100% Sensitivity IgG IgM Combo Dengue Rapid Test Kit

Dengue IgG/IgM Antibody Rapid Test

For the qualitative detection of Dengue ( IgG & IgM ) in serum/plasma and whole blood

Dengue IgG/IgM Combo Rapid Test Kit Home Use Dengue Fever In Vitro Test Cassette Mosquito-Borne Infectious Disease

Main Features

♦ High Sensitivity: 100%

♦ Specificity: 100%

♦ Reliable: Accuracy higher than 97.5%, early detection of the presence of Dengue Antibody

♦ Simple: No Instrument Required

♦ Convenient: Room Temperature Storage, Built-In Control line

♦ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes

♦ Certified by Authoritative Certification System and Standards

♦ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"

Intended Use

The Dengue IgG and IgM Combo Rapid Test is a qualitative test for the detection of IgG and IgM antibodies to dengue virus in human serum plasma ,or whole blood. The test provides a differential detection of anti-dengue IgG and Anti-dengue-IgM Antibodies and can be used for the presumptive distinction between a primary and secondary dengue infection. This test is for In-Vitro Diagnostic use only.

Principle

Serum, plasma, or Whole blood samples may be used with this test. A sample is dispensed on to the membrane The sample then migrates by capillary action towards the test site where anti-Human IgG and anti-Human IgM are immobilized as two distinct lines. The IgG & IgM antibodies present in the sample will bind to the immobilized anti-Human IgG and Anti-Human IgM lines on the membrane. Next the sample buffer is applied which in turn reconstitutes the dried Dengue gold conjugate.

The Dengue conjugate then migrates towards the test zone and binds to Dengue Anti-Human IgG and Dengue Anti-Human IgM complex on the membrane as two separate purple/blue lines if Dengue antibodies are present in the sample. The intensity of the test lines will vary depending upon the amount of antibody present in the sample. The appearance of purple/blue line in a specific test region (IgG or IgM) should be considered as positive for that particular antibody type (IgG or IgM). There will be a third control line on the membrane which will be invisible until the test is run. It will show up as a Red control line to indicate that the test is functioning properly.

Storage

Store the test kits at temperature 4-30°C,in the sealed pouch for the duration of the shelf life (24 months).

Assay Procedure

All test cassettes, buffers and specimens must be at room temperature (4- 300C) before running the assay procedure. Whole blood samples should be used immediately.

1. Pipette 5μl sample (serum/plasma/whole blood) into the sample well. Wipe the outside of the pipette tip carefully to remove excess of sample.

2. Next dispense 4 drops (120μl) of sample diluent buffer into the buffer well.

3. Record the results after 15-20 minutes. Discard the test cassette after 20 minutes.

Interpretation of Results

Negative: The control line is the only line visible in the test zone. No IgG or IgM antibodies were detected. The result does not exclude dengue infection. A new sample should be drawn from the patient in 3-5 days and then should be retested.

IgG Positive: The control line and G line are visible in the test zone. The test is positive for IgG antibodies. This is indicative of a past dengue infection.

IgM Positive: The control line and M line are visible in the test zone. The test is positive for IgM antibodies. This is indicative of a primary dengue infection.

IgM and IgG Positive: The control line, M and G lines are visible in the test zone. The test is positive for IgM and IgG antibodies. This is indicative of a secondary dengue infection (see limitation).

Invalid: The test results are INVALID, if no control line is visible, regardless of the presence or absence of lines in the IgG or IgM test zone of the strip. Repeat the test using a new cassette.

Performance Characteristics

1.A panel of samples containing confirmed positive and negative samples were used. The reference test kit used was from Pan Bio (Australia). The results are tabulated below.

2. CROSS REACTIVITY: No cross reactivity was observed with Hemoglobin (20 mg/100 ml) , and Triglycerides (500 mg/100 ml).

Newscen Biopharm Co., Limited is a professional manufacturer of in vitro diagnostic products and related supporting apparatuses, which is jointly founded by Tianjin Pharmaceutical Group, Tianjin Zhongxin Pharmaceuticals Co., Ltd and oversea Chinese entrepreneurs.

Founded in 2003, the company is one national high tech corporation and Tianjin Grade A medical device manufacturer. Over the years, the company has been committed to the research, development, production and sales of in vitro diagnostic products and related supporting apparatuses, and also has provided OEM and ODM and technology transfer and cooperation as well as some other customer market based diversified services to customers at home and abroad.

NewScen is based on independent innovation and relies on the talent sharing at home and abroad, information interaction advantage, antibody preparation and new product R & D technology platform to develop and produce nine series about one hundred kinds of products including tests and instruments and put on the market in succession.

HIV (1 + 2) antibody rapid test Kit and other IVD (In Vitro Diagnostic) devices obtained National Patent and National Class of New Drug Certificate; HCV Antibody Rapid Test is the first double antigen sandwich test HCV patented product; NewScen’s quantitative test broke through the technical difficulty of the colloid gold quantitative detection, opening up a new situation for clinical application of Colloidal Gold test. Rapid immuno assay reader provides an open and common platform for qualitative and quantitative detection of the Colloidal Gold test.

The company has received CFDA medical device certificates of 32 products, 49 independent Intellectual Property Rights, FDA certificates of series of products and European CE certificates of 16 products. Production management is in strict accordance with the regulations of in vitro diagnostic product production as well as international quality management system (ISO 9001, ISO 13485) so as to ensure high product quality. Products are sold throughout the country and in North America, South America, Southeast Asia, Europe, the Middle East, Africa and other international markets.

Currently, the company integrated Colloidal Gold test, immunochromatographic interpretoscope and cloud technology and other technical advantages, and created management integrated POCT system, so as to achieve convenient, accurate and efficient onsite data collection and remote guidance or data sharing of the monitoring center and promote the development of modern testing technique and the improvement of diagnosis and treatment level.

NewScen has obtained the project support from Tianjin or the country for nine times in succession, has been identified as one Hightech Enterprise in Tianjin, has obtained the title of “Top 100 Enterprise in Tianjin” among Tianjin SMEs, and is the rapid diagnostic Hightech demonstration project base and National 863 Project undertaker awarded by the NDRC (National Development and Reform Commission).

Fecal Occult Blood, Serum Ferritin and Hepatitis C rapid test products were named Tianjin independent innovation products; brand “YBT”products have been awarded the title of “Chinese Women and Children Favorite Brand Product” by Chinese Women and Children Development Center; “YBT” trademark was named “Tianjin Famous Trademark”.

“Honesty, Verity, Authenticity, and Innovation", is our persistent commitment.

“Encouraging Our Employees Growing With Company” is the driving force beneath our surging growth.