Whole Blood Fever Dengue Antigen Rapid Test Cassette

Dengue NS1 Antigen Rapid Test

For the qualitative detection of Dengue NS1 Antigen in serum/plasma and whole blood

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Intended Use

The Dengue NS1 Antigen Rapid Test is a qualitative test for the detection of NS1 antigen of dengue virus in human serum or plasma.. Dengue fever is a worldwide health problem, and in epidemic proportions in some countries. The World Health Organization estimates that annually, 50-100 million people are infected worldwide with the dengue virus.

Studies have shown that early detection of Dengue NS1 virus using tests like the Dengue NS1 Rapid test can help in early confirmation, clinical treatment, and control of dengue viral infections. This test is effective new diagnostic tools for early diagnosis of dengue virus infection. The test is for In-Vitro Diagnostic use only.

Principle

Serum, or plasma, 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-Dengue antibodies are immobilized.. The NS1 antigen present in the sample will bind to the immobilized Mab-anti-Dengue Antibodies immobilized in the test zone. on the membrane. Next the sample buffer is applied which in turn reconstitutes the dried Dengue gold anti-NS1 mouse antibody conjugate.

The Dengue conjugate then migrates towards the test zone and binds to Dengue NS1 antigen-Dengue Anti-NS1 antibodiy to form a complex on the membrane as a separate red to blue lines if Dengue NS1 Antigens are present in the sample. The intensity of the test lines will vary depending upon the amount of antigen present in the sample. The appearance of pink to dark blue line in the test region should be considered as positive for NS1 antigen in the sample. There will be a second control line on the membrane which will be invisible until the test is run. It will show up as a red to blue control line to indicate that the test is functioning properly.

Storage

Store the kit between 4°C and 30°C. Do not store the kit in direct sunlight. Only remove and open the number of cassettes to be immediately used. The test kit should be used until the expiration date of the kit. Please refer to the package label for the expiration date.

Assay Procedure

All test cassettes, and specimens must be at room temperature (4- 300C) before running the assay procedure. Serum or plasma samples should be used immediately after collection. The use of Icteric or Lipemic samples should be avoided.

1. Pipette 30 μl of serum or plasma,or 50 μl of whole blood into the “S” well.
2. Next dispense 2 drops of sample diluent buffer into the “S” well.
3. Read the results between 15-20 minutes. Discard the test cassette after 20 minutes. Do not read after 20 min.

Interpretation of Results

Negative: The control line is the only line visible in the test zone. No NS1 antigens were detected. The result does not exclude dengue infection.

Positive: The control line and the test line line is visible in the test zone. The test is positive for NS1 antigens. This is indicative of dengue infection.

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

Expected Value

Recent studies have shown that DENV nonstructural protein 1 (NS1) is detectable in the blood as early as the onset of symptoms and persists well into the convalescent phase of the infection. Primary NS1 kit for (i) early-convalescent-phase samples, (ii) acute-phase samples with false-negative PCR results, and (iii) IgM-negative convalescent-phase samples from patients with confirmed secondary DENV infections.

Results show that NS1 can be detected in 22% of serum samples collected more than 10 days after the onset of illness and in 22% of samples that did not elicit an IgM response. Additionally, NS1 was detected in 37% of the tested acute-phase samples with false-negative PCR results, suggesting that NS1 detection may be valuable in increasing the sensitivity of current acute-phase diagnostics.

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.