Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction

Ellume

Status: Completed

Conditions: Influenza

Treatments: Diagnostic Test: Viral culture; Diagnostic Test: Ellume Home Flu Test; Diagnostic Test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); Diagnostic Test: ellume.lab Flu A+B Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT03595358

IE-FLU-AUS-1801

Details and patient eligibility

About

The primary purpose of the study is to validate the sensitivity and specificity of the Ellume Home Flu Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to reverse transcriptase polymerase chain reaction (RT-PCR)

Secondary aims are to:

Validate the sensitivity and specificity of the Ellume Home Flu Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture; Evaluate the participant's satisfaction with the convenience and ease of use of the Ellume Home Flu Test; Evaluate the participant's interpretation of the Ellume Home Flu Test results compared to the interpretation by site staff; Evaluate the operator's satisfaction and ease of use of the ellume·lab Flu A+B Test.

Enrollment: 25 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female participants aged ≥ 2 years; and
• Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation; and
• Rhinorrhea; and
• ≤ 72 hours from onset of ILI symptoms; and
• Participant (or parent/legal guardian) capable and willing to give informed consent/assent; and
• Participant (or parent/legal guardian) able to read and write in English.

Exclusion criteria

• Participants aged < 2 years.
• Participants who have undergone treatment with Tamiflu (oseltamivir), Relenza (zanamivir) or Symmetral (amantadine) within the previous 7 days;
• Participants who have been vaccinated by means of an Influenza nasal spray/mist vaccine within the previous 7 days;
• Participants who have had a nose bleed within the past 30 days;
• Participants who have had recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
• Participants currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent.
• Participants previously enrolled in IE-FLU-AUS-1801;
• Participants 18 years of age or older unable to understand English and consent to participation;
• Parent/legal guardian of participants < 18 years of age unable to understand English and consent to participation of child.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Arm

Experimental group

Description:

Ellume Home Flu Test and ellume.lab Flu A+B Test Upper respiratory tract samples from participants will be tested with: Ellume Home Flu Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and viral culture.

Treatment:

Diagnostic Test: ellume.lab Flu A+B Test

Diagnostic Test: Ellume Home Flu Test

Diagnostic Test: Viral culture

Diagnostic Test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)