Usefulness of quantitative hepatitis B surface antigen testing in hepatitis B community-based screening
Kao-Chi Chang 1 , Chih-Yi Lee 2 , Te-Sheng Chang 3 , Chao-Hung Hung 4 , Wei-Ming Chen 1 , Mei-Yen Chen 5 , Tung-Jung Huang 6 , Wen-Nan Chiu 7 , Jing-Hong Hu 7 , Yu-Chih Lin 8 , Wei-Cheng Huang 9 , Nien-Tzu Hsu 10 , Sheng-Nan Lu 11
Affiliations
Affiliations
1
Division of Hepatology and Gastroenterology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chiayi, Taiwan.
2
Department of Laboratory Medicine, Chang Gung Memorial Hospital, Chiayi, Taiwan.
3
Division of Hepatology and Gastroenterology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chiayi, Taiwan; Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Yunlin, Taiwan; School of Medicine, College of Medicine, Chang Gung University, Taoyuan, Taiwan.
4
Department of Internal Medicine, Division of Hepato-Gastroenterology, Kaohsiung Chang Gung Memorial Hospital, Taiwan.
5
College of Nursing, Chang Gung University of Science and Technology, Chiayi, Taiwan.
6
Division of Thoracic Medicine, Chang Gung Memorial Hospital, Yunlin, Taiwan.
7
Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Yunlin, Taiwan.
8
Division of Family Medicine, Chang Gung Memorial Hospital, Yunlin, Taiwan.
9
Department of Geriatric, Chang Gung Memorial Hospital, Chiayi, Taiwan.
10
Biostatistics and Bioinformatics Center of Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.
11
Department of Internal Medicine, Division of Hepato-Gastroenterology, Kaohsiung Chang Gung Memorial Hospital, Taiwan; Biostatistics and Bioinformatics Center of Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan. Electronic address: [email protected].
PMID: 32896456 DOI: 10.1016/j.jfma.2020.08.031
Abstract
Background/purpose: Low viral load (LVL) of hepatitis B virus (HBV) is a predictor of chronic HBV infection. However, the usefulness of quantitative hepatitis B surface antigen (qHBsAg) in predicting LVL in community-based screening has not been well studied. We aimed to measure the prevalence of LVL in HBV carriers and validate the efficacy of qHBsAg in predicting LVL.
Methods: This community-based screening study was conducted in Taiwan. HBV DNA was assayed in HBsAg carriers. Participants were randomized to training and validation sets to determine the ability of qHBsAg to predict LVL. Receiver operating characteristic curves were used to identify the best cutoff values in the training set.
Results: Among the 2919 participants, 359 (12.2%) were HBsAg carriers. There were 132 and 137 carriers in the training and validation sets, respectively. Significant correlations were found between qHBsAg and HBV DNA in both training and validation sets. Thirty and 29 participants with qHBsAg <8 IU/mL in the training and validation sets, respectively, had LVL. Using 8 IU/mL as the cutoff, negative predictive value (NPV) of qHBsAg for HBV DNA levels >2000 IU/mL was 100%. The best cutoff level of qHBsAg to predict HBV LVL was 200 IU/mL, with a sensitivity, specificity, and accuracy of 75.0%, 76.1%, and 75.8%, respectively, in the training set. The positive predictive value and NPV were 70.0% and 77.9%, respectively, in the validation set.
Conclusion: Approximately 60% of HBsAg carriers had HBV LVL, and qHBsAg <8 IU/mL accurately predicts LVL. This quantitative test provides additional information for community-based screening.
Keywords: Community-based screening tool; HBV DNA; Hepatitis B virus; Quantitative hepatitis B surface antigen.
结果：在2919名参与者中，有359名（12.2％）是HBsAg携带者。训练和验证集中分别有132和137个载体。在训练和验证组中均发现了qHBsAg和HBV DNA之间的显着相关性。在训练和验证组中分别有30名和29名qHBsAg <8 IU / mL的参与者患有LVL。使用8 IU / mL作为临界值，qHBsAg对HBV DNA水平> 2000 IU / mL的阴性预测值（NPV）为100％。在训练集中，预测HBV LVL的最佳qHBsAg截止水平为200 IU / mL，敏感性，特异性和准确性分别为75.0％，76.1％和75.8％。在验证集中，阳性预测值和NPV分别为70.0％和77.9％。
结论：大约60％的HBsAg携带者具有HBV LVL，而qHBsAg <8 IU / mL可以准确预测LVL。该定量测试为基于社区的筛查提供了更多信息。
"HBV DNA检测在基于社区的筛查中的使用非常有限，因为它昂贵且需要合适的实验室设备和技术人员。 所有用于预测HBV DNA的HBsAg临界值分别为8、20或200 IU / mL，均小于250 IU / mL，可以在当地诊所或医院轻松进行评估而无需稀释。 换句话说，没有稀释的定量检测与传统的定性检测具有相似的成本，并且可以满足预测HBV DNA水平的需求。"
The use of HBV DNA tests in community-based screening is very limited, because it is expensive and requires suitable laboratory equipment and technicians. The HBsAg cutoff values of 8, 20, or 200 IU/mL, which are all used to predict HBV DNA, are all <250 IU/mL and can be easily evaluated in local clinics or hospitals without dilution. In other words, quantitative testing with no dilution has similar costs to the traditionally used qualitative testing and can meet the demand of predicting the HBV DNA level."