Type: | IVD Reagent |
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Quality Certification: | CE;ISO13485 |
Transport Package: | 50*34.5*38cm 12.5kg 1000PCS/CTN |
Specification: | 25pcs/box |
Trademark: | testsealabs |
Origin: | Hangzhou |
Samples: |
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Customization: |
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Suppliers with verified business licenses
item
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value
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Place of Origin
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China
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Brand Name
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testsealabs
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Model Number
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Influenza |
Power Source
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Manual
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Warranty
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2 years
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After-sale Service
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Online technical support
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Power Supply Mode
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Plug-in
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Material
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Plastic
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Shelf Life
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2 years
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Quality Certification
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CE/ ISO9001/ ISO13485 |
Instrument classification
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Class II
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Safety standard
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GB15979-2002
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Testsealabs Disease Influenza A+B Rapid Test Kit(Nasal Swab)
Testsea Flu A + Flu B one step combo card test is a colored chromatographic immunoassay for the simultaneous qualitative detection of Influenza type A and Influenza type B from nasopharyngeal swab samples from patients suspected of Influenza A and/or Influenza B infection.
Detection for: Influenza A and B antigens in nasal swab or throat swab or nasal aspirate specimens
Reading time:8minutes
Relative Sensitivity: TypeA:87.2%; TypeB:92.5%;
Relative Specificity: TypeA:94.5%; TypeB:97.5%
Accuracy: TypeA:92.8%;TypeB:96.7%
Allow the test specimen, extraction buffer to equilibrate to room temperature(15-30C) prior to testing,
1.Remove the Flu A/B test cassette from the sealed foil pouch and use it within one hour Best results will be obtained if the assay is performed immediately after opening the foil pouch.
2.Pace the Extraction Tube in the work station. Hold the extraction reagent bottle upside down vertically. Squeeze the bottle and let the solution drop into the extraction tube freely without touching the edge of the tube. Add 8 drops of solution (Approx0.3mL) to the Extraction Tube.
3.Place the swab specimen in the Extraction Tube Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab.
4.Remove the swab while squeezing the swab head against the inside of the Extraction Tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol.
5.Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface
6.Add three drops of the solution(approx80ul) to the sample well and then start the timer. Read the result at 8 minutes. Do not interpret the result alfter15 minutes.
LIMITATIONS
1.Testsea lnfluenza A/B Cassette (Swab Nasal Aspirate) is for professional in vitro diagnostic use only The test should be used for the detection of influenza A and or B virus in nasal swab, throat swab or nasal aspirate specimens. Neither the quantitative value nor the rate of increase in influenza A and/or B virus concentration can be determined by the qualitative test
2.Influenza A/B Cassette (Swab/Nasal Aspirate) will only indicate the presence of influenza A and for B virus in the specimen from both viable and non-viable influenza A and B strains
3.As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
4.A negative result obtained from this kit should be confirmed by culture. A negative result may be obtained if the concentration of the influenza A and/or B virus present in the nasal swab is not adequate or is below the detectable level of the test.
5.Excess blood or mucus on the swab specimen may interfere with test performance and may yield a false positive result.
6.The accuracy of the test depends on the quality of the swab sample. False negatives may result from improper sample collection or storage.
7.The use of over the-counter and prescription nasal sprays at high concentrations can interfere with results leading to either invalid or in correct test results.
8.A positive result for influenza A and for B does not preclude an underlying co-infection with another pathogen, therefore the possibility of an underlying bacterial infection should be considered.
9.Performance of the test has not been established for monitoring antiviral treatment of influenza.
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