Wondfo Biotech SARS-CoV-2 COVID19 IgM / IgG antibodies rapid test comes per box of 20 cassettes. This classic clinical presentation includes only one bottle of buffer solution for the full contents of the pack. It does come with the necessary pipettes. THIS PRODUCT IS ONLY AVAILABLE FOR SALE TO HEALTH PROFESSIONALS
The Wondfo Biotech SARS-CoV-2 Antibody (lateral flow) rapid test kit is a Point of Care Test (PoCT) which requires a lancet prick of the finger to get a drop of blood, add 2 drops of reagent and you will get a result within 15 minutes (see attached IFU).
It is registered by the Australian Therapeutic Goods Administration (ARTG number 333902), sponsored by Tayler Dental Consulting Pty Ltd. Little Whales Pty Ltd is the authorised distributor in Australia and New Zealand.
In Australia, this test kit may only be supplied to accredited pathology laboratories, registered medical practitioners, healthcare professionals in residential aged care facilities, or Commonwealth, state or territory department of health or their agencies.
One of the advantages of rapid antibody tests is that the antibody response stays in the system long after the infection has cleared. The problem with molecular testing is that once the viral load in the body reduces, the tests become less accurate. Antibody tests are useful in screening for people who have been infected and developed antibodies but were asymptomatic. It is therefore a more flexible solution for community based screening. People’s autoimmune responses vary greatly therefore some people are symptomatic faster than others and some not symptomatic at all and therefore can be hidden carriers. Antibody rapid tests can be used as an adjunct to PCR tests to assist getting people back to work sooner.
The Antibody tests will not replace the current PCR test for COVID-19. The two would work in unison to make diagnosis more effective.
- For unvaccinated patients – a second chance to test if infection has occurred, after viral particles are no longer detectable
- For travellers – potential proof of seronegative status as required for travel to some countries
- For vaccinated patients – an opportunity to check for the presence of neutralising antibodies
- Choice of venous blood or fingertip capillary sampling offers flexibility across a range of clinical settings
- The ability to offer opportunistic testing as a private service
Please follow all advice on COVID-19 management and testing provided by the Australian Commonwealth Government and by the Department of Health in your state or territory.
This PoC antibody test is not intended for self-testing. They are designed to be used by a health professional.
2. Bond K, Nicholson S, Hoang T, Catton M, Howden B, Williamson D. Post-market validation of serological assays for COVID-19. Updated report 2 June 2020. Report prepared for Office of Health Protection, Commonwealth Government of Australia, The Therapeutic Goods Administration (TGA) of Australia. Melbourne; Doherty Institute: 2020.
3. Australian Government Department of Health Therapeutic Goods Administration. Post-market evaluation of serology-based point of care tests [web page]. Updated 19 October 2020 [accessed January 2021] https://www.tga.gov.au/post-market-evaluation-serologybased-point-care-tests 3. Australian Government Department of Health. Post-market validation of serological assays for COVID-19 – updated report. [web page] Updated 4 June 2020
5. Valdivia A, Torres I, Latorre V et al. Suitability of two rapid lateral flow immunochromatographic assays for predicting SARS-CoV-2 neutralizing activity of sera. J Med Virol 2020; Dec 17 : 10.1002/jmv.26697 [Epub ahead of print]
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