1. INTENDED USE
Quicking Influenza type A Ag Rapid Test is an immunochromatographic assay for the qualitative detection of the influenza type A antigen (including the subtype H1N1) from the secretions sample of upper respiratory tract. With accuracy and simple operation, the test can provide an urgent solution for doctors and public health departments in the screening and census of population who may infected by the prevalent H1N1 type A of influenza (the swine flu).
2. TEST PROCEDURE
1) Allow all kit components and specimen to reach room temperature (20-30°C) prior to testing.
2) Remove the test device from the foil pouch prior to use.
3) Place the test device horizontally, Drop 3 drops of the specimen into “S” hole.
4) Interpret test results in 5-7 minutes. Do not interpret after 10 minutes.
3. INTERPRETATION OF RESULTS
Positive: The presence of both C band and T band.
Negative: Only clear C band appears.
Invalid: No coloured band appears in C zone regardless of whether T band appears.
4. STORAGE
The kit can be stored at room temperature (2-30°C, 36-86oF).
The test kit is stable until the expiration date marked on the foil pouch.
DO NOT FREEZE.
Do not store the test kit in direct sunlight.
5.Package size
20 tests/box
6.Performance
6.1. Detection Limit: influenza A, 1.2 ×105 TCID50/ml.
6.2. Comparison with another commercial influenza test of immunochromatographic assay.
influenza A Test | The reference | Total | |
positive | negative | ||
Quicking positive | 223 | 18 | 241 |
Quicking negative | 14 | 310 | 324 |
Total | 237 | 328 | 565 |
Quicking Flu A test Sensivity: 223/ 237 × 100% = 94.09%
Quicking Flu A test Specificity: 310/ 328 × 100% = 94.51%
6.3. The following antigens has been evaluated to be sensitive to Quicking Influenza A Antigen rapid test.
H1N1, excellent sensitive
H3N2, good sensitive
H5 strains, sensivie
H7 strains, sensivive
H9 strains, sensitive
We have only evaluated to the above commonly epidemic influenza virus serotypes in human beings. Other serotypes influenza A rapid test may also sensitive to this test. Further evaluation need to be confirmed if there is suspect.
6.4. Cross- reaction
No cross reaction with type B, C influenza virus, adeno virus, parainfluneza, coronavirus which may cause respiratory symptoms like Influenza A.
Influenza-A Ag RAPID TEST STRIP(ISO9001+ISO13485)