SARS-CoV-2 Antigen Rapid Test Kit Nasal Swab Virus Antigen Rapid Diagnostic CE Certificated Simple Operation

Intend Use

This rapid test kit is intended for the qualitative detection of SARS-CoV-2 viral nucleocapsid antigens from human anterior nasal of secretion from individuals suspected of COVID-19.

Diagnostic Accuracy

Product Feature

• Simple to use
• Convenient, no devices required
• Rapid, get result in 15 minutes
• Stable, with high accuracy
• Inexpensive, cost-efficiency

Main Components

• Test Cassette
• Sample tube with prefilled sample extraction buffer
• Swab
• Instruction for use

Use Step

• Wash and dry hands before you begin to perform the test.

• Please check the expiration date printed on the BOX. Do not use it beyond the expiration date. Lay all the supplied materials on a clean, dry and flat surface.

• Take sample tube with sample extraction buffer and remove the sealed film of the sample tube. Then place the tube in the tube stand (The tube stand is the outer box, see below.)

• Open the sealed pouch and remove the test cassette. Lay it face up on a clean, dry and flat surface.

• Remove the swab from the container, being careful NOT to touch the soft end, which is the absorbent tip.

• Gently, insert the entire absorbent tip of the swab (around 1.5 cm) into your nostril. Slowly, rotate the swab in a circular against the inside walls of your nostril 5 times or more. Be sure to collect any nasal drainage that maybe present on the swab. Gently remove the swab. Use the same swab to repeat steps in the other nostril and slowly, take out the swab.

• Insert the swab into the sample tube with prefilled extraction buffer. 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. Try to release as much liquid as possible. Dispose of the used swab in accordance with applicable local regulations.

• Close the cap 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 15-20 minutes 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

Applicable

• Screen for employees or schools or other mass screening

• Regular home testing

• Individuals who frequently work in high-risk environments or who do not have a fixed place of work

• Busy office workers who want to check themselves in a short time in order to feel at ease

Other Information

• Do not use the test if the packaging is damaged. Do not use broken test components.
• All test components are only intended to be used for this test. Do not reuse the test or test components.
• The test should be carried out immediately or within one hour after opening the foil pouch (10°C -30°C, humidity <60%).
• Samples be processed as soon as possible after sample collection. If the test cannot be performed immediately, the sample should be stored in a sealed state, stored at 2~8°C for 8 hours, and stored below -20°C for 1 month. Long-term storage is not recommended.

Certificate

• CE cetificated
• Iceland registration
• Philipines certificated
• Germant BfArm List

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.