An easy ten-minute COVID-19 rapid antigen test, that eye care professionals can use to test both staff and patients in practice, is now available in Australia.
CareStart, a shallow nasal test, has been given approval for use by the Therapeutic Goods Administration (TGA) and the United States Food and Drug Administration, as well as CE marking. Simple to use, with no special equipment required, extensive clinical trials in the United States demonstrated a sensitivity of 94% and specificity of 99.3%, with local validation data from the Doherty Institute, NSW Health (Westmead) and PathWest. It has been described as “the most sensitive of all TGA approved tests, as validated by NSW Health”, and is able to detect both the Alpha and Delta variants of COVID-19.
The first test to gain TGA approval in Australia more than 12 months ago, CareStart has been used by the Commonwealth Government and AUSMAT for daily testing of staff at Howard Springs and on international deployments. It is also being used for the Commonwealth Government’s aged care pilot in south-west Sydney and by various large private companies across Australia, including the Commonwealth Bank of Australia, Fortescue Metals Group, Lendlease, DHL and QANTAS.
This data determined that CareStart is the most sensitive of all TGA approved tests as validated by NSW Health
Easy, Painless Procedure with Shallow Sampling
The CareStart test is easy to perform and comfortable for the person being tested, with a swab taken from both nostrils, approximately 2.5cm from the edge of each nostril. The swab is then inserted into a vial where the sample is interpreted as positive, negative or inconclusive within 10 minutes.
The result is clearly indicated via a colour change, and anyone who tests positive must be instructed to undergo a laboratory-based PCR test, then notify their local Public Health Unit and follow instructions, including mandatory isolation until a negative PCR test is received or instructed otherwise.
A Test to Get the Industry Going
Good Optical Services has been appointed as the exclusive distributor of CareStart tests to the ophthalmic industry.
Rick Good, owner of Good Optical Services, says he looked long and hard to find a high-quality rapid antigen test that optometry practices could rely on for accuracy.
“Patients have missed vital eye health appointments and eye care practices around the country have been challenged during the pandemic. We were looking for a test to help the profession get moving again.
“CareStart will put patients and practitioners at ease, whether or not visitors to the practice have been vaccinated,” he said. “Practices can feel comfortable when unvaccinated patients or suppliers come in for a consultation or to purchase products.”
The rapid antigen tests kits are available in packs of 20, with each kit comprising a test device, a sterile anterior nasal swab, an extraction vial, and an extraction vial cap. To comply with TGA guidelines the optometrist or ophthalmologist needs to pre-register and a nominated practice staff member will need to undertake a short online course before the practice can begin to use them.
Mr Good said, “We’ve kept the price for these kits as low as possible – our priority in distributing CareStart is to support the ophthalmic industry and the community’s need for continued eye health services.”