TB (Tuberculosis) Rapid Test Kit

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

Summary Description

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.

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)

Specimen Collection

1. The TB Tuberculosis Rapid Test (Whole Blood/Serum/Plasma) can be performed using whole blood (from venipuncture or fingerstick) serum, or plasma specimens.

2. To collect Venipuncture Whole Blood Specimens: Collect anti-coagulated blood sample (EDTA, heparin, and sodium citrate) following standard laboratory procedures.

3. To collect Fingerstick Whole Blood Specimens:

Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.

Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.

Puncture the skin with a sterile lancet. Wipe away the first sign of blood. Add the Fingerstick Whole Blood specimen to the test cassette by using hanging drop:

Position the patient’s finger so that the drop of blood is just above the sample pad(s) of the test cassette.

Allow 2 hanging drops of fingerstick whole blood to fall into the center of sample pad(s) on the test cassette, or move the patient’s finger so that the hanging drop touches the center of the sample pad(s). Avoid touching the finger directly to the sample pad(s).

Gently form a rounded drop of blood over the puncture site and add the fingerstick whole blood specimen to test device using a capillary tube Touch the end of capillary tube to blood until filled to approximately 50 ul .

Place the bulb onto the top end of the capillary tube dispense the whole blood into the specimen well(s) of the test device.

4. Separate Whole Blood,serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear,
non-hemolyzed specimens.

5. Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.

6. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.

7. If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents.

Interpretation of Results

Negative:

No apparent band in the test region (T), a pink-colored band appears in the control region (C). This indicates that no TB antibody has been detected.

Positive:

In addition to a pink-colored band in the control region (C), a pink-colored band will appear in the test region (T). This indicates that the specimen contains TB.

Invalid:

If no band appears in the control region (C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.

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.

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.