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Products > Infectious Disease Test > > TB Tuberculosis Test Device Strip TB-P01D
Product name : TB Tuberculosis Test Device Strip TB-P01D
Item : TB-P01D
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Details:

Product Name

Specimen

Format

Catalog No

Sensitivity

Strip width

Certificate

TB Tuberculosis Test Device

Serum/Plasma

Strip

TB-P01B

 

3.0mm

 

TB-P01D

4.0mm

 

Specifications

Certificate:CE,ISO9001,ISO13485

Specimen:Serum/Plasma

Model No:TB-P01D

Sensitivity: >97%
Accuracy: >99%
Reaction Time:15 minutes

Intended Use:

TB(tuberculosis) Test strip is a rapid direct binding test for the qualitative detection of antibodies to Mycobacterium tuberculosis(M.tuberculosis) antigen in human serum or plasma, as an aid in the clinical assessment of Mycobacterium tuberculosis viruses infection.

Principle of the Procedure:

One Step Anti-TB Test uses a double antigens “sandwich principle”1 for the detection of M.tuberculosis antibody in human serum/plasma.Two recombinant Tuberculosis antigens (TB Ag 1&2) were mixed and immobilized on the test band region, and an antibody to Tuberculosis on the control band region of nitrocellulose membrane. Another Tuberculosis antigen (TB Ag 3),coupled with colloidal gold particles, is dried on a conjugate pad.During the assay,the specimen is allowed to react with the colored conjugate (antigen-colloid gold conjugate);the mixture then migrates chromatographically along the membrane by capillary action.If the specimen contains Tuberculosis antibody,the recombinant antigen immobilized on the membrane will capture the antibody-antigen-colloidal gold complex and form a colored test band on the membrane,indicating a positive result. Absence of the test band suggests a negative result.To serve as a procedural control, a colored band at control region always appears in the test area.This one step test is very sensitive and only takes about 15 minutes.Test results are read visually without any instrument.

INTERPRETATION OF RESULTS

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

 


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