Clinical Research Details

Clinical Research

Alere RSV 1825301: Collection of Nasopharyngeal and Nasal Swabs for Use in Development of Rapid Diagnostic Tests for Influenza A&B and RSV

Study Description

The purpose of this study is to collect nasal and nasopharyngeal (nose and throat) swab samples from people suspected of having the flu or RSV to help make new tests for detecting Influenza A&B and RSV, and/or make current tests better.

The study doctor or study staff member will collect either two (2) nasopharyngeal (nose and throat) swabs or one (1) nasal and (1) nasopharyngeal (nose and throat) swab from you. Standard collection techniques will be used. If the collection of a nasal or nasopharyngeal swab is part of your standard of care that swab will be collected first. The entire process will take about 10-20 minutes of your time.

Inclusion/Exclusion Criteria

Inclusion Criteria

  1. Suspected to have flu or RSV                                           
  2. Onset of at least 2 of the following flu/ RSV-like symptoms within previous 3 calendar days:

            FLU:

    - Fever >99.5

    - Headache

    - Extreme tiredness

    - Dry cough

    - Sore throat

    - Runny or stuffy nose

    - Muscle aches

                  RSV:

     - Runny or stuffy nose

     - Dry cough

     - Irritability

     - Decreased activity

     - Myalgias

     - Fever >99.5

     - Breathing difficulties

  3. Able and willing to provide two (2) nasopharyngeal swabs (NPS) or one (1) nasal swab and one (1) nasopharyngeal swab
  4. Able and willing to provide written informed consent

Exclusion Criteria

  1. Subject has received a nasal vaccine (i.e., FluMist) within the past 10 days
  2. Subject has taken the Synagis vaccine in the past 12 months
  3. Subject is currently taking or has taken an antiviral medication- i.e., Amantadine, Rimantadine, Relenza (Zanamivir), Tamiflu (Oseltamivir Phosphate), and Flumadine- for influenza within the past 30 days
  4. Subject is currently enrolled in a study to evaluate an investigational drug
  5. Vulnerable populations as deemed inappropriate for study by the site’s PI

Investigators