PMID- 35181626 OWN - NLM STAT- MEDLINE DCOM- 20220404 LR - 20220405 IS - 1550-8080 (Electronic) IS - 0091-7370 (Linking) VI - 52 IP - 1 DP - 2022 Jan TI - ROP-ESAT6-CFP10 as Tuberculosis-Specific Antigen in Interferon Gamma Release Assay. PG - 126-132 AB - OBJECTIVE: The ROP-ESAT6-CFP10 antigen (Changzhou Niujin Shisong Biotech [CBI], China) was recently developed using recombinant overlapping peptide (ROP) technology. We used ROP-ESAT6-CFP10 as a tuberculosis (TB)-specific antigen and compared it with existing interferon-gamma release assays (IGRAs). METHODS: Healthy volunteers and patients who were diagnosed with TB within a one-year period were enrolled. Samples were tested with QuantiFERON-TB Gold (QFT; QIAGEN Sciences Inc., USA), T-SPOT.TB (Oxford Immunotec, UK), and ELISpot using ROP-ESAT6-CFP10 as a TB-specific antigen (ROP-TB). For ROP-TB, two concentrations (1 mug and 5 mug) of ROP-ESAT6-CFP10 were used as TB-specific antigens. Agreement between assays was evaluated. RESULTS: A total of 35 TB patients and 20 healthy volunteers were evaluated. Agreement between T-SPOT.TB and ROP-TB 1 mug, QFT and ROP-TB 1 mug, and ROP-TB 1 mug and ROP-TB 5 mug/mL were 79.1% (kappa=0.483), 76.7% (kappa=0.557), and 95.3% (kappa=0.894), respectively. The median number of spots between the T-SPOT.TB and ROP-TB assays in the TB patients had no significant difference. CONCLUSIONS: ELISpot using newly developed ROP-ESAT6-CFP10 showed good agreement with T-SPOT.TB and QFT. Since ROP technology can lower the manufacturing cost, ROP-ESAT6-CFP10 might work as a good source of TB-specific antigen for IGRAs. CI - Copyright (c) 2022 by the Association of Clinical Scientists, Inc. FAU - Kim, Moon Jung AU - Kim MJ AD - Department of Laboratory Medicine, Myongji Hospital, Hanyang University Medical Center, Goyang, Korea. FAU - Ha, Eun-Hye AU - Ha EH AD - Division of Pulmonary and Critical Care Medicine, Myongji Hospital, Hanyang University Medical Center, Goyang, Korea. FAU - Lee, Young-Kwan AU - Lee YK AD - MJCELL-BIO Inc., Research and Development Center, Goyang, Korea. FAU - Park, Sang Joon AU - Park SJ AD - Division of Pulmonary and Critical Care Medicine, Myongji Hospital, Hanyang University Medical Center, Goyang, Korea. FAU - An, Chang Hyeok AU - An CH AD - Division of Pulmonology, Department of Internal Medicine, Hanil General Hospital, Seoul, Korea. FAU - Park, So-Yeon AU - Park SY AD - Department of Rheumatology, Myongji Hospital, Hanyang University Medical Center, Goyang, Korea. FAU - Kim, Soo-Kyung AU - Kim SK AD - Department of Laboratory Medicine, Myongji Hospital, Hanyang University Medical Center, Goyang, Korea skkim1@ewha.ac.kr. AD - Department of Laboratory Medicine, Ewha Womans University College of Medicine, Seoul, Korea. LA - eng PT - Journal Article PL - United States TA - Ann Clin Lab Sci JT - Annals of clinical and laboratory science JID - 0410247 RN - 0 (Antigens, Bacterial) SB - IM MH - Antigens, Bacterial MH - China MH - Humans MH - Interferon-gamma Release Tests MH - *Latent Tuberculosis/diagnosis MH - *Mycobacterium tuberculosis MH - Tuberculin Test MH - *Tuberculosis/diagnosis OTO - NOTNLM OT - Interferon gamma release assay OT - Latent tuberculosis infection OT - Overlapping peptide EDAT- 2022/02/20 06:00 MHDA- 2022/04/05 06:00 CRDT- 2022/02/19 05:29 PHST- 2022/02/19 05:29 [entrez] PHST- 2022/02/20 06:00 [pubmed] PHST- 2022/04/05 06:00 [medline] AID - 52/1/126 [pii] PST - ppublish SO - Ann Clin Lab Sci. 2022 Jan;52(1):126-132.