ISO13485 15 Min Dengue Antibody IgM IgG Test Kit For Hospital Clinic

Rapid Test Kit Dengue Antibody Test Kit Detection IgG/IgM Antibody Raoid Test Kit 25 Tests Kit High Quality Rapid Antibody Test Kit

Intenden Use
The Dengue IgG/IgM Antibody Test Kit is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to dengue virus in serum/plasma/whole blood to aid in the diagnosis of Dengue viral infection.
Specifications

Product Features

• Test your anytime and anywhere
• Applicable to hospital, clinic, etc.
• simple and easy operation
• high Accuracy
• It is applicable to samples from different sources including Serum, Plasma, Whole Blood.

Advantages

• Easy to operate, no request other instruments
• Higher sensitivity and specificity
• The pathogen can be detected at the initial stage of infection
• Simple operation, get result rapidly

Main Components

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

Material Needed But Not Provided

• Specimen collection containers Centrifuge (for plasma only)
• Micropipette
• Timer
• Lancets (for fingerstick whole blood only)

Analytical Resualts

Use Step

• Take off the outer packing, put the cassette onto the desk with the sample window up.
• Drop 1 drop (30μl) of serum/plasma/whole blood vertically into the sample well of cassette. Add about 2 drops (80-100μl) 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:

1. Two distinct red lines appear. One line should be in the control region (C) and another line should be in the IgG test region (T1), indicating the Dengue IgG positive.
2. Two distinct red lines appear. One line should be in the control region (C) and another line should be in the IgM test region (T2), indicating the Dengue IgM positive.
3. Three distinct red lines appear in the control region (C), the IgG test region (T1) and the IgM test region (T2), indicating the Dengue IgG and Dengue IgM positive.

• NEGATIVE: One red line appears in the control region(C). No apparent red or pink line appears in the test region (T1 and T2).
• 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. Do not open the inner packaging until ready, it must be used in one hour, if opened (Humidity≤60%, Temp: 20℃-30℃). Please use immediately when the humidity＞60%.

Precautions

• For IN VITRO diagnose only.
• Do not use after the expiration date.
• The test result is invalid over 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.

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.

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.