Pinner USA presents Pinner C19, a rapid Covid-19 test performed via chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in whole human blood, serum or plasma. The test assists in the diagnosis of primary and secondary SARS-Cov-2 infections. Pinner C19 requires only a few drops of blood from a finger prick and provides results within minutes.
The Pinner C19 Rapid Covid-19 Test tests for both IgM and IgG antibodies in the blood. IgM is produced by the human immune system to eliminate pathogens in the early stages of the infection; IgG displays at a later stage of the disease.
Pinner C19 Rapid Covid-19 test was developed and produced in China by our production partner in which has met the stringent quality management system audits of CFDA (Chinese Food and Drug Administration) and ISO 13485 and has recently received World Health Organization (WHO) certification. The CDC of China has evaluated this test. According to their conclusion, IgG has an accuracy of 100% and, IgM has an accuracy of 90.0%.
The FDA has published the “Policy for Diagnostic Tests for Coronavirus Disease-2019 During the Public Health Emergency”. https://www.fda.gov/media/135659/download on March 16, 2020, and has provided the guidelines for the usage and distribution of serological tests.
Due to the rapid and increasing need for testing in the United States, Pinner USA believes the Pinner C-19 Rapid Covid-19 test will deliver needed results easily and rapidly. Many countries have used and continue to use these rapid tests for their citizens. In practice, the tests provide the Chinese government with immediate results and have helped slow the pandemic by testing millions of citizens.
Pinner USA Inc, in compliance with this new policy, has provided the necessary validation data via the required “Notification” to FDA and has also implemented the required statements on its website, product, and reports.
Our test, Hangzhou Biotest Biotech’s COVID-19 IgG/IgM Rapid Test Cassette, has finalized all FDA requirements, and has been listed by the FDA, under the title “What Laboratories and Manufacturers are Offering Tests for COVID-19?“ – https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2#5e80170c1e661
As required by this policy, the Pinner USA test can be provided only to “point-of-care” facilities, including laboratories, hospitals, clinics, physician’s offices, and anywhere healthcare workers are involved in treating and/or testing patients.
Pinner C19 is available for theuse of healthcare specialists at www.rapidc19.com
Video Link: http://player.vimeo.com/video/398391347
Company Name: Pinner
Contact Person: Media Relations
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Phone: (201) 580-3674
Address:206 Pegasus Ave. Ste D6
Country: United States