Madiyal Mridula, Sagar Siddharth, Vishwanath Shashidhar, Banerjee Barnini, Eshwara Vandana Kalwaje, Chawla Kiran
Assistant Professor, Department of Microbiology, Kasturba Medical College, Manipal University , Manipal, Karnataka, India .
Tutor, Department of Microbiology, Kasturba Medical College, Manipal University , Manipal, Karnataka, India .
J Clin Diagn Res. 2016 Nov;10(11):DC22-DC25. doi: 10.7860/JCDR/2016/24108.8921. Epub 2016 Nov 1.
Antibodies to Hepatitis B surface Antigen (Anti-HBs) levels are measured as markers for immune response to vaccination and in decision making for post-exposure prophylaxis against Hepatitis-B. Several immunoassay formats are used to measure Anti-HBs, thus carrying the possibility of variation in measured levels between different assays. This study compares the performance of Chemiluminescence Immunoassay (CLIA) against Enzyme-linked Immunosorbent Assay (ELISA) in measuring Anti-HBs titer by looking into concordance between the two test reports.
To compare the agreement between ELISA and CLIA in measurement of Anti-HBs antibody titers.
This prospective comparative study conducted at Kasturba Medical College, Manipal measured consecutive serum samples (69) sent for anti-HBs levels during May-June 2016 using both CLIA (Abbott Architect) and ELISA (Bio-Rad). Anti-HBs values of ≤10mIU/ml was considered as non-protective and >10mIU/ml as protective. The agreement between the tests in classifying the antibody titers as non-protective or protective was computed using Kappa coefficient, and the difference in individual titer values between the tests compared using Bland-Altman plot on SPSS (v.15).
Out of the 69 samples analysed, 18 samples (26.1%) were of health-care personnel and remaining of patients. Agreement between ELISA and CLIA in identifying the antibody titers as protective and non-protective were 96.5% and 90.9% respectively, resulting in an agreement of 0.84. The coefficient-of-variation of ELISA and CLIA were 74.5% and 113.1%, respectively. Three value based discordant results were noted; two samples deemed protective by ELISA were reported as non-protective by CLIA. One non-protective titer by ELISA was reported as protective by CLIA.
Analytical agreement is good between the two immunoassays. However there are some discrepancies in quantitative measurement. This may have been due the variation in the standard calibrators used in each assay. Though CLIA showed more variation in the values, it has the advantage of being automated test with low turn around time. Therefore, both the test methodologies can be reliably used in place of each other for detection of Anti- HBs titer.
乙型肝炎表面抗原抗体（抗-HBs）水平作为疫苗免疫反应的标志物以及暴露后预防乙型肝炎决策的依据进行检测。多种免疫测定方法用于检测抗-HBs，因此不同检测方法之间测量水平可能存在差异。本研究通过观察两种检测报告之间的一致性，比较化学发光免疫分析（CLIA）和酶联免疫吸附测定（ELISA）在检测抗-HBs滴度方面的性能。
比较ELISA和CLIA在抗-HBs抗体滴度测量中的一致性。
本前瞻性比较研究在马尼帕尔卡斯图尔巴医学院进行，于2016年5月至6月期间，使用CLIA（雅培Architect）和ELISA（伯乐）对连续送检的69份血清样本进行抗-HBs水平检测。抗-HBs值≤10mIU/ml被视为无保护作用，>10mIU/ml被视为有保护作用。使用Kappa系数计算两种检测方法在将抗体滴度分类为无保护或有保护方面的一致性，并使用SPSS（v.15）上的布兰德-奥特曼图比较两种检测方法之间个体滴度值的差异。
在分析的69份样本中，18份样本（26.1%）来自医护人员，其余为患者样本。ELISA和CLIA在将抗体滴度鉴定为有保护作用和无保护作用方面的一致性分别为96.5%和90.9%，一致性系数为0.84。ELISA和CLIA的变异系数分别为74.5%和113.1%。记录到3个基于数值的不一致结果；ELISA判定为有保护作用的2份样本，CLIA报告为无保护作用。ELISA检测的1个无保护滴度，CLIA报告为有保护作用。
两种免疫测定方法之间的分析一致性良好。然而，在定量测量方面存在一些差异。这可能是由于每种检测方法中使用的标准校准物不同所致。尽管CLIA显示的值变化更大，但它具有自动化检测且周转时间短的优点。因此，两种检测方法均可可靠地相互替代用于检测抗-HBs滴度。
