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COVID-19 Antigen Rapid Test Cassette
For the qualitative detection of SARS-CoV-2 antigen in human throat swab or nasal swab
COVID-19 Antigen Rapid Test Cassette is for in vitro qualitative detection of specific antigens to SARS-CoV-2 present in human
throat or nasal cavity. It cannot be used as the basis for the diagnosis and exclusion of COVID-19.
This reagent is used to detect cases with suspected symptoms of COVID-19 within 7 days. If suspected symptoms are more than
7 days, it is recommended to test with COVID-19 antibodies or nucleic acid reagents.
The main clinical symptoms of COVID-19 are: Fever, dry cough, fatigue, a few patients will have stuffy nose, runny nose and
This kit uses double antibody sandwich immunoassay to detect specific antigens to SARS-CoV-2 in human throat or nasal cavity.
The membrane was precoated with SARS-CoV-2 specific antibody on the test zone and goat anti mouse IgG antibody on the
control zone. During the test, the specimen is allowed to react with SARS-CoV-2 specific antibody-colloidal gold particles
conjugate, which was predried on the test. The conjugate binds to the SARS-CoV-2 forming an antibody~antigen complex. The
complex moves forward on the membrane by the capillary action, then the complex is captured by specific antibody to
SARS-CoV-2 on the test zone to produce a visual red color line. The color of line is positive correlated with the amount of
SARS-CoV-2 in specimen.
Regardless of the presence of SARS-CoV-2, as the mixture continues to move across the membrane to the control zone, the
complex is captured by immobilized goat anti mouse IgG antibody to form a distinct red line.
REAGENTS AND MATERIALS PROVIDED
MATERIALS REQUIRED BUT NOT PROVIDED
1. Timer or stopwatch
2. Biohazard disposal container
3. Disposable gloves
4. Disposable sampling swab
For Medical Professional and In Vitro Diagnostic use ONLY
Read the package insert completely before use. It is very important that the correct procedure is followed. Fail to add the patient
sample may lead to a false result.
1. This product is an in vitro diagnostic reagent to qualitatively detect the SARS-CoV-2 antigen in human throat or nasal cavity.
2. The reagent may cause false negative results in COVID-19 patients with asymptomatic infection.
3. Do not use the test if the pouch is damaged or the seal is broken.
4. Do not modify the test procedure.
5. Do not touch the reaction zone of the reagent.
6. Each test is for single use only.
7. Make sure the test is not expired (EXP Date is indicated on the kit box).
8. All the waste and specimen should be treated in case of transmitting disease and must be properly disinfected (autoclaving is
preferred) before disposal.
9. Always interpret the results under good light conditions to avoid misreading of the results.
10. Different batch of product components cannot be mixed.
11. If desiccant bag is not present in the pouch, DO NOT USE the test.
12. Always add accurate volume of specimen by following the instruction.
13. The test cassette must be used directly after unsealing. It is not allowed to divide it for use.
14. If the reagent is stored in refrigerator, it should be restored to room temperature before testing.
15. Observe the result in 15~20 minutes. Interpret the test result after 20 minutes may cause false result.
COVID-19 Antigen Rapid Test Cassette should be stored in dark place at 2~30°C for 24 months from the date of manufacture.
Keep the test cassette in sealed pouch until use. Once you have taken the test cassette out of the pouch, use it immediately. Do
not use the test beyond the indicated expiration date.
1. Throat Swab Sample
Take a disposable sampling swab out, insert it into the throat of
the patient. Use the swab to gently wipe the pharyngeal tonsils
on both sides of the patient for at least 3 times, and then wipe
them on the posterior pharyngeal wall for at least 3times.
Withdraw the swab from the throat.
2. Nasal Swab Sample
Take a disposable sampling swab out, insert it into the nostril
of the patient. Carefully insert the swab into the nostril. Gently
rotating, pushing the swab until meet resistance at the level of
the turbinates (less than one inch into the nostril).
Rotate the swab several times against the nasal wall then remove it from the nostril.
Samples should be tested as soon as possible after collection. Throat or nasal swabs are stable for up to 24 hours at 2~8°C.
SWAB PREPARATION (THROAT / NASAL)
1. Remove the pointed nozzle cap out of the sample collection tube. Twist and open the sample preservation solution tube, then
add the sample extraction solution into the sample collection tube.
2. Insert the patient swab into the sample collection tube. While squeezing the buffer tube, stir the swab more than 5 times.
3. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
4. Press the pointed nozzle cap tightly onto the tube.
1. All clinical samples must be at room temperature before beginning the assay.
2. Open the package, the pouch should be sealed well. If the test reagent store in the refrigerator, it should be restored to room
temperature. Then open the pouch and take out the test cassette, place it on the platform.
3. Add 2 drops of patient sample extraction solution which from the tube into S Well, Observe the result in 15～20 minutes,
interpret the test result after 20 minutes may cause false result.
INTERPRETATION OF RESULTS
1. Positive: One color line in the control zone (C) and one color line in the test zone (T). This indicates that the sample contains
2. Negative: Only one color line in the control zone (C). This indicates that no SARS-CoV-2 antigen has been detected.
3. Invalid: If no color line appears in the control zone (C), the test is invalid. Discard the test cassette and perform with new
COVID-19 Antigen Rapid Test Cassette has a built-in procedural control that demonstrates assay validity. A color line appeared
on the control zone (C) indicates that the test runs correctly.
1. The kit is only used to detect human throat swab or nasal swab.
2. The accuracy of the test depends on the process of sample collection. Improper sample collection, improper sample
storage or repeated freezing and thawing of samples will affect the test results.
3. The test results of this reagent are for clinical reference only and should not be used as the sole basis for clinical
diagnosis and treatment. The clinical management of the patient should be considered in combination with other
laboratory tests of the patient's symptoms/signs history and treatment response.
1. Negative reference sample coincidence rate: 10 negative enterprise reference samples were tested and the
results were all negative.
2. Positive reference sample coincidence rate: 5 antigen positive enterprise reference samples were tested and the
results were all positive.
3. Minimum detectability:
3.1 3 limited detection of enterprise reference samples were used for testing, repeated 3 times, L1 should be negative,
L2 and L3 should be positive.
3.2 The minimum detectability of this product for the SARS-CoV-2 virus strain is no more than 1.25×103.2TCID50/mL.
4. Intra-lot repeatability: Parallel determination of enterprise repeatable reference samples, each repeated 10 times,
R1 should be negative, R2 and R3 should be positive.
5. Inter-lot repeatability: Parallel determination of enterprise repeatable reference samples with 3 batches of
reagents, each batch repeated 10 times. With 3 batches of reagents, R1 should be negative, R2 and R3 should be
6. Interfering substances: α - interferon, zanamivir, ribavirin, ritonavir, pramivir, lopinavir, abidol, levofloxacin,
azithromycin, ceftriaxone, meropenem, tobramycin have no effect on the test results of this product.
7. Cross reaction: There was no cross-reaction with potential cross-reactive substances.
Product disclaimer: This product has been manufactured under strict GMP regulation to ensure the diagnostic accuracy
of the test. It is out of control of the manufacture when the test is performed in diverse environment and by diverse group
of individuals that may affect the results to a certain degree.
Note: The manufacturer, the distributor, or its associates will not be liable for any losses, claims, liability, costs or damages,
whether direct or indirect or consequential arising out of or related to an incorrect diagnosis, whether a positive or negative
by use of this product.
Contact Person: Ms. Anna Lee