Intended use

The LIOFeron®TB/LTBI is a 2 component kit consisting of HUMAN BLOOD STIMULATION TUBES (component 01) and HUMAN IFN-γ ELISA (component 02) for diagnosing Latent TB Infection (LTBI)/TB. As for other Interferon Gamma Release Assay (IGRA) tests on the market, this test may react positive in TB patients also, but it cannot differentiate between LTBI and active TB. The test is intended for professional in vitro diagnostic use. The test is NOT intended for personal use.

Principle

 

The LIOFeron®TB/LTBI is a cytokine release assay based on the fact, that cells from human blood will secrete IFN-γ when exposed to special M. tuberculosis antigens.

The HUMAN BLOOD STIMULATION TUBES contain a positive control tube, a negative control tube and TB antigen tubes for each patient. The human blood sample (heparinized) is taken from the patient by venepuncture and 1 mL each is pipetted into negative-, positive- and TB antigen tubes. The tubes are gently mixed by shaking upside down and placed into a 37°C incubator overnight. Next, the clear supernatant (human plasma) is carefully removed and analysed using HUMAN IFN-γ ELISA which quantitates the amount of IFN-γ produced in response to the antigens from M. tuberculosis. These special antigens are distinguishable from those present in BCG and most other non‑tuberculous mycobacteria.

For detailed description of HUMAN IFN-γ ELISA which is based on the principle of the enzyme immunoassay (EIA) refer to the corresponding instructions for use.

Measuring IFN-γ level at once by using HUMAN IFN-γELISA. Quick Reference Guide of Procedure: Schematic test procedure of using HUMAN BLOOD STIMULATION TUBES.

 Also available:

  • Lithium Heparin single tubes for blood collection (for better control over correct specimen handling)
  • Stand-Alone Software for data analysis
  • Fully-automation solutions

Further information and assay details are available on request. Please call us or send us an e-mail.