Guide to Onsite Covid-19 Testing - Vision Research

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Guide to Onsite Covid-19 Testing - Vision Research
Guide to Onsite Covid-19 Testing

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Vison R&D is the licensed distributor throughout the UK & Ireland for Mexacare GmbH
with a history of 35 years as a German diagnostic manufacturer.

To ensure validity and efficacy, all rapid testing must be administered by a medical
professional. Through our collaboration with Medel Healthcare, we provide health
     6XSSOLHV(TXLSPHQW
professionals on site to manage our clinics.
         6XSSOLHV(TXLSPHQW

                                                              Nationwide Coverage
Guide to Onsite Covid-19 Testing - Vision Research
Process

Step 1. Patient Books appointment
        Using Medel Healthcare App
          • Booking Link Generated and passed to Company HR or point of care
          • Employees choose appointment time
          • Employees fill out pre questionnaire
          • Pre Questionnaire is overlooked by our Health Professional
          • Required to Download our Health Passport App for results

Step 2. Patient Undergoes Procedure
           • Live Schedule gives nurse ability to know the person’s name and
          health information (filled in by patient at sign up)
           • Performs Procedure, professionally and informatively
           • Issues Verbal Result and selects “Detected” “Not Detected”on our
          system
           • Results issuer adds result to Patients App Profile (This will be
          explained further)

Step 3. Patient
        Receives   3DWLHQWUHFHLYHV

        Result
                        5HVXOW

           • Issuer adds result to patients profile on
          health passport Europe application
Guide to Onsite Covid-19 Testing - Vision Research
Onsite Rapid Covid-19 Testing
   Services available in Ireland and UK. Pricing on request for UK.

  Antigen Test: New Model Sales Pitch
  Ability to do multiple locations a day with same testing crew

                                100 patients:

                                                                  €15 - Supply Antigen
                                                                  Nurses €150 p/h

                                4 Nurses 1h = €600
                                100 Antigen Supply = €1500
                                Total €2,100

                                                                    PCR Test

hen you need to know quickly
Guide to Onsite Covid-19 Testing - Vision Research
Purchasing of tests directly
Services available in Ireland and UK. Pricing on request for UK.
When you need to know quickly

                 COVID-19 Antigen Rapid Test
   What is the MEXACARE COVID-19 Antigen Rapid Test?

  Antibody Test €15 each
   The MEXACARE Coronavirus Antigen Rapid Test is a rapid chromatographic immunoassay for the qua-
   litative detection of SARS-CoV-2 antigens present in the human nasopharynx. One antigen (protein of
   COVID-19) is usually detectable in upper respiratory tract samples during the acute phase of infection.
  box of 25
   Positive results indicate the presence of viral antigens.

    Relative Sensitivity        93,48% (95 % CI*: 88,4 %-98,5%)
    Relative Specificity        99,62% (95 % CI*: 98,9%->99,9%)
    Accuracy                    98,01% (95 % CI*: 96,6%-99,47%)
   When should I test with the MEXACARE COVID-19 Antigen Rapid Test
   Like the RT-PCR test. which is currently the gold standard. an antigen test is able to detect infection with
   the novel coronavirus SARS-CoV 2 very early after infection.
                                                                               €15 pp - Test Alone
   In the earliest stages of the disease - during the incubation period (according to the WHO an average of
   5-6 days) and in the first 2-3 days after the onset of symptoms. a test with the MEXACARE COVID-19
   Antigen Rapid Test is therefore recommended. Since the test detects protein components of the actual
   virus (so-called antigens) and not antibodies (the immune reaction of the human body against the virus).
   acute infections with SARS-CoV-2 can be detected at this early stage.
   The benefits of the MEXACARE COVID-19 Antigen Rapid Test
   √   Very high sensitivity (>93 %) and specificity (>99 %)
   √   Fast availability of test results (approx. 15 minutes)
   √   No expensive laboratory equipment needed
   √   No additional reagents required
   √   All materials for direct on-site testing included (Point-of-Care)
   √   No need to transport samples to the laboratory

Fast and easy test procedure

                                                                                       Package Contents
        3 drops of                                                                     20 Sealed pouches each con-
   extracted specimen                                                  positive        taining one test cassette and
                                                                                       one desiccant
                                                                                       20 Sterile swabs
                                                                                       20 Specimen collection contai-
                                                                                       ners with extraction buffer
                                                                                       1 Workstation
                                                                                       1 Package insert
                                                                       negative
                                                                                       Storage

                                                                                         Antigen Test €15 each
                                                                                       2 – 30°C (Room Temperature)

                                                                       invalid           box of 20
                                                                                       Swab        15 min.
COVID-19
Antigen Rapid Testing

Vision R & D in collaboration with German manufacturer Mexacare diagnostics is
providing Rapid Covid 19 tests and testing services to UK and Irish companies
facilitating a safer working environment through rapid screening and testing.

