Packing specification:

20 tests per box; 40 tests per box

Application:

Rapidly detecting M. Tuberculosis antibody (IgG) in human serum to aid in diagnosis of tuberculosis in clinic.

Working principle:

 It lays an important basis for the kit to aid in diagnosis of TB by detecting serum M. tuberculosis antibody that the M. tuberculosis antibody level in healthy human sera is abnormaly higher than that in TB infected ones. The kit integrates the method of immunological determination with immunochoromatograhy in one test. After drops of serum sample are added to sample well of the cassette, the serum can be seen migrating upwards, at first combines with the colloid gold labelled with specific antigen, forming “antibody- antigen-colloid gold” complex, then the complex flows laterally and is finally captured by recombinant TB antigen protein coated on the test line (T Line ) of the nitrocellulous membrane,forming a red line, which is visible by naked eyes. The color shades depend upon M.tuberculosis antibody (IgG) concentration in the serum sample. Meanwhile, whether there is M tuberculosis antibody (IgG) in the sample, the colloid gold labelled with specific antigen once migrating through control line (C Line) will difinitely be captured by protein A coated on it, forming the other red line, and meaning that the kit works well.

Main components

Packing specification                  20tests/box            40tests/box

1. Testing cassettes             20pcs                           40pcs

2. Buffer                                    10ml×1bottle               10×2bottles

3. Instruction sheet                      1pcs                             1pcs

Elements for testing cassettes:

 colloid gold labeled with TB antigen, NC membrane coated with TB antigen, absorbent paper, glass fiber, plastic film, BSA, tri-sodium citrate, sheep anti rabbit IgG, aluminum foil bags;

Elements for buffer:

distilled water, BSA, tris, sucrose, Na₃N (0.1%)

Items necessary for the test but no provided with:

blood collecting tubes, pipette

Storage and period of validity:

12 months at room temperature (4~30°C) in a dry place.

Sample collection:

 routinely collect blood from veins, test should be conducted immediately when serum is separated from the blood, try to avoid hemolysis or repeatedly thawing and freezing. Na₃N is prohibited to use for sample preservation. Centrifugation or filtration is advisable before test is conducted while sediment or precipitate appears in the sample.

Operation procedures

1.Take one test cassette out, number the sample

2.Firstly add 30μl serum sample, then add 2~3 drops of buffer (50 ~100μl) to the sample well

3.Observe the result right after 15 minutes

Interpretation of test results

1.Positive: red appears on both C line and T line

2.Negative: red appears on C line only

3.Invalid: red appears on T line only or no color appears on either C line or T line.

Test limitation

1.Any wrong operation may lead to erroneous results, therefore ideal test should comply with the above procedures.

2.Positive or negative results only show the existence or inexistence of M. tuberculosis antibody (IgG) in the serum and can never be taken as an only index for the TB diagnosis. If necessary, the other methods such as smear or culture, referring to clinic symptoms are also adopted to make final diagnosis.

3.Test efficacy for other types of TB remains dim.

4.Test efficacy remains dim for whole blood, plasma and samples collected from other parts of the body, such as pleural fluid and ascites, cerebrospinal fluid. 

Precautions

1.put on gloves, gauze mask and protective cloth before conduct the test

2.the kit is for disposable use only

3.the kit is for in vitro use only

4.do not use when package is in damaged condition

5.do not use when kit expires

6.do not intermingle the components of kits of different batches

7.do not damp the test cassette before test operation

8.prevent foreign object or hand from touching NC membrane

9.pay attention to preservative Na₃N contained in the buffer, operate carefully lest buffer or serum spills, otherwise wash away the spilt fluid with 1% sodium hypochlorite or clear away with absorbent paper.

10.used and contaminated materials should be disinfected in autoclave under 121°C,0.15Mpa for 30 mins or immersed in 5% sodium hypochlorite for 40~60 minutes or incinerated prior being discarded.

 

Zhuhai Encode Medical Engineering Co.,Ltd (herinafter referred to as Encode) was established in 1994, as one of the earliest
and largest manufacturers of in-vitro diagnostic field in China. Encode specializes in R&D, production and distribution of in-vitro diagnostic products. As a hi-tech and innovative enterprise, we have researched and developed series of microbiological diagnostic productds and immunology diagnostic rapid tests, which are used for diagnosis of infection disease, cardiac markers, tumor markers, fertility test, durgs of abuse and sexual transmitted disease.

Encode occupies a land of 15,000 m2 in Zhuhai. There are 2,000 GMP standard clean workshops of microbiology diagnostic products, colloidal gold diagnostic products and molecular with automatic manufacturing lines and passed the quality management system evaluation by SFDA and GDFDA.

Encode has established extensive cooperation with research centers in universtities, such as Lanzhou University, South China University of Technology, Jinan University and Shanghai Plumonary Hospital, etc. Whith strong R&D and technological innovation capability. Encode ranks leading level in terms of IVD industries field in China. We have also obtained ISO 13485:2003, ISO 9001:2001, CE and have been granted the title of national hi-tech enterprise.

Today, we provide medical products and health care solution to clients not only in China, but also worldwide, such as Europe, Africa, Middle East, South East, Asia etc.

With the experience and dedication of the scientific staffs, Zhuhai Encode Medical Engineering Co.,Ltd will continue our endeavor to provide professional in-vitro diagnostic products and health care solutions to the worldwide and make our contributions to the career of human health.