The methodologies utilized in the Indiko Plus Anazlyer are traceable to international reference methods and materials. Crafted for small and medium-sized laboratory environments, this economical solution aligns with the In Vitro Diagnostic Regulation (IVDR). Prioritizing sample-oriented testing, it facilitates swift result generation, thereby bolstering the overall quality of patient care. Its application protocols span a wide range of tests, encompassing routine clinical chemistry tests, as well as specialized ones such as specific proteins, drug abuse testing, therapeutic drug monitoring, and immunosuppressant drug testing.
The system boasts straightforward and swift daily start-up and maintenance procedures, ensuring operational efficiency. Users benefit from continuous access to samples, cuvettes, and reagents, eliminating interruptions in the testing process. The utilization of disposable cuvettes ensures user safety and contamination-free analysis. Additionally, the system features versatile automated dilution capabilities, simplifying sample processing.
A reflex testing capability contributes to savings in operator time, automatically triggering specific tests. Measurement reliability is upheld through a real-time Quality Control (QC) program, allowing continuous monitoring. The system further streamlines processes with the automatic upload of calibrator and control values, reducing manual errors and saving time. Comprehensive results archiving, associated with calibration and reagent lot data, ensures full traceability for enhanced quality control and compliance.
The system reagents designed for Thermo Scientific™ Indiko™ and Indiko Plus analyzers introduce best-in-class methodologies, ensuring smooth operations in your laboratory. The extensive test menu includes panels covering organs, body functions, and lifestyle aspects.
These assays are always ready for immediate use, benefiting from full validation, compliance, and the convenience of barcoding. With Thermo Scientific™ Indiko system reagents, standardized test performance is readily available, providing a reliable and efficient solution for your laboratory needs.
Completely compliant and thoroughly validated, the applications and claims are aligned with the stringent EU regulatory requirements for In Vitro Diagnostic (IVD) products. This ensures comprehensive quality assurance in the laboratory. The CE marking process serves as a testament to adherence to applicable safety and performance standards.
Designed for optimal cost-efficiency, the system features volume-optimized kit sizes to minimize waste. With maximum reagent stability, the need for calibration is reduced, leading to optimized Quality Control (QC) processes and fewer repeats. Notably, there is no requirement for additional on-site method adjustment. Multicontrols and multicalibrators are available for clinical chemistry and specific proteins.
The highest quality standards are upheld, guaranteeing accurate and precise test results through traceability to international reference standards. The use of ready-to-use barcoded reagents facilitates faster operations and minimizes errors. Backed by over 50 years of expertise in developing advanced IVD instrumentation, this solution brings a legacy of excellence from Thermo Fisher Scientific.
“The received results are precise and repeatable. That’s why we are able to offer the highest quality of laboratory analysis to our patients,” states Natalia Bilska, a biomedical scientist working at the medical diagnostic laboratory “Medica.” The laboratory, located in Radom, Poland, operates with two Thermo Scientific™ Indiko™ Plus clinical chemistry analyzers, conducting 600 to 800 biochemistry tests daily.
Natalia maintains a positive outlook, stating, “Indiko Plus requires a very small sample volume to perform an analysis, which allows us to perform trustworthy tests even for our youngest patients.”
Lab procedures encompass daily startup and standby protocols, along with the identification of barcoded reagents, clot detection, and the management of (pre-)dilution, reruns, and reflex testing. The system facilitates the real-time transfer of Quality Control (QC) data and establishes a bidirectional connection to the Laboratory Information System (LIS).
The automation designed for your laboratory is characterized by a compact footprint, making it suitable for any available space. It eliminates the need for external water or drainage connections, ensuring quick and easy installation.
For the benchtop analyzer equipped with a self-contained water supply (category B), it allows the loading of various sample cups and barcoded primary tubes. The system offers three distinct sample racks and provides real-time monitoring of reagent usage and expiration dates, ensuring full calibration and lot traceability. This comprehensive approach streamlines laboratory processes efficiently.
With a rich legacy backed by over 50 years of experience, the Indiko platform boasts the installation of more than 6,500 chemistry analyzers worldwide. All these analyzers, synonymous with reliability, were manufactured in Vantaa, Finland. Thermo Fisher Scientific’s Vantaa Center of Excellence stands as a high-tech powerhouse renowned for its advanced In Vitro Diagnostic (IVD) instrumentation and laboratory automation solutions. Notably, the center adheres to the stringent requirements of the FDA and various international institutions, ensuring the highest standards of quality and compliance.
