None listed
Conditions
Brief summary
This is key research (with the participation of MyHealthTest) to determine if certain human pathology tests using alternative sampling methods can be proven to be as effective as those done with traditional pathology methods. MyHealthTest is a new online business which will offer human pathology tests and support services direct to the individuals. Customers will order a limited set of targeted tests online and access their test results through a secure online portal. They will also be able to share these results with others including their GP. This will allow individuals to monitor and track aspects of their health and wellness from the convenience of their home. GPs and pharmacists will also be able to order tests for their patients/customers. The types of tests proposed to be offered in the future by MyHealthTest include: 1. HbA1c the key period test required by diabetics which provides evidence of how well they are managing their health. 2. Lipid Panel a series of cholesterol tests including Total Cholesterol and Triglycerides. 3. hs-CRP (high-sensitivity C-reactive protein) - used to determine if you are suffering from a significant infection/inflammation and a good indicator of risk of cardiovascular disease. One of the test sample collection methods to be used by MyHealthTest is dried blood spots where capillary blood will be placed onto a dried blood spot card via a finger prick. The dried blood spot sample will be done by the customer or their carer. This is different to the mainstream blood collection method, where venipuncture blood collection is the current process usually performed at a pathology collection centre by a phlebotomist or trained nurse. Although dried blood spot samples have been used as a new born screening tool for many decades, to date there has been limited use of dried blood spot for diagnostic tests as part of disease management. A number of research projects undertaken by universities and medical schools show comparative results can be obtained between tests done with capillary blood on dried blood spot collection medium and venous blood samples. This evidence has focussed on comparison between the two blood sample types. In addition, MyHealthTest want to test the validity of self urine and saliva collection for testing of hormones. A precondition for MyHealthTest to offer alternative sample collection processes is to ensure the processes will deliver comparative and acceptably precise results to that of the standard samples for various tests. The criteria for the proposed dried blood spot, urine and saliva sample collection processes are the sample must: 1. be able to be collected by a lay-person; 2. be able to be legally transported through standard post; 3. not deteriorate during transport 4. deliver comparative and acceptably precise results This research project will compare dried capillary blood, urine and saliva samples against mainstream pathology samples for different pathology tests
Interventions
Participants will be asked to come in to a collection centre. They may be asked to fast for a minimum 12-hour fast in the morning. Participants may be be recontacted by our team, and would undergo the same procedures (venous blood collection, capillary blood collection, urine collection and/or saliva collection), not less than 6 weeks before the previous collection. A single session will last up to 60 minutes.
The Clinical Nurse will explain the study procedures (as per Information Sheet) and
Participants will be asked to come in to a collection centre. They may be asked to fast for a minimum 12-hour fast in the morning. Participants may be be recontacted by our team, and would undergo the same procedures (venous blood collection, capillary blood collection, urine collection and/or saliva collection), not less than 6 weeks before the previous collection. A single session will last up to 60 minutes. The Clinical Nurse will explain the study procedures (as per Information Sheet) and will obtain written informed consent. Study procedures and data collection will include: i) Medical history questionnaire: a code will be assigned to each participant. The Clinical Research Nurse will complete a brief medical history questionnaire, including date of birth, gender, past/previous medical history, and past/previous use of medications. ii) Fasting: Participants may be advised not to consume food, alcohol or caffeine for 12 hours prior to the collection. They will also be advised that they can consume water during the fasting period. Prior to collection, participants will be asked to confirm when they last ate or consumed alcohol or caffeine: no risks associated. iii) Venous blood collection: Venous blood will be collected from an arm vein by the Clinical Research Nurse following standard sterile techniques. The maximum amount of blood that will be collected will be about 50 ml (approximately 1/10 of a blood donation), drawn into appropriate tubes for analysis. The tubes with blood will be kept on ice for transportation to the pathology lab. Minimal physical risks associated with drawing venous blood are pain, bruising or bleeding at the time the needle is inserted. Serious adverse effects are blood clot or infection, but they are very rare. Some subjects may faint during the procedure. Those risks will be minimised by using careful sterile techniques, with the patients sitting comfortably on a chair. If bruising occurs, ice cubes or cold packs will be placed over the area for a few seconds, followed by the placement of a cotton pad and bandage over the site. If fainting occurs, needle will be removed and the participant will lie down and/or raise the feet for a minute or two. After resting for five to ten minutes, if the participant is feeling well and vital signs are normal, the participant can continue on as normal. iv) Capillary blood collection: Capillary blood will be collected from a finger prick by the participant under the guidance of the Clinical Research Nurse following standard sterile techniques. The maximum amount of blood that will be collected will be 40ul (0.04ml) in 8 blood spots on purpose specific cellulose filter paper. The filter paper will be placed into a breathable envelope for transportation to the pathology lab. The blood spots will dry during transportation. Minimal physical risks associated with collecting capillary blood are minor pain, bruising or bleeding at the time the finger is lanced. A serious adverse effect could be infection, but this is very rare. Those risks will be minimised by using careful sterile techniques, with the patients sitting comfortably on a chair. A sterile safety lancet will be used to prick the finger. After venous blood collection, capillary blood samples will be collected by the participant onto the filter paper, as per instructions provided at the collection. v)Saliva and urine collection: Participants will be guided to self-collect saliva samples. Approximately 2 ml of saliva will be collected per test into a 2ml tube/saliva collection device using the passive drool method or using a saliva oral swab. Participants will be given a sterile, leakproof urine collection container, and instructed to collect up to 50 ml of urine from midstream, in a bathroom. Venous blood samples, urine and/or saliva will be transported to the pathology lab at the end of each morning by the Research Nurse. Dried blood spot samples collected onto the filter papers will be provided to the Pathology Lab. Samples will be analysed in duplicates.
Sponsors
The Australian National University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Adults > 18 years-old. Participants fluent in English and able to provide consent for participating in research.
Exclusion criteria
Participants who do not have restrictions to have their blood drawn (ie. due to religious matters or have donated blood in the 4 weeks prior to the research) Participants who have no difficulty in providing venous blood samples.
Outcome results
None listed