Devyser RHD is a real-time PCR kit for determining the fetal RHD genotype from cell-free DNA in maternal plasma, enabling an accurate decision on which RhD-negative pregnant women truly need anti-D prophylaxis. Its single-exon design (Exon 4) with triplicate analysis and a GAPDH internal control using a dynamic range algorithm provides a simple procedure and a low rate of inconclusive results.
Professional Note
Please read the instructions for use (IFU) carefully before performing the test. Contact a Viet Huy technical specialist for on-site validation support in your laboratory.
Coming soon
| `- Analysis target | RHD gene, single-exon design (Exon 4). |
| Technology | Real-time PCR on maternal plasma cfDNA; triplicate analysis. |
| Detection channels | 3 channels (FAM, VIC, ROX); GAPDH internal control with a dynamic range algorithm (automatic QC for each run, fewer inconclusive results). |
| Performance | Sensitivity 99.91% / specificity 99.86% (n=3,626); 12 years of operational data from Karolinska on more than 100,000 pregnant women. |
| Testing time point | From gestational week 10. |
| Sample source | Maternal blood (EDTA tube) - samples are stable for up to 6 days at room temperature. |
| Turnaround time | 4.5 hours. |
| Instruments | ABI 7500, QuantStudio, LightCycler - common real-time PCR systems. |
Coming soon