ArticleTransfusion2013
Sensitivity of individual-donation and minipool nucleic acid amplification test options in detecting window period and occult hepatitis B virus infections.
Article in Transfusion, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Improved Safety of Nucleic Acid Amplification Technology Combined With Serological Tests for Screening Blood Donors: A Systematic Review and Meta-Analysis.Reviews in medical virology · 2026Pooled it
- Occult HBV among anti-HBc-reactive blood donors in Colombia: low HBsAg prevalence, genotype F3, and small-S variation relevant to HBsAg detectability.Scientific reports · 2026Article
- Re-Entry Evaluation of Chinese Blood Donors with Unconfirmed Hepatitis B Screening Results.Viruses · 2022Review
- Efficacy of Different Testing Scenarios in Reducing Transfusion-Transmitted Hepatitis B Virus (TT-HBV) Infection Risk.Viruses · 2022Article
- The impact of nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus yields from a single blood center in China with 10-years review.BMC infectious diseases · 2022Article
- Hepatitis B seroconversion revisited: new insights into the natural history of acute hepatitis B virus (HBV) infection from quantitative and highly sensitive assays and novel biomarkers.Virology journal · 2021Article
- Article
- Considerations for Group Testing: A Practical Approach for the Clinical Laboratory.The Clinical biochemist. Reviews · 2020Review
- Excluding Occult Hepatitis B Infection before Assigning False-Positive Status to Non-Repeatable NAT Reactivity: Concerning Stolz et al. "Safe-Testing Algorithm for Individual-Donation Nucleic Acid Testing: 10 Years of Experience in a Low-Prevalence Country" [Transfus Med Hemother. 2019 Apr;46(2):104-10].Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2020Article
- Reassessment of hepatitis B virus window periods for two transcription-mediated amplification assays using screening data of South African blood donors.Transfusion · 2019Article
- Safe-Testing Algorithm for Individual-Donation Nucleic Acid Testing: 10 Years of Experience in a Low-Prevalence Country.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2019Article
- Article
- Hepatitis B Virus Blood Screening: Need for Reappraisal of Blood Safety Measures?Frontiers in medicine · 2018Review
- Occult Hepatitis Infection in Transfusion Medicine: Screening Policy and Assessment of Current Use of Anti-HBc Testing.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2017Review
- Screening and diagnosis of HBV in low-income and middle-income countries.Nature reviews. Gastroenterology & hepatology · 2016Review
- Automated Triplex (HBV, HCV and HIV) NAT Assay Systems for Blood Screening in India.Journal of clinical and diagnostic research : JCDR · 2016Review
- Article
- Factors in enhancing blood safety by nucleic acid technology testing for human immunodeficiency virus, hepatitis C virus and hepatitis B virus.Asian journal of transfusion science · 2014Review
- Nucleic acid testing-benefits and constraints.Asian journal of transfusion science · 2014Article
- Individual donation nucleic acid technology testing to minimize human immunodeficiency virus-1, hepatitis C virus, and hepatitis B virus transfusion transmitted infections.Asian journal of transfusion science · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundSeveral comparison studies showed that the Ultrio assay (Novartis Diagnostics) used in individual-donation nucleic acid amplification testing (ID-NAT) format was as sensitive as the TaqScreen assay (Roche) on minipools of six donations (MP6), but the sensitivity of HBV DNA detection has been improved in the new Ultrio Plus version of the assay. A head-to-head comparison study was designed to compare the clinical sensitivity of the Ultrio and Ultrio Plus assay in ID, MP4, and MP8 formats using TaqScreen MP6 as a reference assay. STUDY DESIGN AND
methodsPlasma samples of 107 hepatitis B surface antigen (HBsAg)-negative, HBV ID-NAT (Ultrio) positive-yield samples and 29 HBV DNA-negative, HBsAg-positive samples were used for comparison of NAT options in replicate testing of dilutions. Viral loads and relative sensitivities were determined by probit analysis against the Eurohep standard.
resultsUltrio Plus detected a significantly (p < 0.00001) higher proportion of replicate assays on HBV NAT yields (77%) than Ultrio ID (62%) and TaqScreen MP6 (47%), whereas Ultrio Plus MP4 and MP8 detected 53 and 41%, respectively. On HBsAg-yield samples missed by Ultrio screening, the reactivity rate increased significantly (p < 0.0001) from 23% in Ultrio to 65% in Ultrio Plus and further to 72% (p = 0.10) in the TaqScreen assay. The overall improvement factor of the analytical sensitivity offered by the target enhancer reagent in the Ultrio Plus assay was 2.5 (2.0-3.1)-fold on the Ultrio yield samples, but 43 (11-350)-fold on the HBsAg yields. In ID-NAT format the analytical sensitivity of TaqScreen relative to Ultrio Plus was 2.0 (1.0-4.2), 0.9 (0.7-1.3), and 1.6 (0.9-3.0) on the Eurohep standard, HBV NAT-, and HBsAg-yield samples respectively.
conclusionThe clinical sensitivity of the currently available commercial NAT methods is mainly driven by the pool size.
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