Xiamen Wiz Biotech CO.,LTD.

SARS-CoV-2 Antigen Rapid Test

Package Insert
(For Medical Professional use only)
Version: 01 Effective Date: 2020-08

INTENDED USE
SARS-CoV-2 Antigen Rapid Test is intended for the qualitative detection of SARS-CoV-2 Antigen in oropharyngeal swab and
nasopharyngeal swab specimens in vitro.

SUMMARY
The SARS-CoV-2 is an enveloped β-coronavirus, circular or elliptical particle diameter of about 60 ~ 140nm, often pleomorphic, obviously
different from SARS-CoV and MERS-CoV in genetic characteristics. The main clinical manifestations include fever, fatigue and other
systemic symptoms, accompanied by dry cough, dyspnea, etc., which can rapidly develop into severe pneumonia, respiratory failure,
acute respiratory distress syndrome, septic shock, multi-organ failure, severe acid-base metabolism disorder, and even life-threatening.
SARS-CoV-2 has been identified as the main means of transmission through respiratory droplets (sneezing, coughing, etc.) and contact
(picking nostril with the hand in contact with the virus, rubbing eyes, etc.).
SARS-CoV-2 is sensitive to ultraviolet ray and heat, and can be inactivated at 56 ℃ for 30 minutes and by fat soluble solvent such as
ethyl ether, 75% ethanol, chlorine disinfectant, peracetic acid and chloroform.

PRINCIPLE
SARS-CoV-2 Antigen Rapid Test employs immuno-lateral chromatography technology for the qualitative detection of antigens. The
colloidal gold particles labeled with the anti-SARS-CoV-2 antibody 1 are fixed on the conjugation pad. The anti-SARS-CoV-2 antibody 2 is
bound on the “T” test line of nitrocellulose membrane. The Goat Anti-Mouse IgG is bound on the “C” control line of nitrocellulose
membrane. When the concentration of SARS-CoV-2 in the specimen is higher than the minimum detection limit, which can conjugate with
the anti-SARS-CoV-2 antibody 1 labeled with colloidal gold particles to form a complex. This complex migrates on the membrane via
capillary action until the test line, where it will be captured by the anti-SARS-CoV-2 antibody 2 bound on the test line, forming
“Au-Anti-SARS-CoV-2 antibody 1-(SARS-CoV-2) - Anti-SARS-CoV-2 antibody 2 complex. These complexes are deposited to display
color as the determination of antigen positive, the rest of anti-SARS-CoV-2 antibody 1 labeled with colloidal gold particles conjugate with
the Goat Anti-Mouse IgG and deposit to display color as the determination of quality of the “C” control line. When the concentration of
SARS-CoV-2 in the specimen is lower than the minimum detection limit or no SARS-CoV-2, the complexes only deposit and display color
in the “C” control line.

KIT COMPONENTS
Cassette type:
1 test/kit, 2 tests/kit, 3 tests/kit, 5 tests/kit, 10 tests/kit, 20 tests/kit, 25 tests/kit, 30 tests/kit, 40 tests/kit, 50 tests/kit, 100 tests/kit, 200
tests/kit.
 Test device: Mouse anti- SARS-CoV-2 monoclonal antibody, Goat Anti-Mouse IgG polyclonal antibody, Nitrocellulose membrane.
 Extraction solution: Phosphate Buffer solution (0.01M, pH7.4±0.2)
 Extraction tube
 Package insert

MATERIALS REQUIRED BUT NOT PROVIDED

 Sterile swabs(oropharyngeal swab or nasopharyngeal swab)
 Timer

REAGENT STORAGE AND STABILITY

Store the kit at 2-30°C/ 36-86°F, out of direct sunlight, valid for 12 months. Do not freeze the kit. The test device should be used within 60
minutes after opening the foil pouch. For production date and expiration date, please refer to the product label.

APPLICABLE INSTRUMENT
Apply to continuous immune analyzer WIZ-A202 or portable immune analyzer WIZ-A101 manufactured by Xiamen WIZ Biotech co., LTD.

SPECIMEN REQUIREMENTS
1. Specimen collection
Oropharyngeal swab specimen collection:
The patient should tilt their head slightly upward, open their mouth wide and make a sound of "ah" to expose both pharyngeal tonsils. The
disposable swab should be used to cross the tongue base. Wipe both pharyngeal tonsils back and forth with slight force for at least three
times, and then wipe the posterior pharyngeal wall up and down for at least three times.
Nasopharyngeal swab specimen collection:
Gently hold the patient’s head with one hand, carefully insert the swab into the nostril and slowly go deep along the bottom of the lower
nasal passage. When the top of the swab reaches the back wall of the nasopharyngeal cavity, gently rotate it for one round (pause for a
moment once reflex cough), and then slowly remove the swab.
2. Specimen storage
After treatment, the specimens can be stored at room temperature (15-30℃) for up to 24 hours, at 2-8℃ for up to 72 hours and at -20℃
for up to 36 months. The specimens are allowed to be frozen and thawed for three times.

ASSAY PROCEDURE
before using the reagent, operate it strictly according to the package insert to ensure the accuracy of the results.
Note:
1. The fresh specimens shall be treated with extraction solution as soon as possible after collection, but no later than 1 hour after
collection.

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2. Test device, sample and instrument must be at room temperature (15~30℃) during the testing.

Sample preparation
1. Remove one specimen extraction tube from the kit before testing.
2. Label one specimen extraction tube or write specimen number on it.
3. Place the labeled specimen extraction tube in a rack in the designated area of the workspace.
4. Add 10 drops of extraction solution to the specimen extract tube.
5. Dip the swab head into the extraction solution in the extraction tube and rotate the swab close to the specimen extraction tube wall for
about 10 seconds or 10 times to dissolve the specimens in the solution as much as possible.
6. Squeeze the tip of the swab along the inner wall of the specimen extraction tube to keep the liquid in the tube as much as possible,
remove and discard the swab.
7. Tighten tube cover and stand by.
Sample detection
1. Before the detection, the test device and the sample are taken out from the storage condition and balanced to room temperature
(15-30℃).
2. Tearing the packaging of the aluminum foil pouch, take out the test device, and place it horizontally on the test table.
3. Vertically invert the specimen extraction tube (the extraction tube with processed specimens), add 2 drops vertically into the sample
well of the test device.
4. The test results should be interpreted within 15 to 20 minutes, invalid If more than 30 minutes.
5. Visual or instrument interpretation can be used in the interpretation. the continuous immune analyzer WIZ-A202 or the portable immune
analyzer WIZ-A101 manufactured by Xiamen WIZ Biotech Co., Ltd. is used for interpretation. Please refer to the user manual of the
corresponding instrument for the operation of the instrument.

POSITIVE VALUE/LIMIT OF DETECTION

Positive value/limit of detection: 1.7×102 TCID50/mL
Select the confirmed inactivated SARS-CoV-2 medium, (concentration 3.4×105 TCID50/mL), use gradient dilution method to find out the
virus medium to reach the critical value of the detection. Repeat the action for 20 time and the test result is positive for at least 19 times.

INTERPRETATION OF TEST RESULTS

 Negative
The red line in the “C” control line region appears. No line appears in the “T” test line regions.
Negative result indicates that the content of the SARS-CoV-2 antigen in the sample is below the
limit of detection or no antigen.
 Positive
The red line in the “C” control line region appears and a red line appears in the “T” test line region.
Positive result indicates that the content of the SARS-CoV-2 antigen in the sample is higher than
the limit of detection.
 Invalid
Once the red line in the “C” control line region doesn’t appear, which will be treated as invalid.
The invalid result indicates that the procedure is not correct or that the test device is out of date or
invalid. In this case, the package insert should be read carefully and repeat the test with a new test
device. If the problem persists, discontinue using the test kit of this Lot number immediately and
contact your local distributor.

Note: The color of the test strip will vary with different samples. However, regardless of the color of
the test strip, it should be judged as positive result within the specified detection time.

LIMITATION
1. The SARS-CoV-2 Antigen Rapid Test is for in vitro diagnostic use only. The test should be used for the detection of SARS-CoV-2
Antigen in oropharyngeal swab and nasopharyngeal swab specimens only.
2. This test kit can only be used for the qualitative detection of SARS-CoV-2 antigens, and can’t determine the quantity of SARS-CoV-2
antigens in samples.
3. If the test result is negative and clinical symptoms persist. It is recommended to repeat sampling or use other testing methods for
testing. A negative result cannot preclude the possibility of exposure to or infection with SARS-CoV-2 virus at any time.
4. The test results of the test kits are for clinicians' reference only, and should not be used as the only basis for clinical diagnosis. The
clinical management of patients should be comprehensively considered in combination with their symptoms/signs, medical history,
other laboratory tests and treatment responses, etc.
5. Due to the limitation of the detection reagent methodology, the limit of detection of this reagent is generally lower than that of nucleic
acid reagents. Therefore, the test personnel should pay more attention to the negative results and need to combine other test results to
make a comprehensive judgment. It is recommended to use nucleic acid testing or virus isolation and culture identification methods to
review negative results which have doubts.
6. Analysis of the possibility of false negative results:
(1) Unreasonable specimen collection, transportation and processing, low virus titer in the sample, no fresh sample or freezing and
thawing cycling of the sample may lead to false negative results.
(2) The mutation of viral gene may lead to changes in antigenic determinants, which lead to negative results.
(3) The research on the SARS-CoV-2 has not been completely thorough; the virus may mutate and cause the differences for best
sampling time (virus titer peak) and sampling location. Therefore, for the same patient, we can collect samples from multiple locations
or follow up for multiple times reduce the possibility of false negative results.

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PERFORMANCE CHARACTERISTICS
 Using enterprise reference for testing, the results meet the requirements of enterprise reference.

