ArticleVox sanguinis2026
Routine use of a spike-in DNA in-process control for foetal RHD genotyping: Testing the real-world effectiveness of this 'canary'.
Article in Vox sanguinis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesNon-invasive foetal RHD (fRHD) genotyping is widely implemented to prevent unnecessary administration of antenatal anti-D prophylaxis. Reliable assay performance is critical. In line with expert recommendations, we validated and implemented an artificial spike-in extraction control in our previously published assay. In this study, we report on assay verification and its performance in a 2-year cohort. STUDY DESIGN AND
methodsfRHD typing was performed with cell-free DNA isolated from maternal plasma from gestational age week 27 or later. A circular plasmid with a fragment of glycoprotein B gene of the Phocid herpes virus type 1 (PhHV1-gB) (spike-in control) was added to the plasma before DNA extraction. Assay accuracy was verified with gestational week-27 plasma samples and corresponding cord blood samples from D-negative pregnant women. In addition, assay performance over time was evaluated in a 2-year cohort.
resultsThe performance verification of our modified assay showed no false negative and one false positive test result in a small clinical cohort (n = 191). In a further 47,391 samples across 1111 runs, we observed eight false negative results due to technical failures that were prevented by the addition of the spike-in control. In this larger series, the spike-in control was the sole detector of a technical problem most likely related to different batches of the DNA extraction kit.
conclusionThis study demonstrates the prevention of false negative fRHD typing results by the addition of an artificial extraction control. This control allows improved monitoring of assay performance, thereby ensuring assay consistency. Findings underscore the importance of thorough quality assurance measures in fRHD genotyping.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.