Sub-Protocol #2 of Umbrella Protocol Study: Limit of Blank Characterization of Vancomycin Biosensor Nutromics Device.

This is a prospective study with an Umbrella Protocol; where each sub-Protocol investigates a particular condition(s) and challenges to various Vancomycin biosensors and electrode properties. The study will enroll healthy participants in the community. Participants will be recruited for participation in stages depending on the Research and Development needs. This registration described Sub-Protocol #2. The Sub-Protocol #2 investigates the Impact of physical activity, mobility, and physiological interferences on the Limit of Blank (LoB) of Vancomycin Biosensors used in the Nutromics Sensor Device. The primary aim is to assess the impact of physical activity, mobility and physiological interferences (ie; sweat) on the LoB of the Nutromics Sensor Device. This includes evaluating any potential degradation in accuracy or precision or signal-to-noise ratio of the measurements. The study will enroll no more than 50 participants. Participants may participate in more than one sub-Protocol of the Study, subject to their continued eligibility. Potential participants will be recruited by flyers on community, university, and Nutromics Operations noticeboards. Prospective participants will express interest via email to clinical.researchcentre@nutromics.com. Participants who have previously participated or expressed interested in studies at the Nutromics Clinical Research Centre may also be contacted and asked if they are interested in participating. Prospective participants will be sent an Online Health Screening. Nutromics employees can participate in this study. Participants who meet the inclusion criteria (as per the Online Health Screening Survey) will be contacted for a brief phone screening for inclusion/exclusion criteria, including an explanation of the study details. A copy of the patient information sheet and consent form will be given to the participants who meet the inclusion criteria and still express interest in participating in the study following the phone discussion. Eligible participants who agree to participate in the study will be given time to consider their decision. Eligible participants who agree to participate in the study will be asked to attend an on-site Visit, where written consent will be obtained before any study procedures are conducted. All on-site visits, and the procedures outlined below will be performed by the Clinical Research Coordinator (research nurse). Participants will arrive on-site and have two Nutromics Sensor Devices applied to the same upper arm. The Nutromics Sensor Device is wearable device that has four microneedles that enter just below the skin and are the biosensing component of the study Participant shall drink water when required / desired throughout the study. The volume of water consumed will be recorded. On Site Visit 1. Written informed consent will be obtained 2. Participants without childbearing potential will progress straight to Step #3 3. A test for Pregnancy in all participants with childbearing potential (2mL sample of blood collected in a serum tube either via venipuncture) 4. Pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected immediately prior to application of Nutromics Sensor Devices. 5. Participants will be weighed wearing minimal clothing, such as a sports bra and shorts, or a gown. No shoes to be worn. Any water to be consumed during the study should also be held during weighing. 6. Selection of site where the Nutromics Sensor Devices will be applied following blood collection (+15 min). 7. Application of two Nutromics Sensor Devices on the same upper arm. 8. Pain Assessment post application (+15 min) of Nutromics Sensor Devices 9. Participant remains seated at rest for 30 minutes (+5 min) 10. Participant walks at steady speed on treadmill for 30 minutes (+5 min) (Rate of Perceived Exertion (RPE) 2-3) 11. Participant jogs on treadmill for 30 minutes (RPE 7-8) 12. Participant remains seated at rest for 30 minutes (+5 min) 13. Participants will be reweighed wearing minimal clothing, same clothing as worn in Step #5 14. Immediately prior to the removal of the Nutromics Sensor Devices, pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected (-15 min) 15. Nutromics Sensor Devices are Removed 3.5 hours (+15 min) following their application 16. Images are taken of the application sites for each of the Nutromics Sensor Device following their removal. Care will be taken to avoid identifiable features. 17. The participant is observed for 15 minutes (+15 min) following removal of the Nutromics Sensor Devices, after which they are discharged from the study.