CE 100% Specificity Early Detection Helicobacter Pylori Rapid Test Kit

H. Pylori Antigen Detection Test Kit

For the qualitative detection of Antigens to H. pylori in feces

Main Features

☀ High Sensitivity: 100%

☀ Specificity: 100%

☀ Reliable: Accuracy higher than 97.5%, early detection of the presence of H.Pylori Antigens

☀ 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"

Summary and Explanation of The Test

The infection of Helicobacter pylori (H. pylori) is associated with a variety of gastro-intestinal diseases, such as stomach ulcer, chronic active gastritis and gastric, duodenal and gastric adenocarcinoma. Antibodies to H.Pylori are developed in individuals infected with H. pylori as a serological response. Detecting these specific antibodies to H. pylori can be used as a qualitative assay in the diagnosis of H. pylori infection. It may be used either as an adjunction to endoscopy or as an alternative measure in symptomatic patients.

The H. pylori Antigen Detection Test kit is a chromatographic immunoassay (CIA) for the rapid determination of antigens to H. pylori in feces specimens. The test is to be used as an aid in the diagnosis of infection due to H. pylori.

Principle

The H. pylori Rapid Test is a lateral flow, immune chromatographic - screening test. H. pylori antigens are precoated onto membrane as a capture reagent on the test band region. During the assay the specimen feces is allowed to react with H.pylori antibodies-gold conjugate. The mixture then moves laterally on the membrane chromatographically to the test region with immobilized antibodies of H. pylori. If H. pylori antibodies are present in the specimen, two red bands are formed on the test cassette. One red band in the control region indicates a negative result.

Reagents and Materials Provided

1. Test Device: A pouch contains a single test for HPAg and a desiccant.

2. Sample collection (with diluent).

3. Instruction for use.

Materials Required But Not Provided

Clock or Timer

Warning and Precautions

1. For in vitro diagnostic use only.

2. All patient samples should be treated as if capable of transmitting diseases.

3. Do not interchange reagents from different lots or use test kit beyond expiration date.

4. Interference substance in the samples or failed operation may cause false result. Please retest with a new one or use other way to confirm.

5. Patient specimens may contain infectious agents and should be handled as capable of transmitting disease. Wear disposable gloves throughout the specimen collection and assay procedures.

Storage

The H. pylori Rapid Test should be stored at temperature 4-30°C the sealed pouch for the duration of the shelf life (24months).

Do the test in 1 hour when you open the pouch

Sample Collection and Preparation

1. Collect stool sample by using the sample collection device provided.

2. Unscrew the top of the sample collection device, take out the sample collection stick, and collect the sample by dipping the stick into 3 different places of the stool sample.

3. Put the sample collection stick back in the sample collection device and screw together tightly.

4. If the sample cannot be tested on the day of collection, store the stool sample at 4℃ for up to 7 days. Bring the specimen to room temperature before test.

Assay Procedure

1. Remove the test device from foil pouch by tearing along the notch.

2. Specimen collection. Please see Specimen Collection and Preparation.

3. Shake the sample collection device several times.

4. Holding the sample collection device upright, carefully screw off the cap of collection device.

5. Squeeze 2-3 drops (80-100ul) of the sample solution on the test cassette.

6. Observe the result in15 minutes.

Interpretation of Results

Negative: Only one pink band appears. This indicates that no H. pylori antibodies have been detected.

Positive: Two pink bands appear. This indicates that the specimen contains H. pylori antibodies.

Invalid: If no band appears, this indicates a possible error in performing the test. The test should be repeated using a new device.

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.