BIOHIT introduces innovative stool sample collection system for clinical diagnostics
BIOHIT OYJ has launched the FAEX™ Sample System, a CE-marked stool collection and handling solution designed for seamless integration into diagnostic workflows. This multi-functional system combines standardised collection with precision dispensing capabilities to address laboratory efficiency needs while improving patient compliance in gastroenterological specimen collection.
Advanced design enhances diagnostic reliability
The BIOHIT FAEX Sample System represents a significant advancement in stool sample management for clinical laboratories. The dual-function design serves as both a standard test tube and a precision dropper, enabling accurate sample dispensing across multiple diagnostic platforms including ELISA, chemiluminescence assays, lateral flow tests, and proprietary diagnostic kits.
Technical features include a precision-engineered collection stick designed for consistent sampling volume – a critical factor in quantitative diagnostic accuracy. The system’s screw-tight cap incorporates leak-proof threading to maintain sample integrity throughout transport and storage while reducing contamination risks and improving laboratory safety.
Regulatory compliance supports clinical implementation
The FAEX Sample System has achieved CE marking in compliance with Regulation (EU) 2017/746 for In Vitro Diagnostic Devices (IVDR), meeting stringent European regulatory standards for clinical diagnostics. This certification enables immediate implementation in clinical laboratory settings across the EU, supporting standardisation efforts in gastroenterological testing protocols.
Jussi Hahtela, CEO of BIOHIT OYJ, commented: “The BIOHIT FAEX Sample System exemplifies our commitment to providing innovative solutions that address real-world challenges for patients and laboratories. By combining precision and efficiency, we are empowering customers to streamline their workflows and improve the patient experience. The unique adaptability of the BIOHIT FAEX Sample System makes it an excellent addition to other manufacturers’ diagnostic kits, while also serving as a reliable standalone solution for laboratories.”
Addressing pre-analytical variables in gastrointestinal diagnostics
Pre-analytical variables represent a significant source of error in laboratory diagnostics. The FAEX system addresses several critical factors in stool testing, including standardisation of sample volume, preservation of analyte stability, and reduction of sample heterogeneity.
For clinical laboratory scientists, these improvements potentially translate to enhanced reproducibility in quantitative assays where stool sample consistency has traditionally presented analytical challenges. The system’s versatility makes it particularly valuable for laboratories performing comprehensive gastroenterological testing panels requiring multiple aliquots from a single specimen.
Integration with existing diagnostic workflows
The system has been engineered for compatibility with established laboratory procedures, requiring minimal protocol adjustments while improving efficiency. This design consideration is particularly valuable for high-throughput clinical laboratories seeking to standardise pre-analytical procedures without disrupting existing diagnostic workflows.
BIOHIT OYJ specialises in gastrointestinal diagnostics with a focus on non-invasive testing methods. The FAEX Sample System complements their existing portfolio of diagnostic solutions for gastrointestinal disease screening, diagnosis, and monitoring.
- For more information, visit: https://www.biohithealthcare.com/en/products/biohit-faex-sample-system
