P359 Evaluation of usability and performance of home fecal sampling using a dedicated device
Solhaug, H.(1)*;Haukø, I.(2);Mørk, E.(1);
(1)Calpro AS, Research and development, Oslo, Norway;(2)Calpro AS, Sales and Marketing, Oslo, Norway;
Background
Monitoring faecal calprotectin (fCal) levels is important in treating patients with inflammatory bowel disease (IBD). Analysis of faecal samples can be divided into sample collection and sample extraction, of which the former is very time-consuming and tedious work for the lab personnel. This step can easily be improved by allowing the patient to perform the sample collection at home with required amount of sample directly into the extraction buffer. Any home faecal collection device needs to show conformity to the golden standard of weighing method. Home sampling presents a solution but requires clear instructions to the user. The collected sample is also required to maintain stability during transportation.
Methods
The present study aimed to determine the usability of EasyExtractTM and a quick guide for home sampling performed by lay users. The usability study was conducted according to FDA guidelines on usability engineering. Twenty-four participants without prior knowledge of the product or procedure received an EasyExtractTM, a simulated human faecal sample, and a quick-guide to perform the home sampling. Matched participant-observer questionnaires were assessed to determine the usability. Performance studies of EasyExtractTM included consistent sample uptake, agreement with the weighing method, and stability (at room temperature, after transportation, and after freeze-thaw cycles). All samples were analysed with CalproLab ELISA (CALP0170) to determine fCal concentration. Appropriate statistical methods were used to quantify and visualize the results.
Results
100% of the participants in the usability study completed sampling successfully. EasyExtractTM and the quick guide got an average rating of 4.8 on a scale of 1-5 (1=difficult, 5= easy). In-house performance studies show that the average sample weight collected 29.2 mg with a CV of 2.7%. It also showed that the extracts remained stable during transport at RT for 5 days, and no changes after repeated freeze-thaw cycles. The collection device also shows strong agreement with the established weighing method.
Conclusion
EasyExtractTM and the quick guide enabled participants to sample accurately without prior experience with the device. Additionally, EasyExtractTM allows for consistent weight and agrees with the golden standard of weighing method. Furthermore, fCal stability is maintained at RT for 5 days and repeated freeze-thawing cycles. EasyExtractTM is a useful tool for home-sampling of fCal.