S U H T L A E H Y C A G E L CoronavirusT esting: S U - - PowerPoint PPT Presentation

▶
s u h t l a e h y c a g e l
SMART_READER_LITE
LIVE PREVIEW

S U H T L A E H Y C A G E L CoronavirusT esting: S U - - PowerPoint PPT Presentation

Feb 12, 2023 750 likes •916 views

S U H T L A E H Y C A G E L 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

slide-1
SLIDE 1

L E G A C Y H E A L T H U S

slide-2
SLIDE 2

CoronavirusT esting: GuangzhouFenghua Bioengineering CO.,L TD .

SARS-CoV-2 Antibody Rapid Test

ReGenCoViD19, LLC 460 Park Avenue New York, New York http://www.regencovid-19.com/ In Exclusive Collaborationwith Legacy Health US, LLC www.legacyhealthus.com info@legacyhealthus.com sales@legacyhealthus.com

L E G A C Y H E A L T H U S

slide-3
SLIDE 3

What is FenghuaBiological? http://www.bio-fenghua.com/en/products.asp

L E G A C Y H E A L T H U S

slide-4
SLIDE 4

What is Fenghua?

  • In business since 1999 and is FDA registered.
  • Produces wide range of medical/clinical screening

and tests – prenatal, neonatal, HIV, hepatitis and many others.

  • Is dedicated to meeting clinical demands.
  • Has built a team with strong R&D abilities,

integrated technical and customer-oriented 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.

L E G A C Y H E A L T H U S

slide-5
SLIDE 5

What is an antibody test?

  • Antibody tests will identify a person’s response to the

virus after or during infection

  • Antibody testing can also identify people that were

exposed to the virus but were asymptomatic

  • Testing more than one variety of antibody (IgM and

IgG) is more accurate and increases the likelihood of detection, no matter where a person is in the course of infection

L E G A C Y H E A L T H U S

slide-6
SLIDE 6

When, After Initial Infection, WillAntibodies BePresent?

L E G A C Y H E A L T H U S

slide-7
SLIDE 7

Quick Facts about the ReGenCoVid19 SARSCoV-2 Antibody RapidTest

  • No special equipment needed –the kit contains it all
  • Simple finger-prick procedure
  • Instant results in 10mins
  • Identifies both IgM and IgG antibodies
  • Detection rate exceeds FDA requirements
  • See http://www.bio-

fenghua.com/en/pro_show.asp?id=115

L E G A C Y H E A L T H U S

slide-8
SLIDE 8

Applications of the ReGenCoViD19 T est

To screen suspected infection cases To identify patients without the virus antibodies To help identify asymptomatic patients who could infect others and help enable public health epidemiological contact tracing To re-confirm molecular tests and exclude false negative or positive results Because this test detects antibodies which the body forms when it is exposed to a virus including the COVID-19 virus, this test is not used to diagnose whether or not you have the COVID-19 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.

L E G A C Y H E A L T H U S

slide-9
SLIDE 9

Applications of the test

ReGen SARS-CoV-2 Antibody Rapid T est Molecular Laboratory SARS-CoV

  • 2

RT-PCR Test

L E G A C Y H E A L T H U S

slide-10
SLIDE 10

The Antibody Test Manufactured by Fenghua is European Union Certified

Europe

L E G A C Y H E A L T H U S

slide-11
SLIDE 11

The Antibody Test Manufactured by Fenghiais Registered in Europe

L E G A C Y H E A L T H U S

slide-12
SLIDE 12

The ReGenCoViD19 SARS-CoV-2 Antibody Rapid Test and the FDA

  • The ReGenCoViD19 test complies with the FDA 3/16/20

Policy for Diagnostic Tests for Coronavirus Disease-2019.

  • After test validation, the Pre-EUA notification was filed
  • n April 23.
  • On April 24 FDA responded that it does not object to

distribution and use of the test kits by healthcare workers and laboratories at the point of care, with instructions given to users and patients.

  • On May 2 the request for full FDA EUA authorization was

filed with extensive clinical test data. An expedited FDA 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.

L E G A C Y H E A L T H U S

slide-13
SLIDE 13

The Rapid CoVid19 Kit

L E G A C Y H E A L T H U S

slide-14
SLIDE 14

The T estingCassette

L E G A C Y H E A L T H U S

slide-15
SLIDE 15

Thank you!

Please e-mail svictor@regenmedicalpc.com or sales@leagcyhealthus.com with any questions you may have. For more information: http://www.regencovid-19.com Or https://www.legacyhealthus.com Dr Steven Victor

  • Hon. Steven S. Honigman

Ritesh Shah R.Ph.

L E G A C Y H E A L T H U S