TB (Tuberculosis) Rapid Test Kit

For the Qualitative Detection of Antibody against Tuberculosis in serum and plasma

Main Features

♦ High Sensitivity

♦ Specificity

♦ Reliable: high accurate, early detection of the presence of TB

♦ 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 TB Rapid Test is a chromatographic immunoassay (CIA) for direct qualitative detection of Tuberculosis antibody in human serum or plasma



Principle

Tuberculosis remains an important socio-economical and medical problem throughout the world. According to the Centers for Disease Control, the incidence of TB is expected to increase from 7.5 million cases per year in 1995 to 11.9 million in 2005.

The case fatality rate is estimated at 55% for untreated people and 15% for the treated patients. The commonly used diagnostic tests for the tuberculosis such as sputum examination of acid fast bascilli, culture of sputum or other fluids, the tuberculin skin test and radiological investigations do not achieve the required diagnostic sensitivity.



Summary

Tuberculosis Rapid Test (Whole Blood/Serum/Plasma) is a membrane-based screening test for the rapid detection of IgM anti-Mycobacterium Tuberculosis and IgG anti-Mycobacterium Tuberculosis in human whole blood, serum or plasma.

This innovative rapid screening test is based on lateral flow immunochromatography and is among the easiest point of care (POC) assay diagnostics.

The Tuberculosis Rapid Test (Whole Blood/Serum/Plasma)is suitable to test for antibodies in whole blood, serum or plasma. It is for professional in vitro diagnostic use only.

Interpretation of Results



Materials Supplied

1. Test Cassette

2 Pipette Dropper

3. Desiccant

4. Buffer

5. Package Insert

Material Required But Not Provided

1. Clock or Timer
2. Specimen collection containers.
3. Timer
4. Lancets (for fingerstick whole blood only)
5. Centrifuge (for plasma only)

Storage and Stability

All reagents are ready to use as supplied. Store unused test device unopened at 2°C-30°C.

If stored at 2°C-8°C, ensure that the test device is brought to room temperature before opening.

The test device is stable through the expiration date printed on the sealed pouch.

Do not freeze the kit or expose the kit over 30°C.

Warnings and Precautions

1. For professional In Vitro diagnostic use only.

2. Warning: the reagents in this kit contain sodium azide which may react with lead or copper plumbing to form
potentially explosive metal azides. When disposing of such reagents, always flush with large volumes of water to
prevent azide build-up.

3. Do not use it if the tube pouch is damaged or broken.

4. Test is for single use only. Do not re-use under any circumstances.

5. Handle all specimens as if they contain infectious agents. Observe established standard procedure for proper
disposal of specimens

6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are
assayed.

7. Humidity and temperature can adversely affect results.

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.