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)
– 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.