Devyser Compact v3, 8-A017.3-100

Proven accuracy, specificity, and sensitivity

Devyser Compact is now certified according to the new CE-IVD Regulation (IVDR) and is a prenatal genetic test that aids in diagnosing the most common chromosomal aneuploidies and it is often used as a confirmatory test after other methods, e.g., non-invasive prenatal testing (NIPT). Compact is designed with the “1 tube” concept in mind to simplify laboratory work and minimize the risk of sample mix-up. Since 2007, our goal has been to serve diagnostic laboratories with simple, rapid, accurate, and relevant QF-PCR tests. Now, we enter the IVDR era, and we strive to continue to be the company you can turn to

WORKFLOW – Simple, accurate, and rapid

Devyser’s single-tube approach reduces hands-on time to less than 45 minutes and minimizes the risk of sample mix-up or cross-contamination. The test kit is simple and straightforward for lab technicians to use, making it a good choice for any laboratory. < 45 minutes hands-on time <4.5 hours total time to analyzed results All reagents needed to perform QF-PCR analysis are included. Common PCR- and genetic analyzer instruments validated.

Proven performance

The clinical evidence for scientific validity, analytical performance, and clinical performance of Devyser Compact was evaluated. The test exhibits fully consistent results for 204 samples compared to karyotyping as the gold standard. The work was performed with external collaborators and at the Devyser research laboratory. Amongst the sample specimens used: were chorionic villi (CV) biopsies, amniotic fluid (AF), and whole blood (WB). The study is presented in the Devyser Compact IFU chapter 11.