PTS Diagnostics Announces New Rapid-Detection COVID-19 Test
Developed by parent company, Sinocare Inc., available in the EU, U.K. and South Africa
WHITESTOWN, Ind. (March 24, 2020) – PTS Diagnostics, a U.S. based manufacturer of point-of-care medical testing devices announced today the availability to select non-US markets a rapid, cost-effective COVID-19 antibody test, through their parent company.
The CE-marked SARS-CoV-2 Antibody Test developed by PTS Diagnostics’ parent company Sinocare Inc., is a rapid, accurate, easy to use point-of-care antibody test kit which can qualitatively detect IgM and IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15-20 minutes.
The test kit comes with SARS-CoV-2 antibody test strips, a capillary tube, buffer solution and a package insert. To administer the test, a medical professional collects 10 µL of whole blood, serum, or plasma via venous draw collected in an EDTA or heparin tube. The collected sample is then transferred with the provided capillary tube and applied to the test strip’s sampling area. They then add 2-3 drops of buffer solution to the same area and wait 15-20 minutes. The test is qualitative, meaning that results will either read as positive, negative, or invalid. Unlike other COVID-19 tests, results are available onsite within minutes and neither a laboratory nor an instrument is needed.
The SARS-CoV-2 Antibody Test Strip is currently available to our distributors and strategic partners in the U.K., EU and South Africa. It will be rolled out to Australia and Russia in the very near future and is being sold in both five (5) and 25 count test boxes.
“Stopping or slowing the spread of COVID-19 is a global effort that begins and ends with testing and the ability to receive fast and accurate results,” said Jonathan Chapman, CEO and President, of PTS Diagnostics. “We’re excited that this breakthrough at the point of care can help deliver accurate results in minutes as opposed to the hours or days required from most COVID-19 tests. This can potentially increase the number of patients tested per day and eliminate long and unnerving waiting periods for those being tested. A global pandemic requires a global response, and we’re proud to be working with our parent company towards the betterment of public health.”
The test strips are stable for 6 months when stored at 4-30°C and kept away from direct sunlight, moisture, and heat. A clinical evaluation performed by Sinocare revealed 96.3% sensitivity and 98.3% specificity in serum / plasma. In whole blood, the test had 95.0% sensitivity and 98.3% specificity.
For more information, please call customer service in the US at 317-870-5610 (direct) or 877-870-5610 (toll-free US only). Connect with your EU, U.K. or South Africa distribution partner if you are interested in purchasing the SARS-CoV-2 Antibody Test. Find them via PTS Diagnostics Distributors.
About PTS Diagnostics
Through its People, Technology and Service, PTS Diagnostics creates health innovation that drives action and results. Since 1992, we have helped medical professionals and patients achieve better health outcomes through our accurate, precise, fast, affordable, and certified point-of-care medical devices. Healthcare professionals have used our CardioChek products to assess cardiovascular disease risks for millions of patients worldwide through lipid panel screening. And, our A1CNow® systems, which provide fast and reliable HbA1c testing, have helped physicians deliver more effective treatments to patients with diabetes. For more information, visit ptsdiagnostics.com.