Sub-Protocol #3 of Umbrella Protocol Study: Characterization of the Limit of Blank (LoB) for Vancomycin Biosensors on the Nutromics Sensor Device: Optimizing Microneedle Lengths. To assess the impacts of microneedle depth on the Limit of Blank (LoB) of the Nutromics Sensor 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 is a multi-stage sub protocol, evaluating several different depths of the microneedles as well as the impact of an isolation layer on the electrodes on the Nutromics Sensor Devices across the different stages. 10 participants will be enrolled per stage. Stages may run in parallel. Participants will be recruited and enrolled as needed. They will not be randomised or stratified into specific groups but will participate in stages as required for the research and development of the Nutromics Sensor Device. Stage 1 will assess the LoB of the Nutromics Sensor Devices when participants conduct their normal daily activities., Stage 2 will assess the LoB of the Nutromics Sensor Devices when participants perform several physical activities. 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 #3 Synopsis: To assess the impact of microneedle depth on the Limit of Blank (LoB) of the Nutromics Sensor Device. Participants will arrive on-site and have six Nutromics Sensor Devices applied to either upper arm consisting of up to three different configurations. At least 1 set will have 5mm microneedles on the Nutromics Sensor Device with an isolation layer on the needle electrodes. Another set with have 3 mm needle electrodes with an isolation layer, and the last set will have either 3 or 5 mm needle electrodes without an isolation layer (this decision will be based on in-vitro data and previous interim analysis from testing both 3mm and 5mm sets and deciding which set provides the best limit of blank results). The 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. Stage 1: 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 3. Pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected immediately prior to application of Nutromics Sensor Devices. 4. Image of the Device application sites will be taken. 5. Application of six Nutromics Sensor Devices on the upper arm area following blood collection (+15 min). 6. Participants will complete an assessment post application (+15 min) of Nutromics Sensor Devices to assess the pain associated with application of the devices. 7. Participants will remain at the site for 1 hour (+15 min) post application of Nutromics Sensor Devices 8. Immediately prior to the participant leaving the site, pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected, and participants will complete an assessment post application (+15 min) of Nutromics Sensor Devices to assess the pain associated with application of the devices. 9. 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. 10. Participants will be instructed to avoid apply excessive force or pressure on the Nutromics Sensor Devices. 11. In the event the Nutromics Sensor Device(s) fall off, participants are instructed not re-apply the device. 12. Participants will return to the site between 22 - 24 hours post Nutromics Sensor Device application, 13. Immediately prior to the removal of the Nutromics Sensor Devices, pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected (-15 min) 14. The Nutromics Sensor Devices are removed 15. 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. 16. The participant is observed for 15 minutes (+15 min) following removal of the Nutromics Sensor Devices, after which they are discharged from the study. Participants will be asked to report (using an online system) any adverse events Stage 2: Participants will arrive on-site and have six Nutromics Sensor Devices applied to either upper arm consisting of up to three different configurations. At least one set of Nutromics Sensor Devices will have 5mm microneedles with an isolation layer, another set with have 3 mm needles with an isolation layer, and the last set will have either 3 or 5 mm needles without an isolation layer (this decision will be based on in-vitro data and previous interim analysis collected from testing both 3mm and 5mm sets and deciding which set provide the best limit of blank results). 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. 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 3. Pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected immediately prior to application of Nutromics Sensor Devices. 4. Image of the Device application sites will be taken. 5. Application of six Nutromics Sensor Devices on the same upper arm following blood collection (+15 min). 6. Participants will complete an assessment post application (+15 min) of Nutromics Sensor Devices to assess the pain, and mobility impact associated with application of the devices. 7. Following the pain assessment, 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. 8. Participant will remain seated at rest for 1.5 hours (+5 min) 8.1: A member of the study team will apply pressure to one set of the Nutromics Sensor Devices for 60 seconds (i.e.: push the Device firmly onto the skin). Participants will complete an assessment post application (+15 min) of Nutromics Sensor Devices to assess the pain and mobility impact associated with pressure application. 8.2: A member of the study team will apply pressure to another set of the Nutromics Sensor Devices for 60 seconds (i.e.: push the Device firmly onto the skin), 10 minutes after applying pressure to the first set. Participants will complete an assessment post application (+15 min) of Nutromics Sensor Devices to assess the pain and mobility impact associated with pressure application. 8.3: A member of the study team will apply pressure to another set of the Nutromics Sensor Devices for 60 seconds (i.e.: push the Device firmly onto the skin), 10 minutes after applying pressure to the second set. Participants will complete an assessment post application (+15 min) of Nutromics Sensor Devices to assess the pain and mobility impact associated with pressure application. 9. Immediately proceeding completion of #8, participant will walk at steady speed on treadmill for 30 minutes (+5 min) (Rate of Perceived Exertion (RPE) 2-3) 10. Immediately proceeding #9, participant will jog on treadmill for 30 minutes (RPE 7-8) 11. Immediately proceeding #10, participant will remain seated at rest for 30 minutes (+5 min) 12. Immediately proceeding #11, participants will be reweighed wearing minimal clothing, same clothing as worn in Step #5. 13. Immediately prior to the participant leaving the site, pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected, and participants will complete an assessment post application (+15 min) of Nutromics Sensor Devices to assess the pain associated with application of the devices. 14. 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. 15. Participants will be instructed to avoid apply excessive force or pressure on the Nutromics Sensor Devices. 16. In the event the Nutromics Sensor Device(s) fall off, participants are instructed not re-apply the device. 17. Participants will return to the site between 22 - 24 hours post Nutromics Sensor Device application, 18. Immediately prior to the removal of the Nutromics Sensor Devices, pathology test bloods (serum osmolality, FBC, UEC, LFT and CRP) are collected (-15 min) 19. The Nutromics Sensor Devices are removed 20. 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. 21. The participant is observed for 15 minutes (+15 min) following removal of the Nutromics Sensor Devices, after which they are discharged from the study. 22. Participants will be asked to report (using an online system) any adverse events