Clinical Significance |
This test is a blood-based interferon-gamma release assay (IGRA) used as an aid in the diagnosis of Mycobacterium tuberculosis infection. It is an immune response-based, indirect test for M tuberculosis infection (including disease) and is intended for use in conjunction with risk assessment, radiography, and other medical and diagnostic evaluations. Additional testing is needed to determine if a person who has tested positive has latent tuberculosis (TB) infection or TB disease.
This in vitro diagnostic test uses a peptide cocktail simulating ESAT-6, CFP-10, and TB7.7 proteins to stimulate cells in heparinized whole blood. Detection of interferon-γ (IFN-γ) by ELISA is used to identify in vitro responses to those peptide antigens that are associated with Mycobacterium tuberculosis infection. |
Remark |
[Specimen handling method]
① Record patient information and collection time on a dedicated container (4 tubes).
② After collecting blood of 1.0 mL each in the order of gray (Nil) → green (TB1 antigen) → yellow (TB2 antigen) → purple (Mitogen), perform inversion mix 10 times (or repeat for 5 seconds) so that the contents (antigen) on the wall of the dedicated container are mixed well with the blood.
③ After blood collection, the dedicated container must be upright and stored at room temperature, and arrive at the laboratory within 16 hours.
[Precautions]
① Comply with specimen volume (collect 1.0 mL of blood in each dedicated container)
② After blood collection, the dedicated container must be upright and stored and transported at room temperature (within 16 hours)
③ Unable to request before a public holiday |