Evidence map›Paper›PMID 23305156›Full record

ArticleTransfusion2013

Lot-to-lot variability in HLA antibody screening using a multiplexed bead-based assay.

Manish J Gandhi, Danielle M Carrick, Sarah Jenkins, Steven De Goey, Nancy A Ploeger, Gregory A Wilson, Jar How Lee, Jeffrey L Winters, James R Stubbs, Pearl Toy and 2 more

Abstract read
In one paragraph

Article in Transfusion, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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

7 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Review
  6. Utility of HLA Antibody Testing in Kidney Transplantation.Journal of the American Society of Nephrology : JASN · 2015
    Review
  7. 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

12 authors.

Manish J GandhiDepartment of Laboratory Medicine and Pathology, Department of Biomedical Statistics & Informatics, Department of Anesthesiology, Division of Transfusion Medicine, Mayo Clinic, Rochester, Minnesota; Westat, Inc., Rockville, Maryland; One Lambda, Inc., Canoga Park, California; Deparment of Laboratory Medicine, University of California at San Francisco, Blood Systems Research Institute, San Francisco, California.
Danielle M Carrick
Sarah Jenkins
Steven De Goey
Nancy A Ploeger
Gregory A Wilson
Jar How Lee
Jeffrey L Winters
James R Stubbs
Pearl Toy
Philip J Norris
National Heart, Lung, and Blood Institute Specialized Center of Clinically Oriented Research TRALI Study and Retrovirus Epidemiology Donor Study-II

Funding

Transfusion-Related Acute Lung Injury: Incidence and MechanismsP50HL081027 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI TOY, PEARL T · 2005 to 2009
$12.4M
NHLBI NIH HHS HHSN268200517181CNHLBI NIH HHS P50 HL081027NHLBI NIH HHS SCCOR P50HL081027
6 · The paper itself

Abstract

backgroundIdentifying antibodies to HLA (anti-HLA) by solid-phase assays is used to screen blood donors to mitigate transfusion-related acute lung injury risk. Various cutoffs for detection assays have been proposed in the literature; however, these do not take into consideration lot-to-lot variability of commercially available assays. STUDY DESIGN AND

methodsSamples from 93 nontransfused males were tested using five different lots of a multiplex bead-based anti-HLA detection kit. A subset of 17 samples was tested on 5 days using a single lot. An additional 96 samples from donations with varied anti-HLA levels were tested using kits from two different lots. Results were reported as a normalized background (NBG) ratio.

resultsFor the 93 nontransfused donors, NBG values generated using the reference lot were significantly higher than those obtained with three of the four comparator lots. However, for the 96 samples with low-, moderate-, and higher-level anti-HLA, Class I (CL-I) values were 1.4 times lower and Class II (CL-II) values were 1.2 times lower using the reference versus comparator lot. For CL-I antibodies the between-lot standard deviation (SD) was 1.36 (95% confidence interval [CI], 1.19-1.60), while the between-day SD was 1.27 (95% CI, 1.08-1.52). Similarly, for CL-II antibodies the between-lot SD was 0.81 (95% CI, 0.70-0.95), while the between-day SD was 0.50 (95% CI, 0.43-0.60).

conclusionsThere is interlot variability in the tested HLA detection assay as well as significant bias between lots. It may be reasonable to develop a new cutoff when a new lot is obtained.

Indexed as

Blood DonorsAcute Lung InjuryAntibodiesBiological AssayHLA AntigensHumansMaleAntibodiesHLA Antigens

Identifiers

PMID23305156
PMCPMC3626740

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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.