Key Words: NewScen Diagnostic Kit for M. Tuberculosis Antibody (TB) (Colloidal Gold)
Sample type： Serum, Plasma
Detection type： Qualitative
Method: Colloidal Gold Rapid Test
Usage/Application: Laboratory / Hospital / Pathology
Certificate: ISO9001/ ISO13485/ CE by TUV
Format: Strip, Cassette, Midstream
Reading time: 15 minutes
(1) With our company’s Logo
(2) With the natural package
(3) With OEM package
This product is for in vitro qualitative detection of M. tuberculosis (M. tb) antibodies in human serum samples. This product is suitable for the auxiliary diagnosis of tuberculosis. Tuberculosis is caused by Mycobacterium tuberculosis and is a systemic infectious disease, of which tuberculosis is the most, accounting for about 90%. The diagnosis of tuberculosis is mainly based on bacteriology laboratory examinations, combined with chest imaging, epidemiology, and clinical manifestations, necessary auxiliary tests, and differential diagnosis, and made by comprehensive analysis.
NewScen Diagnostic Kit for M. Tuberculosis Antibody (TB) (Colloidal Gold) is intended for qualitative in-vitro detection of antibodies to Mycobacterium tuberculosis in human serum. It applies to auxiliary diagnosis of tuberculosis.
* High Sensitivity
*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 5-10 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”
This kit uses indirect immunocolloidal gold technology to detect the TB IgG antibody in samples. The colloidal gold pad of the reagent contained the colloidal gold particles labeled with monoclonal antibody mouse anti-human (IgG1 subtype). The T-zone of NC membrane is coated with a recombinant expression of Mycobacterium tuberculosis 38KD and 16KD antigen, and the C-zone is coated with goat anti-mouse IgG polyclonal antibody. During the testing, a small number of samples (4 μL) add to the middle position of the NC membrane of the test card, and the samples will spread and flow over the NC membrane and pass through the T zone.
If the samples contain anti-38KD and 16KD specific antibodies, they will bind with the antigen on the T zone and be fixed at the T zone position; Then diluent buffer adds to the sample hole, which dissolves the colloidal gold and drives it to flow on the NC membrane and wash out the non-specific human IgG on the NC membrane; When labeled colloidal gold chromatography to the T zone, if there is human IgG antibody bound to the T zone, it will bind with the colloidal gold to form a mouse anti-human labeled colloidal gold-tuberculosis specific IgG-tuberculosis specific antigen complex, and present a red colloidal gold line on the T zone. If there is no binding human IgG antibody on the T zone, it will not form complex and the T zone does not show color.
When the labeled colloidal gold passes through the C zone, it will combine with the goat anti-mouse IgG to form the colloidal gold-goat anti-mouse IgG complex labeled with mouse anti-human, and present a red colloidal gold line on the C zone. If the C zone does not show color, it indicates that there is a problem in the test, and the result is invalid, it should be retried. This kit adopts the detection method of adding samples on the membrane, which can avoid the Hook effect caused by too much non-specific IgG in samples.
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 tuberculosis such as sputum examination of acid-fast bacilli, culture of sputum or other fluids, the tuberculin skin test, and radiological investigations do not achieve the required diagnostic sensitivity.
The kit should be stored at room temperature (4-30°C, do not freeze) for 18 months from the date of manufacture. Keep the test cassette in a sealed pouch until use. Once you have taken the test cassette out of the pouch, perform the test as early as possible (within 1 hour) to avoid the test cassette from becoming moist. Do not use the test beyond the indicated expiration date.
The diluent buffer should be stored at room temperature (4-30°C, do not freeze).
6.Procedure of NewScen Tuberculosis Antibody (TB) Test Kit:
6.1. Place the test cassette on a flat surface. Use it immediately once unsealed.
6.2. Open the pouch and add a 4μL specimen (serum/plasma) into the middle position of the NC membrane area of the cassette.
6.3. After the sample is completely absorbed, add 2 drops (50~80μL) of diluent buffer to the sample hole and start the timing.
6.4. Observe the result in 15 minutes.
7.1. Negative: No red line appear in the test zone (T) in 15 minutes only a red line shows in the control zone (C), indicates that no TB antibodies have been detected with this test.
7.2. Positive: One red line shows in the control zone (C) and one in the test zone (T) indicates the specimen infects TB possibly, recommend further testing.
7.3. Invalid: No red lines appear in the control zone (C) indicates that the test is invalid. Discard the test cassette and perform with a new cassette.
The kit has a built-in procedural control that demonstrates assay validity. If a red line appeared in the control zone (C), it indicates that the test runs correctly.
8.1. The kit is intended for the qualitative detection of antibodies to TB.
8.2. The positive result cannot be the final diagnosis of TB. Any positive result must be interpreted in conjunction with the patient clinical history and other laboratory testing results. Follow-up and supplementary testing of all positive specimens with other tests are required to confirm any reactive result.
8.3. The kit is a qualitative assay and the results cannot be used to measure the concentration of antibodies.