 Cross reaction
Name Concentration Test result
Influenza B/Y amagata 1.00×10 TCID50/mL
2
Negative

Influenza B/Voctoria 1.07×105 TCID50/mL Negative

Influenza A H1N1 1.00×102 TCID50/mL Negative

Influenza A H3N2 1.15×102 TCID50/mL Negative

Adenovirus 3 1.24×10 TCID50/mL

5
Negative

Adenovirus 7 1.87×106 TCID50/mL Negative

Human coronavirus 229E 1.00×105 TCID50/mL Negative

Cytomegalovirus 1.00×105 TCID50/mL Negative

Enterovirus 71 2.55×10 TCID50/mL

5
Negative

Human parainfluenza virus 1 1.35×10 TCID50/mL

5
Negative

Human parainfluenza virus 2 6.31×105 TCID50/mL Negative

Human parainfluenza virus 3 3.25×10 TCID50/mL

5
Negative

Measles virus 6.31×10 TCID50/mL

5
Negative

Mumps virus 6.31×10 TCID50/mL

6
Negative

Respiratory syncytial virus 2.00×105 TCID50/mL Negative

Rhinovirus 1A 1.26×105 TCID50/mL Negative

Bacillus pertussis 1.30×10 CFU/mL

6
Negative

Chlamydophila pneumoniae 1.00×10 CFU/mL

5
Negative

Escherichia coli 1.00×105 CFU/mL Negative

Haemophilus influenzae 1.20×106 CFU/mL Negative

Mycobacterium binding 1.00×10 CFU/mL

5
Negative

Mycoplasma Pneumoniae 1.00×106 CFU/mL Negative

Neisseria meningococcus 1.00×105 CFU/mL Negative

Neisseria gonorrhoeae 1.00×105 CFU/mL Negative

Pseudomonas aeruginosa 3.70×10 CFU/mL

6
Negative

Staphylococcus aureus 2.20×106 CFU/mL Negative

Streptococcus pneumoniae 1.00×106 CFU/mL Negative

Streptococcus pyogenes 1.28×106 CFU/mL Negative

Streptococcus salivarius 1.00×105 CFU/mL Negative

 Interfering Substance

Negative Positive
Interfering substance name Concentration
interference result interference result
Mucin 5% Negative Positive
Whole blood 5% (V/V) Negative Positive
α-interferon 500 thousand IU/mL Negative Positive
Zanamivir 500ng/mL Negative Positive
Ribavirin 20μg/mL Negative Positive
Oseltamivir 5μg/mL Negative Positive
Peramivir 0.2mg/mL Negative Positive
Lopinavir 8 mg/mL Negative Positive
Ritonavir 530μg/mL Negative Positive
Umifenovir 4μg/mL Negative Positive

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Levofloxacin 30μg/mL Negative Positive

Azithromycin 4.5μg/mL Negative Positive
Ceftriaxone 0.8mg/mL Negative Positive
Meropenem 1.1mg/ml Negative Positive
Tobramycin 4ng/mL Negative Positive
Phenylephrine 20μg/mL Negative Positive
Oxymetazoline 0.1mg/mL Negative Positive
Beclomethasone 0.1mg/mL Negative Positive
Dexamethasone 2 mg/mL Negative Positive
Flunisolide 0.1mg/mL Negative Positive
Triamcinolone acetonide 10.5ng/mL Negative Positive
Budesonide 2.75ng/mL Negative Positive
Mometasone 10ng/mL Negative Positive
Fluticasone 55μg/mL Negative Positive
Histamine Hydrochloride 10ng/mL Negative Positive
Sodium chloride 5% Negative Positive

 Hook effect
Within the concentration of 3.4×105 TCID50/mL for cell culture medium of SARS-CoV-2 antigen, the test results of this product showed
no Hook effect.

WARNINGS AND PRECAUTIONS

1. The sample should be tested in the laboratory with certain conditions. All samples and materials in the testing process shall be handled
in accordance with the laboratory practice for infectious diseases.
2. The kit shall be stored in strict accordance with the conditions specified in this package insert. Please use it within the validity period.
3. Do not open the sealed pouch until you are ready to perform a test. The kit should be sealed and protected against moisture. If the foil
pouch is damaged or damp, stop using it immediately.
4. Specimen collection and detection should be performed accordance with the package insert strictly.

SYMBOLS
Key to symbols used:

Consult Instructions For Use Contains sufficient for < n> tests Manufacturer

In Vitro Diagnostic Medical Device Use-by Date Do Not Reuse

Store at 2-30℃ Catalogue number Batch code

EU Authorised Representative Date of manufacture Caution

Xiamen Wiz Biotech CO., LTD.

Address: 3-4 Floor, NO.16 Building, Bio-medical Workshop, 2030 Wengjiao Xi Road, Haicang District, Xiamen City, Fujian
Province, 361026, P.R. China
Tel:+86-592-6808278 Fax: +86-592-6808279

Wellkang Ltd
Address: 16 Castle St,Dover, Kent, CT16 1PW,England,UK