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Funding of study was exhausted prior to completion of study
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All | Anyone presenting with influenza-like-illness |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Public Health Notification | Biological | For any H5 positive results, notification of the result to the site's local public health authorities. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MSD Influenza A Test Results Against Cell Culture | A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared. | 1 day |
| MSD Influenza B Test Results Against Cell Culture | A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences. | 1 day |
| MSD Influenza A Test Results Against Culture and PCR | A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences. | 1 day |
| MSD Influenza B Test Results Against Culture and PCR | A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals visiting a primary care site.
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Perodin, PhD, CCRP | Meso Scale Diagnostics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Health Research Center | San Diego | California | 92106 | United States | ||
| Dartmouth-Hitchcock Medical Center |
no participants were excluded
391 participants were selected from multiple U.S.Primary Care sites and exhibited influenza-like illness
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants w/ Disease | Positive for Flu A by reference test |
| FG001 | Participants w/o Disease | Participants without Flu A by reference method |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants w/ Disease | Positive for Flu A by reference test |
| BG001 | Participants w/o Disease | Participants without Flu A by reference method |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MSD Influenza A Test Results Against Cell Culture | A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared. | per protocol | Posted | Number | participants | 1 day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Disease | Positive for Flu by reference test |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dennis Mertz, Director Regulatory and Clinical Affairs | Meso Scale Diagnostics, LLC. | 240 631-2522 | 2809 | dmertz@mesoscale.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D009976 | Orthomyxoviridae Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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Viral transport media containing nasal swab extract.
| Lebanon |
| New Hampshire |
| 03756 |
| United States |
| John T Mather Hospital | Port Jefferson | New York | 11777 | United States |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex/Gender, Customized | NA. Analysis of gender distribution is not relevant to the study. The disease state is not specific to gender. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | MSD Influenza B Test Results Against Cell Culture | A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences. | Posted | Number | participants | 1 day |
|
|
|
|
| Primary | MSD Influenza A Test Results Against Culture and PCR | A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences. | Posted | Number | participants | 1 day |
|
|
|
|
| Primary | MSD Influenza B Test Results Against Culture and PCR | A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences. | Posted | Number | participants | 1 day |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Participants w/o Disease | Participants without Flu by reference method | 0 | 374 | 0 | 374 |
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| D012140 |
| Respiratory Tract Diseases |
| Specificity |
| 0.997 |
| 2-Sided |
| 95 |
| 0.98 |
| 1.0 |
Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test. |
| No |
| Superiority or Other |
| Specificity |
| 0.997 |
| 95 |
| 0.98 |
| 1.0 |
Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test. |
| No |
| Superiority or Other |
| Specificity |
| 0.997 |
| 2-Sided |
| 95 |
| 0.98 |
| 1.0 |
Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test. |
| No |
| Superiority or Other |