ISO13485 25 Tests Dengue Antigen Antibody Test Kit For NS1 IgM IgG

Rapid Test Kit Dengue NS1/IgG/IgM Antigen And Antibody Rapid Test Kit 25 Tests High Accuracy Rapid Test Kit

Intenden Use
Dengue NS1 Antigen & IgG/IgM Antibody Rapid Test Kit is a rapid Immunochromatography for the qualitative detection of antibodies (IgM and IgG) and dengue virus NS1 antigen to dengue virus in serum/plasma/whole blood to aid in the diagnosis of Dengue viral infection.
Specifications

 
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

Analytical Resualts

Use Step

• Take off the outer packing, put the panel onto the desk with the sample window up.
• NS1: Drop 3 drops (80-100μl) of serum/plasma/whole blood vertically into the sample well of NS1. If the whole blood sample is thick, add about 1 drop (40-50μl) of specimen buffer into the sample well of NS1
• IgG/IgM: Drop 1 drop (30μl) of serum/plasma/whole blood vertically into the sample well of IgG/IgM, add about 2 drops (80-100μl) of specimen buffer into the sample well of IgG/IgM.
• Observe the test results immediately within 15-20 minutes, the result is invalid after 20 minutes.

Interpreation Of Result
 

• For Dengue NS1:

1. 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).
2. NEGATIVE: One red line appears in the control region(C). No apparent red or pink line appears in the test region (T).
3. 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.

• For Dengue IgG/IgM:

1. POSITIVE: Two distinct red lines appear. One line should be in the control region (C) and another line should be in the IgG test region (G), indicating the Dengue IgG positive.
2. POSITIVE: Two distinct red lines appear. One line should be in the control region (C) and another line should be in the IgM test region (M), indicating the Dengue IgM positive.
3. POSITIVE: Three distinct red lines appear in the control region (C), the IgG test region (G) and the IgM test region (M), indicating the Dengue IgG and Dengue IgM positive.
4. NEGATIVE: One red line appears in the control region(C). No apparent red or pink line appears in the test region (G and M).
5. INVALID: No red bands appear or control line fails to appear, indicating that the operator error or reagent failure.

Storage And Expiry

Store as packaged in the sealed pouch at 2-30℃, avoid hot and sunshine, dry place, valid for 24 months. DO NOT FREEZE. Some protective measures should be taken in hot summer and cold winter to avoid high temperature or freeze-thaw.

Precautions

• For IN VITRO diagnose only.
• Do not use after the expiration date.
• The test result is invalid after 20 minutes.
• The strength of the quality control line does not indicate the quality problem of the reagent, a test result that is clearly visible demonstrates the reagent is effective.
• All samples and reagents should be considered potentially hazardous and handled in the same manner as an infectious agent after use.
• 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

Other Informations

• The results of the reagent are only for clinical reference, which is not the only basis for clinical diagnosis and treatment.
• Negative result may occur when detecting short-term infected samples or some second time infected samples, indicating that the specific antibodies of Dengue IgM does not exist or the concentration is below the detection limit. Some patients may not produce enough antibodies to be detected in their body within 7 - 10 days, it may show negative results. For some patients, if the Dengue infection is still suspected, they need to do a new Dengue rapid test 3-4 days later.

FAQ

• MOQ?

MOQ is 10000 pcs

• Shippment?

We choose Air cargo or Ocean cargo.

• Delivery date?

It will depend on your order quantities. We will confirm with you after you placed the order.

• Payment Method?

Business to business account.

• Do you support OEM/ODM order?

Of couse, we support OEM/ODM order.

• Are you a manufacturer or trading company?

We are manufacturer.

• After-sales Service

Any questions or needs you can contact us online / by e-mail, ect. we will get back to you within 24 hours.