Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000950460p
Ethics application status
Submitted, not yet approved
Date submitted
30/07/2025
Date registered
29/08/2025
Date last updated
29/08/2025
Date data sharing statement initially provided
29/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Human Factors and Clinical Validation of the iHealth Labs Inc. Flu A&B/COVID-19/Respiratory syncytial virus (RSV) Rapid Test in Anterior Nares Nasal Samples For Over the Counter (OTC) Use. IH-018
Scientific title
Human Factors and Clinical Validation of the iHealth Labs Inc. Flu A&B/COVID-19/RSV Rapid Test in Anterior Nares Nasal Samples For Over the Counter (OTC) Use. IH-018
Secondary ID [1] 315037 0
IH-018
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID -19 338381 0
RSV 338382 0
Influenza A 338383 0
Influenza B 338491 0
Condition category
Condition code
Infection 334686 334686 0 0
Other infectious diseases
Respiratory 334796 334796 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a prospective study conducted at three or more sites (with a simulated home environment) for the clinical validation of the iHealth Flu A&B/COVID-19/RSV Rapid Test for the differential detection of influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV) in anterior nares nasal samples. The study will evaluate the investigational test performance using subject-collected samples in symptomatic individuals compared to the comparator tests. Five Hundred or more subjects who are currently experiencing symptoms associated with influenza A & B COVID-19 and RSV may be enrolled. A minimum of 16-25 RSV positive study samples should be from subjects aged 6- 23 months, and a minimum of 16-25 RSV positive samples should be from individuals above 60 years of age.
Each enrolled subject will either self-collect one sample from their anterior nares (from both nostrils) or have one sample collected from him/her by another individual. The subject/tester will run the sample on the investigational test using the provided test Quick Reference Instructions (QRI). Each subject will also provide another anterior nares sample (from both nostrils) collected by one of the study personnel for comparator testing. The comparator sample will be shipped to the reference laboratory for testing.
If a standard of care (SOC) test sample is ordered or scheduled during the same study visit, a minimum wait of 15 minutes is required before any study samples are collected. A minimum wait of 15 minutes is required between the investigational and comparator sample collections. For the investigational test procedure the anticipated time needed to collect samples and complete the test using the test unit, is up to 15 minutes per sample, There will also be a 15 minute delay between sampling for the immediate investigational test and the comparator test. The location/setting of the testing will be at a minimum of three (3) clinical research locations and will provide all enrolled subjects, or testers testing another individual, a private area that resembles a home setting, “simulated home environment”. This will be in a private clinic room at the site. The 'simulated home environment’ site will be a private room with typical home furniture such as a table, chairs, good lighting and devoid of clinical equipment. The participant will utilize the chair provided. The private area that resembles a home setting, “simulated home environment”, will have such items sufficient to follow the instructions including e.g., hand washing, to perform all the study procedures without any assistance from the study personnel or another person.
Test results from the iHealth Flu A&B/COVID-19/RSV Rapid Test (investigational test) will be compared to the test results generated from the comparator assay.
Twenty five (25) or more subjects who are self-collecting and testing, and twenty-five (25) or more subjects collecting a sample and performing the testing on another subject (child or adult), will participate in the human factors assessment where the study personnel or a healthcare provider will evaluate the subject/tester’s ability to correctly prepare the test components for testing, collect a sample, perform the test and interpret the test results. The human factors assessment will occur on the same day as the sampling for investigational/comparator testing, The participants will complete one test as part of this assessment and the anticipated time needed to complete the human factors assessment is 15 minutes per participant. The location/setting of human factors assessments is the same as for the investigational test procedures described above.
All subjects participating in the human factors assessment will also be required to complete a labeling and comprehension questionnaire and will be provided with a mock panel with different investigational test results for interpretation. All investigational and comparator results collected in the human factors assessment will be included in the study data analysis without any modifications. No investigational test results will be reported to a third party or used for any treatment decisions.
An external positive and negative control sample is to be tested daily by the study personnel prior to any subject testing with the investigational test. The control results will be used to verify that the test device is performing as intended and that there is no contamination.
If a daily external control test fails (invalid), testing may be repeated once. Invalid and failed tests will be recorded, and the study monitor is to be notified of any control failures and repeated testing.
Upon repeated failed testing, notify the study monitor immediately.
Timepoints
The estimated length of the sample collection and testing phase is expected to be two (2) to 20 weeks with an additional two (2) to three (3) weeks of study preparation and two (2) weeks of final study closeout. The total estimated study duration is six (6) to 25 weeks.



Intervention code [1] 331634 0
Early detection / Screening
Comparator / control treatment
The comparator tests will include a 510(k) cleared or de novo cleared highly sensitive RT-PCR test for COVID-19, influenza A/B and RSV test such as the 510(k) cleared Xpert Xpress CoV-2/Flu/RSV plus, as applicable. Descriptions of the reference test method(s) are included in the study manual operations.
Test results from the iHealth Flu A&B/COVID-19/RSV Rapid Test (investigational test) will be compared to the test results generated from the comparator assay.
Results from the iHealth Flu A&B/COVID-19/RSV Rapid Test will be compared to results from a 510(k) cleared or de novo cleared highly sensitive RT-PCR test for COVID-19, influenza A/B and RSV test such as the 510(k) cleared Xpert Xpress CoV-2/Flu/RSV plus, as applicable. The study will evaluate the investigational test performance using subject-collected samples in symptomatic individuals compared to the comparator tests. In the event that a comparator test result is invalid, inconclusive, or has an error or no result for any sample, the test may be repeated once, according to the comparator test instructions for use. Any repeated sample that yields an invalid, inconclusive, error or no result will be considered unevaluable. The specific comparator test method(s) for this study will be detailed in the study manual of operations.
Control group
Active

