Clinical trial NCT03595358: Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction
Official title: A Prospective Multi-Centre Study of the Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Lead sponsor: Ellume Pty Ltd
Sponsor class: INDUSTRY
First posted: 2018-07-23
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Ellume Home Flu Test.
timeFrame: 1 day
measure: Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by ellume.lab Flu A+B Test.
timeFrame: 1 day
measure: Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by Ellume Home Flu Test.
timeFrame: 1 day
measure: Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by ellume.lab Flu A+B Test.
timeFrame: 1 day
measure: Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by Ellume Home Flu Test.
timeFrame: 1 day
measure: Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by ellume.lab Flu A+B Test.
timeFrame: 1 day
measure: Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by Ellume Home Flu Test.
timeFrame: 1 day
measure: Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by ellume.lab Flu A+B Test.
timeFrame: 1 day
Secondary outcomes:
measure: Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by Ellume Home Flu Test.
timeFrame: 1 day
measure: Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.
timeFrame: 1day
measure: Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by Ellume Home Flu Test.
timeFrame: 1 day
measure: Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.
timeFrame: 1 day
measure: Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by Ellume Home Flu Test.
timeFrame: 1 day
measure: Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.
timeFrame: 1 day
measure: Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by Ellume Home Flu Test.
timeFrame: 1 day
measure: Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.
timeFrame: 1 day
measure: Percent of participants who correctly interpret the result of the Ellume Home Flu Test
timeFrame: 1 day
measure: Scores from questionnaire to assess ease of use, comfort and convenience of the Ellume Home Flu Test.
timeFrame: 1 day
measure: Scores from questionnaire to assess ease of use and convenience of the ellume.lab Flu A+B Test.
timeFrame: 1 day
Other outcomes:
Locations:
city: Kanwal
country: Australia
facility: Paratus Clinical Kanwal Trial Clinic
state: New South Wales
Study officials:
References: