Influenza Human
Conditions
Keywords
Influenza infections, Orthomyxoviridae infections
Brief summary
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).
Detailed description
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.
Interventions
BIOLOGICALPublic Health Notification
For any H5 positive results, notification of the result to the site's local public health authorities.
Sponsors
Centers for Disease Control and Prevention
Meso Scale Diagnostics, LLC.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any subject (all ages) presenting with ILI (defined as fever \[subjective or documented\] and cough or sore throat), and suspected of having influenza. * Subject (parent, guardian, or authorized legal representative) gives informed consent or assent (child) to the study, and provides signed authorization for use and disclosure of protected health information.
Exclusion criteria
* Any subject classified as high risk for exposure to avian or novel influenza, as determined by a Risk-Assessment Questionnaire. * Subjects who had prior nasal wash/aspirate or nasopharyngeal wash/aspirate specimens collected for routine health-care purposes within the same suspected influenza infection episode.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MSD Influenza A Test Results Against Cell Culture | 1 day | 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. |
| MSD Influenza B Test Results Against Cell Culture | 1 day | 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. |
| MSD Influenza A Test Results Against Culture and PCR | 1 day | 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. |
| MSD Influenza B Test Results Against Culture and PCR | 1 day | 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. |
Countries
United States
Participant flow
Recruitment details
391 participants were selected from multiple U.S.Primary Care sites and exhibited influenza-like illness
Pre-assignment details
no participants were excluded
Participants by arm
| Arm | Count |
|---|---|
| Participants w/ Disease Positive for Flu A by reference test | 17 |
| Participants w/o Disease Participants without Flu A by reference method | 374 |
| Total | 391 |
Baseline characteristics
| Characteristic | Participants w/ Disease | Participants w/o Disease | Total |
|---|---|---|---|
| Age, Customized Between 0 and 100 years | 17 participants | 374 participants | 391 participants |
| Sex/Gender, Customized Female | NA participants | NA participants | — |
| Sex/Gender, Customized Male | NA participants | NA participants | — |
| Sex/Gender, Customized Result Totals | 17 participants | 374 participants | 391 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 374 |
| serious Total, serious adverse events | 0 / 17 | 0 / 374 |
Outcome results
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.
Time frame: 1 day
Population: per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants w/ Disease | MSD Influenza A Test Results Against Cell Culture | Flu A Positive by MSD test | 14 participants |
| Participants w/ Disease | MSD Influenza A Test Results Against Cell Culture | Flu A Negative by MSD test | 3 participants |
| Participants w/o Disease | MSD Influenza A Test Results Against Cell Culture | Flu A Positive by MSD test | 5 participants |
| Participants w/o Disease | MSD Influenza A Test Results Against Cell Culture | Flu A Negative by MSD test | 369 participants |
95% CI: [0.59, 0.94]Wilson score method
95% CI: [0.97, 0.99]Wilson score method
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.
Time frame: 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants w/ Disease | MSD Influenza A Test Results Against Culture and PCR | Flu A Positive by MSD Test | 22 participants |
| Participants w/ Disease | MSD Influenza A Test Results Against Culture and PCR | Flu A Negative by MSD Test | 3 participants |
| Participants w/o Disease | MSD Influenza A Test Results Against Culture and PCR | Flu A Positive by MSD Test | 1 participants |
| Participants w/o Disease | MSD Influenza A Test Results Against Culture and PCR | Flu A Negative by MSD Test | 369 participants |
95% CI: [0.7, 0.96]Wilson score method
95% CI: [0.98, 1]Wilson score method
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.
Time frame: 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants w/ Disease | MSD Influenza B Test Results Against Cell Culture | Flu B Positive by MSD Test | 22 participants |
| Participants w/ Disease | MSD Influenza B Test Results Against Cell Culture | Flu B Negative by MSD Test | 5 participants |
| Participants w/o Disease | MSD Influenza B Test Results Against Cell Culture | Flu B Positive by MSD Test | 1 participants |
| Participants w/o Disease | MSD Influenza B Test Results Against Cell Culture | Flu B Negative by MSD Test | 363 participants |
95% CI: [0.63, 0.92]Wilson score method
95% CI: [0.98, 1]Wilson score method
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.
Time frame: 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants w/ Disease | MSD Influenza B Test Results Against Culture and PCR | Flu B Positive by MSD Test | 22 participants |
| Participants w/ Disease | MSD Influenza B Test Results Against Culture and PCR | Flu B Negative by MSD Test | 6 participants |
| Participants w/o Disease | MSD Influenza B Test Results Against Culture and PCR | Flu B Positive by MSD Test | 1 participants |
| Participants w/o Disease | MSD Influenza B Test Results Against Culture and PCR | Flu B Negative by MSD Test | 366 participants |
95% CI: [0.6, 0.9]Wilson score method
95% CI: [0.98, 1]Wilson score method