in vaccinated children, in liver transplant recipients receiving Anti-HBs immunoprophylaxis, and in chronic carriers. The "a" determinant is the double-loop of HBV surface structure located from position 124 to 147 of HBsAg. It exists in all HBV genotype, also be the main antibody combined site of commercial HBsAg detecting assay. HBV variants with mutations on the "a"determinant have been identified following vaccination. Natural variation and mutation can induce HBsAg conformational changes, also account for the false-negative results in immunoassays. Due to the above factors, more improvements are done to decrease the interference of false-negative results caused by mutation. Routine techniques used by Chinese laboratories are in the process of changing from ELISA to ELCA/ECL. Meantime, newly developed HBsAg commercial assays exist, showing a performance increase in terms of specificity and sensitivity. Meantime, so-called generation 2 HBsAg detecting assay has been launched by Roche daignaostics, Germany. It is essential to know clearly and evaluate these commercial assays in Chinese clinical laboratories due to their high costs. Applying rationally can make largest profit on medical resource.
2. Objectives
Evaluate the performance of Gen.2 ECL assay detecting HBsAg in conjuction with its clinical value.
3. Contents
1) Performance of Gen.2 ECL HBsAg immunoassay detecting HBVmutants forms.
2) A view of clinical application with Gen.2 ECL HBsAg immunoassay via prevalent test in Shanghai Area.
4. Methods
1) The portocol is designed to evaluate newly launched Gen.2 ECL immunoassay comparing to another two HBsAg commercial immunoassays (Abbott ELCA and Kehua ELISA) via 8 hospitals. First, collecting 212 patient samples to know the accordance and precision. Secondly, analyze the HBsAg mutant detection capabilities of Gen.2 ECL immunoassay in comparison to Abbott ELCA and Kehua ELISA assay by detecting 13 recombinant mutants and 3 natural mutants;.Thirdly,8 seroconversion panels are used to investigate the sensitivity of these 3 assays. At last, account the sensitivity, specificity, concordance rate, ROC curve of Gen.2 ECL immunoassay in parallel with Abbott assay known as the golden standard from 1916 routine samples. My aid is to get the conculsion through above experiments:
·Which one is well designed to anti-mutants interference;
·Which one is optimized to respond to the HBV conversion;
·Which one can help to screening hepatitis disease earlier, shortening the mean time of diagnostic window.
2) Analyze 950 health checkup samples by Gen.2 ECL immunoassay from Shanghai XX hospital, have a close look at clinical application of this newly launched assay.
5. Results
The study showed nearly 100% coincidence results to 212 positive serum sample among Roche Gen.2 ECL assay, Abbott ELCA (99.25% includes one negative result) and kehua ELISA assay (100%). Generally these 3 assays had consistent correlation trend which means the higher results of Roche, the higher abbott/Kehua did. The phenomena appeared in low-result segment particularly. Roche Gen.2 assay could detect 98.1% mutant forms (totally 13 recombinant mutants and 3 natural mutants) as Abbott ELCA assay got 87.6% and Kehua got only 19.3%. So Roche Gen.2 ECL assay had a higher precision than Abbott and Kehua. Also Kehua ELISA assay showed large vacancy in detecting HBV mutants. In 5 seroconversion panels test, Roche Gen.2 ECL assay could catch most stages of hepatitis B disease while Kehua gave poor performance:The day-since-first-HBsAg-positive-bleed of Roche was 162 days,78 days earlier versus Kehua; median was 19 days,20 days earlier versus Kehua; the sensitivity was statistically significant better for Roche HBsAg assay versus Kehua(wilcoxon, P=0.043<0.05).8 seroconversion panels were detected nearly the same with Roche versus Abbott. The day-since-first-HBsAg-positive-bleed of Roche was 179 days,15 days later versus Abbott; median was 16 days while Abbott is 15.5days; the sensitivity was not statistically significant better between Roche HBsAg assay versus Abbott(wilcoxon, P=0.553>0.05). A sensitivity index (number of samples not detected devided by the total panel number investigated, f-neg/panel) was:Roche Gen.20.49, Abbott ELCA 0.55, Kehua ELISA 0.90 (Index closer to "0" showed better clinical sensitivity). Calculating 1916 routine outpatient sample results, got the data of Gen.2 ECL HBsAg assay:sensitivity 99.7%, false-negative rate 0.3%, specificity 99.0%, false-positive rate 1.0%, PPV 98.5%, NPV 99.8%, ROC curve 0.994, SD 0.002,95% confidence range from 0.990 to 0.998.
