Sub-Protocol #1 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 #1. 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). Sub-Protocol #1 Synopsis; To assess Limit of Blank of the Nutromics Sensor Device regarding its the performance and stability over extended periods of wear. This includes evaluating any potential degradation in accuracy or precision of the measurements when the Nutromics Sensor Device is used continuously over a long duration. 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. After completing all study visits procedures, participants will be allowed to leave the study site with the devices on their arm. Participants will return to the study site the following day (i.e. 24 hours later), where the Devices will be removed. The schedule of events is outlined below. On Site Visit 1.Written informed consent will be obtained . Participants without childbearing potential will progress straight to Step #3 2.A pregnancy test will be conducted in all participants with childbearing potential and the result will be received prior to proceeding to Step #3. 3.Pathology test bloods (serum osmolality, Full Blood Count (FBC), Electrolytes, Urea and Creatinine (UEC), Liver Function Tests (LFT) and C-Reactive Protein (CRP)) are collected immediately prior to application of Nutromics Sensor Devices. 4.Application of two Nutromics Sensor Devices on the same upper arm following blood collection (+15 min). 5.Participants will complete an assessment post application (+15 min) of the Nutromics Sensor Devices to assess the pain associated with application of the devices . 6.Participants will remain at the site for 1 hour (+15 min) post application of Nutromics Sensor Devices 7. Immediately prior to the participant leaving the site, pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected 8.Participants may perform their normal daily activities including sports, showering, etc.; and the type of activity, start and end time of these activities shall be recorded by the participant. The Devices should not be submerged in water. 9.Participants will be instructed to avoid applying excessive force or pressure on the Nutromics Sensor Devices. 10. In the event the Nutromics Sensor Device(s) fall off, participants are instructed not re-apply the device. 11. Participants will return to the site between 22 - 24 hours post Nutromics Sensor Device application, 12.Immediately prior to the removal of the Nutromics Sensor Devices, pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected (-15 min) 13.The Nutromics Sensor Devices are removed 14. 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. 15. The participant is observed for 15 minutes (+15 min) following removal of the Nutromics Sensor Devices, after which they are discharged from the study. 16. Participants will be asked to report (using an online system) any adverse events .