Rapid antigen testing is an extremely efficient, economical and reliable process to screen
personnel and provide a high level of security and safety to the working environment.

    EU certified effiency       Pricing On       Professional Medical When
                                                                      Resultsyou  need
                                                                              within         to kn
       rating of 98%             Request               Services        15 minutes

          The Antigen Tests are available for purchase in unit volumes of 25
                                                                                             COV
          info link: https://visionresearch.io/our-services/professional-testing-services/
                                                                       What is the MEXACA
Whilst extremely easy and simple to use to ensure validity and efficacyThe
                                                                         the MEXACARE
                                                                              tests must beCoro
                                                                       litative
administered by a professional. A junior doctor or nurse can be provided        detection
                                                                           to make   on siteof SA
visits to companies                                                    COVID-19) is usually d
                                                                       Positive results indicat
1. A fully registered NMBI nurse, licenced to work in Ireland with experience in taking
bloods and health screening procedures.
                                                                         Relative Sensitivity
2. An IMC registered doctor at junior level.                             Relative Specificity
                                                                         Accuracy
3. A General Practice doctor on the Specialist Register for GP Services providing a gold
standard service.
                                                                       When should I test w
                                                                       Like the RT-PCR test.
                                                                       the novel coronavirus S
                                                                       In the earliest stages o
                                                                       5-6 days) and in the fi
info link: https://visionresearch.io/our-services/medical-sector/      Antigen Rapid Test is t
                                                                       virus (so-called antigen
What you need to know quickly

     What you need to know
      Vision R&D, in collaboration with Mexacare and Medel Healthcare is providing onsite
      COVID-19 testing.

      According to the HSE and Public Health England, a three-pronged approach is the correct
      standard of care to implement when considering this approach to staff safety.

      A combination of 1. Antigen testing, 2. PCR testing & 3. Antibody testing is best practice.
      This is a complex issue and to simply opt for antigen testing is the wrong approach. It is
      documented that if a member of your personnel is antigen tested within 12 weeks of a
      positive diagnosis of COVID-19, then antibody testing should be deployed. Unless they are
      symptomatic, it must be assumed that they will have residual viral nucleic acid, which
      may result in a false positive when using antigen testing.

w
When
  quickly
      you need to know quickly
     COVID-19 Antigen Rapid Test
                            https://visionresearch.io/our-services/covid-antibody-test/
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What you need to know quickly
      What is the MEXACARE COVID-19 Antigen Rapid Test?
      The MEXACARE Coronavirus Antigen Rapid Test is a rapid chromatographic immunoassay for the qua-
      litative detection of SARS-CoV-2 antigens present in the human nasopharynx. One antigen (protein of
     COVID-19 Antigen Rapid Test
      COVID-19) is usually detectable in upper respiratory tract samples during the acute phase of infection.
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      When should I test with the MEXACARE COVID-19 Antigen Rapid Test
     an average of 5-6 days) and in the first 2-3 days after the onset of symptoms a test with the
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     The
      The benefits  ofthe
          benefits of  theMEXACARE
                           MEXACARE COVID-19
                                   COVID-19   Antigen
                                            Antigen    Rapid
                                                    Rapid Test Test

     √√ Very
         Very high sensitivity (>93 %) and specificity (>99 %)
               high sensitivity (>93 %) and specificity (>99 %)
     √ Fast availability
      √  Fast   availability of
                              of test
                                 testresults
                                      results(approx.
                                               (approx.15 15
                                                          minutes)
                                                             minutes)
     √ No expensive laboratory equipment needed
      √  No    expensive    laboratory  equipment   needed
     √√ NoNoadditional
               additional reagents     required
                            reagents required
     √√ AllAllmaterials
              materials forfordirect
                               directon-site
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                                                     included      (Point-of-Care)
                                                              (Point-of-Care)
     √√ NoNoneed
               needtoto transport    samplestoto
                         transport samples        the
                                                the    laboratory
                                                    laboratory

