Antigen Test Kit
COVID-19 Rapid Antigen Test
Home Test
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(Oral Fluid) ALL TEST COVID-19 Antigen Rapid Test
Contents:
- Test device
- Buffer
- Package insert
- Biosafety Bag
- Collection device (Funnel, tube and tube tip)
ALL TEST COVID-19 Antigen Rapid Test (ARTG 376310)
– Fast home testing kit
– Fast result in 15 mins assay time
– Simple operation, no equipment required
Rapid Antigen Test (oral fluid specimen)
Relative Sensitivity 90.1% (95&Cl*:82.5%~95.1%)
Relative Specificity 99.3% (95%Cl*:97.7%~99.9%)
Accuracy 97.0% (95%Cl*:94.9%~98.5%)
Intended use:
The COVID-19 Antigen Rapid Test (Oral Fluid) is a single-use test kit intended to detect the novel coronavirus SARSCoV-2 that causes COVID-19 in human oral fluid. This test is designed for home use1 with self-collected oral fluid samples from symptomatic individuals who are suspected of being infected with COVID-19 within the first 7 days of symptom onset.
The COVID-19 Antigen Rapid Test (Oral Fluid) obtain a preliminary result only, the final confirmation should be based on clinical diagnostic results.
The COVID-19 Antigen Rapid Test (Oral Fluid) is intended to be used by laypersons as a self-test for home and workplace (in offices, for sporting events, airports, schools, etc.).
Professional Use
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
The Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is a rapid test that displays visual markings when it detects novel coronaviruses’ (2019-nCoV) antigen on the nasal or throat swab. The test is to be used as an aid to assist rather than confirm the diagnosis of coronavirus infection disease (COVID-19). This means the test results cannot be used as the sole basis for treatment or other management decision. For in vitro diagnostic use only. For professional use only.
The Wondo COVID-19 Antigen Test is easy to use, cost-efficient and can be done at the point of care, allowing for prompt testing no matter where the patient is. This is comparatively more convenient than the standard laboratory method of RT-PCR, which requires sophisticated equipment and highly trained laboratory technicians.
Wondfo 2019-nCoV Antigen Test only supply to one or more of the following: (a) a laboratory that is an accredited pathology laboratory within the meaning of the Health Insurance Act 1973 (b) a medical practitioner who is registered under a law of a state or territory to practice medicine, a person registered under a law of a state or territory to practice paramedicine (a paramedic), or an organisation, business or institution that employs or engages a medical practitioner or a paramedic.
Wondfo Biotech Rapid Antigen Test (ARTG 375754)
– POC
– Professional use
– Not for self-test
Rapid Antigen Test (nasopharyngeal swab or oropharyngeal swab specimen)
Sensitivity 98.11% (95%CI: 93.55%-99.53%)
Specificity 99.72% (95%CI: 98.45%-99.95%)
Total agreement: 98.92% (95%CI: 97.33%-99.71%)
*Rapid antigen tests are supplied for use by relevant health practitioners, and in appropriate circumstances.
If you don’t have a health professional onsite, then ask us how we can assist you in having an AHPRA registered clinician working with your worksite to allow Rapid Antigen Testing
For TGA advice and Q&A on the supply and administration of Rapid Antigen Testing Kits in Australia please follow this LINK
If you are an AHPRA registered health professional or work in an organisation/industry that has involvement of a health professional and would like more information please fill out this form and we will reply ASAP.