Proven Workflow Flexibility for CMV Detection in Routine Diagnostics
In today’s molecular diagnostics landscape, laboratories need more than sensitivity, they need solutions that fit seamlessly into their existing workflows.
To meet this demand, ANCHOR Diagnostics conducted a cross-laboratory study of its 30-minute ANCHOR CMV PCR Kit (CE IVD), assessing compatibility and analytical performance using the MagNA Pure 96 nucleic acid extraction system and cobas z480 real-time PCR cycler (both Roche).
The goal was clear: to demonstrate reliable detection of cytomegalovirus (CMV) DNA in clinically relevant sample matrices (EDTA plasma and cerebrospinal fluid*) and to verify consistent, reproducible results across independent laboratories.
Study Design and Setup:
The cross-site study was performed at two independent sites, ANCHOR Diagnostics (Hamburg) and MVZ Labor 28 (Berlin), following identical workflows.
Study Overview:
- Sample types: EDTA plasma, CSF*
- Nucleic acid extraction: MagNA Pure 96
- PCR platform: cobas z480
- Sample concentration range: 5,000 IU/mL to 100 IU/mL
Objective: Comparison study evaluating the analytical performance of the ANCHOR CMV PCR Kit with regards to its sensitivity and precision.
Key Results:
The study confirmed that the ANCHOR CMV PCR Kit delivers high reproducibility across a clinically relevant range of viral loads and excellent agreement of its analytical sensitivity across two independent laboratories.
Highlights:
- Sensitivity: Reliable detection down to 300 IU/mL (~0.6 IU/µL) in both CSF and EDTA plasma
- Precision: Comparable variability across laboratories even at low viral loads, confirming excellent reproducibility.
- Cross-site correlation: Overall strong result agreement between both laboratories, reinforcing reliability
These findings confirm the kit’s analytical reliability and operational flexibility, supporting its use in time-critical CMV diagnostics.
Why These Results Matter
This study reinforces what laboratories value most, trust in performance and flexibility in implementation.
The ANCHOR CMV PCR Kit enables reliable detection in a PCR run of just 30 minutes, proven consistent across laboratories. This underlines the kit’s suitability for routine diagnostics, giving labs confidence to integrate it into existing workflows without additional complexity.
“The purpose of this study is to prove that our kits perform exactly where and how labs need them to.”
- Dr. Tobias Ruckes, Head of Sales & Marketing, ANCHOR Diagnostics
From Data to Daily Practice
By confirming technical performance, the ANCHOR CMV PCR Kit empowers laboratories to achieve reliable, rapid, and reproducible results with minimal training.
Paired with ANCHOR’s rapid 30-minute PCR runtime, this flexibility translates into faster diagnostics, reproducible results and smoother operations, and greater confidence in molecular CMV detection.
Get the complete comparison study incl. all data here Download Whitepaper
For questions related to implementation of molecular CMV testing in your laboratory, please contact:
*Note: In this study, CSF samples and the applied workflow (MagNA Pure 96 nucleic extraction system and cobas z480 PCR cycler, both from Roche) were only used for feasibility purposes and fall outside the approved intended use of the ANCHOR CMV PCR Kit.
