Development and evaluation of a novel multiple-antigen ELISA for serodiagnosis of tuberculosis.
In this study, we describe the development and evaluation of a novel multiple-antigen ELISA for rapid diagnosis and screening of active tuberculosis (TB). The humoral immune responses of 136 active TB patients and 57 healthy subjects against antigens Rv3425, 38kDa and lipoarabinomannan (LAM) from Mycobacterium tuberculosis H37Rv were examined by ELISA. Three essential results were obtained. (i) Rv3425 antigen is a potential candidate for serodiagnosis of active TB. Of 136 active TB patients, Rv3425 antigen provided a sensitivity of 31.6%, lower than that of LAM antigen, but higher than that of 38kDa antigen, with an overall specificity of 100%. (ii) For 62 smear-negative pulmonary TB patients and 15 extra-pulmonary TB patients, the multiple-antigen test provided a sensitivity of 43.5% and 26.7%, respectively, representing an improvement over acid-fast bacilli (AFB) smear-based diagnosis. (iii) Compared with the single-antigen ELISA and the two available commercial kits, the multiple-antigen test offered the highest accuracy (71.0%). In conclusion, the multiple-antigen ELSIA test based on Rv3425, 38kDa, and LAM antigens is a potentially useful tool for the serodiagnosis and screening of active TB. Combinations of Rv3425 with other mycobacterial antigens may also be worthy of further investigation.
Zhang
Shu-Lin
SL
State Key Laboratory of Genetic Engineering, Institute of Genetics, Fudan University, No. 220 Handan Road, 200433 Shanghai, PR China.
Zhao
Jun-Wei
JW
Sun
Zhan-Qiang
ZQ
Yang
En-Zhuo
EZ
Yan
Ji-Huan
JH
Zhao
Qi
Q
Zhang
Guo-Long
GL
Zhang
Hong-Mei
HM
Qi
Yuan-Ming
YM
Wang
Hong-Hai
HH
Sun
Qing-Wen
QW
D000293:Adolescent; D000328:Adult; D000368:Aged; D000942:Antigens, Bacterial / Q000235:genetics / Q000276:immunology*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D005838:Genotype; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D008070:Lipopolysaccharides / Q000276:immunology; D008297:Male; D008875:Middle Aged; D012336:RNA, Ribosomal, 16S / Q000235:genetics; D012338:RNA, Ribosomal, 23S / Q000235:genetics; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods*; D014376:Tuberculosis / Q000175:diagnosis* / Q000276:immunology; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis / Q000276:immunology; D055815:Young Adult
D000942:Antigens, Bacterial; D007074:Immunoglobulin G; D008070:Lipopolysaccharides; D012336:RNA, Ribosomal, 16S; D012338:RNA, Ribosomal, 23S; D011933:Reagent Kits, Diagnostic; C050016:lipoarabinomannan; C072681:Mycobacterium tuberculosis antigens