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CoronavirusT esting: S U GuangzhouFenghua H Bioengineering CO.,L TD . T L A E H Y C SARS-CoV-2 Antibody Rapid Test A ReGenCoViD19, LLC G 460 Park Avenue E New York, New York L http://www.regencovid-19.com/ In Exclusive Collaborationwith Legacy Health US, LLC www.legacyhealthus.com info@legacyhealthus.com sales@legacyhealthus.com
What is FenghuaBiological? http://www.bio-fenghua.com/en/products.asp S U H T L A E H Y C A G E L
S What is Fenghua? U H T L A • In business since 1999 and is FDA registered. E H • Produces wide range of medical/clinical screening and tests – prenatal, neonatal, HIV, hepatitis and Y many others. C A • Is dedicated to meeting clinical demands. G • Has built a team with strong R&D abilities, E integrated technical and customer-oriented L support, exceeding competitors in year-to-year excellent financial status and reliable scientific, medical, business and social partners. • Has long-standing strategic relationships with multiple leading universities, research institutes and high-tech enterprises.
What is an antibody S U test? H T L A • Antibody tests will identify a person’s response to the E virus after or during infection H Y • Antibody testing can also identify people that were C exposed to the virus but were asymptomatic A G • Testing more than one variety of antibody (IgM and E IgG) is more accurate and increases the likelihood of L detection, no matter where a person is in the course of infection
When, After Initial Infection, WillAntibodies S BePresent? U H T L A E H Y C A G E L
Quick Facts about the S ReGenCoVid19 SARSCoV-2 U H Antibody RapidTest T L A • No special equipment needed –the kit contains it all E H • Simple finger-prick procedure Y C • Instant results in 10mins A G • Identifies both IgM and IgG antibodies E L • Detection rate exceeds FDA requirements • See http://www.bio- fenghua.com/en/pro_show.asp?id=115
Applications of the ReGenCoViD19 T est S To screen suspected infection cases U H To identify patients without the virus antibodies T L To help identify asymptomatic patients who could infect others and help A enable public health epidemiological contact tracing E H To re-confirm molecular tests and exclude false negative or positive results Y C Because this test detects antibodies which the body forms when it is A exposed to a virus including the COVID-19 virus, this test is not used to G diagnose whether or not you have the COVID-19 E L A positive result suggests that you may have been infected with the COVID-19 virus. You should get tested by a diagnostic test A negative test could mean that either you do not have the infection or your infection is at an early stage and antibodies have not yet developed in your body. you should monitor your health closely and be retested in 3-7 days, if symptoms appear, or if you suspect you have been exposed to the virus exposed to the virus. •
Applications of the test S U H T L A E H Y C A G E Molecular Laboratory SARS-CoV -2 ReGen SARS-CoV-2 Antibody Rapid L T est RT-PCR Test
The Antibody Test S U H Manufactured by T L A E Fenghua is H Y European Union C A G Certified E L Europe
S U H The Antibody Test T L A E Manufactured by H Y C Fenghiais A G E L Registered in Europe
The ReGenCoViD19 SARS-CoV-2 Antibody Rapid Test and the FDA S U H • The ReGenCoViD19 test complies with the FDA 3/16/20 T Policy for Diagnostic Tests for Coronavirus Disease-2019. L • After test validation, the Pre-EUA notification was filed A E on April 23. H • On April 24 FDA responded that it does not object to distribution and use of the test kits by healthcare Y workers and laboratories at the point of care, with C instructions given to users and patients. A • On May 2 the request for full FDA EUA authorization was G filed with extensive clinical test data. An expedited FDA E L response is expected to authorize use of the test for the duration of the coronavirus emergency. • After EUA authorization is received, an application for FDA 510k clearance will be filed for authorization to use the test indefinitely after the emergency. • Bottom line - The ReGenCoViD19 SARS-CoV-2 Antibody Rapid Test can now be used at the point of care by healthcare workers.
S U H T L A The Rapid E H CoVid19 Kit Y C A G E L
S U H T L A E H Y C A G E The T estingCassette L
Thank you! S Please e-mail svictor@regenmedicalpc.com or U H sales@leagcyhealthus.com T with any questions you may have. L A E H For more information: Y C http://www.regencovid-19.com A Or G E https://www.legacyhealthus.com L Dr Steven Victor Hon. Steven S. Honigman Ritesh Shah R.Ph.
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