 The FDA-cleared eSensor® CF Carrier Detection (CFCD) System offers highly accurate and reproducible cystic fibrosis carrier results delivered in an easy to interpret report. Each kit includes all reagents necessary for PCR amplification and mutation detection in a single box. Reports include a summary “carrier” or “non-carrier” call, plus individual carrier status for each of the 23 ACOG/ACMG-recommended markers. Poly-T tract reflex test results are automatically reported for R117H carrier samples.
The eSensor® CFCD System delivers 99% accuracy (compared to DNA sequencing of 481 samples, 3 external sites) and 100% reproducibility (23 samples with all non-carrier and carrier genotypes, 3 sites).
Advantages of the eSensor® Cystic Fibrosis Carrier Detection (CFCD) System include:
- All reagents for PCR amplification and mutation detection in a single box
- Summary report with “carrier” or “non-carrier” call
- Automatic Poly-T tract reflex testing
- On-array controls to confirm test validity
- Built-in monitor to detect amplicon contamination
- Instrumentation with minimal moving parts helps maintain system
reliability and reduce laboratory down-
time
At the core of the eSensor detection technology are DNA fragments attached to electrodes on the surface of a small circuit board. This DNA microarray is the basis of detection by the eSensor System for any DNA sequence.
Each electrode is electronically active and detects a different DNA sequence. Finding the complementary sequence in the target DNA generates a characteristic electrical signal.
Each eSensor DNA Detection System cartridge can detect several different DNA targets at once, providing a cost-effective platform for complex analysis.
 Download the eSensor Poster
FDA - Summary of 510(k) safety and
effectiveness
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