Evidence map›Paper›PMID 32167669›Full record

ArticleJournal of thrombosis and haemostasis : JTH2020

Combination of two complementary automated rapid assays for diagnosis of heparin-induced thrombocytopenia (HIT).

Theodore E Warkentin, Jo-Ann I Sheppard, James W Smith, Na Li, Jane C Moore, Donald M Arnold, Ishac Nazy

Open access · hybridAbstract read
In one paragraph

Article in Journal of thrombosis and haemostasis : JTH, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
4.5field-weighted citation impact, top 5% 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

19 citing papers in PubMed, 35 citations in OpenAlex.

  1. Article
  2. Article
  3. Observational
  4. Review
  5. Article
  6. Article
  7. Article
  8. Autoimmune Heparin-Induced Thrombocytopenia.Journal of clinical medicine · 2023
    Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Indeterminate serotonin release assays are associated with a high mortality rate.Research and practice in thrombosis and haemostasis · 2022
    Article
  14. Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Article
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

7 authors at 2 institutions in 1 country.

Theodore E WarkentinDepartment of Pathology and Molecular Medicine, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
Jo-Ann I SheppardDepartment of Pathology and Molecular Medicine, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
James W SmithDepartment of Medicine, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
Na LiMcMaster Centre for Transfusion Research, Hamilton, ON, Canada.
Jane C MooreDepartment of Medicine, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
Donald M ArnoldDepartment of Medicine, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
Ishac NazyDepartment of Medicine, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
McMaster University · CAHamilton Regional Laboratory Medicine Program · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHIT diagnosis typically uses complementary diagnostic assays (eg, a PF4-dependent enzyme-immunoassay [EIA] and a platelet activation assay such as the serotonin-release assay [SRA]).

objectivesTo determine whether the combination of two automated assays-a latex immunoturbidimetric assay (LIA) that evaluates competitive inhibition of a HIT-like monoclonal antibody and a chemiluminescence immunoassay (CLIA) for detecting anti-PF4/heparin IgG-optimizes diagnostic sensitivity while also yielding good specificity, particularly at high assay reactivities. PATIENTS/

methodsWe determined operating characteristics using combined LIA/CLIA results from a HIT observational trial (n = 430; derivation cohort) and 147 consecutive patients with HIT (n = 147; supplementary derivation cohort). We also evaluated 678 consecutive samples referred for HIT testing (replication cohort). LIA/CLIA reactivities were scored individually as "negative" (<1.00 U/mL, 0 points), "weak" (1.00-4.99 U/mL, 1 point), "moderate" (5.00-15.99 U/mL, 2 points) and "strong" (≥16.00 U/mL, 3 points), thus contributing up to 6 points (maximum) when LIA/CLIA results were combined. We also examined whether higher LIA/CLIA scores predicted presence of platelet-activating antibodies by conventional and modified (PF4- or PF4/heparin-enhanced) SRA.

resultsCombined LIA/CLIA testing yielded high diagnostic sensitivity (~99%) similar to EIA. Interpretation of LIA/CLIA results using the 6-point scale indicated progressively greater likelihood for the presence of platelet-activating antibodies with increasing scores (semi-quantitative reactivity). A LIA/CLIA score ≥ 4 points predicted the presence of platelet-activating antibodies by SRA or PF4-enhanced SRA with high probability (~98%).

conclusionCombined LIA/CLIA testing optimizes diagnostic sensitivity, with progressively greater probability of detecting platelet-activating antibodies with higher assay reactivity that reaches 98% when both automated assays yield moderate or strong results.

Indexed as

Platelet Factor 4ThrombocytopeniaAnticoagulantsHeparinHumansImmunoenzyme TechniquesPlatelet ActivationAnticoagulantsHeparinPlatelet Factor 4blood plateletsclinical laboratory techniquesheparinimmunoassaythrombocytopenia

Identifiers

PMID32167669
PMCPMC7317897
OpenAlexW3012190183

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.