Evidence map›Paper›PMID 28795528›Full record

ArticleJournal of thrombosis and haemostasis : JTH2017

Limit of detection and threshold for positivity of the Centers for Disease Control and Prevention assay for factor VIII inhibitors.

C H Miller, B Boylan, A D Shapiro, S R Lentz, B M Wicklund, Hemophilia Inhibitor Research Study Investigators

Abstract read
In one paragraph

Article in Journal of thrombosis and haemostasis : JTH, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.6field-weighted citation impact, top 16% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Evaluation of CDC's Hemophilia Surveillance Program - Universal Data Collection (1998-2011) and Community Counts (2011-2019), United States.Morbidity and mortality weekly report. Surveillance summaries (Washington, D.C. : 2002) · 2020
    Article
  6. Reagent substitution in the chromogenic Bethesda assay for factor VIII inhibitors.Haemophilia : the official journal of the World Federation of Hemophilia · 2019
    Article
  7. Article
  8. Article
  9. Article
  10. Effects of pre-analytical heat treatment in factor VIII (FVIII) inhibitor assays on FVIII antibody levels.Haemophilia : the official journal of the World Federation of Hemophilia · 2018
    Article
  11. Laboratory testing for factor VIII and IX inhibitors in haemophilia: A review.Haemophilia : the official journal of the World Federation of Hemophilia · 2018
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

C H MillerDivision of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, GA, USA.ORCID 0000-0002-3989-7973
B BoylanDivision of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, GA, USA.
A D ShapiroIndiana Hemophilia and Thrombosis Center, Indianapolis, IN, USA.
S R LentzUniversity of Iowa Carver College of Medicine, Iowa City, IA, USA.
B M WicklundKansas City Regional Hemophilia Center, Kansas City, MO, USA.
Hemophilia Inhibitor Research Study Investigators
Centers for Disease Control and Prevention · USIndiana Hemophilia and Thrombosis Center · USUniversity of Iowa · US

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

Essentials Immunologic methods detect factor VIII (FVIII) antibodies in some inhibitor-negative specimens. Specimens were tested by modified Nijmegen-Bethesda assay (NBA) and fluorescence immunoassay. The NBA with preanalytical heat inactivation detects FVIII inhibitors down to 0.2 NBU. IgG SUMMARY: Background The Bethesda assay for measurement of factor VIII inhibitors called for quantification of positive inhibitors by using dilutions producing 25-75% residual activity (RA), corresponding to 0.4-2.0 Bethesda units, with the use of 'more sensitive methods' for samples with RA closer to 100% being recommended. The Nijmegen modification (Nijmegen-Bethesda assay [NBA]) changed the reagents used but not these calculations. Some specimens negative by the NBA have been shown to have FVIII antibodies detectable with sensitive immunologic methods. Objective To examine the performance at very low inhibitor titers of the Centers for Disease Control and Prevention (CDC)-modified NBA (CDC-NBA), which includes preanalytic heat inactivation to liberate bound anti-FVIII antibodies. Methods Specimens with known inhibitors were tested with the CDC-NBA. IgG

Indexed as

AutoantibodiesCenters for Disease Control and Prevention, U.S.Factor VIIIFluoroimmunoassayHemophilia AHumansImmunoglobulin GLimit of DetectionPredictive Value of TestsReproducibility of ResultsUnited StatesAutoantibodiesF8 protein, humanFactor VIIIImmunoglobulin Gcomplicationsfactor VIIIhemophilia Aimmunologyinhibitor

Identifiers

PMID28795528
PMCPMC5716470
OpenAlexW2744390672

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.