Randomly enrolled 950 healthcheck samples from a Shanghai hospital, then detected them by Roche Gen.2 ECL HBsAg immunoassay (Male/Female rate: 1.081:1; Age ranged from 19-88 years old, distributes on 48.06±12.85 years old). HBsAg positive rate was 8.32%, male positive rate was 9.02% while female was 7.21%, ranged between 45±11 years old. There was no statistically significance on Gender (X2=0.973, P value=0.324>0.05) and age (X2=5.556, P value=0.592> 0.05).
According to above studies, Roche Gen.2 ECL HBsAg immunoassay presented great performance on both sensitivity and specificity. It took obvious advantage comparing to Kehua assay specially in detecting HBV mutants. It also helped to screening hepatitis disease earlier, shortening the mean time of diagnostic window. Investigation revealed no obvious false-positive rates by using Roche Gen.2 assay in clinical experiment. So we could get the conclusion that Roche Gen.2 ECL HBsAg immunoassay is a proper choice for clinical laboratory.
根据WHO数据统计,全球乙肝病毒(Hepatitis B Virus, HBV)感染人数高达20亿。我国更是乙型肝炎的高发区,加强对乙型肝炎(以下简称乙肝)的检出能力并及早给予治疗,是保障我国人民健康的重要措施。
与其它包膜病毒相比,HBV具有较强的抵抗外环境灭活的能力。在HBV感染患者的整个病程中,乙肝病毒表面抗原(又称：乙肝表面抗原/Hepatitis B Surface Antigen/HBsAg)是最早出现的血清学标志物,通常在临床症状出现前出现,在肝脏损害和黄疸等生化指标改变前的2到8周便可检测到,并在能痊愈的患者中数月后被机体自动清除,因此被常规作为诊断急慢性HBV感染,血液或器官捐献者的筛查指标,也常用于人群乙肝感染和传播的监测。但是HBV变异发生率较高容易导致漏检,尤其发生在接种乙肝疫苗免疫预防的儿童、肝移植受者和慢性携带者中。a决定簇为HBV颗粒表面突起的双环状结构,在S蛋白亲水基团的124至147位置,是主要的商品化HBsAg检测试剂中乙肝表面抗体(又称：Hepatitis B Surface Antibody/Anti-HBs)的结合位点,所有的HBV基因型都有a决定簇。上述疫苗或药物诱导的变异会引起HBV表面的a决定簇的氨基酸序列替代或变化,导致假阴性结果。为了减少HBV变异导致的乙肝患者漏检事件,降低输血传播乙肝的潜在风险,通过改善检测技术和试剂来提高检测的灵敏度和特异度尤为重要。为提高实验室检测质量,目前国内检验技术从早期的酶联免疫吸附法(英文简称：ELISA)更新为了国际主流使用的化学发光法(英文简称ELCA/ECL),德国罗氏诊断公司更推出的第二代改良型化学发光IIBsAg检测试剂盒。但化学发光检测系统和试剂价格较为昂贵,为了合理高效地利用医疗资源,临床实验室应当客观地了解和评估这些临床检测系统和试剂提高检测乙肝的准确度和灵敏度的程度,在适合的范围内使用。本文就该试剂和现在实验室广泛使用的科华酶联免疫(英文简称：ELISA)试剂以及目前全球公认的金标准----雅培试剂进行多中心评估。
二.研究目的
评估第二代化学发光HBsAg检测试剂的性能,并了解其临床应用价值。
三.研究内容
1.通过中国8家医院的多中心评估,评价在检出HBV突变能力方面做了改进的第二代化学发光试剂的临床检测性能。
2.了解第二代化学发光HBsAg检测试剂的临床应用价值,同时进行小范围的流行病学调查。
四.研究方法
1.收集8家医院212例临床确诊乙肝阳性标本,评估罗氏第二代化学发光试剂,雅培化学发光试剂,科华酶联免疫试剂检测的准确度；6家医院检测13种重组突变株和3种自然突变株,评价试剂检出HBV变异的能力；8家医院检测8组血清转换盘评估试剂的灵敏度；6家医院收集1916例临床标本计算第二代化学发光试剂的灵敏度,特异度和ROC曲线。分析3种试剂对于中国人群标本检测的差异：
·哪一种试剂检出HBV基因突变能力强,准确度高；
·哪一种试剂能最准确,灵敏地反应出患者的血清学转换情况；
·哪一种试剂更早地筛查出患者的HBsAg阳性结果,帮助缩短窗口期。
2.另一方面,使用罗氏第二代HBsAg化学发光检测试剂检测上海市某中心城区三甲医院950例体检人群,探讨第二代化学发光试剂实际临床应用。
五.研究结果
首先,临床确诊的阳性标本验证临床符合率,罗氏化学发光试剂与科华酶联免疫试剂临床阳性符合率为100%；罗氏和雅培化学发光试剂符合率为99.25%(雅培一例为阴性)。且罗氏和科华、雅培的相关趋势总体而言基本保持一致,即罗氏的值越高,相应的科华或者雅培也处于高值,反之亦然,且低值区更符合相关趋势。其次,在HBV突变株检测实验中,3种试剂差异较为明显。13株重组乙肝病毒血清突变株和3株天然变异株比对结果,罗氏的第二代HBsAg检测试剂变异株总检出率为98.1%,雅培的化学发光试剂盒能检出约87.6%的突变株,科华的ELISA试剂盒仅能检出约19.3%的突变株。再次,血清转换盘评估试剂敏感度的实验中,罗氏第二代HBsAg检测试剂和科华ELISA试剂共同参与了5组血清转换盘检测。大多数情况下,罗氏ECL第二代试剂检测结果已经表现出阳性,而科华ELISA试剂时间比较滞后：科华试剂总延迟天数为230天,中位值为39天；罗氏试剂总延迟天数为162天,比科华提早了78天；中位值为19天,比科华提早20天,两者比较结果有统计学显著差异(wilcoxon配对检验,P=0.043<0.05)。罗氏和雅培两个化学发光试剂的8组血清转换盘比较,罗氏总延迟天数179天,中位值15. 5天,雅培总延迟天数164天,提早了15天,中位值为16天,两者结果无统计学显著性差异(wilcoxon配对检验,P=0.553>0.05)。试剂的临床灵敏度用敏度指数(假阴性样本数/检测总样本数,越接近于“0”说明临床灵敏度越高)表示,罗氏为0.49,雅培为0.55,科华为0.90。最后,利用6家医院1916例门诊常规患者标本结果计算罗氏ECL第二代化学发光试剂的特异度和敏感度,结果为灵敏度99.7%,假阴性率0.3%,特异度99.0%,假阳性率1.0%,约登指数0.987,阳性预期值98.5%,阴性预期值99.8%, ROC曲线下面积为0.994,标准误0.002,95%可信区间为0.990到0.998。
