Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.

Ellume

Status: Completed

Conditions: Influenza

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03248960

iE-FLU-AUS-1701

Details and patient eligibility

About

The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture.

The secondary aims are to:

Validate the sensitivity and specificity of the iTreat Flu A+B 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).

Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with influenza-like symptoms.

Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the iTreat Flu A+B Test.

Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.

Enrollment: 381 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female participants aged ≥ 18 years: iTreat Flu A+B Test and ellume.lab Flu A+B Test OR aged ≥ 1 and <18 years: ellume.lab Flu A+B Test only; and
• Fever ≥ 37.8°C (100°F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8°C (100°F) or feeling feverish within 24 hours of presentation; and
• Rhonorrhea or blocked nose; 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 <1 year.
• 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 have used any investigational device within 30 days preceding informed consent.
• Participants 18 years of age or older unable to understand English and consent to participation.
• Parent/legal guardian of Paticipants <18 years of age unable to understand English and consent to participation of child.
• Participants who have had prior exposure to iTreat Flu A+B Test.
• participants who have been previously enrolled in the iE-FLU-AUS-1701 study.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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381 participants in 1 patient group

iTreat Flu A+B Test and ellume.lab Flu A+B Test

Experimental group

Description:

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

Treatment:

Diagnostic Test: iTreat Flu A+B Test

Diagnostic Test: ellume.lab Flu A+B Test

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

Diagnostic Test: Viral culture