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Published on: June 11, 2013
Routine use of a spike-in DNA in-process control for foetal RHD genotyping: Testing the real-world effectiveness of
Renske M van 't Oever1,2, Heleen Woortmeijer2, Ahmad Javadi3
1Department of Obstetrics, Division of Foetal Therapy, Leiden University Medical Center, Leiden, The Netherlands.
Vox Sanguinis
|February 11, 2026
Summary
An artificial spike-in control prevents false negative results in non-invasive fetal RHD (fRHD) genotyping. This quality assurance measure improves assay consistency for antenatal anti-D prophylaxis decisions.
Area of Science:
- Molecular Diagnostics
- Genetics
- Immunology
Background:
- Non-invasive fetal RHD (fRHD) genotyping is crucial for antenatal anti-D prophylaxis decisions.
- Assay reliability is paramount for accurate fRHD determination.
- Previous assays lacked a robust internal control for extraction efficiency.
Purpose of the Study:
- To validate and implement an artificial spike-in extraction control for fRHD genotyping.
- To assess the performance and consistency of the modified assay over a 2-year period.
Main Methods:
- fRHD typing was performed on cell-free DNA from maternal plasma (≥ gestational week 27).
- An artificial spike-in control (Phocid herpes virus type 1 glycoprotein B gene fragment) was added pre-extraction.
- Assay accuracy was verified using clinical samples, and performance was evaluated in a large cohort.
Main Results:
- Initial verification showed high accuracy with one false positive in 191 samples.
- Over 47,391 samples, eight false negatives due to technical failures were detected and prevented by the spike-in control.
- The spike-in control identified issues related to DNA extraction kit batches, ensuring assay consistency.
Conclusions:
- The addition of an artificial extraction control effectively prevents false negative fRHD typing results.
- This quality control measure significantly enhances monitoring of assay performance and consistency.
- Robust quality assurance is essential for reliable non-invasive fRHD genotyping.