另外,罗氏ECL第二代化学发光HBsAg检测试剂临床应用实验共选取上海某中心城区医院随机采样的950例体检标本,男女之比约1.081：1,年龄均值为48.06±12.85岁,年龄范围在19岁～88岁之间。总阳性率为8.32%,男性阳性率为9.02%,女性7.21%,男性略高于女性,性别之间差异无统计学意义(X2=0.973,自由度=948,P=0.324>0.05)；HBsAg阳性者年龄主要分布在45±11岁,不同年龄阳性率无统计学显著差异(X2=5.556,P值为0.592>0.05)。
上述一系列实验表明,罗氏ECL第二代化学发光检测试剂在检测突变的能力和敏感度方面明显优于国产的ELISA试剂,略优于第一代雅培化学发光试剂,能更早更灵敏准确地检出阳性结果,缩短窗口期。使用在临床小规模体检以及流行病学调查时,没有出现明显的高阳性率,基本与之前文献报道相符合,很适合临床应用于常规患者样本检测和流行病学调查,是目前较为理想的实验室检测工具。
1. Backgroud
According to WHO statistics, Hepatitis B virus (Abbreviate:HBV) infection is a global health problem that two billion people have been infected worldwide. It is even much more serious in China. So what we should do is to improve the detection ability of HBV and give early treatment. It is a significant case to maintain chineses'health.
HBV has strong capacity resistant to abominable environment. Hepatitis B surface antigen(Abbreviate:HBsAg) is one of the first serum markers to appear during the course of HBV infection and can be detected 2 to 8 weeks before biochemical evidence of liver dysfunction and the onset of jaundice. HBsAg is cleared within a few months in self-limiting illness. So HBsAg is the established serological marker used routinely for the diagnosis of acute or chronic HBV infection, the screening of blood or organ donors, and the surveillance of persons at risk of acquiring or transmitting. But HBV antigenic variation occurs frequently, especially S gene mutations has been detected in vaccinated children, in liver transplant recipients receiving Anti-HBs immunoprophylaxis, and in chronic carriers. The "a" determinant is the double-loop of HBV surface structure located from position 124 to 147 of HBsAg. It exists in all HBV genotype, also be the main antibody combined site of commercial HBsAg detecting assay. HBV variants with mutations on the "a"determinant have been identified following vaccination. Natural variation and mutation can induce HBsAg conformational changes, also account for the false-negative results in immunoassays. Due to the above factors, more improvements are done to decrease the interference of false-negative results caused by mutation. Routine techniques used by Chinese laboratories are in the process of changing from ELISA to ELCA/ECL. Meantime, newly developed HBsAg commercial assays exist, showing a performance increase in terms of specificity and sensitivity. Meantime, so-called generation 2 HBsAg detecting assay has been launched by Roche daignaostics, Germany. It is essential to know clearly and evaluate these commercial assays in Chinese clinical laboratories due to their high costs. Applying rationally can make largest profit on medical resource.
