Objective: To determine the validity of tuberculosis (TB) antigen cocktail (ESAT-6, CFP-10 and MPT64) for pulmonary tuberculosis and TB meningitis diagnosis.Methods: This is a descriptive observational study design. The study was conducted at the Clinical Pathology Laboratory of Dr. Hasan Sadikin General Hospital during September 2012 until March 2013 for the pulmonary tuberculosis study and from January 2014 to May 2014 for the TB meningitis study. The TB antigen cocktail rapid immunochromatography (ICT) test was conduncted on all samples. The sputum and cerebrospinal fluid (CSF) were cultured as gold standards.Results: There were 149 pulmonary and 41 TB meningitis subjects. The sensitivity of rapid ICT TB antigen cocktail for diagnosing pulmonary tuberculosis was 95.7% with a specificity of 87.2%. Of 41 TB meningitis subjects, based on Marais criteria, there were 6 (16%) subjects with a definite TB meningitis, 26 (63%) subjects with probable TB meningitis, and 9 (21%) subjects with possible TB meningitis. The sensitivity and specificity of TB antigen cocktail rapid ICT for TB meningitis diagnosis were 83.3% and 68.5%, respectively.
Conclusions:In this study, rapid ICT TB antigen cocktail (ESAT-6, CFP-10 and MPT64) from sputum sample has good validity for diagnosing a pulmonary tuberculosis. Cerebrospinal fluid sample has moderate validity to diagnose TB meningitis.
The early diagnosis of definite tuberculous meningitis (TBM) is very important in reducing its mortality. The current gold standard ofTBM relies on the isolation of M. tuberculosis from cerebrospinal fluid (CSF) either with direct staining or M. tuberculosis culture, but theseexamination have a low sensitivity due to the pausibasilary condition. Recently there is an assay using rapid Immunochromatography(ICT) cocktail antigen TB in CSF to diagnose TBM. This method can detect ESAT-6, CFP-10 and MPT-64 antigen as an important virulencefactor for the spreading of bacteria to extra pulmonary which is secreted by M. tuberculosis in CSF from TBM patient. The aim of thisstudy was to know the validity of rapid ICT cocktail antigen TB using CSF against MODS culture and acid-fast bacili as a gold standardto diagnose TBM by analyzing. This study iscarried out by a descriptive observational study using cross sectional study design. Thesubjects are patients who were diagnosed as suspected TBM based on Marais criteria and were obtained from the Department of NeurologyHospital Dr. Hasan Sadikin. The examination was done at the Clinical Microbiology Department of Clinical Pathology Dr. Hasan Sadikinhospital since January 2014 until May 2014. A total of 41 subjects which consisted of six (6) subjects with a definite diagnosis of TBM,26 with probable TBM and nine (9) with possible TBM were enrolled in this study. The result of this assay againts acid-fast bacili has the100% sensitivity, 64.1% specificity, 12.5% PPV, 100% NPV, LR(+) 2.78, LR(–)0 and 65.8% accuracy. The result of this assay againtsM. tuberculosis culture has the 83.3% sensitivity, 68.5% specificity, PPV 31.2%, NPV 96%, LR(+) 2.65, LR(–)0.24, accuracy 70.7% andprevalence ratio 7.8. Based on this study, it can be concluded that the validity of this assay againts acid-fast bacili has a high sensitivity,moderate specificity, low PPV, high NPV and moderate accuracy. The result of this assay againts M. tuberculosis culture has a moderatesensitivity and specificity, low PPV, high NPV and moderate accuracy.
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