A Feasibility Study for Diagnosis of Latent Tuberculosis Infection Using an IGRA Point-of-Care Platform in South Korea.

Purpose: This study aimed to evaluate ichroma (TM) IGRA-TB, a novel point-of-care platform for assaying IFN-gamma release, and to compare it with QuantiFERON-TB Gold In-Tube (QFT-GIT) for identifying Mycobacterium tuberculosis (M. tb) infection. Materials and Methods: We recruited 60 healthy subjects, and blood samples were obtained in QFT-GIT blood collection tubes. The blood collection tubes were incubated at 37 degrees C, and culture supernatant was harvested after 18-24 hours. IFN-gamma responses were assessed by the ichroma (TM) IGRA-TB cartridge and the QFT-GIT IFN-gamma enzyme-linked immunosorbent assay. Three active TB patients were recruited as a positive control for M. tb infection. Results: The area under the receiver operating characteristic curve of the ichroma (TM) IGRA-TB test for differentiating between infected and non-infected individuals was 0.9706 (p<0.001). Inconsistent positivity between the two tests was found in three participants who showed weak positive IFN-gamma responses (<1.0 IU/mL) with QFT-GIT. However, the two tests had excellent agreement (95.2%,kappa=0.91, p<0.001), and a very strong positive correlation was observed between the IFN-gamma values of both tests (r=0.91, p<0.001). Conclusion: The diagnostic accuracy demonstrated in this study indicates that the ichroma (TM) IGRA-TB test could be used as a rapid diagnostic method for detecting latent TB infection. It may be particularly beneficial in resource-limited places that require cost-effective laboratory diagnostics.