Devyser RHD

Non-invasive determination of fetal RHD status from gestation week 10

Devyser RHD

Non-invasive determination of fetal RHD status from gestation week 10

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.

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

Dr. Agneta Wikman, Associate professor
Karolinska University Hospital

Learn more about how our RHD kit can help your team get the results they need.

Clinical performance

Diagnostic sensitivity

Diagnostic specificity

Correlation to Rhesus serology of the newborn

Clinical performance

≥ 99.7%

Diagnostic sensitivity

≥ 99.5%

Diagnostic specificity

≥ 99.7%

Correlation to Rhesus serology of the newborn

Discover the benefits

Simplifed testing with high sensitivity

A single exon analysis (exon 4) allows non-invasive detection of fetal RHD status from gestation week 10. The assay design simplifies laboratory work, automation and analysis.

Quick start and cost control

All required PCR reagents are included in
Devyser’s kit. You can get started immediately
and control your costs.

CE-IVD product

Standardised and validated routine workflow according to the European Regulations and guidelines.

Learn more about how our RHD kit can help your team get the results they need.

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Discover the benefits and advantages

Accurate and high sensitivity testing from gestational week 10

A single exon analysis can accurately and non-invasively detect fetal RHD status from gestational week 10, & simplify both laboratory work and analysis.

Requires only 3 reactions per sample

Minimises amount of maternal plasma required, allowing more samples to be analysed per run. This simplifies the lab workflow and speeds up turnaround time.

High throughput lab screening possible

Process large sample volumes quickly and deliver quick results to patient with the fully automated workflow.

Discover the benefits and advantages

Accurate and high sensitivity testing from gestational week 10

A single exon analysis can accurately and non-invasively detect fetal RHD status from gestational week 10, and simplify both laboratory work and analysis.

Requires only 3 reactions per sample

Minimises amount of maternal plasma required, allowing more samples to be analysed per run. This simplifies the lab workflow and speeds up turnaround time.

CE-IVD Product

Product reliability guaranteed by the CE-IVD standard and ensures high confidence in the results. This involves a standardised routine workflow that meets regulatory standards.

Expert review 07

Fetal RHD Screening in Clinical Routine - Experiences and Considerations

This paper explores an approach which uses non-invasive prenatal testing to determine the fetal RHD status, allowing targeted administration of antenatal anti-D prophylaxis only to those who will benefit from it. Learn more about the current strategies of fetal RHD and the experiences and considerations surrounding planning a fetal RHD screening program.

More about the method

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.

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.

Kit Design

Maximise laboratory workflow and time needed for sample setup and processing and analyse more samples.

  • Smplifies the laboratory workload
  • Decrease overall testing costs
  • High confidence in results
  • Deliver quick results to the clinicians
  • Maintain low level of societal RHD immunization
  • Reduce risks associated with blood based products
  • Amplification of exon 4
  • Non-invasive test
  • No need to specifically extract cfDNA
  • Testing from week 10 until week XYZ
  • Enable targeted prophylaxis
  • CE-IVD marked

Workflow

A single exon analysis enabling fast laboratory workflow and analysis.

  • Deliver quick accurate results
  • Simplifies laboratory workflow
  • Speeds up turnaround time
  • Deliver quick results to the patients
  • Decrease overall testing costs
  • Flexibility in choice of real time instrument
  • 3 reactions per sample
  • Can be fully automated
  • ABI 7500, QS 6, QS7 compatibility

Data Analysis

Flexibility in data analysis

  • Reliable
  • Can be downloaded and installed on any PC
  • Performed with software provided with instrument

Workflow

Devyser RHD assay set-up

Mix cfDNA extracted from maternal plasma with kit reagents

Real-time PCR run

The clinical samples are processed and amplification data is displayed in real time

Data analysis

Analysis of raw data and determination of fetal RHD status

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  • Downloads
  • Product details

IFU and software settings

Enter access code found in the lower right corner of the label on the kit box.

Certificates

Download a specific Batch Release Certificate (BRC) below by entering the BATCH/LOT number and then click on "Find".

Product details

CE-IVD Certified Kits

Name
Scope
Pack Size
Article Number
Devyser RHD CE-IVD
Detection of fetal RHD DNA from maternal plasma. Single exon analysis (exon 4).
78
8-A060

Research Use Only Kits

Name
Scope
Pack Size
Article Number
Devyser RHD RUO
Detection of fetal RHD DNA from maternal plasma. Single exon analysis (exon 4).
78
8-A406