  FastFast
       andand
            easy
              easytest  procedure
                   test procedure

 the qua-                                                                                  Package Contents

protein of
           3 drops of                                                                      20 Sealed pouches each con-
     extracted specimen                                                   positive         taining one test cassette and
infection.                                                                                 one desiccant
                                                                                           20 Sterile swabs
                                                                                           20 Specimen collection contai-
                                                                                           ners with extraction buffer
                                                                                           1 Workstation
                                                                                           1 Package insert
                                                                          negative
                                                                                           Storage
                                                                                           2 – 30°C (Room Temperature)

                                                                          invalid
ction with                                                                                 Swab        15 min.

 verage of
COVID-19
 he actual
 he virus).
Whatyou need to know quickly

COVID-19  IgG/IgM
      COVID-19         Rapid
               IgG/IgM Rapid Test Test Antibody

What is the MEXACARE COVID-19 lgG/lgM Rapid Test?
The
 What isMEXACARE
          the MEXACARE     COVID-19
                               COVID-19 lgG/lgM
                                          IgG/IgM Rapid Antibody
                                                              Test? Test is a rapid, qualitative
immunochromatographic as-say for the differential detection of lgM & lgG antibodies
 The MEXACARE
against   SARS CoV-2COVID-19virusIgG/IgM Antibody
                                   in human    serum,Test plasma
                                                          is a rapid,orqualitative
                                                                        whole bloodimmunochromatographic
                                                                                         samples. The testas-     is
 say for thefor
intended     differential detection of IgM
                 the determination      of a& current
                                               IgG antibodies
                                                         or past  against SARSwith
                                                                    infection      CoV-2
                                                                                       thevirus in human serum,
                                                                                            SARS-CoV-2        virus
 plasma  or whole  blood   samples.  The test is intended   for the determination
and for monitoring the disease status after SARS-CoV-2 virus infection. The MEXACAREof a current  or past infection
 with the SARS-CoV-2 virus and for monitoring the disease status after SARS-CoV-2 virus infection.
COVID-19     lgG/lgM Rapid Test has a sensitivity of 94.55% and a specificity of 97.26%.
 The MEXACARE COVID-19 IgG/IgM Rapid Test has a sensitivity of 94.55% and a specificity of 97.26%.
MEXACARE GmbH is an ISO 13485 certified manufacturer for rapid medical tests.
MEXACARE GmbH is an ISO 13485 certified manufacturer for rapid medical tests.

When      shouldI Itest
 When should         testwith
                           withthe the  MEXACARE
                                     MEXACARE           COVID-19
                                                      COVID-19         lgG/lgM
                                                                    IgG/IgM        Rapid
                                                                               Rapid       Test?
                                                                                       Test?
The MEXACARE COVID-19 lgG/lgM Rapid Test is intended to complement the RT-PCR
tests,   which areCOVID-19
 The MEXACARE          currentlyIgG/IgM
                                     performedRapid inTest
                                                       large   numberstoby
                                                            is intended         doctors, laboratories
                                                                              complement                   and public
                                                                                             the RT-PCR tests,  which
health     authorities     throug-hout        the   world    in  the    fight  against    the   novel  Corona-Virus
 are currently performed in large numbers by doctors, laboratories and public health authorities throug-
SARS-CoV-2.
 hout the world in the fight against the novel Corona-Virus SARS-CoV-2.
During
 During thetheearliest
                earliest    stages
                       stages   of theof  the disease
                                       disease              - in the period
                                                 - in the incubation     incubation    period
                                                                                (according       (according
                                                                                             to WHO           to WHO
                                                                                                      around 5-6  days
around     5-6and
 on average)    days onontheaverage)     andafter
                             first 2-3 days    on the   first 2-3
                                                    the onset        days after
                                                                of symptoms        theRT-PCR
                                                                                - only  onset of cansymptoms    - only
                                                                                                     give you satisfac-
 tory test  results as  the body    has not  produced    antibodies    in  detectable  quantities.
RT-PCR can give you satisfac-tory test results as the body has not produced antibodies in
 3-5 days after
detectable        the onset of the disease‘s symptoms (cough, light fever, sore throat) IgM antibodies can
               quantities.
 already
3-5   days beafter
              detected
                     the inonset
                            the blood.
                                    of theAt disease’s
                                             this point, testing
                                                          symptoms with the   MEXACARE
                                                                           (cough,   light COVID-19
                                                                                            fever, soreIgG/IgM
                                                                                                          throat)Rapid
                                                                                                                   lgM
 test is recommended as positive results can now be obtained. IgG antibodies are produced later by the
antibodies can already be detected in the blood. At this point, testing with the MEXACARE
 immune system and are detectable in the body for a long time after recovery. In this way, undetected
COVID-19 lgG/lgM Rapid test is recommended as positive results can now be obtained.
 infections (e.g. infections that proceed without symptoms) or the serological protection of the test sub-
lgG   antibodies
 ject can            are produced later by the immune system and are detectable in the body
           be determined.
for a long time after recovery. In this way, undetected infections (e.g. infections that
proceed without symptoms) or the serological protection of the test sub-ject can be
determined.

