LVT Medical, subsidiary of specialist medical distributor Leviathan Viral Testing Africa, has won the exclusive distribution rights in Africa for Assure Tech’s FaStep Rapid Diagnostic Test for Covid-19.

The FaStep Rapid Diagnostic Test is FDA Reviewed and Authorized, and is being used in a number of countries for the rapid identification of the presence of antibodies created in response to exposure to the novel coronavirus.

The FaStep Rapid Test is intended to qualitatively detect IgM and IgG antibodies separately, providing accurate results in just 15 minutes. No laboratory equipment is necessary to conduct the test, which uses whole blood, serum, or plasma.

“Antibody tests form a vital element in efforts to track and trace Covid-19,” says Gerald Naidoo, CEO of Leviathan Viral Testing Africa. “As the most accurate, highest quality antibody test on the market, we are proud to be bringing this solution to assist with South Africa’s Covid-19 response.

“Antibody testing has seen some criticism, but much of that is based on the fact that sub-standard tests are being used – most of which have had no validation by the appropriate authorities. The FaStep Rapid Test has been validated and approved by the world’s leading scientists to provide results with close to 100% accuracy.

“Antibody testing serves a very specific purpose, helping to identify individuals who have developed an immune response to SARS-COV-2, allowing them to safely get on with their lives without the risk of infecting people,” Naidoo adds. “It does not, however, allow for identification of infection in asymptomatic cases, or within the first few hours of infection, and we therefore recommend antibody testing as part of a specialised response that includes direct testing as well.”

Naidoo points out that, because it is unknown how long antibodies to SARS-CoV-2 remain present in the body after infection, and because of the interval between infection and seroconversion, multiple tests can be done with the FaStep Rapid Test a few days apart to help improve accuracy.

Testing is straightforward and the results are immediate.

Most importantly, no specialised skills or equipment are needed to conduct the test, making this an ideal solution for companies that are implementing their own testing regimes

“In addition, the Assure Covid-19 IgG/IgM Rapid Test Device has been designed to minimise the likelihood of false positive test results, providing further peace of mind,” he says. “False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes, and are common among lower quality tests.

“By eliminating the risk of false positives, the FaStep Rapid Test has set an extremely high standard in serology testing that is unmatched by most other solutions on the market.

“We believe that this test not only offers an internationally verified and validated option, but one that could help minimise the bottlenecks we are seeing in our labs at the moment.

“By offering unmatched precision and extremely fast turnaround times, the FaStep Rapid Test can eliminate the need for validation by direct testing for many people, freeing up the labs to focus on high priority samples.

“We are looking forward to working with the public and private sectors to speed up South Africa’s Covid-19 response with this cost-effective, accurate solution.”