None listed
Conditions
Brief summary
This research study is looking at the ability of the Roche Diagnostics cobas Liat device to reliably and accurately detect Group A Strep (GAS) infection in skin sores. Currently, this device is approved for testing of GAS throat infections. Throat and skin infection with GAS bacteria is common in childhood, but repeated infections can lead to Acute Rheumatic Fever (ARF) and Rheumatic Heart Disease (RHD). Early diagnosis and therefore treatment of GAS infections are key to preventing ARF and RHD, particularly in places with high rates of infections. Analysed and deidentified results from this study will be shared with the study collaborator to support their submission of an application to the Therapeutic Goods Administration to obtain approval for this test to be implemented in clinics for detecting skin infections across Australia.
Interventions
The intervention in this study will be the utilisation of the Roche Diagnostics cobas Liat Strep A Point of Care Test (PoCT) for GAS (Group A Streptococcus) infection for diagnosis of impetigo and other skin infections. Trained health service staff at designated regional/remote Australian health clinic sites will take a swab of the patient's skin sore with a long cotton bud like testing stick which is transferred to a liquid amies media collection tube. Liquid from the collection tube is transfe
The intervention in this study will be the utilisation of the Roche Diagnostics cobas Liat Strep A Point of Care Test (PoCT) for GAS (Group A Streptococcus) infection for diagnosis of impetigo and other skin infections. Trained health service staff at designated regional/remote Australian health clinic sites will take a swab of the patient's skin sore with a long cotton bud like testing stick which is transferred to a liquid amies media collection tube. Liquid from the collection tube is transferred to the cobas Liat Strep A test tube for testing on the cobas Liat machine for detection of GAS infection. This result takes approximately 15 minutes. The result from the test will not inform the clinical treatment of patients, and clinicians will treat as per standard of care clinical guidelines. The result from the swab will be recorded in study case report forms and may be recorded in the clinics patient management system should they wish to. The skin swab will then be sent to a laboratory for comparison testing using the standard microbial culture.
Sponsors
CSIRO Health and Biosecurity
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 0-< /=18 years 2. Parent or guardian willing and able to provide informed consent 3. Patients presenting to clinic with impetigo or other skin issue that has not been diagnosed or treated in the preceding 14 days 4. Patients with impetigo or other skin issue identified during routine clinical examination and have not been diagnosed or received treatment for skin issues in the preceding 14 days
Exclusion criteria
1. Aged > 18 years 2. Diagnosed or treated for impetigo or other skin issue in the preceding 14 days 3. Cannot provide informed consent
Outcome results
None listed