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

NCT03595358 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-06-15

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Ellume Home Flu 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.

DIAGNOSTIC_TEST

ellume.lab Flu A+B 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.

DIAGNOSTIC_TEST

Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

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.

DIAGNOSTIC_TEST

Viral culture

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.

Sponsors & Collaborators

  • Ellume Pty Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2018-11-16
Completion
2018-11-16

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03595358 on ClinicalTrials.gov