NMPARegistration Certificate No.: | GXZZ 20183400233 |
Specification: | 12*8 well strips (32 tests) |
Sample Type: | Peripheral blood and non-blood samples such as pleural effusion, seroperitoneum and cerebrospinal fluid. |
Clinical Significance: | The infection status of mycobacterium tuberculosis in human is judged via in vitro testing of the specific T cell immune response of mycobacterium tuberculosis in the peripheral blood of human. |
Principles and Technology Platform: | γ-interferon gamma release assay (IGRA), and enzyme linked immunospot assay (ELISPOT) |
The testing antigen of I-SPOT.TB product comes from the major special project of infectious diseases in the 12th Five-Year Plan (2013ZX10003001-002), and the special patented antigen mixed with ESAT 6 and CFP-10 improves the sensitivity of tuberculosis detection.
I-SPOT.TB is more suitable for testing of tuberculosis infection in special populations such as the immunocompromised people. Expert Opinions on Mycobacterium Tuberculosis γ-Interferon Release Test and Clinical Application (2021) suggests that ELISPOT (I-SPOT.TB) methodology should be prioritized for patients with immunosuppression.
Not affected by BCG vaccine and most environmental mycobacteria NTM
It has no restriction of specimen types, and is applicable to whole blood specimens and non-blood specimens. Expert opinions on clinical application of interferon‐γ release assay of Mycobacterium tuberculosis (2021 edition)suggests that ELISPOT (I-SPOT.TB) methodology is an effective supplement and auxiliary aid for the diagnosis of active extrapulmonary tuberculosis.
No standard curve required, single testing possible, no reagent loss
It is equipped with the only automatic spot counter with independent intellectual property rights in China (HXZZ 20192220535), which can automatically interpret the results without artificial subjective influence. The instrument can be connected to the LIS system. Results are automatically uploaded to the hospital system, reducing the workload of inspectors
Fosun Diagnostics has been deeply engaged in the field of tuberculosis diagnosis IGRA for more than ten years, established professional service standards for tuberculosis diagnosis, built a strong technical service team, and provided professional terminal laboratory services.