EZ-T Anti-Tuberculosis Rapid Screen Test Kit


Intended Use

The One Step Anti-TB (Mycobacterium Tuberculosis) test is a rapid, serological, immunochromatographic assay for the detection of antibodies to Mycobacterium Tuberculosis (TB) Antigen in human whole blood, serum or plasma. The test is used to obtain a visual, qualitative result and is intended for healthcare professional use.

Summary and Biological Principle of the Assay

The One step Anti-TB(Mycobacterium Tuberculosis) Test uses a double antigens "sandwich principle" for the detection of Tuberculosis antibody in human whole blood, serum or 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.

Regents and Materials Supplied

  • Test cards individually foil pouched with a desiccant
  • Plastic dropper
  • Sample Diluent
  • Safety lancet
  • Alcohol swab
  • Package Insert

Specimen Collection

  1. Clean the area to be lanced with an alcohol swab.
  2. Squeeze the end of the fingertip and pierce with safety lancet.

Note: Whole blood, serum or plasma collected following regular clinical Laboratory Procedures can be used for this test.

Assay Procedure

  1. Use the plastic tube to collect blood.
  2. Dispense one drop (50ul) of whole blood, serum or plasma to the “S” well of the test card using the plastic dropper according to the figure.
  3. Add one drop of Sample Diluent to the “S” well immediately after the specimen is added.
  4. Interpret test results at 15 minutes. Do not interpret the results after 30 minutes.

Interpretation of Results

  1. Negative: Only one purplish red colored band appears on the control region.
  2. Positive: In addition to the control band, a distinct colored band also appears on the test region.
  3. Invalid: Neither purplish red test band not purplish red control band appears. The specimen should be tested again using a new device.