Evidence map›Paper›PMID 32056107›Full record

Observational studyMolecular diagnosis & therapy2020

Hemolysis and Fetal Fraction in Cell-Free DNA Blood Collection Tubes for Noninvasive Prenatal Testing.

Renee Stokowski, Karen White, Coleen Hacker, Jigna Doshi, Maximilian Schmid

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Molecular diagnosis & therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
3.3field-weighted citation impact, top 9% 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

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
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  4. Review
  5. 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

5 authors at 1 institution in 1 country.

Renee StokowskiAriosa Diagnostics Inc., Roche Sequencing Solutions Inc., San Jose, CA, USA.
Karen WhiteAriosa Diagnostics Inc., Roche Sequencing Solutions Inc., San Jose, CA, USA. karen.white.kw2@roche.com.ORCID 0000-0002-5429-9170
Coleen HackerAriosa Diagnostics Inc., Roche Sequencing Solutions Inc., San Jose, CA, USA.
Jigna DoshiAriosa Diagnostics Inc., Roche Sequencing Solutions Inc., San Jose, CA, USA.
Maximilian SchmidAriosa Diagnostics Inc., Roche Sequencing Solutions Inc., San Jose, CA, USA.
Roche (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLysis of maternal white blood cells in prenatal cell-free DNA (cfDNA) test samples increases the level of maternal DNA and consequently decreases fetal fraction.

objectiveThe objective of this study was to determine whether hemolysis, traditionally used as a marker for cell lysis, is correlated with a decrease in fetal fraction in maternal blood samples collected in specialized cfDNA tubes for noninvasive prenatal testing.

methodsIn the first part of the study, blood from pregnant women was collected into three Roche Cell-Free DNA Collection Tubes. These replicate specimens from the same subject were evaluated for a visual difference in hemoglobin level as a measure of hemolysis. The specimens were then processed with the Harmony

resultsThere was no significant difference in fetal fraction in 339 paired samples, with a difference in hemoglobin levels ranging from 0 to 1000 mg/dL. There was strong correlation in fetal fraction between tubes, regardless of the differences in hemoglobin concentration. The fetal fraction distribution in 203 tracked clinical samples with hemoglobin levels ≥ 500 mg/dL was statistically equivalent to the distribution in a concurrent series of 12,705 samples.

conclusionHemolysis in maternal blood samples collected in specialized cfDNA tubes does not correlate with a decrease in fetal fraction; therefore, it should not be a cause for rejection of samples submitted for prenatal cfDNA testing.

Indexed as

AdultCell-Free Nucleic AcidsFemaleGestational AgeHemoglobinsHemolysisHumansMaternal AgeNoninvasive Prenatal TestingPregnancySpecimen HandlingYoung AdultCell-Free Nucleic AcidsHemoglobins

Identifiers

PMID32056107
PMCPMC7113221
OpenAlexW3006309637

What OpenQuestion holds

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Registered trials

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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.