Colloidal GoldInfectious Disease Test KitTuberculosis Antibody (TB) Test Kit

SKU: IVD testing kits 22, Colloidal Gold Tuberculosis Rapid Test Kit, Whole Blood TB Rapid Test cassette, TUV Tuberculosis Rapid Test Kit

Key Words: NewScen Diagnostic Kit for M. Tuberculosis Antibody (TB) (Colloidal Gold)

Sample type: Serum, Plasma

Detection type method: Qualitative Colloidal Gold

Usage/Application:  Laboratory Medical, Hospital&Private Clinic, Pathology, Community Center, Government Procurement

Format: Cassette, Strip, Uncut sheet

Certificate: NMPA/ CE others

Sensitivity: 90.0%

Specificity: 87.0%

Total Accuracy: 88.2%

Reading time: 15-30 minutes

Packaging Details:

①For Professional Use: 40 Cassette/Kit; 100 Strips/Kit; 50 Strips/Bottle (For Customization)…

②Uncut Sheet for OEM

Description

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.

 

1. Product Description:

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.

 

2. NewScen Provide Tuberculosis Antibody (TB) Test Kit With Below Specification:

 

3. Which conditions does tuberculosis Antibody (TB) Test screen for?

 

4. Principle:

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.

 

TUV Colloidal Gold Whole Blood Tuberculosis Rapid Test Kit 1

 

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 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.

 

5. How do you test for Tuberculosis Antibody (TB) Test Kit?

Click here to download: Instruction of Newscen M. Tuberculosis (TB) Antibody Test Kit (40 cassettes)