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Trial registered on ANZCTR


Registration number
ACTRN12623000811606
Ethics application status
Approved
Date submitted
5/07/2023
Date registered
27/07/2023
Date last updated
27/07/2023
Date data sharing statement initially provided
27/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical Performance of Coronavirus (COVID-19) Antigen Rapid Test Kits for the detection of COVID-19 variants in clinical samples from people aged 7-75 years
Scientific title
Clinical Performance of Coronavirus (COVID-19) Antigen Rapid Test Kits for the detection of COVID-19 variants in clinical nasal swabs, throat swabs, and saliva specimens from people aged 7-75 years who require COVID-19 testing
Secondary ID [1] 310032 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 Infection 330573 0
Condition category
Condition code
Infection 327409 327409 0 0
Other infectious diseases
Respiratory 327518 327518 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is designed to evaluate the clinical performance of the Hough and Coronavirus (COVID-19) antigen rapid test kits for the detection of COVID-19 variants in clinical nasal swabs, throat swabs, and saliva specimens. Real-time polymerase chain reaction (RT-PCR) on specimens collected by nasopharyngeal swabs from the same participant will be used as the reference method. The sensitivity and specificity of the test kits will be determined in relation to the threshold cycles (Ct) of the reference PCR test and the day post onset of symptoms. The peak period for detection will be determined. The SARS-CoV-2 variants in the positive samples will be confirmed by the variant-specific Research Use Only (RUO) assay and sequencing.

Participants are recruited from people presenting themselves for COVID-19 testing at WiSE Specialist Emergency Clinic and/or Austech Medical Laboratories. Specimens are collected from patients who have COVID-19 like symptoms. Participants are recruited across all genders and eligible age groups. Study staff records participants' information such as symptoms and time since symptom onset. For each study participant, the specimen for RT-PCR is collected first, then the antigen rapid test specimens. The antigen rapid test result is read after 15 min to 20 min.
The same group of participants will be included in three arms of the study, one arm is for obtaining data on the Hough COVID-19 antigen rapid home test kit, another arm is for obtaining data on the self-developed Coronavirus (COVID-19) antigen rapid test kits, the comparator arm is to obtain data from the RT-PCR. Three different types of samples can be used in the self-developed COVID-19 antigen rapid test kits, i.e. nasal swab, throat swab and saliva.

The objectives of the study are: 1) to compare the antigen rapid test results to the corresponding PCR data for overall sensitivity and specificity on SARS-CoV-2 variant of concern (VOC) detection; 2) to compare the clinical performance of the selected antigen rapid test kits on the detection of SARS-CoV-2 VOC; 3) to determine if the selected antigen rapid tests have any cross-reactivity with influenza A/B virus and Respiratory Syncytial virus (RSV) in clinical samples.

Approximately 120 participants will be enrolled to this study. The final sample size will depend on the positive rate of SARS-CoV-2 infection. The goal of this study is to collect a total of N=30 confirmed SARSCoV-2 positive participants with positive results in both COVID-19 antigen rapid test results of either delta or omicron variants (omicron BA.1.1.529 or BA.2) across a range of days (0-7 days) post onset of COVID-19-related symptoms and a minimum of N=60 COVID-19 positive/negative participants.

Only one visit per participant except re-sampling for any invalid test result. No follow-up is required. Samples will be collected by the trained medical staff from WiSE Specialist Emergency Clinic or Austech Medical Laboratories. For each study participant, the specimen for RT-PCR is collected first, then the test specimens for antigen rapid tests. All sample collections are completed immediately after each other.

Approximately 1-2 months (June-August, 2022). Study staff identifies eligible participants over the course of a month. If needed, this period can be extended.
Intervention code [1] 326466 0
Diagnosis / Prognosis
Comparator / control treatment
In order to assess the sensitivity and specificity of the COVID-19 antigen rapid test kits, molecular detection of SARS-CoV-2 by the RT-PCR methods is used to be the comparator in this study.
Control group
Active

Outcomes
Primary outcome [1] 335294 0
The sensitivity of Hough and the self-developed Coronavirus (COVID-19) antigen rapid test kits will be determined by determining positive predictive value when compared to the reference RT-PCR method. RT-PCR tests are considered the gold standard for COVID-19 diagnosis as they can detect very low levels of the virus.
Timepoint [1] 335294 0
The antigen rapid tests will be run immediately after sample collection and read after 15-20 min, while RT-PCR will be completed within 24 hours.
Primary outcome [2] 335295 0
To determine the peak period for detecting COVID-19 infection using the antigen rapid test kits, the COVID-19 antigen rapid test results will be compared to the RT-PCR results and the day after the onset of COVID-19 symptoms. This comparison will help identify the optimal timeframe for detecting the virus using the antigen rapid test kits.
Timepoint [2] 335295 0
Only one visit per participant except re-sampling for any invalid test result. The COVID-19 antigen rapid testing will be completed within 20 minutes after sample collection. RT-PCR testing will be completed within 24 hours after sample collection.
Primary outcome [3] 335432 0
The specificity of Hough and the self-developed Coronavirus (COVID-19) antigen rapid test kits will be determined by SARS-CoV-2 variant-specific RUO PCR assays.
Timepoint [3] 335432 0
SARS-CoV-2 variant-specific RUO PCR assays will be completed within 72 hours after sample collection.
Secondary outcome [1] 424506 0
Nil
Timepoint [1] 424506 0
N/A

