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

Not Applicable

Completed

• Conditions: COVID-19 Infection; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12623000811606
• Lead Sponsor: Koi Biotech Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-27
• Study Start: 2023-07-27
• Last Update Posted: 2 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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.

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

• Study Type: Interventional
• Study Design: Not specified