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One Step Anti-TB (Mycobacterium Tuberculosis) Test
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One Step Anti-TB (Mycobacterium Tuberculosis) Test:
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 serum. Two recombinant tuberculosis antigens (TB Ag 1 and 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.
Storage and expiration:
The test kits must be stored at 2 - 30 o C in the sealed pouch and under dry conditions.
Precautions:
1) It is recommended that all specimens be handled in accordance with
biosafety level
2) 2 practices as described in the CDC NIH Publication, Biosafety in
Microbiological and Biomedical Laboratories 2, or other equivalent
guidelines 3-4
3) For in vitro diagnostic use only
4) All serum or plasma specimens should be treated as infectious material.
Do not contact the test card without wearing safety gloves
5) Clean and disinfect all spills of specimens and reagents using a
suitable disinfectant, such as 1% sodium hypochlorite
6) Devices used for the assay should be sterilized before being disposed
7) Do not use beyond expiration date
Specimen collection and preparation:
1) The one step anti-TB (mycobacterium tuberculosis) test may be performed
using human serum or plasma
2) To obtain a serum specimen, collect blood aseptically by venipuncture into a
clean tube without anticoagulants. Permit blood to clot for twenty to thirty
minutes at room temperature. Centrifuge to obtain clear serum and transfer
serum into a clean plastic or glass tube. Specimens containing precipitate
may yield inconsistent test results. Such specimens must be clarified prior
to assaying
3) Alternatively, plasma specimens may be used
4) If the specimens are not tested immediately they should be refrigerated
at 2 - 8 o C
5) For storage periods greater than three days, freezing is recommended
Materials provided:
1) Test cards, individually foil pouched with a desiccant
2) Package insert
3) Sample dispensing plastic dropper with each test pouch
Materials required but not provided:
1) Pipettes to deliver 100pcs of sample
2) Positive and negative controls
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