Validation of the Ellume® Respirio Flu Test and the Ellume® eLab Flu Test for the Rapid Identification of Influenza A/B

Ellume

Status: Completed

Conditions: Influenza A; Influenza B

Treatments: Device: eLab Flu Test; Device: Respirio Flu Test; Device: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02767414

RESP16001

Details and patient eligibility

About

The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza A as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).

The secondary aims are to:

Validate the sensitivity and specificity of the Respirio Flu Test and the eLab Flu Test in detecting Influenza B as compared to the gold standard for detection, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); Evaluate the correct interpretation of the Respirio Flu Test by subjects with influenza-like symptoms; Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the Respirio Flu Test.

Enrollment: 1,500 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects aged ≥ 1 year;
• Rhinorrhea;
• ≤ 5 days from onset of influenza-like illness symptoms;
• Subject (or parent/legal guardian) capable and willing to give informed consent/assent;
• Subject (or parent/legal guardian) able to read and write English.

Exclusion criteria

• Has undergone treatment with antivirals within the previous 7 days;
• Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days;
• Recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
• Currently enrolled in another clinical trial or used any investigational device within 90 days preceding informed consent;
• Has had prior exposure to the Respirio Flu Test or eLab Flu Test.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,500 participants in 1 patient group

Respirio Flu Test and eLab Flu Test

Experimental group

Description:

Upper respiratory tract samples from participants will be tested with: Respirio Flu Test; eLab Flu Test; and Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Treatment:

Device: eLab Flu Test

Device: Respirio Flu Test

Device: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)