Universal IVD Dengue NS1 Antigen Detection Kit Immunochromatography

Rapid Test Kit Dengue NS1 Antigen Detection Test Kit High Accuracy Medical One Step Rapid Test Kit

Intenden Use

The Dengue NS1 Antigen Rapid Test Kit is intended for the qualitative detection of dengue virus NS1 antigen to dengue virus in serum/plasama/whole blood to aid in the diagnosis of Dengue virus infection.

Specifications

Analytical Resualts

• Specificity: 99.02%
• Sensitivity: 97.92%
• Accuracy: 98.67%

Main Components

• Test Cassettes
• Disposable Pipettes
• Specimen Buffer
• Instruction For Use

Material Needed But Not Provided

• Specimen Collection Containers
• Centrifuge (for serum/plasma sample)
• Timer

Use Step

• Take off the outer packing, put the cassette onto the desk with the sample window up.
• Drop 3 drops (80μl-100μl) of serum/plasma/whole blood vertically into the sample well of cassette. If the whole blood sample is thick, add 1 drop (40-50μl) of specimen buffer into the sample well of cassette.
• Observe the test results immediately within 15-20 minutes, the result is invalid after 20 minutes.

Interpreation Of Result

• POSITIVE: Two distinct red lines appear. One line should be in the control region (C) and the other line should be in the test region (T).

• NEGATIVE: One red line appears in the control region(C). No apparent red or pink line appears in the test region (T).

• INVALID: No red 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.

Limitations

• The results of the reagent are only for clinical reference, which is not the only basis for clinical diagnosis and treatment.
• A confirmed diagnosis and treatment should only be made by a physician after all clinical and laboratory findings have been evaluated.
• Cannot be used for screening the general population, but can only be used for the screening of patients with clinical symptoms or when there is suspicious exposure.
• The best time for dengue testing is 6 ~ 14 days after the symptom of fever.
• Do not use other kinds of quality control sample to test the reagent. Components of different batches cannot be exchanged for use to avoid erroneous results.