Cell3TMDirect Fetal RhD Group Genotyping Kit

Reduce cost and time in fetal RhD diagnosis using cell free fetal DNA.

With no cfDNA extraction required, Cell3TMDirect, reduces cost and saves time in fetal Rhesus D diagnosis with sample to result in under three hours.

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Save time and reduce cost

With no cfDNA extraction required, it takes under 3 hours from sample receipt to result.

Less material required

Uses less than <0.25ml of plasma sample, leaving plenty of sample for further tests.

Fully validated

Validated kit and flexible format to fit with laboratory processing. Multiple targeted approach to provide intra assay concordance.

Robust and accurate reporting

96 well formatting within a break-apart plate allows for testing of up to 13 samples per kit. Validated protocol ensures accurate reporting of findings.

The first direct from plasma NIPD test

The first direct from plasma non-invasive prenatal diagnosis kit for Fetal RhD Genotyping provides a quicker, more cost effective and validated assay. The Cell3™Direct Fetal RhD Group Genotyping kit targets sequences specific for exons 5, 7 and 10 of the RhD gene and can distinguish between RhD positive, RhD negative and RhD PSI genotypes in cfDNA.

Meet new NICE guidelines on fetal Rhesus D status

NICE now recommends tests to identify fetal Rhesus D status to the UK NHS. They state “Maternity services should start offering pregnant women who are rhesus negative a test to identify the status of their fetus, under final guidance issued by the National Institute for Health and Care Excellence.

Superior technical performance

Technical sensitivity of our assay was demonstrated using RhD positive genomic DNA spiked into a RhD negative

background at fixed percentages (10%, 5% and 1% equivalent to 30, 15 and 3 genomic equivalents) to reproduce realistic fetal fractions and confirm the sensitivity of the assay. Amplification of all targets across all replicates was observed even at the lowest 1% spike-in fraction, with RhD exon 5 assay capable of discriminating the RhD PSI variant.

Direct from plasma protocol was compared with extracted cfDNA and comparable results were demonstrated using the same plasma sample (male pregnancy, 10 weeks’ gestation). Amplification plots of direct from plasma testing shows robust amplification of all targets: RhD exon 5 (blue), RhD exons 7 and 10 (green) and CCR5 (black).

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