title: Development of a time-resolved fluoroimmunoassay of CFP-10 for rapid diagnosis of tuberculous pleural effusion.
abstract: Tuberculous pleural effusion is the second most common form of extrapulmonary tuberculosis, which is very difficult to rapidly distinguish from malignant pleural effusion in the clinical setting. A time-resolved fluoroimmunoassay (TRF) of CFP-10, a low molecular weight protein secreted by pathogenic Mycobacterium tuberculosis, was developed to differentiate tuberculous pleural effusion from malignant one. The measuring range was 0.3-187.5 ng/ml with the dose-response coefficient of 0.9998 and detection limit of 0.036 ng/ml. The intra-assay and inter-assay coefficients of variation were 3.6-9.2% and 10.0-12.4%, respectively. The concentration of CFP-10 in malignant pleural effusion was less than 0.8 ng/ml. The negative predictive value was 93.1% in malignant pleural effusion (n = 247) while the positive predictive value was 83.0% in tuberculous pleural effusion (n = 235). Moreover, there was a statistically significant difference in the CFP-10 concentration of pleural effusion between the groups before and after clinical therapy of tuberculosis (P < 0.001, n = 81). In addition, the stability of the diagnostic reagents lasted at least 1 year at 4 °C. Therefore, the TRF of CFP-10 may be used for the rapid diagnosis of tuberculous pleural effusion and further monitoring the clinical therapeutic efficacy of tuberculosis.
authors.affiliation: Zhejiang Provincial Key Lab for Technology & Application of Model Organisms, School of Laboratory Medicine & Life Sciences, Wenzhou Medical University, University Town, Wenzhou, Zhejiang, China.
authors.forename: Jianyi
authors.initials: J
authors.lastname: Lu
authors.affiliation: Zhejiang Provincial Key Lab for Technology & Application of Model Organisms, School of Laboratory Medicine & Life Sciences, Wenzhou Medical University, University Town, Wenzhou, Zhejiang, China.
authors.forename: Lilin
authors.initials: L
authors.lastname: Zou
authors.affiliation: Zhejiang Provincial Key Lab for Technology & Application of Model Organisms, School of Laboratory Medicine & Life Sciences, Wenzhou Medical University, University Town, Wenzhou, Zhejiang, China.
authors.forename: Bin
authors.initials: B
authors.lastname: Liu
authors.affiliation: Zhejiang Provincial Key Lab for Technology & Application of Model Organisms, School of Laboratory Medicine & Life Sciences, Wenzhou Medical University, University Town, Wenzhou, Zhejiang, China.
authors.forename: Xiaoqing
authors.initials: X
authors.lastname: Li
authors.affiliation: Zhejiang Provincial Key Lab for Technology & Application of Model Organisms, School of Laboratory Medicine & Life Sciences, Wenzhou Medical University, University Town, Wenzhou, Zhejiang, China.
authors.forename: Jinrong
authors.initials: J
authors.lastname: Tan
authors.affiliation: Zhejiang Provincial Key Lab for Technology & Application of Model Organisms, School of Laboratory Medicine & Life Sciences, Wenzhou Medical University, University Town, Wenzhou, Zhejiang, China.
authors.forename: Ai
authors.initials: A
authors.lastname: Zhao
authors.affiliation: Zhejiang Provincial Key Lab for Technology & Application of Model Organisms, School of Laboratory Medicine & Life Sciences, Wenzhou Medical University, University Town, Wenzhou, Zhejiang, China.
authors.forename: Chunhui
authors.initials: C
authors.lastname: Xiong
authors.affiliation: Zhejiang Provincial Key Lab for Technology & Application of Model Organisms, School of Laboratory Medicine & Life Sciences, Wenzhou Medical University, University Town, Wenzhou, Zhejiang, China.
authors.forename: Xiang
authors.initials: X
authors.lastname: Li
authors.affiliation: Zhejiang Provincial Key Lab for Technology & Application of Model Organisms, School of Laboratory Medicine & Life Sciences, Wenzhou Medical University, University Town, Wenzhou, Zhejiang, China. Electronic address: jxlu313@163.com.
authors.forename: Jianxin
authors.initials: J
authors.lastname: Lu
authors.affiliation: Zhejiang Provincial Key Lab for Technology & Application of Model Organisms, School of Laboratory Medicine & Life Sciences, Wenzhou Medical University, University Town, Wenzhou, Zhejiang, China. Electronic address: jimingao@yahoo.com.
authors.forename: Jimin
authors.initials: J
authors.lastname: Gao
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000995:Antitubercular Agents / Q000627:therapeutic use; D001426:Bacterial Proteins / Q000378:metabolism*; D015415:Biomarkers / Q000378:metabolism; D003937:Diagnosis, Differential; D005260:Female; D015200:Fluoroimmunoassay; D006801:Humans; D008297:Male; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000378:metabolism*; D010996:Pleural Effusion / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology; D016066:Pleural Effusion, Malignant / Q000175:diagnosis; D011237:Predictive Value of Tests; D013997:Time Factors; D016896:Treatment Outcome; D014396:Tuberculosis, Pleural / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology; D055815:Young Adult
chemical_list: D000995:Antitubercular Agents; D001426:Bacterial Proteins; D015415:Biomarkers; C117940:CFP-10 protein, Mycobacterium tuberculosis
keywords: CFP-10; Pleural effusion; Rapid diagnosis; Time-resolved fluoroimmunoassay; Tuberculosis