Clinical Validation of the Point-of-Care MSD Influenza Test

Influenza Human Clinical Trial

Official title:

Clinical Validation of the Point-of-Care MSD Influenza Test

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00863343
• Other study ID #: MSD-ITPOC-01
• Status: Terminated
• Phase: N/A
• First received: March 16, 2009
• Last updated: January 30, 2012
• Start date: March 2010
• Est. completion date: August 2010

Study information

• Verified date: January 2012
• Source: Meso Scale Diagnostics, LLC.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 391
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza Human
• Influenza, Human

Intervention

Biological:
• Public Health Notification
For any H5 positive results, notification of the result to the site's local public health authorities.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	John T Mather Hospital	Port Jefferson	New York
United States	Naval Health Research Center	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Meso Scale Diagnostics, LLC.	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 day	No
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.	1 day	No
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.	1 day	No
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.	1 day	No