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Expansion of Tuberculosis Pleural Effusion Mononuclear Cells in Vitro for Quality Control of Diagnostic Tests
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Deyun JIANG1, Haiping DONG2, Jianrong LOU3, Sihong XU4, Tingmei CHEN1, *, Dawei SHI1, 4, *
Chinese Pharmaceutical Journal | 2025, 60(10) : 1019 - 1025
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Chinese Pharmaceutical Journal | 2025, 60(10): 1019-1025
Expansion of Tuberculosis Pleural Effusion Mononuclear Cells in Vitro for Quality Control of Diagnostic Tests
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Deyun JIANG1, Haiping DONG2, Jianrong LOU3, Sihong XU4, Tingmei CHEN1, *, Dawei SHI1, 4, *
Affiliations
  • 1 College of Laboratory Medicine, Chongqing Medical University, Chongqing 400016, China
  • 2 Guangzhou Key Laboratory of Tuberculosis Research, State Key Laboratory of Respiratory Disease, Department of Tuberculosis, Guangzhou Chest Hospital, Guangzhou 510095, China
  • 3 Guangzhou Leide Medical Laboratory Co., Ltd., Guangzhou 510063, China
  • 4 Key Laboratory of National Health Commission for Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of in Vitro Diagnostics, Division Ⅱ of Diagnostic for Infectious Diseases, National Institutes for Food and Drug Control, Beijing 100050, China
Published: 2025-05-01 doi: 10.11669/cpj.2025.10.003
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OBJECTIVE To explore the feasibility of preparing samples for the quality control of tuberculosis interferon-gamma (IFN-γ) release assays (TB-IGRA) using in vitro expanded tuberculosis pleural fluid mononuclear cells (TB-PFMC). METHODS The cryopreserved TB-PFMC were stimulated and expanded in vitro using three expansion protocols based on CD3/CD28 antibody combined with IL-2, and the status of TB-PFMC was observed and the expansion fold was calculated. The amplification results of three different expansion protocols were compared to determine the optimal protocol. The enzyme-linked immunospot assay (ELISPOT) and enzyme-linked immunosorbent assay (ELISA)TB-IGRA kits were used to detect TB-PFMC before and after the expansion, and the changes of the results were analyzed. RESULTS Protocol 3 was determined to be optimal and used to amplify TB-PFMC from three different patients, and their expansion folds reached 3 535.00 %, 2 800.00 %, and 3 959.00%, respectively, on the 9th day. The results of two TB-IGRA kits after the expansion of TB-PFMC remained positive and no obvious non-specific reactions were observed. CONCLUSION This study proves that TB-PFMC can be successfully amplified by CD3/CD28 antibody combined with IL-2 and the optimal protocol was determined, and the expanded TB-PFMC is suitable for the preparation of reference materials and applied for the quality control of TB-IGRA products.

tuberculosis  /  TB-IGRA  /  quality control  /  T cell expansion  /  pleural fluid
Deyun JIANG, Haiping DONG, Jianrong LOU, Sihong XU, Tingmei CHEN, Dawei SHI. Expansion of Tuberculosis Pleural Effusion Mononuclear Cells in Vitro for Quality Control of Diagnostic Tests[J]. Chinese Pharmaceutical Journal, 2025 , 60 (10) : 1019 -1025 . DOI: 10.11669/cpj.2025.10.003
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doi: 10.11669/cpj.2025.10.003
  • Receive Date：2025-02-08
  • Online Date：2025-11-09
  • Published：2025-05-01
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  • Received：2025-02-08
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Affiliations
    1 College of Laboratory Medicine, Chongqing Medical University, Chongqing 400016, China
    2 Guangzhou Key Laboratory of Tuberculosis Research, State Key Laboratory of Respiratory Disease, Department of Tuberculosis, Guangzhou Chest Hospital, Guangzhou 510095, China
    3 Guangzhou Leide Medical Laboratory Co., Ltd., Guangzhou 510063, China
    4 Key Laboratory of National Health Commission for Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of in Vitro Diagnostics, Division Ⅱ of Diagnostic for Infectious Diseases, National Institutes for Food and Drug Control, Beijing 100050, China
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https://castjournals.cast.org.cn/joweb/zgyxzz/EN/10.11669/cpj.2025.10.003
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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