SARS-COV-2 ANTIGEN RAPID TEST KIT - (COLLOIDAL GOLD) - MEDI-ONE.DE

SARS-CoV-2   Antigen Rapid Test Kit
             (Colloidal Gold)

PREFACE

Severe acute respiratory syndrome coronavirus
2 (SARS-CoV-2, or 2019-nCoV) is an enveloped
non-segmented positive-sense RNA virus. It is
the cause of coronavirus disease 2019 (COVID-
19), which is contagious in humans. SARS-CoV-
2 has several structural proteins including spike
(S), envelope (E), membrane (M) and
nucleocapsid (N).
The antigen is generally detectable in upper
respiratory samples during the acute phase of
infection.

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INTRODUCTION

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                                     INTENDED USE

                   For in vitro qualitative detect of SARS-CoV-2
                   nucleocapsid antigen in nasal(NS) swab specimens
                   directly from individuals who are suspected of
                   COVID-19 by their healthcare provider within the
                   first 5 days of the onset of the symptoms. This test is
                   only provided for use by clinical laboratories or to
                   healthcare workers for point-of-care testing, and not
                   for at home testing.

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                   PRODUCT PHOTOS

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                                                  COMPONENT

TEST KIT POUCH              TEST KIT   TUBE   BUFFER   SWAB

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                       TEST PRINCIPLE

                   The Kit use immunocapture
                   method, it is designed to detect
                   the presence or absence of
                   S A R S - C o V- 2 n u c l e o c a p s i d
                   proteins in respiratory samples
                   from patients with signs and
                   symptoms of infection who are
                   suspected of COVID-19.

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                                                                                   TEST METHOD

1                                     2                                        3

                                     2.Insert the swab into both nostril of   3.Insert the swab into the tube and
                                     the patient. The swab tip should be      plunge the swab up and down in the
1.Twist off the top of the buffer                                             fluid for a minimum of 10 seconds,
                                     inserted up to 2.5 cm (1 inch) from
bottle, slowly dispense all of the
                                     the edge of the nostril. Roll the swab   then hold the swab against the bottom
buffer into the extraction Tube.
                                     5 times along the mucosa inside the      of the tube and rotate 3 turns. Remove
                                     nostril to ensure that both mucus and    the swab . Press the nozzle cap firmly
                                     cells are collected.                     onto the extraction tube.

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                                                                                   TEST METHOD

4                                        5                                     6

4.Tear off the foil pouch, take out                                          6.POSITIVE: Two lines appear. One
the test strip/cassette and place the                                        colored line should be in the control
test kit on a clean and level                                                line region (C), a colored line appears
                                        5.Read the test results between 15
surface.Gently squeeze the ridged                                            in test line (T) region.
                                        and 20 minutes.
body of the tube, dispensing two (2)                                         NEGATIVE: Only one colored control
drops of the processed specimen                                              line appear.
into the sample well.                                                        INVALID: Control line fails to appear.

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SIGNIFICANCE

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RESEARCH BACKGROUND

During the epidemic Situation, many countries have the following problems:

Existing detection methods cannot achieve large-scale rapid screening.

lack of technical expertise and inadequate laboratory capacity, Erroneous Operation can
easily lead to missed inspections.

Can't afford high testing costs.

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                             SIGNIFICANCE

                   According to the WHO, during the
                   outbreak of SARS-CoV-2, in areas with
                   confirmed SARS-CoV-2 community-
                   wide transmission; confirmed outbreaks
                   in closed or semi-closed communities;
                   in high-risk groups; among contacts of
                   confirmed cases; SARS-CoV-2 Antigen
                   Rapid Test Kit (Colloidal Gold) as a tool
                   to monitor disease incidence is a
                   particularly effective detection method.

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ADVANTAGE

1.Easy to collect samples，simple operation，
without professional equipment.

2.The test results are available in 15 minutes,
and the test results are clearly visible.

3.Convenient transportation and low price,
higher accuracy.

4.Suitable for large-scale rapid screening.

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REGISTERED

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                                                    REGISTERED

EU CE Certification   Emergency Use Authorization    FIND-EP

COMPANY PROFILE

JOYSBIO (Tianjin) Biotechnology Co.,
Ltd. is a Chinese R&D-based
biotechnology company that develops,
manufactures, and supplies high-quality
medical in-vitro diagnostic (IVD) rapid
test kits as well as revolutionary
customized solution kits to all parts of
the world. Founded by a team of
professionals with many years of
combined technical,marketing/sales,
operational and manufacturing expertise
in this industry, we offer high quality but
cost-effective rapid test kit.