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目的调整抗乙型肝炎(乙肝)病毒核心抗原抗体免疫球蛋白M(Immunoglobulin M Antibody to Hepatitis B Virus Core Antigen,Anti-HBc-Ig M)诊断试剂临界值,使该指标能够区分急性乙肝(Acute Hepatitis B,AHB)和慢性乙肝(Chronic Hepatitis B,CHB)急性期患者。方法选择A公司国产和美国雅培(Abbott)公司Anti-HBc-Ig M检测试剂,平行检测2658份疑似AHB患者血清标本。利用R语言程序软件(R Programming Software,R)的VGAM程序包,通过最大似然法求得各自的分布参数和估计的阳性率,采用最大似然法、最大准确率法和固定特异度法,以及试剂说明书提供方法求得两种检测试剂的临界值、估计阳性率、灵敏度及特异度指标进行比较。结果采用最大似然法确定临界值,临界值调整前后A公司试剂阳性率为51.58%、12.23%,雅培试剂为28.37%、10.27%。两种试剂受试者工作特征曲线(Receiver Operating Characteristics Curve,ROC)的曲线下面积(Area Under Curve,AUC)均接近于1,都有较高的灵敏度和特异度。最大似然法、最大准确率法和固定特异度法与试剂说明书参考值比较,前三种方法得到的阳性率较为接近,灵敏度、特异度较高,试剂说明书参考值法,灵敏度均较低,假阳性率过高。结论本研究中调整Anti-HBc-Ig M检测试剂临界值的方法,可以使Anti-HBc-Ig M区分AHB和CHB急性期患者的能力更可靠。
Objective To adjust the diagnostic value of anti-HBc-Ig M against Hepatitis B Virus Core Antigen of Hepatitis B virus (HBV) so as to distinguish the acute hepatitis A (Acute Hepatitis) B, AHB) and Chronic Hepatitis B (CHB) in acute stage. Methods Anti-HBc-Ig M detection reagent from domestic company A and American Abbott Company was used to detect the serum samples of 2658 suspected AHB patients in parallel. Using the VGAM package of R Programming Software (R) software, the distribution parameters and the estimated positive rate were obtained by the maximum likelihood method. The maximum likelihood method, the maximum accuracy rate method and the fixed specificity method were used. As well as the method for providing reagents to obtain the critical values of the two detection reagents, estimating the positive rate, the sensitivity and the specificity index for comparison. Results The maximum likelihood method was used to determine the critical value. Before and after the critical value adjustment, the positive rate of reagent A was 51.58% and 12.23%, and that of Abbott reagent was 28.37% and 10.27% respectively. The Receiver Operating Characteristics Curve (ROC) curve area under the curve (Area Under Curve, AUC) was close to 1, with high sensitivity and specificity. The maximum likelihood method, the maximum accuracy method and the fixed specificity method compared with the reagent manual reference value, the positive rate obtained by the first three methods is relatively close, the sensitivity and the specificity are higher, the reagent manual reference value method and the sensitivity are lower, False positive rate is too high. Conclusion The method of adjusting the cutoff value of Anti-HBc-Ig M in this study can make Anti-HBc-Ig M more reliable in discriminating patients with acute phase of AHB and CHB.