Eligibility
Key inclusion criteria
Participants must meet all the following criteria to be enrolled.
1. Volunteer to participate in clinical research; fully understand and be able to sign the informed consent form (ICF); willing to follow and have the ability to complete all trial procedures. A signed parent/guardian PICF and assent PICF for young participants should be obtained for all young participants (younger than 18 years old). If the young participant has the capacity to read and to make the decision, a signed PICF should be obtained from the participant along with a signed parent/guardian PICF.
2. At the time of signing the PICF, the age is 7-75 years (including the boundary values), male or female.
3. Participants must require COVID-19 testing for their COVID-19 like symptoms on the day of testing, e.g. Fever, cough and/or sore throat, fatigue/general feeling of weakness, loss of sense of smell and/or taste, shortness of breath, muscle stiffness/body aches, head cold/running nose, etc.
Minimum age
7 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients unable to fully understand and sign the ICF are excluded;
2. Patients with bleeding disorder are excluded from the study as a precaution;
3. Hospitalized patients/inpatients are excluded;
4. Application of nasal spray within 15 min prior to testing.
5. Patients, who have COVID-19 symptoms more than 7 days prior to testing, are excluded;
6. Eat, drink, smoke, brush your teeth, or chew gum for 10-30 minutes prior to sample collection

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
There are three arms of the study, one arm is for obtaining data on the Hough COVID-19 antigen rapid home test kit, another arm is for obtaining data on the self-developed Coronavirus (COVID-19) antigen rapid test kits, the comparator arm is to obtain data from the RT-PCR.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The statistical analysis includes demographic data, days post onset of COVID-19 symptoms,
PCR and antigen rapid test results. All descriptive summaries and statistical analyses will be
performed using SAS Version 9.4 or later (SAS Institute, Inc., Cary, NC).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/08/2022
Date of last participant enrolment
Anticipated
Actual
26/09/2022
Date of last data collection
Anticipated
Actual
27/09/2022
Sample size
Target
120
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314210 0
Commercial sector/Industry
Name [1] 314210 0
Koi Biotech Pty Ltd
Country [1] 314210 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Koi Biotech Pty Ltd
Address
Suite 1103, 109 Pitt Street, Sydney, NSW 2000
Country
Australia
Secondary sponsor category [1] 316134 0
None
Name [1] 316134 0
Address [1] 316134 0
Country [1] 316134 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313335 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 313335 0
123 Glen Osmond Road, Eastwood, South Australia 5063
Ethics committee country [1] 313335 0
Australia
Date submitted for ethics approval [1] 313335 0
09/05/2022
Approval date [1] 313335 0
17/08/2022
Ethics approval number [1] 313335 0
2022-04-418-A-1

Summary
Brief summary
The goal of the study is to compare the antigen rapid test results to the corresponding PCR data for overall sensitivity and specificity. Specimens are collected from patients who have COVID-19 like symptoms. Participants are recruited across all genders and eligible age groups. Study staff records participants' information such as symptoms and time since symptom onset. For each study participant, the specimen for RT-PCR is collected first, then for the antigen rapid test. The same group of participants will be included in three arms of the study, one arm is for obtaining data on the Hough COVID-19 antigen rapid home test kit, another arm is for obtaining data on the Coronavirus (COVID-19) antigen rapid test kits, the comparator arm is to obtain data from the RT-PCR specimens.
The sensitivity and specificity of the test kits will be determined in relation to the results of the reference PCR test and the day post onset of symptoms. The peak period for detection of COVID-19 infection will be determined. The SARS-CoV-2 variants in the positive samples will be confirmed by the variant-specific RUO assay and sequencing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127778 0
Dr Pankaj Arora
Address 127778 0
WiSE Walk in Specialist Emergency Clinic
17 Khartoum Road, Macquarie Park NSW 2113
Country 127778 0
Australia
Phone 127778 0
+61 404112961
Fax 127778 0
Email 127778 0
[email protected]
Contact person for public queries
Name 127779 0
Donna Lai
Address 127779 0
Koi Biotech Pty Ltd
Suite 1103, 109 Pitt Street, Sydney, NSW 2000
Country 127779 0
Australia
Phone 127779 0
+61 403151568
Fax 127779 0
Email 127779 0
[email protected]
Contact person for scientific queries
Name 127780 0
Donna Lai
Address 127780 0
Koi Biotech Pty Ltd
Suite 1103, 109 Pitt Street, Sydney, NSW 2000
Country 127780 0
Australia
Phone 127780 0
+61 403151568
Fax 127780 0
Email 127780 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.