Superiority of minipool nucleic acid amplification technology for hepatitis B virus over chemiluminescence immunoassay for hepatitis B surface antigen screening

Minegishi, Kiyoshi; Yoshikawa, Akira; Kishimoto, S; Yugi, Hisao; Yokoya, Nair S.; Sakurada, Mikiko; Kiyokawa, Hiroyuki; Nishioka, Kusuya

doi:10.1046/j.1423-0410.2003.00289.x

Cited by 45 publications

(69 citation statements)

References 11 publications

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“…While the minipool sample MPX NAT was superior to the HBsAg assay for detecting HBV during the early stage of acute infection (20)(21)(22), the cost-effectiveness of NAT is a major concern, especially in populations with low HBV prevalence when donors are screened for HBsAg and hepatitis B virus core antibody (anti-HBc antibody). Clinically, HBV DNA quantification is useful for monitoring chronic hepatitis B patients during antiviral therapy as well as HBV-resolved patients during chemotherapy.…”

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confidence: 99%

Highly Sensitive Detection of Hepatitis B Virus Surface Antigen by Use of a Semiautomated Immune Complex Transfer Chemiluminescence Enzyme Immunoassay

et al. 2013

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The performance of hepatitis B surface antigen (HBsAg) screening assays is continuously improved to reduce the risk of transfusion-associated hepatitis B. In this study, a semiautomated immune complex transfer chemiluminescence enzyme immunoassay (ICT-CLEIA) for the detection of HBsAg, which is as sensitive as hepatitis B virus (HBV) DNA PCR, was developed; the ICT-CLEIA assay performance was compared with the performance of the Architect HBsAg QT assay and HBV DNA PCR. The specificities in the initial assay and after retesting were 99.50% (1,988/1,998 samples) and 99.95% (1,997/1,998 samples), respectively. The analytical detection limit was determined to be 0.2 mIU/ml using the 2nd International WHO HBsAg standard, and the cutoff value (0.5 mIU/ml) of the ICT-CLEIA assay was 8.0 standard deviations (SD) above the mean of the HBsAg-negative specimens. The ICT-CLEIA assay could detect HBsAg even in the presence of anti-HBs antibodies and demonstrated a 23.6-dayshorter window period using commercially available HBsAg seroconversion panels than the Architect HBsAg QT assay. Furthermore, the monitoring of the viral kinetics by the ICT-CLEIA assay and the HBV DNA PCR produced very similarly shaped curves during both the HBsAg seroconversion and reverse seroconversion periods. Therefore, the ICT-CLEIA assay may be useful not only for an earlier detection of HBV reactivation but also for the monitoring of hepatitis B patients.

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Highly Sensitive Detection of Hepatitis B Virus Surface Antigen by Use of a Semiautomated Immune Complex Transfer Chemiluminescence Enzyme Immunoassay

et al. 2013

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“…The case observed by us is probably not a rare exception. At a Japanese Red Cross Blood Center Minegishi et al [13] screened 11 million donations with a minipool NAT which could also detect 1,000 copies/ml in a donor with 95% probability. They found, after prescreening for HBsAg with a moderately sensitive reverse passive hemagglutination assay and for high anti-HBc titers, 181 donors who had HBV DNA only.…”

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confidence: 99%

Transmission of Hepatitis B Virus 2 Months Prior to Hepatitis Surface Antigen Positivity of Donor Blood

Meisel¹,

Endres²,

Walter³

et al. 2003

Transfus Med Hemother

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An hepatitis surface antigen(HBsAg)-negative donation transmitted hepatitis B virus (HBV) of the very common genotype A/HBsAg subtype adw2 to the recipient of the erythrocyte concentrate. Two months later the donor became borderline HBsAg-positive. The infectious donation was tested retrospectively by real time PCR and contained approximately 2,000 viral genomes/ml, an amount which would have been well detectable by minipool nucleic acid amplification test (NAT) for HBV DNA at the usual detection limit of 1,000 copies/ml. The case shows that the HBsAg-negative, HBV DNA-positive phase may be longer than previously believed and that HBV DNA screening at a sensitivity achievable by minipool NAT testing would have prevented transmission.

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“…Despite the increased sensitivity of serological HBsAg tests, a residual risk of HBV transmission still exists, and the introduction of HBV NAT in blood screening may be warranted. Using a real-time PCR-based assay, developed with the same primer set included in the CAS HBV test, 76 (42%) HBV DNA-positive, HBsAg-negative donations were detected in minipools of 50 (11). Upon investigation, all samples were traced back to blood drawn during the seronegative window phases.…”

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Multicenter Evaluation of a Semiautomated, Standardized Assay for Detection of Hepatitis B Virus DNA in Blood Donations

et al. 2005

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We evaluated the COBAS Ampliscreen hepatitis B virus (HBV) test using standards, seroconversion panels, consecutive donations, and samples from patients with abnormal alanine aminotransferase and chronic hepatitis C. Specificity was 100% and sensitivity was 20 IU/ml. In seroconversion panels, HBV DNA was detected up to 4 to 18 days before HBsAg, suggesting that this assay is useful in shortening the infectious window phase.

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Superiority of minipool nucleic acid amplification technology for hepatitis B virus over chemiluminescence immunoassay for hepatitis B surface antigen screening

Abstract: The sensitivity of the 50-sample pool MPX NAT system was higher than that of individual HBsAg screening by CLIA. By adopting this NAT-screening system, the JRC has improved the safety of the blood supply and maintained supply across Japan.

Cited by 45 publications

References 11 publications

Highly Sensitive Detection of Hepatitis B Virus Surface Antigen by Use of a Semiautomated Immune Complex Transfer Chemiluminescence Enzyme Immunoassay

Highly Sensitive Detection of Hepatitis B Virus Surface Antigen by Use of a Semiautomated Immune Complex Transfer Chemiluminescence Enzyme Immunoassay

Transmission of Hepatitis B Virus 2 Months Prior to Hepatitis Surface Antigen Positivity of Donor Blood

Multicenter Evaluation of a Semiautomated, Standardized Assay for Detection of Hepatitis B Virus DNA in Blood Donations

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