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SARS-CoV-2 Antigen Rapid Test Cassette

The World Health Organization (WHO) guides that antigen-detecting rapid diagnostic tests (Ag-RDRs) can offer a faster and less expensive way to diagnose active SARS-CoV-2 infection than nucleic acid amplification tests (NAATs), and WHO also recommends that Ag-RDTs meeting minimum performance requirements can be used for primary case detection, contact tracing, during outbreak investigations and monitor trends of disease incidence in communities.


Product Detail

This cassette is intended for the qualitative detection of 2019-nCoV (SARS-CoV-2) nucleocapsid antigens from multiple sample types. 

SARS-CoV-2 Antigen Rapid Test Cassette (15)
SARS-CoV-2 Antigen Rapid Test Cassette (17)

Features

● Efficient: get the result within 15 minutes

● Accuracy: with 95.83% sensitivity and 99.99% specificity.

● Easy to use: 3 steps get the results without extra equipment.

Technical Parameter

Applicable Scope

Professionals

Self-testing

Packing Specification

1 test/kit, 5 tests/kit, 10 tests/kits, 20 tests/kit, 25 tests/kit, 30 tests/kit, 40 tests/kit, 50 tests/kit, 60 tests/kit

1 test/kit, 5 tests/kit, 10 tests/kits, 20 tests/kit, 30 tests/kit

Storage Conditions and Expiration Date

Stored at 2~30℃, and is valid provisionally for 24 months. Once open the pouch, the test should be used within 30min.

Stored at 2-30℃, and is valid for 12 months. Once open the pouch, the test should be used within

30min.

CATALOGUE NUMBER

CG9011-1T-O, CG9011-1T-N, CG9011-5T-O, CG9011-5T-N, CG9011-10T-O, CG9011-10T-N, CG9011-20T-O, CG9011-20T-N, CG9011-25T-O, CG9011-25T-N, CG9011-30T-O, CG9011-30T-N, CG9011-40T-O, CG9011-40T-N, CG9011-50T-O, CG9011-50T-N, CG9011-60T-O, CG9011-60T-N.

CG9011(S)-1T-AN, CG9011(S)-5T-AN, CG9011(S)-10T-AN, CG9011(S)-20T-AN, CG9011(S)-30T-AN.

Certification

CE1434

Turnaround time

15~20 mins

Specimens

Nasopharyngeal Swabs, Oropharyngeal Swabs, Anterior Nasal Swab and Saliva.

Stability

Stable for 24 months at 2°C to 30°C

Clinical Evaluation

1) Nasopharyngeal Swab

The clinical performance of the 2019-nCoV Antigen Rapid Test Cassette was determined by testing 128 positive and 144 negative samples for 2019-nCoV antigen with a sensitivity of 94.53% (95% CI: 89.06%-97.77%) and a specificity of 100% (95% CI: 97.47%-100%) determined by Nasopharyngeal Swab Clinical specimens were determined to be positive or negative using an RT-PCR reference method.

SARS-CoV-2 Antigen Rapid Test Cassette (1)

2) Oropharyngeal Swab:

The clinical performance of the 2019-nCoV Antigen Rapid Test Cassette was determined by testing 118 positive and 118 negative samples for 2019-nCoV antigen with a sensitivity of 91.53% (95% CI: 84.97%-95.86%) and a specificity of 100% (95% CI: 96.92%-100%) determined by Oropharyngeal Swab Clinical specimens were determined to be positive or negative using an RT-PCR reference method.

SARS-CoV-2 Antigen Rapid Test Cassette (2)

Test Procedure

Professionals

SARS-CoV-2 Antigen Rapid Test Cassette (3)

1. Samples storage

1) Open the extraction reagent and drop all the liquid into the extraction tube.

2) Insert the swab into the extraction tube which contains the extraction reagent. Rotate the swab inside the tube using a circular motion to roll the side of the extraction tube so that the solution is expressed and reabsorbed from the swab.

3) Pinch the extraction tube with fingers and elute the liquid on the swab as far as possible into the extraction reagent, then pull out the swab. The extracted solution will be used as test specimen.

4) Buckle the dripper. 

2. Samples testing

1) Remove the test cassette from the sealed pouch.

2) Reverse the specimen extraction tube, holding the specimen extraction tube upright, add 3 drops (about 90μL) of the sample to be tested into each sample hole, then start the timer.

3) Wait for colored lines to appear. Interpret the test results at 15 minutes. Do not read results after 20 minutes.

SARS-CoV-2 Antigen Rapid Test Cassette (4)

Self-testing

SARS-CoV-2 Antigen Rapid Test Cassette (5)

Bring the test kit to room temperature for 15 minutes before testing, put the extraction tube into the external packaging box “Extraction Tube Stand Area”, open the extraction reagent and drop all the liquid into the extraction tube.

Applicable samples: Don’t take antibiotics 1 day before the nasal swab is collected; don’t use disinfectant to clean the nose or smear the nasal cavity 1 day before the nasal swab is collected; don’t smoke at least 30 minutes before collection.

SARS-CoV-2 Antigen Rapid Test Cassette (6)

Put the soft tip of the swab into one nostril. The swab tip should be inserted no less than 2.5 cm (1 inch) from the edge of the nostril (For children younger than 14 years old, it is recommended that the swab tip should be inserted no more than 1.5 cm (0.6 inches) from the edge of the nostril), please do not put the swab deep to maximum 3.5 cm. Roll swab at least 3 times along the mucosa inside the nostril. Leave swab in the nostril for several seconds. Using the same swab, repeat this process for the other nostril. Withdraw swab from the nasal cavity. Caution: This may feel uncomfortable. Do not insert the swab any deeper if you feel strong resistance or pain.

SARS-CoV-2 Antigen Rapid Test Cassette (7)

Insert the swab into the extraction tube which contains the extraction reagent. Rotate the swab inside the tube using a circular motion to roll the side of the extraction tube so that the solution is expressed and reabsorbed from the swab. Pinch the extraction tube with fingers and elute the liquid on the swab as far as possible into the extraction reagent, then pull out the swab. The extracted solution will be used as test specimen.

SARS-CoV-2 Antigen Rapid Test Cassette (8)

Buckle the dripper.

SARS-CoV-2 Antigen Rapid Test Cassette (9)

Lay the cassette horizontally on a flat surface, reverse the specimen extraction tube, holding the specimen extraction tube upright, add 3 drops (about 90μL) of the sample to be tested into the sample hole(area S), then start the timer. Do not disturb during the test.

SARS-CoV-2 Antigen Rapid Test Cassette (10)

Wait for 15 minutes to read. Do not read results after 20 minutes.

SARS-CoV-2 Antigen Rapid Test Cassette (11)

FAQ

How does this kit work?

SARS-CoV-2 Antigen Rapid Test Cassette is based on the specific antibody-antigen reaction and immunoanalysis technology to detect SARS-CoV-2 antigen from anterior nasal swab specimens. During testing, a specimen migrates upward by capillary action. The SARS-CoV-2 antigens if present in the specimen will bind to the antibody conjugates. The immune complex is then captured on the membrane by the pre-coated SARS-CoV-2 nucleocapsid protein monoclonal antibody, and a visible red colored line will show up in the test line region indicating a positive result. In the absence of SARS-CoV-2 antigens, a red colored line will not form in the test line region indicating a negative result.

SARS-CoV-2 Antigen Rapid Test Cassette (12)

What kind of situation should we purchase this kit?

How many test results can we get? What do they mean? What should we do when we get the results?

They are 3 results we might get: Positive (with C & T line); Negative (with C line, without T line); and Invalid (without C line).

SARS-CoV-2 Antigen Rapid Test Cassette (15)

1. If the test result is positive:

-There is currently a suspicion of a COVID-19 infection;

-Contact your doctor / general practitioner or the local health department immediately;

-Please follow local guidelines for self-isolation;

-Follow-up diagnostic procedure in accordance with local requirements will be required to confirm infection.

2. If the test result is negative:

-Continue to comply with all applicable rules regarding contact with others and protective measures;

-There may be an infection even if the test is negative;

-If you have symptoms similar to COVID-19 infection, repeat the test after 1 - 2 days, as the SARS-CoV-2 cannot be precisely detected in all phases of an infection.

3. If the test result is invalid:

Possibly caused by incorrect test execution;

Repeat the test;

If the test results remain invalid, contact your doctor or COVID-19 test center.

 

Are the test results reliable?

Yes, it is reliable. This way had recommended by the WHO (Word Health Organization).

Also you can check the clinical data in this page.

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How many ways can we detect whether we had infected with the COVID-19/ SARS-CoV-2

They are 2 ways we can detected this situations: NAAT and Antigen.

SARS-CoV-2 Antigen Rapid Test Cassette (16)

 (Comes from CDC of Los Angeles)


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