BERLIN, March 10, 2020 /PRNewswire/ -- The fear of the Coronavirus (SARS-CoV-2) is currently spreading throughout Germany and the world. Until now, anyone who fears being exposed has had to have a "polymerase chain reaction" (PCR) laboratory blood test. These tests are in short supply, complicated, invasive, expensive, and time-consuming, sometimes taking several hours or longer to produce a result.
Pharmact AG, a company specializing in the production of rapid diagnostic tests, has now developed the CoV-2 Rapid Test, a simple, easy, point-of-care rapid test for detecting Coronavirus exposure. With only two drops of blood from the fingertip, the test can determine in 20 minutes the presence of immunoglobulins IgM and IgG, which are found in the blood of people who have been exposed. The rapid test allows a quick, reliable diagnosis without the need for a laboratory or a lot of unnecessary time or equipment.
Pharmact AG has completed clinical evaluation and performance review of the test with excellent results. The CoV-2 rapid test cross-matched with the PCR test out of 126 cases, showed 100% agreement in detecting non-affected individuals. This speaks for the excellent ability of the rapid test to differentiate between infections with other, more frequently occurring coronavirus subtypes. The CoV-2 Rapid Test is CE marked and offers maximum safety with its unprecedented performance data. Also, the test has an international pharmacy number and can also be ordered at the pharmacy. "Since the launch of our CoV-2 Rapid Test, Pharmact has received profuse interest in Germany and throughout Europe." CEO Eric Schaber said in a statement. "We are confident that our point-of-care tests will be critical to help tackle what could be a global pandemic."
The CoV-2 Rapid Test shows whether or not infection with SARS-CoV-2 is present in three easy steps:
1. Healthcare professionals take two drops of blood from a patient's fingertip and place them onto the application field of a test cassette, followed by two drops of buffer solution.
2. After about 30 seconds, a red-pink color front forms and moves across the test strip contained in the cassette, over a control line (C) and two test lines (IgM and IgG).
3. After 20 minutes, the result is available. If only the control line (c) is discolored, the patient is not infected with Coronavirus. Discoloration of one or both test lines indicates infection. A positive IgM value indicates an infection in the early phase of the disease (4 to 10 days), and a positive IgG value indicates a later phase (from 11 - 24 days).
Availability: www.pharmact.shop and pharmacies (for instructed and trained medical personnel only)
Scope of delivery: Lancet, pipette, buffer solution, test strip, test cassette, instructions for use
Price: 39.95 Euro
Health insurance companies: German health insurance companies reimburse all corona tests if they are medically necessary.
Pharmact recently started operating in the US and is ready to launch its unique, novel BelDIA PRE Intact Proinsulin Rapid Test that can detect elevated levels of proinsulin in capillary blood, venous blood, plasma, or serum. This point-of-care test can predict the development of type 2 diabetes up to 5 years before the onset of the disease, and even before any elevated blood glucose can be detected. The company hopes that by screening at-risk populations earlier on, this will decrease the incidence of diabetes in the US.
About Pharmact AG
Founded in 2014, Pharmact AG is a German pharmaceutical company headquartered in Berlin, Germany. The company's research center and sales office are both based in Mannheim. Pharmact is operated in Spain by Pharmact Healthcare S.L. in Alicante and the United States by Pharmact Healthcare Inc. in Chapel Hill, North Carolina. Behind an international team of medical experts, the company focuses on preventing disease through early detection. Pharmact AG currently provides healthcare professionals with four qualitative rapid tests for the early detection of SARS-CoV-2 (CoV-2 Rapid Test), myocardial infarction (BelCARDIO), type 2 diabetes mellitus (BelDIA PRE), and for measuring liver fibrosis (BelFIBRO). Pharmact's fifth and most recent project currently in development combats arteriosclerosis (BelACT) and is expected to be launched in Germany later this year. An international board of trustees supports the drug approval process of BelACT. Note that not all products are currently available in the US.