Covid-19 Antigen Test Kit

INTENDED USE

This product is used for in vitro diagnostic test for the qualitative detection of the antigen of SARS-CoV-2 (novel coronavirus) in human nasopharyngeal and/or oropharyngeal swabs. This instruction for use (IFU) must be read and followed carefully prior to use. The reliability of assay results cannot be guaranteed in case of any discrepancies from the instructions for use.

PRINCIPLE

This kit by immune chromatography test, the sample will be under the capillary action to move forward along the test cassette. If the sample contains SARS-CoV-2 antigens, these antigens will be with colloidal gold labeled coronavirus monoclonal antibody. This immune complex will be membrane fixed by coronavirus monoclonal antibody capture, form the purple line which reveals a positive result. If the line does not show any color, the negative result will be displayed. The test cassette also contains a quality control line C, which shall appear in purple regardless of whether there is a detection line.

PRODUCT CONTENTS

Test cassette contains SARS-CoV-2 antibody-coated in the test region and Goat anti-Chicken IgY polyclonal antibody-coated in the control region on the membrane. The test cassette consists of the SARS-CoV-2 antibody, Chicken IgY, and Colloidal gold conjugate coated in the conjugate pad. The specimen extraction solution is a phosphate solution.

WARNINGS AND PRECAUTIONS

The test is a disposable in vitro diagnostic test, which is only used for the detection of human nasopharyngeal swab, or oropharyngeal swabspecimens. The application should be carried out strictly according tothe instructions. Do not use expired and damaged products.

The test should be kept away from moisture. Tests or specimens stored

at low temperatures should be balanced to room temperature beforethey can be used.

Tests should be used as quickly as possible after removal from aluminium pouches, to avoid exposure to air for too long and thepossibility of affecting test results due to humidity.

Do not use specimens that have been placed for too long or contaminated. Please operate in accordance with the laboratory testing procedures for infectious diseases. Waste after use should be treated in accordance with infectious substances and should be discarded. Discard used test tubes and test device in suitable biohazards waste container.

Use a clean swab for every specimen to avoid cross-contamination.

Incorrect operation may affect the accuracy of the results, such as insufficient specimen mixing, insufficient amount, inaccurate detectiontime, etc.

The components in different batches of the kit cannot be mixed and used.

Recommend using "fresh specimen" for testing, if testing not availableon the same day, specimen collected by swab should be kept in minus20 ℃ for storage and transfer in dry condition.

There should be appropriate biosafety assurance procedures for those substances containing and suspected sources of infection. The followingare relevant considerations:

•Handle specimens and tests with gloves. •Do not suck specimens with your mouth. •Do not smoke, eat, drink, cosmetic or handle contact lenses whilehandling these items. •Disinfect the spilled specimen or Test with disinfectant. •Disinfect and treat all specimens, Tests, and potential pollutants in accordance with relevant local regulations. •Each component of the Test remains stable until the expiry date underproper handling and storage conditions. Do not use the expired Test kit.

Documents (PDF)

CATALOG	USER GUIDE
Türkçe	Türkçe
English	English
Deutsche	Deutsche