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This clinical study will collect fresh samples and perform laboratory testing on fresh and archived samples as described in the protocol.
The Idylla console, instrument, and Respiratory (IFV-RSV) Panel cartridge constitute the Idylla respiratory diagnostic system. The IFV-RSV Panel is an in vitro PCR-based molecular diagnostic assay for the simultaneous qualitative detection of nucleic acids for Influenza A (including H1, 2009 H1N1, H275Y mutation of 2009 H1N1, H3), Influenza B, and Respiratory Syncytial Virus (RSV) (A and B) on nasal swab (NS) direct to cartridge or nasopharyngeal swabs (NP) in viral transport media (VTM) in adults, adolescents, and children.
This clinical study will collect data in support of regulatory submission and the indications for use of the IFV-RSV panel and the Idylla diagnostic system. This protocol will demonstrate that the results of this assay, in conjunction with clinical information, may be used as an aid in the diagnosis of infection with Influenza A, Influenza B, and RSV in persons having both a high and low risk for respiratory viral infection.
During this study, participating sites will collect fresh samples, conduct a Reproducibility Study and test the fresh and previously collected frozen samples from individuals presenting with signs/symptoms of influenza like illness (ILI) and respiratory virus in accordance to the sample collection described in this protocol.
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| Measure | Description | Time Frame |
|---|---|---|
| Product performance as measured by positive and negative agreement to a predicate | Product Performance will be assessed based on samples collected in 2015/2016 season (average of 6 months) and archived samples. | Specimen collected during the IFV-RSV season 2015/2016 will be tested within 1 day of enrollment. The Product Performance will be assessed at study completion, an average of 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who present with ILI and/or signs/symptoms of RSV Infection who have met all the inclusion and none of the exclusion criteria are considered eligible to participate in the sample collection phase of this study. Specimens may be collected from subjects in either an inpatient or outpatient setting. An outpatient setting includes facilities such as emergency rooms associated with hospitals, large decentralized hospital/commercial labs, urgent cares and/or physician practices currently undertaking diagnostic testing. An inpatient setting is defined as a hospital where patients are admitted (does not include the emergency room associated with the hospital as this will be considered "outpatient" setting). Patient populations from the United States will be evaluated.
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Pattery, MD | Janssen Diagnostics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacred Heart Hospital - Pensacola | Pensacola | Florida | 32513 | United States |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007251 | Influenza, Human |
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Nasal swabs (NS); Nasopharyngeal swabs (NP) in viral transport medium (VTM)
| D014777 |
| Virus Diseases |
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |