None listed
Conditions
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.
Interventions
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 refer
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.
Sponsors
Koi Biotech Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
7 Years to 75 Years
Healthy volunteers
No
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
Outcome results
None listed