SARS-CoV-2 Antigen Detection Kit (Latex immunochromatography)

SARS-CoV-2 Antigen Detection Kit (Latex immunochromatography)

Instructions for Use
SARS-CoV-2 Antigen Detection Kit(Latex immunochromatography)is a lateral flow immunoassay intended for the qualitative detection of nucleoprotein from SARS-CoV-2 innasal swabs，pharyngeal swabs，sputum，bronchoalveolar，lavage fluid. It is used by professionals as a test and provides a preliminary test result to aid in the diagnosis of infection with individuals suspected of COVID-19.
This test is only provided for use by clinical laboratories or to health care workers for point of care testing, and not for at home testing.
Results from antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. The diagnosis should be confirmed in combination with clinical symptoms or other conventional testing methods.

Test Principlce
This kit adopts Latex immunochromatography assay .
The test card contains:
1. mouse nucleoprotein monoclonal antibody and quality control antibody complex labelled with latex microspheres.
2. Nitrocellulose membranes immobilized with test lines (T line）and one quality control line (C line).
When an appropriate amount of sample is added to the sample well of the test card, the sample will move forward along the test card under capillary action.
If the sample contains an antigen of SARS-CoV-2, the antigen will bind to the latex microspheres labeled SARS-CoV-2 antibody, and the immune complex will be captured by the monoclonal anti-human antibody immobilized on the nitrocellulose membrane to form a red line , showing that the sample is positive for antigen.

Test Reagents
The nominal formula for each medium is as follows:

Reagents And Materials Provided
Materials Provided:

Or

Or

Note:One disposable device contains one swab and 0.5ml sample diluent.
Specification：1T/box,20T/box,25T/box,50T/box,100T/box

Materials Required But Not Provided
1.PPE such as gloves, masks, lab coats, and eye protection
2.Biohazard Waste Container
3.Tube holder

Shelf Life And Storage
1. The original packaging should be stored in a dry place at 2-30°C and protected from light.
2. The shelf life of the test kit is 1 year from date of manufacture. Refer to the product labels for stated expiration date.
3. After opening the inner package, the test card will become invalid due to moisture absorption, please use it within 1 hour.
4. The original packaging should be transported at 2-37℃ for 20 days.

Test Procedure
1. Open the packaging box, take out the inner package and let it equilibrate to room temperature.
2. Remove the test card from sealed pouch and use within 1 hour after opening.
3. Place the test card on a clean and level surface.

①Specimen from SARS-CoV-2 innasal swabs，pharyngeal swabs，sputum，bronchoalveolar，lavage fluid.	②drop in 500ul (about 9-10 drops ) Sample Diluent from the drop bottle to the tube.Place the patient swab sample into the Tube. Roll the swab at least 3 times while pressing the head against the bottom and side of the Tube.	③Roll the Swab head against the inside of the Tube as you remove it. Dispose of the used Swab in your biohazard waste.
④Fill the provided Small, Clear Disposable Plastic Dropper with patient sample from the tube or Put the lid on the dropper bottle.	⑤Drop 60-100ul sample (2-3 drops) into the test card.NOTE: Do not pour sample from the Tube.	⑥Read the result at 15 minutes.The result is valid within 15-20 minutes. It must be repeated

Or

①specimen from SARS-CoV-2 innasal swabs，pharyngeal swabs，sputum，bronchoalveolar，lavage，fluid.	②Break the inner safety core and squeeze the liquid into the bottom of the tube.	③Squeeze the tip of a swab to dilute the specimen
④Twisting the tail cap cover dripper	⑤Squeeze about 60-100ul(2-3drops) specimen diluent onto the reagent card	Read the result at 15 minutes.The result is valid within 15-20 minutes. It must be repeated

INTERPRETATION OF ASSAY RESULT
1. Negative:
If only the quality control line C appears, and the test lines T are not red, it indicates that no antigen is detected, and the result is negative. Due to the limitation of detection sensitivity, negative results may be caused by antigen concentrations lower than the analytical sensitivity of the product.
2. Positive:
If both the quality control line C and the test line T appear , it indicates that antigen is detected.Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a diagnosis is made.
3. Invalid:
If the quality control line C is not displayed, the test result is invalid regardless of whether there is a red test line, and it should be tested again.
Repeat the test using remaining sample or new sample, if results are not clear.
If the test repeated fail to produce a result, discontinue using the kit and contact the manufacture.