STORAGE AND EXPIRY TEST STEPS

Store as packaged in the sealed pouch at 2-30℃, avoid hot and Read the instruction manual thoroughly before testing. Leave the reagent and
SARS-CoV-2 Antigen Rapid Test Kit sunshine, dry place, valid for 12 months. Do not freeze. Some sample at room temperature for 30 minutes before use. Do not open the inner
(Immunochromatography) protective measures should be taken in hot summer and cold winter to packing of the test cassette until ready for testing.
avoid high temperature or freeze-thaw. Do not open the inner 1. Take out the test cassette from the sealed pouch, place it on a clean and level
PRODUCT NAME packaging until ready, it must be used in one hour if opened (Humidity surface with the sample port well up.
SARS-CoV-2 Antigen Rapid Test Kit
≤60%, Temp: 20℃-30℃). Please use immediately when the humidity 2. Apply 2 full drops of the treated sample (60μl-70μl) vertically into the sample
(Immunochromatography)
＞60%. well of the test cassette.
3. Observe the test results immediately within 15~20 minutes, the result is invalid
INTENDED USE over 20 minutes.
This rapid test kit is intended for the qualitative detection of SARS-CoV-2 infection
SAMPLE COLLECTION
By nasopharyngeal swab: The sampler gently holds the head of the
from patients. It is for professional use only. It is an aid in the diagnosis of the
person to be collected with one hand, holds the swab with the other
patients with suspected SARS-CoV-2 infection in conjunction with clinical
hand, sticks the swab to the nostril to enter, and slowly penetrates
presentation and results of other laboratory tests. Results from this test kit should
backwards along the bottom of the lower nasal passage, so as not to
not be used as the sole basis for diagnosis.
exert too much force to avoid traumatic hemorrhage. When the tip of
The test provides preliminary test results. Negative results do not preclude
the swab reaches the posterior wall of the nasopharynx cavity, gently
SARS-CoV-2 infection and should not be used as the sole basis for treatment or
rotate it for one week (in case of reflex cough, stop for a minute), and
other management decision.
then slowly take out the swab.
By oropharyngeal swab: The head of the person to be collected is
PRINCIPLE slightly tilted and his mouth is wide open, exposing the pharyngeal
This kit is an immunochromatography assay. According to the gold
tonsils on both sides. Wipe the swab across the root of the tongue. INTERPRETATION OF RESULTS
immunochromatographic test principle, double antibody sandwich method was POSITIVE: Two (2) distinct colored lines appear. One line should be in the
Wipe the pharyngeal tonsils on both sides of the person to be collected
used to detect SARS-CoV-2 antigen in the samples. When there is virus antigen control region (C) and the other line should be in the test region (T).
back and forth with a little force for at least 3 times, and then wipe up
presence in the sample, the antigen binds with the corresponding colloidal gold NEGATIVE: One (1) colored line appears in the control region(C). No apparent
and down the posterior pharyngeal wall for at least 3 times.
monoclonal antibody and the coated monoclonal antibody at the detection line to colored line appears in the test region (T). The negative result does not indicate
form a compound and then condenses into a red band, indicating a positive result. the absence of analytes in the sample, it only indicates the level of tested
If there is no antigen in the sample, complex cannot be formed at the detection SAMPLE TREATMENT
Add 550μl sample extraction into the sample tube, dip the swab after analytes in the sample is less than the minimum detection limit.
line, and no red band is shown, indicating negative result. INVALID: No colored lines appear, or control line fails to appear, indicating that
collecting the sample into the sample extraction liquid, fully immerse
Whether the sample contains antigen or not, the gold monoclonal antibody will the operator error or reagent failure. Verify the test procedure and repeat the
the tip of the swab, rotate and squeeze the swab 10 times, then pull
bind to the enveloped antibody at the quality control line, form a compound and test with a new testing device.
out the swab, and take the stranded liquid as the sample to test
condense into a red band.
cassette.

KIT COMPONENTS
20 Test cassettes
1 Sample extraction (2 vials for 20 tests)
20 Sample tubes
20 Swabs

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LIMITATIONS *95% CI (Confidence Interval)
1.This reagent is a qualitative detection reagent, which cannot determine the exact
Diagnostic sensitivity: 96.3% (89.4%-99.22%)
MANUFACTURER
content of antigen.
Diagnostic specificity: 97.3% (94.81%-98.84%) LABNOVATION TECHNOLOGIES, INC.
2.The test results of this reagent are only for the reference of clinicians and should
Total coincidence rate: 97.1% (94.88%-98.55%) Add.: 101 and 5th Floor, Building 1, No. 68, 18th Road, Guangming Hi-Tech
not be taken as the sole basis for clinical diagnosis and treatment. Clinical Park, Tangjia Community, Fenghuang Street, Guangming District, Shenzhen
management of patients should be considered in the light of their symptoms/signs, 518107, Guangdong, China
PRECAUTIONS
medical history, other laboratory tests and treatment responses. Tel: 0086-755-86368398 Fax: 0086-755-86368318
1. For IN VITRO diagnostic use only.
3. Restricted by antigen detection reagent method, the lowest detection limit Web: www.labnovation.com
2. Reagents should be used as soon as possible after opened. This E-mail: [email protected]
(sensitivity analysis) is generally lower than that of nucleic acid detection, so the
reagent cannot be reused for disposable.
researchers deal with negative result to give more attention, should be combined
3. The test device should remain in the sealed pouches until use. If EUROPEAN REPRESENTATIVE
with other test results comprehensive judgment, advice to doubt the negative
sealing problem happens, do not test. Don’t use after the expiration
result of nucleic acid detection or virus isolation culture identification method for MedNet EC-REP GmbH
date.
review. Borkstrasse 10, 48163 Muenster, Germany
4.All specimens and reagents should be considered potentially
4.False negative results may be caused by unreasonable sample collection, hazardous and handled in the same manner as an infectious agent after
transport and treatment, and low viral load in samples. use. INSTRUCTIONS OF SYMBOL

PERFORMANCE CHARACTERISTICS
The verification is carried out with enterprise reference and the results meet the
following requirements:
The national reference material of the new coronavirus antigen detection reagent
of the National Institutes for Food and Drug Control was used for verification, and
the results met the following requirements:
Conformance rate of negative reference products: National negative reference
materials (N1-N20) were tested, and the results were all negative, with a
coincidence rate of 100%.
Conformance rate of positive reference products: tested with national positive
reference products (P1-P8), the results are all positive, and the coincidence rate is
100%.
V1.0
Repeatability: The 10 test results of R1 and R2 should be positive, and the color
rendering is uniform.

Sensitivity and Specificity:

SARS-CoV-2 Antigen Nucleic Acid Test

Positive 77 8 85
Negative 3 292 295

TOTAL 80 300 380

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