Participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days. Enrolment visit (Day 1) assessments for all participants will include the collection of throat swabs, testing by staff at the site using the ellume·lab Group A Strep Test and testing for Group A Streptococcus by a central laboratory using bacterial culture and polymerase chain reaction (PCR). All participants will be followed up with a phone assessment of adverse events between Days 2-14.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
132
ellume.lab Group A Streptococcus Test is a rapid diagnostic test intended to be used as an aid in the diagnosis of Group A Streptococcus in symptomatic patients. The sample type used is a throat swab.
Ochre Health Medical Centre
Casey, Australian Capital Territory, Australia
Forbes Medical Centre
Forbes, New South Wales, Australia
Paratus Clinical Wyong Clinic
North Sydney, New South Wales, Australia
Mingara Medical
Tumbi Vmbi, New South Wales, Australia
Wamberal Surgery
Wamberal, New South Wales, Australia
Paratus Clinical Wyoming Clinic
Wyoming, New South Wales, Australia
USC Clinical Trials Centre
Maroochydore, Queensland, Australia
Griffith University Clinical Trial Unit
Southport, Queensland, Australia
The sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture
Time frame: 1 week
The specificity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture
Time frame: 1 week
The overall agreement between the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab and results from bacterial culture
Time frame: 1 week
The sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to PCR
Time frame: 1 week
The specificity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using throat swab as compared to PCR
Time frame: 1 week
The overall agreement between the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab and results from PCR
Time frame: 1 week
Ease of use as assessed by operator questionnaire.
Time frame: 1 week
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