One Step TB Rapid Test Kit High Accuracy Immuno - Chromatography Technique

One Step Bovine Tuberculosis (TB) antibody rapid Test kit for cattle ,rapidly and easily, gold colloidal method

Specimen: Whole Blood/Serum/Plasma

Intended Use

Bovine Tuberculosis Antibody Test is a sandwich lateral flow immunochromatographic assay for the qualitative detection of Tuberculosis Disease in bovine serum.

Test Principle

This test strip is based on fast immuno-chromatography technique to detect Tuberculosis (TB) Ab in bovine serum. When testing, Tuberculosis (TB) Ab in sample combine with antigen coated by colloid gold forming complexes, moving forward to the other head. When reaching the T-line, the specific antigen on the membrane capture the complexes and appear a T line, C line appears, means the test is valid. The T line appears, means there is Tuberculosis (TB) Ab in the sample.

Sample preparation

Whole blood

Collect anticoagulated whole blood, use for that very day;

Serum

Collect blood, put at 37℃ for 1-2h, take the supernatant, centrifuge at 1500r/min for 10min, separate the serum. The serum can store for 2-3 days at 4℃, for long term storage, store at -20℃ in frozen.

Test Procedure

1. Collect 1ml blood, centrifuge at 1500r/min. (If sample can not be detected immediately, should be stored in cool, for more than 24hours, store in frozen.
2. Return the test card package and sample into room temperature.
3. Gradually drip 3 drops of serum/plasma into the sample hole “S”.
4. Interpret the result in 5-10 minutes. Result after 10 minutes is considered as invalid.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

NEGATIVE:* A colored line appears in the Control region (C) and colored lines appears in the Test region (T). This negative result means that the concentrations in the urine sample are below the designated cut-off levels for a particular drug tested.

*NOTE: The shade of the colored lines(s) in the Test region (T) may vary. The result should be considered negative whenever there is even a faint line.

POSITIVE: A colored line appears in the Control region (C) and NO line appears in the Test region (T). The positive result means that the drug concentration in the urine sample is greater than the designated cut-off for a specific drug.

INVALID: No line appears in the Control region (C). Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for Control line failure. Read the directions again and repeat the test with a new test card. If the result is still invalid, contact your manufacturer.

QUALITY CONTROL

A procedural control is included in the test. A line appearing in the control region

(C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.

Notice

1) If the test strip is out of date, damaged, pollution or invalid, change the strip from supplier.

2) Use strip in 1 hour after opening.

3) The test strip is disposable, do not repeat using.

4) Do not use sample diluent from other source.

5) Do not use tap water,purified water, distilled water as negative control.

6) If no liquid movement in 30s after adding testing sample, add one more sample diluent.

7) All cards, testing sample and swabs used should be autoclaved or discarded according to local regulations.

8) This test strip is qualitative determination.

performance characteristics

The specimen correlation study was performed on 300 Blood specimens. 82 positive urine specimens and 218 negative urine specimens were confirmed by GC/MS.

Table 1: Specimen Correlation

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.