CE MSDS Nasopharyngeal Sample Antigen Self Test Kit 99.17% Accuracy

Rapid Test Kit SARS-CoV-2 Antigen Rapid Test Self Testing Antigen Rapid Test Kit

Intend Use

• The rapid test kit is intended for the qualitative detection of SARS-CoV-2 viral nucleocapsid antigens.
• The antigen test result can be used for early isolation of patients with suspected infection, but it cannot be used as diagnosis basis of SARS-CoV-2 infection.
• Further nucleic acid detection should be carried out for suspected population whose antigen test result is positive or negative.

Product Details

Test Principle

• Immunochromatography assay
• Detects SARS-CoV-2 nucleocapsid antigen in the samples with the help of the double antibody sandwich method.
• This complex “migrates” across the membrane and binds to the monoclonal antibody at the Test line (T).
• If there is virus antigen presence in the sample, it binds with the corresponding colloidal gold antibody.
• If the sample does not contain any antigen, then the complex cannot be formed and thus no reddish line forms in the Test line (T). Regardless of whether the sample contains antigen or not, a reddish line forms in the Control line (C).
• In the testing process this will creates a visible red line, you can accroding the red lin to judge the sample contain antigen or not.
• It need to be attention that regardless of whether the sample contains antigen or not, a reddish line forms in the Control line (C).

Product Feature

• High Accuracy,Specificity and Sensitivity
• Test result within 15 minutes
• 24 Months Shelf Life
• Nasal Swab available
• Easy to operate and requires no additional equipment
• Test at home

Main Components

• 1 Test Cassette
• 1 Sample Tube
• 1 Extraction Buffer
• 1 Swab
• 1 Instruction for use

Use Step

• Open the sealed pouch and remove the test casstette. Lay it face up on a clean, dry and flat surface.
• Unpack the sample extraction, add all of the sample extraction into the sample tube and then put the tube into tube stand.
• Gently, insert the entire absorbent tip of the swab (around 1.5 cm) into your nostril. Rotate walls of your nostril 5 times or more. Use the same swab to repeat steps in the other nostril.

• Insert the swab into the ssample tube with extraction buffer. Mix well. Mix well and squeeze the swab 10-15 times by compressing the walls of the tube against the swab. Roll the swab head against the inner wall of the tubes as you remove it.
• Close the cape of the sample tube. Add 3 full drops of the mixed solution vertically into the sample well(S) of the test cassette.
• Read the result 15-20minutes after adding the sample. Result got after 20 minutes is invalid.

Result Interpretation

• POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

• NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

• INVALID: If there is no Control line (C) or only a Test line (T) in the result window, the test did not run correctly and the results are not valid.

Virus Sources

Certificate

Labnovation Technologies, Inc. is an original manufacturer established in Shenzhen, China since 2001. We are dedicated in developing and manufacturing IVD instruments and reagents including HbA1c analyzer and reagents, rapid test reader & reagents, hematology reagents, clinical chemistry reagents, electrolyte reagents, wash solution and urine test reagents.
 

Labnovation products are developed in house, tested extensively in clinics and passed strict quality controls. All of our products are CE marked and approved by SFDA. In the past 15 years, our products have been exported to 110 different countries and used in 8000 hospitals worldwide. We provide both ready-to-use final products and bulk OEM reagents, including ready-to-use reagents, concentrated, and powder.

With an investment of 10% of our annual sales into R&D, we release new products every years. We win more and more domestic and international cooperation by company reputation and products quality while we actively take part in fairs like MEDICA,AACC, ARBA HEALTH and so on through which we are well-known by the companies in this field.