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CE Disposable Nasal Swab Influenza AB Test Kit For IN VITRO Diagnostic

Labnovation Technologies, Inc.
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Address: 101 and 5th Floor, Building 1, No. 68,18th Road, Guangming Hi-Tech Park, Tangjia Community, Fenghuang Street, Guangming District, Shenzhen 518107 ,China

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Labnovation Technologies, Inc.

CE Disposable Nasal Swab Influenza AB Test Kit For IN VITRO Diagnostic

Country/Region china
City & Province shenzhen
Categories Cotton Pad
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Product Details

Rapid Test Kit SARS-CoV-2 Antigen & Influenza A/B Rapid Test Kit 20 Tests/Kit High Accuracy Rapid Test Kit

Intended Use

SARS-CoV-2 Antigen & Influenza A/B Rapid Test Kit provides a simple, rapid detection as an aid in the differential diagnosis of SARS-CoV-2 Antigen and Influenza A & B using nasal swab specimens. This esay- to - use product and rapid results can be used for the screening of early infected patients and asymptomatic patients. It is also effective supplement for nucleic acid detection.

 

Specification

Item

Antigen test strip performance

against PCR

Influenza A test strip performance against PCRInfluenza B test strip performance against PCR
Sensitivity98.03%93.3%97.00%
Specificity100.00%91.00%96.40%

Main Components

  • 20 Test cassettes
  • 2 Sample extraction buffers
  • 20 Sample tubes
  • 20 Swabs
  • 1 Tube Stand
  • 1 Instruction Manual

 

Use  Step

  • Take out the test cassette from the sealed pouch, place it on a clean and level surface with the sample port well up.
  • Apply 2 full drops of the treated sample (60μl-70μl) vertically into each of the two sample wells of the test cassette.

  • Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.

 

Interpretation Of Result

  • POSITIVE: The presence of T (T on nCoV /A or B on Flu) and C lines within the reaction window indicate a positive result on SARS-CoV-2 or Flu A and/or B infection or co-infection.

  • NEGATIVE: One colored line appears in the control region(C). No apparent colored line appears in the test region (T on nCoV /A or B on Flu). The negative result does not indicate the absence of analytes in the sample, it only indicates the level of tested analytes in the sample is less than the minimum detection limit

  • INVALID: No colored lines appear, or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.

 

Feature

  • CE marked
  • Nasal swab sample 
  • 3 items in one cassette
  • Result in 15 minutes

 

PRECAUTIONS

 

  •  For IN VITRO diagnostic use only.
  •  Reagents should be used as soon as possible after opened. This reagent cannot be reused for disposable.
  •  The test device should remain in the sealed pouches until use. If sealing problem happens, do not test. Don’t use after the expiration date.
  •  All specimens and reagents should be considered potentially hazardous and handled in the same manner as an infectious agent after use.

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