COVID-19 ANTIGEN

Rapid test kit

Compact, faster, simpler.
Sensitivity 96,5 %
Specificity 99,7 %

LOD (Limit of detection) 1.3 x 10² TCID50/ml

Beijing Beier Bioengineering Co. Ltd. - Since 1995

COVID-19 & SARS-CoV-2

COVID-19 is an acute respiratory infection caused by the novel coronavirus (SARS-CoV-2). According
to the current epidemiological survey, the incubation period is 1 to 14 days, mostly 3 to 7 days.

S-protein

M-protein

The SARS-CoV-2 virus has four structural proteins known as the S (spike), E (envelope),
M (membrane) and N (nucleocapsid) proteins; the N protein holds the RNA genome and the S, E and
M proteins together form the viral envelope. The N protein is used as a core raw material for rapid
diagnostic reagents for immunology on the market.
Rapid test kit

MED Trade GmbH and ITR Industry To Retail GmbH are general distributors of the rapid test.
Handelshaus Lerch e.K. is the main importer. Beijing Beier Bioengineering has developed the
COVID-19 antigen rapid test. The COVID-19 Antigen Rapid Test is a colloidal „gold immunoassay“ for
the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasopharyngeal and oropharyngeal
swabs from individuals suspected of having COVID-19.

A product of Beijing Beier Bio-

engineering Co. Ltd.

manufacturer of medical
products since 1995.
Product content

ICOV5002-100569
Sample rack

Test cassette Extraction buffer

Extraction pipe Removal sticks

Product features

Easy sampling. Rapid result in 15 min.

No additional equipment Results are easy to read.

required. Suitable for large-scale population
screenings in the population.

The test is shipped exclusively in thermoboxes to protect it from

SECURE SHIPPING temperature fluctuations and thus guarantee the reliability of the test
even after transport.
How it works

Test line Control line

Conjugated gold coated

anti-N protein antibody
(monoclonal antibody)

Samples block Conjugated block Nitrocellulose membrane Absorbent block

The COVID-19 Antigen Rapid Test is a lateral flow immunoassay based on the principle of double anti-
body sandwich technology. The monoclonal SARS-CoV-2 nucleocapsid protein antibody conjugated
to colour microparticles is used as a detector and sprayed onto the conjugated block. During the test,
the SARS-CoV-2 antigen in the sample interacts with the SARS-CoV-2 antibody conjugated to colour
microparticles, forming an antigen-antibody complex. This complex migrates due to capillary action
on the membrane to the test line where it is captured by the pre-coated monoclonal SARS-CoV-2
nucleocapsid protein antibody. A coloured test line (T) would be visible in the result window if
SARS-CoV-2 antigens are present in the sample.

The absence of the T-line indicates a negative result. The control line (C) is used for procedural control
and should always be displayed when the test procedure is properly performed.
Tested and approved

The Covid-19 Antigen Rapid Test of Beijing Beier Bioengi-

neering is a certified COVID-19 antigen rapid test approved
in Germany and has been included by the „Bundesinstitut
für Arzneimittel und Medizinprodukte“ (Federal Institute for
Drugs and Medical Devices) in the list of antigen tests for
the direct pathogen detection of the coronavirus SARS-
CoV-2, which is the subject of the claim according to §1
sentence 1 of the Coronavirus Test Ordinance - TestV,
which entered into force on 15.10.2020.

Tested and approved by Link:

the „Bundesinstitut für
Arzneimittel und https://antigentest.bfarm.de/ords/antigen/r/antigentests-auf-
Medizinprodukte“ sars-cov-2/liste-der-antigentests?session=13553366248404
Sampling

Oropharyngeal swab Nasopharyngeal swab

Tilt the patient‘s head back For an oropharyngeal Insert the rod into one nos- Carefully remove the swab
70 degrees. swab, take a second dry tril, along the lower nasal carefully with a twisting
stick, insert it into the canal. Up to the level of the motion. (Perform sampling
mouth and swab the back outer ear opening. Leave in both nostrils with the
of the throat and tonsils the stick in the opening for same swab).
(avoid the tongue). a few seconds to allow the
secretion to be absorbed.
Test method

Please read the instructions for use enclosed in the package carefully before
IMPORTANT! performing the test. Allow the test cassette, buffer solution and sample to adjust
to room temperature (15 - 30 °C or 59 - 86 °F) before testing.

1 2 3 4

Take an extraction tube Pour the entire contents Dip the patient stick into When removing the
and a test cassette and re- (450 µl) of the buffer the buffer solution for 15 Remove the stick by pres-
move the foil by pulling the solution into the extraction seconds. Stir well by sing against the sides of
tab. Place the test cassette tube. brushing the stick against the tube at the same time
on a flat surface. the side of the extraction to squeeze the liquid out of
tube five times. the stick.
Test method

5 6 7 Notice

If you use a frozen sample,

it must be warmed to room
temperature before testing.

Attach the lid of the Do not apply more than 2 Read the test result within
extraction tube to the top maximum 3 drops (80 µl) of 15 - 20 minutes. Results
end. Then carefully turn the sample to the sample read after more than 20
the extraction tube over 5 area of the test strip. minutes are not reliable.
times.
Interpretation of the result

positive negative invalid

Cross-reactivity (analytical specificity)

Cross-reactivity was assessed by testing 32 commensal and pathogenic microorganisms that may be
present in the nasal cavity. No cross-reactivity was observed with recombinant MERS-CoV NP protein
when tested at a concentration of 50 μg/ml. No cross-reactivity was observed with the following
viruses when tested at a concentration of 1.0x106 PFU/ml: Influenza A (H1N1), Influenza A
(H1N1pdm09), Influenza A (H3N2), Influenza B (Yamagata), Influenza B (Victoria), Adenovirus (types
1, 2, 3, 5, 7, 55), Human metapneumovirus, Parainfluenza virus (types 1, 2, 3, 4), respiratory syncytial
virus, enterovirus, rhinovirus, human coronavirus 229E, human coronavirus OC43, human coronavirus
NL63, human coronavirus HKU1.

No cross-reactivity was observed with the following bacteria when tested at a concentration of 1.0 ×
107 CFU/ml: Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Haemophi-
lus influenzae, Streptococcus pyogenes (group A), Streptococcus pneumoniae, Staphylococcus
aureus, Candida albicans.
contact

MED Trade GmbH Beijing Beier Bioengineering Co. Ltd.

Rattey 42 No.99 Chuangxin Road

17349 Schönbeck Lucheng Industrial Development Zone
Huangcun Town
Daxing District
mobil +49(0)174 3225639 Beijing
phone +49(0)395 45555459 P. R. China
Fax +49(0)395 5821037

E-Mail [email protected]

Ust ID DE 812457916
HRB HRB 4752

Web med-trade.net