2. Objectives
Evaluate the performance of Gen.2 ECL assay detecting HBsAg in conjuction with its clinical value.
3. Contents
1) Performance of Gen.2 ECL HBsAg immunoassay detecting HBVmutants forms.
2) A view of clinical application with Gen.2 ECL HBsAg immunoassay via prevalent test in Shanghai Area.
4. Methods
1) The portocol is designed to evaluate newly launched Gen.2 ECL immunoassay comparing to another two HBsAg commercial immunoassays (Abbott ELCA and Kehua ELISA) via 8 hospitals. First, collecting 212 patient samples to know the accordance and precision. Secondly, analyze the HBsAg mutant detection capabilities of Gen.2 ECL immunoassay in comparison to Abbott ELCA and Kehua ELISA assay by detecting 13 recombinant mutants and 3 natural mutants;.Thirdly,8 seroconversion panels are used to investigate the sensitivity of these 3 assays. At last, account the sensitivity, specificity, concordance rate, ROC curve of Gen.2 ECL immunoassay in parallel with Abbott assay known as the golden standard from 1916 routine samples. My aid is to get the conculsion through above experiments:
·Which one is well designed to anti-mutants interference;
·Which one is optimized to respond to the HBV conversion;
·Which one can help to screening hepatitis disease earlier, shortening the mean time of diagnostic window.
2) Analyze 950 health checkup samples by Gen.2 ECL immunoassay from Shanghai XX hospital, have a close look at clinical application of this newly launched assay.
5. Results
The study showed nearly 100% coincidence results to 212 positive serum sample among Roche Gen.2 ECL assay, Abbott ELCA (99.25% includes one negative result) and kehua ELISA assay (100%). Generally these 3 assays had consistent correlation trend which means the higher results of Roche, the higher abbott/Kehua did. The phenomena appeared in low-result segment particularly. Roche Gen.2 assay could detect 98.1% mutant forms (totally 13 recombinant mutants and 3 natural mutants) as Abbott ELCA assay got 87.6% and Kehua got only 19.3%. So Roche Gen.2 ECL assay had a higher precision than Abbott and Kehua. Also Kehua ELISA assay showed large vacancy in detecting HBV mutants. In 5 seroconversion panels test, Roche Gen.2 ECL assay could catch most stages of hepatitis B disease while Kehua gave poor performance:The day-since-first-HBsAg-positive-bleed of Roche was 162 days,78 days earlier versus Kehua; median was 19 days,20 days earlier versus Kehua; the sensitivity was statistically significant better for Roche HBsAg assay versus Kehua(wilcoxon, P=0.043<0.05).8 seroconversion panels were detected nearly the same with Roche versus Abbott. The day-since-first-HBsAg-positive-bleed of Roche was 179 days,15 days later versus Abbott; median was 16 days while Abbott is 15.5days; the sensitivity was not statistically significant better between Roche HBsAg assay versus Abbott(wilcoxon, P=0.553>0.05). A sensitivity index (number of samples not detected devided by the total panel number investigated, f-neg/panel) was:Roche Gen.20.49, Abbott ELCA 0.55, Kehua ELISA 0.90 (Index closer to "0" showed better clinical sensitivity). Calculating 1916 routine outpatient sample results, got the data of Gen.2 ECL HBsAg assay:sensitivity 99.7%, false-negative rate 0.3%, specificity 99.0%, false-positive rate 1.0%, PPV 98.5%, NPV 99.8%, ROC curve 0.994, SD 0.002,95% confidence range from 0.990 to 0.998.
Randomly enrolled 950 healthcheck samples from a Shanghai hospital, then detected them by Roche Gen.2 ECL HBsAg immunoassay (Male/Female rate: 1.081:1; Age ranged from 19-88 years old, distributes on 48.06±12.85 years old). HBsAg positive rate was 8.32%, male positive rate was 9.02% while female was 7.21%, ranged between 45±11 years old. There was no statistically significance on Gender (X2=0.973, P value=0.324>0.05) and age (X2=5.556, P value=0.592> 0.05).
According to above studies, Roche Gen.2 ECL HBsAg immunoassay presented great performance on both sensitivity and specificity. It took obvious advantage comparing to Kehua assay specially in detecting HBV mutants. It also helped to screening hepatitis disease earlier, shortening the mean time of diagnostic window. Investigation revealed no obvious false-positive rates by using Roche Gen.2 assay in clinical experiment. So we could get the conclusion that Roche Gen.2 ECL HBsAg immunoassay is a proper choice for clinical laboratory.
引文
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