Point-of-care testing (POCT) is an invaluable tool in fast-paced environments such as emergency departments and cardiology suites. TOPMEDLAB Medical Technology, a Chinese company focused on in vitro diagnostic products, has developed an innovative immunofluorescence analyzer to help overcome the pain points of POCT. This user-friendly instrument offers rapid results and is easy to maintain, making it ideal for situations where time is of the essence.
Rapid on-the-go testing
TOPMEDLAB developed the ROFI INFINI analyzer, a fully automated immunofluorescence detection system, to enable rapid and convenient on-the-go testing in settings such as fever clinics, emergency departments, chest pain centers and cardiology suites. Yunping Zhang, Vice President of Production at TOPMEDLAB, explained: “ROFI INFINI is a fully automated system that is ideal for handling whole blood samples, serum and plasma. It is easy to operate, and can be used within one minute of powering up. The designated test is performed directly from a blood collection tube using air displacement liquid handling – no system liquid lines are required within the instrument – and the test report is issued quickly afterwards. This enables rapid testing for cardiac and tumor markers, as well as infectious diseases and other microbial pathogens.
Advanced pipetting technology
TOPMEDLAB approached Tecan to discuss the possible use of the Cavro® Air Displacement Pipettor (ADP) and the benefits it offered for the ROFI INFINI analyzer. Yunping continued: “The ROFI INFINI must offer quick and simple operation to meet the needs of doctors and patients. Tecan gave us a detailed explanation of the product and its advantages, helped us to evaluate its safety and effectiveness for our purpose, and its suitability for our specific instrument needs. We chose the Cavro ADP for several reasons, including its straightforward maintenance, which is ideal for a POCT setting and contributes to a low long-term cost. Many of the products on the Chinese market use cap-puncturing solutions to achieve full automation, but these have inherent issues, such as plastic particles from the cap blocking the needle. In addition, they often employ reusable needles that need to be cleaned between samples, which can be a source of cross-contamination. In contrast, the Cavro ADP uses disposable tips, taking advantage of air displacement liquid handling to fundamentally eliminate the risk of cross-contamination. The Cavro ADP can also detect clots and air bubbles – which can easily occur when testing whole blood – and this is a clear advantage for minimizing measurement errors. Importantly, integration of the Cavro ADP ensures the overall accuracy of our equipment; we had previously evaluated a different product, but found it lacked the necessary reliability and consistency. The Cavro ADP was simply the best choice for our instrument in terms of repeatability, reliability and durability, as well as ease of maintenance and integration.
A fully automated workflow
The ROFI INFINI combines fully automated scheduling with precision liquid handling to enable automation of the entire POCT workflow. “The Cavro ADP is responsible for the entire liquid handling process. Sample tubes are placed in the analyzer – time-consuming centrifugation is not required – and automatically uncapped while the Cavro ADP attaches a disposable tip. The system then positions the reagents and consumables while the Cavro ADP aspirates the sample and dispenses it into the micro-buffer solution for reaction. An aliquot of this solution is then placed into the loading position of the test card, and the sample tube is recapped to avoid contamination. After three to eight minutes of incubation, the liquid enters the measurement position and is read fluorescently, with the results reported in 10 minutes. The combination of the Cavro ADP with our system’s fully automatic scheduling enables testing of as little as 20 μl of blood – a huge benefit in pediatrics.
An experienced partner
Partnering with Tecan enabled TOPMEDLAB to harness the company’s liquid handling expertise throughout the instrument development process. “Tecan helped us a lot during the instrument design phase, and integration of the Cavro ADP into the analyzer went smoothly. Practical application guidance was also provided, including pipetting techniques, equipment installation, and maintenance – as well as offering solutions to application challenges – and verification studies at the Henan Provincial People's Hospital and the Beijing Chaoyang Hospital have demonstrated excellent results. Tecan is a very professional enterprise, with a large team behind it, and invests significantly in research and development. This greatly shortens the product development cycle for innovative medical companies like TOPMEDLAB and, at the same time, reduces the risks, which is a great advantage. Without the Cavro ADP, we would have had to build the liquid lines ourselves, and the complexity of the workload and maintenance would be unimaginable. Integration of a Tecan Cavro pipettor overcame this issue and ensured the positioning and reputation of the ROFI INFINI in the marketplace. Currently, the ROFI INFINI is only available in the domestic market – although it has been designed in accordance with both China's CFDA certification and the European Union In Vitro Diagnostics Regulation – so we hope to establish overseas sales channels in the future. The cooperation with Tecan has been excellent from the outset, giving us confidence that our equipment will operate very well after mass production.
