Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).
This is a multicenter, prospective study to evaluate the performance of the MSD Influenza Test for the detection and differentiation of influenza A (including A/H1, A/H3, and A/H5 subtypes) and influenza B. Nasal swabs from subjects presenting at the clinical care facility with ILI will be collected and tested on the MSD Influenza Test. Results from the Test will be compared to results obtained from viral culture performed on a second nasal swab at a reference laboratory.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All | Anyone presenting with influenza-like-illness |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local/Regional Public Health Notification | Biological | For any H5 positive results, notification of the result to the site's local/regional public health authorities. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the sensitivity and specificity of influenza A and B, and subtypes A/H1 and A/H3 with nasal and throat specimens for the MSD Influenza test as compared to cell culture and sequencing in a cross-section of the general population | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the specificity of influenza subtype A/H5 in nasal and throat specimens for the MSD Influenza test as compared to cell culture and sequencing in a cross section of the general population. | 4 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Individuals visiting a health care facility.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Perodin, PhD, CCRP | Meso Scale Diagnostics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hospital of Pediatrics | Hà Nội | Vietnam | ||||
| Children's Hospital #2 |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D009976 | Orthomyxoviridae Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Viral transport media containing nasal swab extract.
| Ho Chi Minh City |
| Vietnam |
| Children's Hospital 1 | Ho Chi Minh City | Vietnam |
| Hospital for Tropical Diseases | Ho Chi Minh City | Vietnam |
| D012140 |
| Respiratory Tract Diseases |