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External quality assessment of noninvasive fetal RHD genotyping

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@article{788b6f3331ce4a8790acf262fc2a0d8f,
title = "External quality assessment of noninvasive fetal RHD genotyping",
abstract = "BACKGROUND AND OBJECTIVES: Fetal RHD genotyping of cell-free maternal plasma DNA from RhD negative pregnant women can be used to guide targeted antenatal and postnatal anti-D prophylaxis for the prevention of RhD immunization. To assure the quality of clinical testing, we conducted an external quality assessment workshop with the participation of 31 laboratories.MATERIALS AND METHODS: Aliquots of pooled maternal plasma from gestational week 25 were sent to each laboratory. One sample was fetal RHD positive, and a second sample was fetal RHD negative. A reporting scheme was supplied for data collection, including questions regarding the methodological setup, results and clinical recommendations. The samples were tested blindly.RESULTS: Different methodological approaches were used; 29 laboratories used qPCR and two laboratories used ddPCR, employing a total of eight different combinations of RHD exon targets. Fetal RHD genotyping was performed with no false-negative and no false-positive results. One inconclusive result was reported for the RHD positive sample. All clinical conclusions were satisfactory.CONCLUSION: This external quality assessment workshop demonstrates that despite the different approaches taken to perform the clinical assays, fetal RHD genotyping is a reliable laboratory assay to guide targeted use of Rh prophylaxis in a clinical setting.",
keywords = "Exons, Female, Fetus/metabolism, Genotyping Techniques/standards, Humans, Plasma/chemistry, Pregnancy, Prenatal Diagnosis/standards, Real-Time Polymerase Chain Reaction, Rh-Hr Blood-Group System/blood, Rho(D) Immune Globulin, Rh prophylaxis, cell-free fetal DNA, fetal RHD genotyping, external quality assessment",
author = "Clausen, {Frederik Banch} and {\AA}sa Hellberg",
note = "{\textcopyright} 2020 International Society of Blood Transfusion.",
year = "2020",
month = jul,
doi = "10.1111/vox.12908",
language = "English",
volume = "115",
pages = "466--471",
journal = "Vox Sanguinis",
issn = "0042-9007",
publisher = "Wiley-Blackwell Publishing Ltd",
number = "5",

}

RIS

TY - JOUR

T1 - External quality assessment of noninvasive fetal RHD genotyping

AU - Clausen, Frederik Banch

AU - Hellberg, Åsa

N1 - © 2020 International Society of Blood Transfusion.

PY - 2020/7

Y1 - 2020/7

N2 - BACKGROUND AND OBJECTIVES: Fetal RHD genotyping of cell-free maternal plasma DNA from RhD negative pregnant women can be used to guide targeted antenatal and postnatal anti-D prophylaxis for the prevention of RhD immunization. To assure the quality of clinical testing, we conducted an external quality assessment workshop with the participation of 31 laboratories.MATERIALS AND METHODS: Aliquots of pooled maternal plasma from gestational week 25 were sent to each laboratory. One sample was fetal RHD positive, and a second sample was fetal RHD negative. A reporting scheme was supplied for data collection, including questions regarding the methodological setup, results and clinical recommendations. The samples were tested blindly.RESULTS: Different methodological approaches were used; 29 laboratories used qPCR and two laboratories used ddPCR, employing a total of eight different combinations of RHD exon targets. Fetal RHD genotyping was performed with no false-negative and no false-positive results. One inconclusive result was reported for the RHD positive sample. All clinical conclusions were satisfactory.CONCLUSION: This external quality assessment workshop demonstrates that despite the different approaches taken to perform the clinical assays, fetal RHD genotyping is a reliable laboratory assay to guide targeted use of Rh prophylaxis in a clinical setting.

AB - BACKGROUND AND OBJECTIVES: Fetal RHD genotyping of cell-free maternal plasma DNA from RhD negative pregnant women can be used to guide targeted antenatal and postnatal anti-D prophylaxis for the prevention of RhD immunization. To assure the quality of clinical testing, we conducted an external quality assessment workshop with the participation of 31 laboratories.MATERIALS AND METHODS: Aliquots of pooled maternal plasma from gestational week 25 were sent to each laboratory. One sample was fetal RHD positive, and a second sample was fetal RHD negative. A reporting scheme was supplied for data collection, including questions regarding the methodological setup, results and clinical recommendations. The samples were tested blindly.RESULTS: Different methodological approaches were used; 29 laboratories used qPCR and two laboratories used ddPCR, employing a total of eight different combinations of RHD exon targets. Fetal RHD genotyping was performed with no false-negative and no false-positive results. One inconclusive result was reported for the RHD positive sample. All clinical conclusions were satisfactory.CONCLUSION: This external quality assessment workshop demonstrates that despite the different approaches taken to perform the clinical assays, fetal RHD genotyping is a reliable laboratory assay to guide targeted use of Rh prophylaxis in a clinical setting.

KW - Exons

KW - Female

KW - Fetus/metabolism

KW - Genotyping Techniques/standards

KW - Humans

KW - Plasma/chemistry

KW - Pregnancy

KW - Prenatal Diagnosis/standards

KW - Real-Time Polymerase Chain Reaction

KW - Rh-Hr Blood-Group System/blood

KW - Rho(D) Immune Globulin

KW - Rh prophylaxis

KW - cell-free fetal DNA

KW - fetal RHD genotyping

KW - external quality assessment

UR - http://www.scopus.com/inward/record.url?scp=85081750187&partnerID=8YFLogxK

U2 - 10.1111/vox.12908

DO - 10.1111/vox.12908

M3 - Journal article

C2 - 32166750

VL - 115

SP - 466

EP - 471

JO - Vox Sanguinis

JF - Vox Sanguinis

SN - 0042-9007

IS - 5

ER -

ID: 61695612