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Study was cancelled before enrollment for reasons not related to safety and performance.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ellume·lab Group A Streptococcus Test | Experimental | ellume·lab Group A Streptococcus Test Pharyngeal samples from participants will be tested with: ellume.lab Group A Streptococcus Test; Polymerase Chain Reaction (PCR) and bacterial culture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ellume·lab Group A Streptococcus Test | Diagnostic Test | 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 participants. The sample type used is a throat swab. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals | 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 | Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals | 1 Week |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals | 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 PCR |
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Inclusion Criteria:
Male and female participants aged 3 years of age or older
Must currently be presenting with symptoms characteristic of pharyngitis, possibly Group A Strep, including:
Acute onset of sore throat;
Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation and;
At least one of the following:
≤ 14 days from onset of signs and symptoms of pharyngitis
Parent/legal guardian of Participants < 18 years of age capable and willing to give informed consent
Participants ≥18 years of age capable and willing to give informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barnaby H Montgomery | Optimal Clinical Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optimal Clinical Trials | Grafton | Auckland | 1010 | New Zealand | ||
| Totara Clinical Research Ltd |
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| Bacterial Culture | Diagnostic Test | Pharyngeal swab is collected from participant and this specimen is inoculated into 5% sheep blood agar plates. Beta-haemolytic colonies are isolated, followed by latex agglutination test. |
|
| Polymerase Chain Reaction (PCR) | Diagnostic Test | Polymerase Chain Reaction (PCR) is a molecular diagnostic technique for the detection and identification of Group A Streptococcus, both for clinical samples and isolates. Polymerase Chain Reaction (PCR) allows template bacterial RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected. |
|
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals |
| 1 Week |
| Ease of use as assessed by operator questionnaire | The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale). | 1 Week |
| New Lynn |
| Auckland |
| 0600 |
| New Zealand |
| Papamoa Pines Medical Centre | Papamoa | Tauranga | 3118 | New Zealand |
| Lakeland Clinical Trials | Rotorua | 3010 | New Zealand |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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