Nonacus reviews latest accreditation efforts.

Currently, the RhD genotyping landscape doesn’t feature a full EQA (European Quality Assurance) scheme but this latest report published in Blood Transfusion represents a big step forward towards an EQA. The authors have set themselves an objective to implement a regular EQA scheme through their working group.

Chris Sale- CEO from Nonacus said:

“The publication of this report represents the next step in the recognition and validation of non-invasive prenatal diagnosis for RhD. We hope that in the future, expectant mothers will have much better care options due to these new diagnostics.”

Our full review of the publication is below:

The publication begins with a summary of the current NIPD of fetal RhD genotyping testing landscape and subsequent management of anti-D prophylaxis administration.

The authors describe how there is a trend towards countries implementing or seeking approval for regional and national screening programs. As with any genetic test implemented in a clinical testing laboratory, in order to comply with laboratory accreditation schemes it is mandatory to participate in an External Quality Assurance (EQA) scheme. The publication describes the set up, implementation and results of a EQA workshop for RhD genotyping.

Within the results and discussion the authors observe that across the 22 participating laboratories there is a variety of RhD exons (4,5,7 and 10) being targeted and a range of analysis criteria being used to determine the fetal RhD status.

Despite the variability in methodologies all laboratories correctly identified the fetal RhD +ve sample. The fetal RhD -ve sample was also correctly identified in 18/22 laboratories, with the remaining laboratories having an inconclusive (3/22) or non concordant (1/22) result. However, the latter would be at no detriment to the management of the pregnancy.

This EQA workshop publication clearly provides evidence and a foundation from which to implement a regular EQA scheme, which the authors state is a future aim of this working group.

References
1. Diagnostic accuracy of routine antenatal determination of fetal RHD status across gestation: population based cohort study: BMJ 2014;349:g5243 doi: 10.1136/bmj.g5243
2. NICE recommends test to identify fetal rhesus D status: BMJ 2016;355:i6106 BMJ 2016;354:i3944
3. Sensitivity of fetal RHD screening for safe guidance of targeted anti-D immunoglobulin prophylaxis: prospective cohort study of a nationwide programme in the Netherlands: BMJ 2016;355:i5789

 

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