Reliability and validity of salivary cortisol levels of healthy adults measured using a point of collection analysis method
Not Applicable
Completed
- Conditions
- Healthy adultsOther - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12624000531516
- Lead Sponsor
- James Cook University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
The eligibility criteria for participant inclusion in the study are adults (>18 years) who are:
•Willing and able to attend the study site and provide saliva samples at one collection session.
•Willing and able to provide informed, written consent.
Exclusion Criteria
smoking, caffeine or food within 6o minutes prior to saliva collection
not willing to provide consent
under 18 years old
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Salivary Cortisol levels (nmol/L) measured using both a point of collection IPRO© salivary cortisol and the reference standard laboratory collection and analysis method <br>[Saliva sampling will be conducted at one data collection session for this study. Duration of data collection is estimated to be a maximum of 30 minutes, For the index test IPRO© Saliva Analysis (Index Test) Saliva is collected using a technique where the participant places a swab attached to a plastic tube into their mouth. When sufficient saliva has been absorbed by the swab it is placed into a collection tube and sealed.<br>For the reference standard whole saliva will be collected by unstimulated passive drool. into a polypropylene vial, <br> single collection time point. single analysis timepoint. Both samples are collected at the same time at a single visit, Saliva sampling for the reference standard (drooling) is first, then immediately after the index test sampling (swab) will occur,]
- Secondary Outcome Measures
Name Time Method repeated measurement reliability of the ipro system over time[Following collection of the swab samples, and nested within the usual analysis and saliva level reporting methods, a researcher will record saliva cortisol levels reported using the ipro analysis cube at multiple time point pre and post the manufacturer recommended 10 minute time post saliva application to the Lateral flow device. These will be at 1 minute intervals prior to, at and following the 10 minute manufacturers recommended time for recording the cortisol level from the ipro cube reader. For example researcher will record the cortisol level from the cubes reader at 6 , 7 , 8 , 9 , 10 (recommended time), 11 , 12, 13, and 14 minutes following application of the saliva sample to the lateral flow device.]