QuikRead go® HbA1c device evaluation report by POCT for SCOT

Work completed by Robyn Wilson, Director at POCT for SCOT Ltd, July 2023.

Device summary

The user-friendly QuikRead go is a fully automated portable system. Capable of rapid laboratory standard photometric and turbidimetric measurements of CRP, Haemoglobin, HbA1c, Strep A and Faecal Occult Blood.

The QuikRead go requires minimal hands-on interaction, an intuitive user interface, and the option to connection to healthcare information systems giving full result traceability and total confidence to the test results.

Purpose of this document

The purpose of this document is to share information on the QuikRead go from the perspective of an independent reviewer. This document may then be shared for other potential users to determine if the QuikRead go has the design features and capabilities that may be attractive to Point of Care services.

Design

The QuikRead is lightweight and readily portable for the Point of Care setting. The QuikRead is fully portable, meaning the area required to set the device on for use need only be small, the portable nature of the device also means that it can be used in any setting even those that are mobile, such as an ambulance or van.

There is a touch screen at the front which is clear to use and very intuitive to allow for even the most basically trained users to be able to effectively use the device. The sample holder is small, with a door that automatically opens. It is a closed system with no sharp edges or parts that could break easily, this is crucial to a Point of Care device as travelling is part of the role and therefore the device must be as robust as possible to allow for this.

The system comes complete with a carry case capable of fitting the device, power cables and consumables for easy transfer between Point of Care settings.

Analytical Performance

It would be expected that any new user of the QuikRead go would undertake their own verification study to ensure that the device meets their local requirements and is capable of contributing positively to the services it is meant for. Therefore, performance evaluation results found by our team are only available by request.

Usability

The device is incredibly user friendly. The screen provides adequate instructions to the user that are visual and easy to understand. There is no maintenance involved in the running of the device apart from keeping it clean and performing internal quality control as would be standard practice for any device and familiar to users.

The test cartridge is small, sample collection is easy and adding the patient sample to cartridge is simple and highly unlikely to be able to be carried out incorrectly.

Patient comfort

Only a small amount of sample is required for analysis, such as a finger prick sample. This is thought to be the least invasive and convenient for the patient for HbA1c analysis. Convenience is further enhanced by the fact that the test could be performed in a variety of Point of Care settings in the community such as clinic, pharmacy or a GP alongside the traditional settings or wards and outpatient areas. The test takes a small amount of time meaning patients do not have a long period to wait either for testing or continuation of care.

Anecdotally, it has been fed back that patients’ who have their tests done in a local setting and then see the results feel more empowered by this and tend to accept interventional treatment more willingly. This type of patient engagement will serve to reduce heavier impacts on health services in the long term as treatments could be targeted and focussed on prevention rather than curative.

Consumables and stock management

Both quality control material and reagent cartridges can be stored unopened at room temperature for up to 2 months. If longer storage is required then this can be done so between 2 and 8 degrees. The packaging is small and compact so is thought to take up little room. Reagent and quality control material have relatively long shelf lives (approximately 1 year from manufacture) when stored appropriately, suggesting lot management could be well controlled.

Other considerations

Should a QuikRead device break, then the supplier of the device would provide a loan whilst repairs were taking place. This should ensure that no clinical area is without a usable device should it be required. The device comes with a 2-year warranty which can be extended for a further 3-year upon purchase. This gives the user reassurance about the life span of the device.

The QuikRead also has the capability of processing a number of other tests and does not solely need to be used for HbA1c. This may add a level of cost-effectiveness not seen in other devices.

Conclusion

The QuikRead analyser has demonstrated its usability in the Point of Care setting and should be considered by anyone who wishes to add HbA1c testing to their Point of Care test repertoire.

The evaluation report on QuikRead go for HbA1c from POCT for SCOT is available to download here.