Home Use ISO 20 Minutes Dengue NS1 Ag Rapid Test Kit

Dengue NS1 Antigen Rapid Test

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

Home Use Mosquito-Borne Infectious Disease Diagnostic Device For Dengue NS1 Ag Rapid Test Kit

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.

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.

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

Specimen Collection and Preparation

1. Whole blood specimen collection

☀ Whole blood is collected in syringe or evacuated tube containing the anticoagulant.

☀ Whole blood specimens should be tested immediately after collection. In the case of storing at 2-8°C, it should be tested within 24 hours.

2. Plasma/Serum specimen collection

☀ Plasma or serum specimens should be tested immediately after collection.

☀ Do not leave the specimens at room temperature for prolonged period. Specimens may be stored at 2-8°C for up to 3days. For long term storage, specimens should be kept below -20°C.

Specimens containing precipitate may yield inconsistent test results. Such specimens must be clarified prior to assay.

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.

Storage

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

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.