Stages of COVID-19 disease according to current state of knowledge:
                                                                                       Infectious - day -2 to +14 :
                                                                                       Patient excretes infectious
                                                                                       amounts of Sars-Cov-2 virus
                                                                                       - on average 2-3 more people
                                                                                       become ill (1)
                                                                                       Healthy without symptoms: until
                                                                                       day 0 and from day +10 to +14
                                                                                       at the earliest: Patient has no
                                                                                       fever for at least 48 hours and
                                                                                       no symptoms of infection for at
                                                                                       least 24 hours.
                                                                                       In addition, the RKI requires two
                                                                                       negative tests for the virus with
                                                                                       a 24-hour difference. (2)
                                                                                       Immune: specific antibodies IgG
                                                                                       against the corona virus signal
                                                                                       immunity. For how long? Ana-
                                                                                       logy to the other corona viruses
                                                                                       some years (3)
All advantages of the
      COVID-19 Antigen Rapid Test

        √ Test cassette for qualitative detection
        √ Fast, simple, inexpensive - no laboratory equipment required
        √ Safe Point of Care test with results within 15-20 minutes
        √ High Accuracy (>98) enables reliable detection of infected patients
    √ High specificity (>99%) prevents false positive results
All advantages
    √ Detection of the
                of viruses by antigens
COVID-19 Antigen Rapid Test:
    √ Complements MEXACARE COVID-19 IgG/IgM Antibody Rapid Test and RT-PCR as a
RESEAR CH + DE VELOPMENT

√    Test cassette for qualitative detection

√
        powerful tool forcomprehensive diagnosis
     Fast, simple, inexpensive - no laboratory equipment required

√       √ Checking the risk of infection by patients
     Safe Point of Care test with results within 15-20 minutes

√       √ Offers the possibility of effective screening of large parts of the population
     High sensitivity (>93%) enables reliable detection of infected persons

√    High specificity (>98%) prevents false positive results

√    Detection of viruses by antigens

√    Complements MEXACARE COVID-19 IgG/IgM Antibody Rapid Test and RT-PCR as a powerful tool for

     comprehensive diagnosis                                                                                                                 Accurate Rapid Tests from Your
√    Checking the risk of infection by patients

√    Offers the possibility of effective screening of large parts of the population                                                                  COVID-19 Antigen

                           Catalogue No.                                     Description                        No. of tests
                                3011030                         MEXACARE COVID-19 Antigen Rapid Test                20
                                3011016                       MEXACARE Influenza A+B Antigen Rapid Test             20
                                3011033                 MEXACARE COVID-19 & Influenza A+B Ag Combo Rapid Test       20

                           All tests are CE certified

                                                                                           RESEARCH + DEVELOPMENT

                                                                                                 8QLW0%XVLQHVV3DUN
                                                                                                               MEXACARE GmbH
                                                                                                 %DOO\PRXQW$YHQXH%DOO\PRXQW
                                                                                                                        -
                                                                                                                         Hans-Bunte-Str. 6
                                                                                                                 69123 Heidelberg
                                                                                                   
                                                                                                                           Germany
                                                                                             phone         +49 (0) 62 21- 90682-41
                                                                                             fax,QIR#YLVLRQUHVHDUFKLR
                                                                                                           +49 (0) 62 21- 90682-47
                                                                                                              www.mexacare.com
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