New License in South Africa
South African Health Products Regulatory Authority (SAHPRA) issues license for Test-it CoV-2 Rapid Test, a highly-accurate, fast and affordable screening test to detect COVID-19 immune responses
Life Assay Diagnostics (Pty) Ltd, a manufacturer of world-class in-vitro diagnostic tests in Cape Town, announced today that effective 1 October 2020 it has received a license from the South African Health Products Regulatory Authority (SAHPRA) to manufacture its new Test-it CoV-2 Rapid Test, a rapid point-of-care lateral flow immunoassay for the detection of IgM and IgG antibodies in response to SARS-CoV-2, which causes COVID-19 disease. This makes Life Assay Diagnostics the only local manufacturer licensed by SAHPRA to produce Covid-19 IgM/IgG serological tests in the country.
The Company is ramping up production at its state-of-the-art, ISO certified Cape Town plant to meet immense demand for the new test as governments, businesses and schools seek to protect citizens, employees and students from the harmful effects of COVID-19.
Covid-19 has claimed over one million lives and infected over 37.8 million people globally. Serological antibody tests determine whether a person has been exposed to SARS-CoV-2 and the body has mounted an immune response. This information becomes a critical component in the management and control of the disease. Life Assay’s Test-it CoV-2 Rapid Test has many advantages over other tests:
- Easy to use; no laboratory, additional equipment, power source or special training required – unlike most other tests on the market.
- Fast; results in ten minutes or less.
- Highly-Accurate; uses a small fingerstick blood sample (similar to a diabetic test or an iron test for blood donations), which significantly reduces sampling errors versus current nostril swab screening tests, plus it includes a control feature that augments testing accuracy.
- Reliable; it can detect a patient’s immune response over an extended period of time (IgM-early phase and IgG-later phase), which means the Test-it CoV-2 Rapid Test is far more useful than other tests that can only detect the virus during a limited window.
- Durable; usable in almost any location, with a long shelf life.
- Superior Quality; designed to be one of the most accurate and useful tests on the market.
- Affordable; dedicated to delivering products at attainable prices for our customers.
Over the past 11 years, Life Assay Diagnostics has built a strong reputation in the field of rapid point-of-care (POC) tests and is highly regarded by customers, which include major governmental health agencies and leading philanthropic organizations. The Company has manufactured rapid screening tests for a variety of diseases including COVID-19, typhoid fever, HIV, brucellosis, leptospirosis and preeclampsia.
Founder and CEO Louis Roux stated, “When we learned about the threat of COVID-19 earlier this year, we immediately started developing a highly-accurate, reliable and affordable rapid test that is scalable.” Mr. Roux added, “We are very proud of the quality of our product and our ability to source most of our materials locally. It is very important for us to deliver superior products that are easy to use and readily available to everyone in the community.”
Easy To Use
- Test device on a flat surface.
- Clean finger and use safety to obtain fingerstick blood sample.
- Use pipette to collect fingerstick blood and transfer to the test cassette, followed by two drops of buffer fluid.
- Wait 10 minutes and read results.
LifeSADX CEO Dr. Deon Kellermann said, “We cannot rely on PCR tests alone. They are expensive, time consuming, highly prone to user error, and have an alarmingly high rate of false negatives. A review of the literature shows that PCR’s false negative rate can be as high as 38% on the day of symptom onset, and can increase to an alarming 66% on day 21 after first symptoms. Antibody tests are superior long-term indicators of the body’s immune response to the virus, during all the stages of disease progression. This information is very important as we continue to treat and ultimately attempt to eradicate the extreme effects of the virus.”
LifeSADX and Life Assay Diagnostics is also in the process of seeking regulatory approval in multiple countries for a second Covid-19 product, LifeSADX CoV-2 IgT, an enhanced screening test with even higher sensitivity and specificity that detects total antibodies.
“In our trials, there were a number of cases where our total antibody test, the LifeSADX CoV-2 IgT, identified a patient as positive, whilst the more expensive and time-consuming PCR test did not detect the virus, which can leave the body long before lingering antibodies still persist,” said Mr. Roux. “Therefore, we believe LifeSADX CoV-2 IgT has the potential to be a critical tool in the fight against COVID-19, once we receive the necessary licenses and regulatory approvals. We are working with strategic partners to scale production of our tests given heightened demand projections to fight COVID-19.”
About Life Assay and LifeSADX
Life Assay Diagnostics (Pty) Limited and LifeSADX Corporation serve the global community with lateral flow and urine diagnostic tests to combat COVID-19, typhoid fever, preeclampsia, leptospirosis, brucellosis and HIV.
For more information regarding products, strategic partnerships and order inquiries, please contact email@example.com.
Director of Sales LifeSADX Corporation
Tel: +1 508 310 3830