The single-exon design results in high sensitivity and simple response algorithms

Dr. Agneta Wikman

Associate professor, Karolinska University Hospital, Stockholm, Sweden

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1 Apricot

Devyser RHD

Devyser RHD is a CE-IVD test kit used by clinical labs to determine fetal RHD status from maternal plasma as early as gestation week 10. Devyser’s unique single-exon design significantly simplifies your laboratory workflow and analysis. It also enables you to increase throughput and shorten turnaround times.

  • User-friendly assay with high sensitivity and specificity
  • Fast implementation
  • CE-IVD

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Devyser RHD

Devyser RHD is a CE-IVD test kit used by clinical labs to determine fetal RHD status from maternal plasma as early as gestation week 10. Devyser’s unique single-exon design significantly simplifies your laboratory workflow and analysis. It also enables you to increase throughput and shorten turnaround times.

  • User-friendly assay with high sensitivity and specificity
  • Fast implementation
  • CE-IVD

Fetal RHD detection in early pregnancy using a single-exon assay in a routine clinical setting is feasible and accurate

More information about early fetal RHD screening using a single-exon assay is available in the study “Noninvasive single-exon fetal RHD determination in a routine screening program in early pregnancy“. The objective of the study was to develop a simple and robust assay suitable for fetal RHD screening in first-trimester pregnancy and to estimate the sensitivity and specificity of the test after its implementation in an unselected pregnant population. The study included pregnant women attending their first antenatal visit, and fetal RHD determination was performed for all women who typed RhDnegative by routine serology. DNA was extracted by an automated system and quantitative polymerase chain reaction was done by an assay based on exon 4. The study found that both sensitivity and specificity were close to 99%, provided samples were not collected before gestational week 8. It concludes that fetal RHD detection in early pregnancy using a single-exon assay in a routine clinical setting is feasible and accurate.

Agneta Taune Wikman, Eleonor Tiblad, Anita Karlsson, Martin L Olsson, Magnus Westgren, Marie Reilly, Obstet Gynecol 2012 Aug; 120(2 Pt 1):227-34.

Fetal RHD screening and targeted prophylaxis resulted in lower immunisation risk and costs compared with no RAADP

The cost-effectiveness of the method has been examined in another study, “Cost-effectiveness of first trimester non-invasive fetal RHD screening for targeted antenatal anti-D prophylaxis in RhD-negative pregnant women: a model-based analysis”.The objective was to estimate the cost-effectiveness of first trimester non-invasive fetal RHD screening for targeted antenatal versus no routine antenatal anti-D prophylaxis (RAADP) or versus non-targeted RAADP. The study concluded that based on effect data from a population-based cohort study, targeted prophylaxis was associated with lower immunisation risk and costs versus no RAADP. Based on effect data from theoretical calculations, non-targeted RAADP was predicted to result in lower costs and immunisation risk compared with targeted prophylaxis.

M Neovius, E Tiblad, M Westgren, M Kublickas, K Neovius, A Wikman, BJOG. 2016 Jul;123(8):1337-46.

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Product Details

CE-IVD

Devyser RHD CE-IVD
Detection of fetal RHD DNA from maternal plasma. Single exon analysis (exon 4).
8-A060
Pack size: 
78

RUO

Devyser RHD RUO
Detection of fetal RHD DNA from maternal plasma. Single exon analysis (exon 4).
8-A406
Pack size: 
78