IVD device development – Orion Diagnostica’s QuikRead go®
The development of an IVD (in vitro diagnostic) device provides many challenges. An IVD device does not only have to comply with regulatory requirements and pass all certifications but also often contains complicated measurement technology and precision mechanics. A good example of this is Orion Diagnostica’s QuikRead go instrument.
This instrument lets you measure CRP (C-reactive protein) using fingertip blood samples. CRP levels rise significantly during bacterial infections but don’t rise at all or only slightly due to viruses. CRP measurements help doctors decide whether patients have a bacterial infection and need antibiotics. Antibiotics have no effect on viral infections, so use of the QuikRead go CRP test can ensure that antibiotics are given to patients that need them and can prevent inappropriate use of antibiotics.
“Avoiding unnecessary use of antibiotics helps control the growing problem of antibiotic resistance. According to a 2015 WHO report, bacteria that have become resistant to antibiotics are a serious threat to all of us”, says Ossi Korhonen, who is in charge of instrument development at Orion Diagnostica. QuikRead go provides CRP values within a few minutes, which is very important for patients. Blood samples don’t have to be sent to a lab for analysis, so patients don’t have to wait for results. “I think we still have the world’s fastest CRP test, and that’s a major competitive advantage”, Korhonen points out. And QuikRead go instruments do more than measure CPR: They can detect strep throat and fecal occult blood (not visible blood in stool).
Technically challenging but reliable machinery
Orion Diagnostica created QuikRead go’s blood sample analysis algorithm on top of Espotel’s SW platform, and Espotel designed the device’s electronics and mechanics. The instrument has an embedded Linux system and a touchscreen.
Especially demanding is the internal mechanism, which takes care of opening and closing the measurement hatch, keeping the cuvette sealed, and moving it during measurement.
“We succeeded in using mainly moderately priced plastic parts. Metal parts would have been easier to use but would have made the tester much more expensive. Normally this kind of instrument would have several motors, but we were able to do it with two”, says Espotel’s Project Manager Pasi Pulkkinen.
“The instrument has to shake the cuvette to mix the sample with the reagents. We made a fairly complicated but inexpensive and reliable machinery. The biggest difference between the current instrument and its previous version is how it shakes the cuvette. Now it always does it the same way”, Korhonen says.
“QuikRead go is also good at recognizing shapes. A camera notices the cuvette’s location and checks that it’s correct and checks that the stopper is closed. The camera helps to minimize the number of mistakes”, Pulkkinen explains.
Flexible all-round service
Orion Diagnostica and Espotel have worked together for a long time. Espotel already participated in the development of the QuikRead instrument’s previous version.
The current QuikRead go system has already been on the market for a few years, and Espotel takes care of design maintenance and software updates. Korhonen stresses the importance of compatibility between all instruments and new software. In other words, it must be possible to install new software in old instruments too, and vice versa current software into possibly updated electronics.
Some components have had to be replaced during the product life, and Espotel assisted in this. Espotel has also helped with technical certifications. Orion Diagnostica has taken care of medical certifications, but Espotel has provided the required documentation.
“It’s very important for us that the service is comprehensive, and we’re very happy that Espotel has taken care of the entire project. When we’ve needed more resources, Espotel has quickly rounded up more people from within the company or through its partner network. It’s good to have things taken care of smoothly through a single partner. What we specifically want from Espotel is know-how and solutions, and they’ve been good at providing them. We’ve been getting exactly what we wanted”, Korhonen summarizes.
For more information contact
Head of Instrument Development, Orion Diagnostica
Project Manager, Espotel