---
title: Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction
nct_id: NCT03595358
overall_status: COMPLETED
phase: NA
sponsor: Ellume Pty Ltd
study_type: INTERVENTIONAL
primary_condition: Influenza
countries: Australia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03595358.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03595358"
ct_last_update_post_date: 2023-06-15
last_seen_at: "2026-05-12T07:31:56.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT03595358](https://clinicaltrials.gov/study/NCT03595358)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 25
- **Lead Sponsor:** Ellume Pty Ltd
- **Conditions:** Influenza
- **Start Date:** 2018-08-31
- **Completion Date:** 2018-11-16
- **CT.gov Last Update:** 2023-06-15

## 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

- **Minimum age:** 2 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Arm** (EXPERIMENTAL) — 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.

## Interventions

- **Ellume Home Flu Test** (DIAGNOSTIC_TEST) — The Ellume Home Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples.
- **ellume.lab Flu A+B Test** (DIAGNOSTIC_TEST) — The ellume.lab Flu A+B Test is a rapid in vitro diagnostic test intended to be used at point-of-care for the detection of influenza A or influenza B in nasal swab samples.
- **Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)** (DIAGNOSTIC_TEST) — Reverse Transcriptase Polymerase Chain Reaction (RT\_PCR) is a molecular diagnostic technique for the detection and identification of influenza viruses, both for clinical samples and isolates. The Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) allows template viral RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.
- **Viral culture** (DIAGNOSTIC_TEST) — Nasopharyngeal samples will be inoculated into appropriate culture media for influenza viral culture. In this test, the virus is actually grown and further identified in the laboratory as influenza A or B.

## Primary Outcomes

- **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.** _(time frame: 1 day)_ — Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
- **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.** _(time frame: 1 day)_ — Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
- **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.** _(time frame: 1 day)_ — Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
- **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.** _(time frame: 1 day)_ — Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
- **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.** _(time frame: 1 day)_ — Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
- **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.** _(time frame: 1 day)_ — Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
- **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.** _(time frame: 1 day)_ — Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.
- **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.** _(time frame: 1 day)_ — Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.

## Secondary Outcomes

- **Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by Ellume Home Flu Test.** _(time frame: 1 day)_
- **Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.** _(time frame: 1day)_
- **Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by Ellume Home Flu Test.** _(time frame: 1 day)_
- **Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.** _(time frame: 1 day)_
- **Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by Ellume Home Flu Test.** _(time frame: 1 day)_
- **Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.** _(time frame: 1 day)_
- **Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by Ellume Home Flu Test.** _(time frame: 1 day)_
- **Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.** _(time frame: 1 day)_
- **Percent of participants who correctly interpret the result of the Ellume Home Flu Test** _(time frame: 1 day)_
- **Scores from questionnaire to assess ease of use, comfort and convenience of the Ellume Home Flu Test.** _(time frame: 1 day)_
- **Scores from questionnaire to assess ease of use and convenience of the ellume.lab Flu A+B Test.** _(time frame: 1 day)_

## Locations (1)

- Paratus Clinical Kanwal Trial Clinic, Kanwal, New South Wales, Australia

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.paratus clinical kanwal trial clinic|kanwal|new south wales|australia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03595358.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03595358*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*