Evaluation of 17 CE-marked HBsAg assays with respect to clinical sensitivity, analytical sensitivity, and hepatitis B virus mutant detection

2006 ◽  
Vol 78 (S1) ◽  
pp. S66-S70 ◽  
Author(s):  
Heiner Scheiblauer ◽  
Heidemarie Soboll ◽  
Sigrid Nick
2008 ◽  
Vol 14 (5) ◽  
pp. 251-256 ◽  
Author(s):  
Toshikazu Uchida ◽  
Seiichi Shimojima ◽  
Kenichiro Gotoh ◽  
Toshio Shikata ◽  
Satoaki Mima

2004 ◽  
Vol 5 (4) ◽  
pp. 325-328 ◽  
Author(s):  
Anna Maria Pelizzari ◽  
Maddalena Motta ◽  
Elisabetta Cariani ◽  
Paola Turconi ◽  
Erika Borlenghi ◽  
...  

2009 ◽  
Vol 16 (8) ◽  
pp. 1236-1246 ◽  
Author(s):  
Pierre Cambron ◽  
Jeanne-Marie Jacquet ◽  
Bernard Hoet ◽  
Marc Lievens

ABSTRACT Pending removal from the market of a commercial assay (the AUSAB [Abbott Laboratories] enzyme immunoassay [EIA]) for the determination of antibodies to hepatitis B surface antigen (HBsAg), a new in-house quantitative enzyme-linked immunosorbent assay (ELISA) to measure antibodies against HBsAg (anti-HBs) was developed (anti-HBs in-house). Specific anti-HBs antibodies were sandwiched between the precoated HBsAg ad and ay subtypes purified from plasma from hepatitis B virus (HBV) human carriers and the recombinant HBsAg adw2 subtype tagged with horseradish peroxidase. The assay was calibrated against the 1st International Reference Preparation for anti-hepatitis B immunoglobulin (lot 1977-W1042). Analytical sensitivity and the limit of quantitation were estimated at 0.43 mIU/ml and 2.0 mIU/ml, respectively. Overall reproducibility was 11.86%, and accuracy was estimated to be 94.89%. More than 4,000 samples from seven clinical trials were tested with the anti-HBs in-house assay and compared to results generated with AUSAB EIA and AUSAB radioimmunoassay (RIA). During the technical validation, the anti-HBs in-house assay was compared to the AUSAB RIA as a reference (n = 919). Overall assessment of concordance and Deming's regression analysis were performed. The coefficient of correlation between the AUSAB RIA and anti-HBs in-house assay was 0.9815 with a slope of 0.9187. The overall agreement between anti-HBs in-house and AUSAB RIA was 97.61%, considering the clinical cutoffs at 3.3 mIU/ml and 1.0 mIU/ml for the respective assays. From a clinical perspective, seroprotection rates and anti-HBs geometric mean antibody concentrations for individual studies calculated with either the in-house assay or the reference assays were similar. Conclusions of individual studies were confirmed. The performance characteristics of the in-house assay are acceptable. There is no evidence that use of the new assay would lead to different clinical conclusions from the reference method.


1991 ◽  
Vol 324 (24) ◽  
pp. 1705-1709 ◽  
Author(s):  
T. Jake Liang ◽  
Kiyoshi Hasegawa ◽  
Nurit Rimon ◽  
Jack R. Wands ◽  
Edna Ben-Porath

2002 ◽  
Vol 73 (1) ◽  
pp. 148-151 ◽  
Author(s):  
Sydney Tang ◽  
Stephen K. N. Ho ◽  
Kelly Moniri ◽  
Kar Neng Lai ◽  
Tak Mao Chan

1994 ◽  
Vol 21 (6) ◽  
pp. 1152 ◽  
Author(s):  
Jean-Charles Duclos-Vallee ◽  
Pierre Laurent-Puig ◽  
Marie-Anne Loriot ◽  
Catherine Buffet ◽  
David Malka ◽  
...  

2004 ◽  
Vol 18 (3) ◽  
pp. 295-300 ◽  
Author(s):  
Henry Lik-Yuen Chan ◽  
Albert Ka-Keung Chui ◽  
Wan-Yee Lau ◽  
Francis Ka-Leung Chan ◽  
Alex Yui Hui ◽  
...  

1994 ◽  
Vol 68 (3) ◽  
pp. 1651-1659 ◽  
Author(s):  
K Hasegawa ◽  
J Huang ◽  
S A Rogers ◽  
H E Blum ◽  
T J Liang

2015 ◽  
Vol 53 (6) ◽  
pp. 1831-1835 ◽  
Author(s):  
Jack Bee Chook ◽  
Woon Li Teo ◽  
Yun Fong Ngeow ◽  
Kok Keng Tee ◽  
Kee Peng Ng ◽  
...  

Hepatitis B virus (HBV) has been divided into 10 genotypes, A to J, based on an 8% nucleotide sequence divergence between genotypes. The conventional practice of using a single set of primers to amplify a near-complete HBV genome is hampered by its low analytical sensitivity. The current practice of using overlapping conserved primer sets to amplify a complete HBV genome in a clinical sample is limited by the lack of pan-primers to detect all HBV genotypes. In this study, we designed six highly conserved, overlapping primer sets to cover the complete HBV genome. We based our design on the sequences of 5,154 HBV genomes of genotypes A to I downloaded from the GenBank nucleotide database. These primer sets were tested on 126 plasma samples from Malaysia, containing genotypes A to D and with viral loads ranging from 20 to >79,780,000 IU/ml. The overall success rates for PCR amplification and sequencing were >96% and >94%, respectively. Similarly, there was 100% amplification and sequencing success when the primer sets were tested on an HBV reference panel of genotypes A to G. Thus, we have established primer sets that gave a high analytical sensitivity for PCR-based detection of HBV and a high rate of sequencing success for HBV genomes in most of the viral genotypes, if not all, without prior known sequence data for the particular genotype/genome.


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