Outcomes
Primary outcome [1] 342355 0
The primary objective of this study is to evaluate the performance (positive percent agreement, negative percent agreement and 95% confidence intervals for upper and lower bounds) of the iHealth Flu A&B Rapid Test for the qualitative and differential detection of influenza A using AN swab samples collected and processed in the test by lay users.
Timepoint [1] 342355 0
Cumulative test results will be assessed for performance within 4 weeks of the final sample being tested
Primary outcome [2] 342434 0
The primary objective of this study is to evaluate the performance (positive percent agreement, negative percent agreement and 95% confidence intervals for upper and lower bounds) of the iHealth Flu A&B Rapid Test for the qualitative and differential detection of influenza B using AN swab samples collected and processed in the test by lay users.
Timepoint [2] 342434 0
Cumulative test results will be assessed for performance within 4 weeks of the final sample being tested
Primary outcome [3] 342435 0
The primary objective of this study is to evaluate the performance (positive percent agreement, negative percent agreement and 95% confidence intervals for upper and lower bounds) of the iHealth COVID-19 Rapid Test for the qualitative and differential detection of COVID-19 antigens using AN swab samples collected and processed in the test by lay users.
Timepoint [3] 342435 0
Cumulative test results will be assessed for performance within 4 weeks of the final sample being tested
Secondary outcome [1] 450465 0
The secondary objective is to evaluate the usability of the investigational test
Timepoint [1] 450465 0
The timepoint/s at which the usability questionnaire will be administered to participants, will be within 5 days after final sample test
Secondary outcome [2] 450807 0
Another secondary outcome is "Labeling and comprehension of the investigational test QRI."
Timepoint [2] 450807 0
The timepoint will be within 5 days after final sample test
Secondary outcome [3] 450809 0
The study may also assess the user accuracy/performance around the limits of detection (LoD) of the investigational test, when performed by untrained operators (without any laboratory background) at clinical sites operating under a Clinical Laboratory Improvement Amendments (CLIA)-Waiver license. This will be the case if the study data are collated for Emergency Use Authorization (EUA) Point Of Care (POC) submission.
Timepoint [3] 450809 0
The usability questionnaire will be completed immediately after the participant has finished performing the investigational test and interpreting the results. All user accuracy, labeling, and comprehension assessments will be completed in the United States prior to initiation of the clinical investigation in Australia. Therefore, no timepoints for these outcomes are applicable to the Australian study.
Secondary outcome [4] 450810 0
Additional primary outcome The primary objective of this study is to evaluate the performance (positive percent agreement, negative percent agreement and 95% confidence intervals for upper and lower bounds) of the iHealth RSV Rapid Test for the qualitative and differential detection of RSV antigens using AN swab samples collected and processed in the test by lay users.
Timepoint [4] 450810 0
Cumulative test results will be assessed for performance within 4 weeks of the final sample being tested

Eligibility
Key inclusion criteria
1. Written informed consent obtained prior to study enrollment.
2. Male or female aged six (6) months or older.
3. Subject is currently exhibiting two or more symptoms associated with COVID-19, influenza or RSV (such as, but not limited to, fever, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea and must present within six (6) days of symptom onset). Subject must still be exhibiting symptoms on the day of sample collection.

Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject who is 18 years of age (or the state’s legal age of majority) or older and does not understand or is not able and willing to sign the study informed consent.
2. Subject has had seasonal influenza and/or the SARS-CoV-2 and/or the RSV vaccine within the past 5 days.
3. Subject is not able to tolerate sample collection, or is not willing to contribute the required swab samples for testing or complete the study procedures.
4. Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), or peramivir (Rapivab®).
5. Subjects currently undergoing treatment and/or within the past thirty (30) days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-2.
6. Subjects who have taken Evusheld (tixagevimab/cilgavimab) within the last 90 days.
7. Subjects who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to the study sample collection.
8. Subjects who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/09/2025
Actual
Date of last participant enrolment
Anticipated
1/10/2025
Actual
Date of last data collection
Anticipated
30/10/2025
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319600 0
Commercial sector/Industry
Name [1] 319600 0
iHealth Labs Inc
Country [1] 319600 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
iHealth Bio Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 322104 0
None
Name [1] 322104 0
Address [1] 322104 0
Country [1] 322104 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318165 0
Bellberry Human Research Ethics Committee F
Ethics committee address [1] 318165 0
Ethics committee country [1] 318165 0
Australia
Date submitted for ethics approval [1] 318165 0
24/07/2025
Approval date [1] 318165 0
Ethics approval number [1] 318165 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143322 0
Dr Dr Naheed Kanji
Address 143322 0
Key Health Bondi Junction. 47 Spring Street, Bondi Junction NSW 2022
Country 143322 0
Australia
Phone 143322 0
+61 438 260 270
Fax 143322 0
Email 143322 0
[email protected]
Contact person for public queries
Name 143323 0
Julie von Grum
Address 143323 0
Crow Clinical. PO Box 35 Currumbin QLD 4223
Country 143323 0
Australia
Phone 143323 0
+61 423766321
Fax 143323 0
Email 143323 0
[email protected]
Contact person for scientific queries
Name 143324 0
Julie von Grum
Address 143324 0
Crow Clinical PO Box 35 Currumbin QLD 4223
Country 143324 0
Australia
Phone 143324 0
+61 423766321
Fax 143324 0
Email 143324 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Will not be seeking patient consent for this.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.