Ads by Google
CE CERTIFICATE
The test is used to obtain a visual, qualitative result and is intended for healthcareprofessional 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 oC in the sealed pouch and underdry conditions. Precautions: 1) It is recommended that all specimens be handled in accordance with biosafety level2) 2 practices as described in the CDC NIH Publication, Biosafety in Microbiological and Biomedical Laboratories2, or other equivalent guidelines 3-43) For in vitro diagnostic use only4) All serum or plasma specimens should be treated as infectious material. Do not contact the test card without wearing safety gloves5) Clean and disinfect all spills of specimens and reagents using a suitable disinfectant, such as 1% sodium hypochlorite6) Devices used for the assay should be sterilized before being disposed7) 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 thirtyminutes 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 oC 5) For storage periods greater than three days, freezing is recommended Materials provided: 1) Test cards, individually foil pouched with a desiccant2) Package insert3) Sample dispensing plastic dropper with each test pouch Materials required but not provided:1) Pipettes to deliver 100pcs of sample2) Positive and negative controls
Anti-TB (Mycobacterium Tuberculosis) Rapid Test(CE)