Performance of rapid tests for detection of HBsAg and anti-HBsAb in a large cohort, France

详细信息    查看全文

• 作者：Julie Bottero¹ ; ² ; ³ ; ^{julie.bottero@sat.aphp.fr} ; Anders Boyd¹ ; ³ ; ^&dagger ; ; Joel Gozlan⁴ ; ^&dagger ; ; Maud Lemoine⁵ ; Fabrice Carrat¹ ; ² ; ⁶ ; Anne Collignon⁷ ; Nicolas Boo⁸ ; Philippe Dhotte⁹ ; Brigitte Varsat¹⁰ ; Gé ; rard Muller¹¹ ; Olivier Cha¹² ; Odile Picard³ ; Jean Nau¹³ ; Pauline Campa³ ; Benjamin Silbermann¹⁴ ; Marc Bary¹⁵ ; Pierre-Marie Girard¹ ; ² ; ³ ; Karine Lacombe¹ ; ² ; ³
• 关键词：Hepatitis B ; Rapid tests ; Screening
• 刊名：Journal of Hepatology
• 出版年：2013
• 出版时间：March, 2013
• 年：2013
• 卷：58
• 期：3
• 页码：473-478
• 全文大小：1264 K

文摘

| Figures/TablesFigures/Tables | ReferencesReferences

Background & Aims

The systematic use of rapid tests performed at points-of-care may facilitate hepatitis B virus (HBV) screening and substantially increase HBV infection awareness. The aim of this study was to evaluate the effectiveness of such tests for HBsAg and anti-HBsAb detection among individuals visiting a variety of healthcare centers located in a low HBV-prevalent area.

Methods

Three rapid tests for hepatitis B surface antigen (HBsAg) detection (VIKIA?, Determine? and Quick Profile?) and one test for anti-hepatitis B surface antibody (anti-HBsAb) detection (Quick Profile?) were evaluated in comparison to ELISA serology. Sensitivity (Se), specificity (Sp), positive and negative predictive values (PPV and NPV, respectively) and area under the ROC curve were used to estimate test performance. Non-inferiority criteria of the joint Se, Sp were set at 0.80, 0.95.

Results

Among the 3956 subjects screened, 85 (2.1 % ) were HBsAg-positive and 2225 (56.5 % ) had a protective anti-HBsAb titer. Test Se and Sp (lower bound of 97.5 % CI) were as follows: 96.5 % (89.0 % ), 99.9 % (99.8 % ) for Vikia?; 93.6 % (80.7 % ), 100.0 % (99.8 % ) for Determine?; and 90.5 % (80.8 % ), 99.7 % (99.5 % ) for Quick Profile?; with all three tests achieving minimal non-inferiority criteria. False negatives were typically observed in inactive HBsAg carriers. The anti-HBsAb Quick Profile? test had excellent specificity (97.8 % ) and PPV (97.8 % ) albeit low sensitivity (58.3 % ), thus failing to establish non-inferiority.

Conclusions

All three HBsAg rapid tests could be considered ideal for HBV screening in low HBV-prevalent countries, given the ease of use, rapidity, and high classification probabilities. The anti-HBsAb Quick Profile? could be considered reliable only for positive tests.