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| Name | Class |
|---|---|
| Quidel Corporation | INDUSTRY |
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Group A streptococcal (GAS) pharyngitis in children represents a frequent diagnostic challenge in pediatric emergency departments, since isolated signs and clinical prediction rules are insufficient to accurately discriminate between GAS and non GAS infections. Rapid antigen detection tests (RADTs) therefore remain essential, simple and rapid tools, allowing for rapid GAS identification and prompt antibiotic prescription. However, their sensitivity is not optimal. The aim of the present study is to test the accuracy of a new fluorescent immunoassay (Sofia Strep A FIA) using the optical technology for GAS detection in children 3-15 years old with pharyngitis, compared to a standard RADT, using throat culture as the gold standard (or PCR for discrepant results, i.e. negative culture with any positive RADT).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofia Strep A FIA | Diagnostic Test | Patients who presented with sore throat will be performed throat swab for the new fluorescent immunoasssay (Sofia Strep A FIA), for a standard RADT (Alere Testpack Strep A) and for culture and backup PCR in case of discrepant results. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis | Comparison of the sensitivity and specificity of two rapid tests (Sofia StrepA FIA and Alere Testpack Strep A) using standard throat culture as reference. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of the new Sofia Strep A FIA test in children with pharyngitis stratified on the pretest probability of GAS infection (according to McIsaac scores) | sensitivity and specificity of the two tests in relationship to the pretest-probability of GAS infection as measured by the McIsaac score | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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Children 3 to 15 years old presenting to the PED with pharyngitis and Mc Isaac score ≥ 2
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| Name | Affiliation | Role |
|---|---|---|
| Laurence Lacroix, MD | University Hospital, Geneva | Principal Investigator |
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| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |