Antigen Rapid Test Cassette ( Nasal Swab), 25 tests/kit

1. Due to epidemic prevention supplies, please contact us for more details before place an order;2. MOQ: 2000 kits Antig

Contact Us To Purchase

1. Due to epidemic prevention supplies, please contact us for more details before place an order;

2. MOQ: 2000 kits 

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Antigen rapid tests
Ag rapid tests are useful fordetectingSARS-CoV-2antigens, most often nucleocapsid, produced by the replicating virus in respiratory secretions.
Based on the above principle, COVID-19 Antigen Rapid Test Cassettte (Nasal Swab), this link of product, is intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens from individuals who are suspected of COVID-19 by their healthcare provider.

Product Introduction

Catalog: ICOV5002

Packing Specification: 25 test/ box.

Storage Condition: Store as packaged in the sealed pouch at the temperature (4-30℃ or 40-86℉).

Period of Validity: 24 months.

Kit Size: 268*124*65mm.

Antigen Rapid Test Cassette ( Nasal Swab), 25 tests/kit(图2)


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For in vitro diagnostic use only.

[INTENDED USE]

The COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in nasal swab from individuals who are suspected of COVID-19 by their healthcare provider.

Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in nasal swab during the acute phase of infection. 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 results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary for patient management.

The COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is intended for use by medical professionals or trained operators who are proficient in performing lateral flow tests. The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation.

[SUMMARY]

The novel coronaviruses (SARS-CoV-2) belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

[PRINCIPLE]

The COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is a lateral flow immunoassay based on the principle of the double-antibody sandwich technique. SARS-CoV-2 nucleocapsid protein monoclonal antibody conjugated with color microparticles is used as detector and sprayed on conjugation pad. During the test, SARS-CoV-2 antigen in the specimen interacts with SARS-CoV-2 antibody conjugated with color microparticles making antigen-antibody labeled complex. This complex migrates on the membrane via capillary action until the test line, where it will be captured by the pre-coated SARS-CoV-2 nucleocapsid protein monoclonal antibody. A colored test line (T) would be visible in the result window if SARS-CoV-2 antigens are present in the specimen. Absence of the T line suggests a negative result. The control line (C) is used for procedural control, and should always appear if the test procedure is performed properly.

[WARNINGS AND PRECAUTIONS]

* For in vitro diagnostic use only.

* For healthcare professionals and individuals trained in point of care settings.

* 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.

* Do not use this product after the expiration date.

* Please read all the information in this leaflet before performing the test.

* The test cassette should remain in the sealed pouch until use.

* All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

* The used test cassette should be discarded according to federal, state and local regulations.

[COMPOSITION]

Materials Provided

* 25 Test Cassettes: each cassette with desiccant in individual foil pouch

* 25 Extraction Reagents: ampoule containing 0.3mL of extraction reagent

* 25 Sterilized Swabs: single use swab for specimen collection

* 25 Extraction Tubes

* 25 Dropper Tips

* 1 Work Station

* 1 Package Insert

Materials Required but not Provided

* Timer

[STORAGE AND STABILITY]

* Store as packaged in the sealed pouch at temperature (4-30℃ or 40-86℉). The kit is stable within the expiration date printed on the labeling.

* 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 labeling.

[SPECIMEN]

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 false results; therefore, training in specimen collection is highly recommended due to the importance of specimen quality to obtain accurate test results.

Acceptable specimen type for testing is a direct nasal swab specimen obtained by the dual nares collection method.

Prepare the extraction tube according to the Test Procedure and use the sterile swab provided in the kit for specimen collection.

Nasal Swab Specimen Collection

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1. Remove the swab from the package.

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2. Tilt patient's head back about 70°.

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3. While gently rotating the swab, insert swab about 2.5 cm (1 inch) into nostril until resistance is met at turbinates.

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4. Rotate the swab several times against nasal wall and repeat in other nostril using the same swab.

Specimen Transport and Storage

Do not return the swab to the original swab packaging. Freshly collected specimens should be processed as soon as possible, but no later than one hour after specimen collection.

[TEST PROCEDURE]

Note: Allow the test cassettes, reagents and specimens to equilibrate to room temperature (15-30℃ or 59-86℉) prior to testing.

1. Put an extraction tube on the work station.

2. Unscrew the lid of an extraction reagent. Add all of the extraction reagent into the extraction tube.

3. Sampling refers to section ‘Specimen Collection’.

4. Insert the nasal swab specimen into the extraction tube which contains extraction reagent. Roll the swab at least 5 times while pressing the head against the bottom and side of the extraction tube. Leave the nasal swab in the extraction tube for one minute.

5. Remove the nasal swab while squeezing the sides of the tube to extract the liquid from the swab. The extracted solution will be used as test sample.

6. Cover the extraction tube with a dropper tip tightly.

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7. Remove the test cassette from the sealed pouch.

8. Reverse the specimen extraction tube, holding the tube upright, transfer 3 drops (approximately 100 μL) slowly to the specimen well (S) of the test cassette, then start the timer.

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

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