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.

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.