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COVID-19 Antigen Rapid Test Kit

The COVID-19 Antigen Rapid Test Kit is a chromatographic immunoassay intended for the qualitative detection of SARS-CoV-2 antigen in nasopharyngeal swab and oropharyngeal swab specimens. It is suitable for early auxiliary diagnosis of SARS-CoV-2 infection

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Product Detail

COVID-19 Antigen Rapid Test Kit

Product Name

COVID-19 Antigen Rapid Test Kit

Specification

1 test/kit, 40tests/kit

Intended Use

The COVID-19 Antigen Rapid Test Kit is a chromatographic immunoassay intended for the qualitative detection of SARS-CoV-2 antigen in nasopharyngeal swab and oropharyngeal swab specimens. It is suitable for early auxiliary diagnosis of SARS-CoV-2 infection. The reagent only provides preliminary screening test results, only for clinical reference, not as the basis for confirming diagnosis or excluding infection.

Principle

COVID-19 Antigen Rapid Test Kit has two pre-coated lines, "C" Control line, "T" Test line on the surface of the nitrocellulose membrane. Both the control line and test line in the result window are not visible before applying any specimens. Mouse monoclonal anti-SARS-CoV-2 antibody is coated on the test line region and rabbit monoclonal anti-chicken IgY antibody is coated on the control line region. Mouse monoclonal anti-SARS-CoV-2 antibody conjugated with color particles are used as detectors for SARS-CoV-2 antigen device. During the test, SARS-CoV-2 antigen in the specimen interact with monoclonal anti-SARS-CoV-2 antibody conjugated with color particles making antigen-antibody color particle complex. This complex migrates on the membrane via capillary action until the test line, where it will be captured by the mouse monoclonal anti-SARS-CoV-2 antibody. A colored test line would be visible in the result window if SARS-CoV-2 antigens are present in the specimen. The intensity of colored test line will vary depending upon the amount of SARS-CoV-2 antigen present in the specimen. If SARS-CoV-2 antigens are not present in the specimen, then no color appears in the test line. The control line is used for procedural control, and should always appear if the test procedure is performed properly and the test reagents of the control line are working.

Warnings and Precautions

1. Please read all the information in this lalet before performing the test.

2.Do not re-use the test kit.

3.Do not use the test kit if the pouch is damaged or the seal is broken.

4.Do not use after the expiration date.

5.Do not use the extraction diluent of another lot.

6.Do not smoke, drink or eat while handling specimen.

7. Wear personal protective equipment, such as gloves and lab coats when handling kit reagents. Wash hands thoroughly after the tests are done.

8.Clean up spills thoroughly using an appropriate disinfectant.

9.Handle all specimens as if they contain infectious agents.

10.Observe established precautions against microbiological hazards throughout testing procedures.

11.Dispose of all specimens and materials used to perform the test as biohazard waste. Laboratory chemical and biohazard wastes must be handled and discarded in accordance with all local, state, and national regulations.

Components

Component Name

Quantity(specification)

1 Test/Kit

40 Test/Kit

Test Card

anti-SARS-CoV-2 nuclenocapsid protein monoclonal antibody and rabbit monoclonal anti-chicken IgY antibody coated on the nitrocellulose membrane

Color particles -labeled mouse monoclonal anti-SARS-CoV-2 antibody and chicken IgY antibody fixed on glass fiber conjugate pad

Absorbent paper

PVC board

Plastic clip

Desiccant

1 Test

40 Tests

Extraction Diluent

1 set

4 bottles

Extraction Tube

40 sets

Sterile Swab

1 piece

40 pieces

Manual

1 serving

1 serving

 

Storage Conditions

Store the kit at 2-30°C / 36-86°F out of direct sunlight. Kit materials are stable until the expiration date printed on the label. Do not freeze the kit.

Once open the pouch, the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration.

The LOT and the expiration date were printed on the label.

Specimen Requirements

Specimens obtained early during symptom onset will contain the highest viral titers; specimens obtained after five days of symptoms are more likely to produce negative results when compared to an RT-PCR assay. Inadequate specimen collection, improper specimen handling and/or transport may yield a falsely negative result; therefore, training in specimen collection is highly recommended due to the importance of specimen quality for generating accurate test results.

Specimen Collection

Nasopharyngeal Swab Specimen: Insert sterile sample swab through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. Swab should reach depth equal to distance from  nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions. Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the swab tip is saturated with fluid from the first collection. If a deviated septum or blockage creates difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril.

Oropharyngeal Swab Specimen: Insert swab into the nosterior oharvnx and tonsillar areas. Rub swab over both tonsillar oillars and posterior oropharynx and avoid touching the tongue, teeth, and gums.

 

SPECIMEN TRANSPORT AND STORAGE

Specimen should be tested as soon as possible after collection. Specimens may be stored at room temperature for up to 1 hours or at 2-8°C/ 36-46°F for up to 4 hours prior to testing.

Test Procedures

Note: Allow the test device and specimens to equilibrate to temperature(15-30 or 59-86°F)prior to testing.

SPECIMEN TRANSPORT AND STORAGE

Specimen should be tested as soon as possible after collection. Specimens may be stored at room temperature for up to 1 hours or at 2-8°C/ 36-46°F for up to 4 hours prior to testing.

Test Procedures

Note: Allow the test device and specimens to equilibrate to temperature(15-30 or 59-86°F)prior to testing.

1Procedures for 1 Test/Kit

A. Puncture the sealing film of the extraction tube with the tip of the dripper.

B. Insert the sampling swab into the extraction tube, press the outer wall of the tube with one hand to press the sampling swab, and twist the swab at least 5- 10 times with the other hand.

C. Pull the swab head away from the dilution liquid surface, squeeze out the liquid, to make the solution in the tube as the test specimen, then cover the tube head.

D. Take out the test card from the aluminum foil bag and place it flat on the desktop. Add 2 drops of specimen from the extraction tube to the specimen hole of the test card.

E. Timing, judge the test result after 15~30 minutes.

Do not read test results after 30 minutes. It may give false results.



Procedures for 40 Tests/Kit

1. Open the diluent bottle and add 10 drops of diluent to the extraction tube.

2. Insert the sampling swab into the extraction tube, press the outer wall of the tube with one hand to press the sampling swab, and twist the swab at least 5-10 times with the other hand.

3. Pull the swab head away from the dilution liquid surface, squeeze out the liquid, to make the solution in the tube as the test specimen, then cover the tube head.

4. Take out the test card from the aluminum foil bag and place it flat on the desktop. Add 2 drops of specimen from the extraction tube to the specimen hole of the test card.

5. Timing, judge the test result after 15-30 minutes.

Do not read test results after 30 minutes. It may give false results.

 

 

 

 


Interpretation of Results


Positive: Two lines appear. One colored line should be in the control region (C), and another apparent colored line adjacent should be in the test region (T). Positive results indicate the presence of viral antigens but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

Negative: One colored line appears in the control region (C). No line appears in the test region (T). Negative results are presumptive. Negative test results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions, including infection control decisions, particularly in the presence of clinical signs and symptoms consistent with COVID-19, or in those who have been in contact with the virus. It is recommended that these results be confirmed by a molecular testing method, if necessary, for patient management.

Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test card. If the problem persists, discontinue using the lot immediately and contact your local distributor.

Limitations

1.For in vitro diagnostic use only.

2.For healthcare professionals and professionals at point of care sites. Do not use this product as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status of COVID-19. A physician must interpret the results in conjunction with the patient's history, physical findings, and other diagnostic procedures.

3. The test procedure, precautions and interpretation of results for this test must be followed strictly when testing.

4. The test should be used for the detection of SARS-CoV-2 antigen in nasopharyngeal swab and oropharyngeal swab specimens.

5.Proper specimen collection is critical, and failure to follow the procedure may give inaccurate results. Improper specimen collection, improper specimen storage or repeated freezing and thawing of specimens can lead to inaccurate results.




COVID-19 Antigen Rapid Test Kit
The COVID-19 Antigen Rapid Test Kit is a chromatographic immunoassay intended for the qualitative detection of SARS-CoV-2 antigen in nasopharyngeal swab and oropharyngeal swab specimens. It is suitable for early auxiliary diagnosis of SARS-CoV-2 infection
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E-Mail:sales@runkunmed.com;
Location: No: 380 Baling East Road Yueyang Hunan China
Tel:+86-730-8725981

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