Several ELISA tests based on mycobacterial antigens have been used for the rapid diagnosis of tuberculosis (TB), although demonstration of Mycobacterium tuberculosis in a smear or culture is the most reliable method. In the present study, the diagnostic value of 16-kDa and 38-kDa mycobacterial antigens was investigated in patients who were diagnosed with tuberculosis by clinical and/or bacteriological findings in Turkey.The PATHOZYME-TB Complex Plus commercial ELISA kit was used for measuring immunoglobulin G against 38-kDa and 16-kDa recombinant antigens. Humoral immune response was analysed in a group of 179 TB patients (143 smear-positive, 19 smear-negative, eight lymphadenitis and nine pleuritis), 15 inactive TB cases and in control groups consisting of 40 healthy volunteers and 20 subjects with pulmonary diseases other than TB.The sensitivity, specifity, positive predictive value and negative predictive value of the test were determined at 52.5%, 93.3%, 95.9% and 39.7%, respectively in TB cases. Antibodies were detected at above cut-off level in three (20%) out of 15 subjects with inactive TB.In conclusion, the ELISA test has a very good specifity and an acceptable sensitivity and positive predictive value. It is thought that it could be used in combination with other methods to increase diagnostic accuracy, especially for culture-negative tuberculosis cases, which are difficult to diagnose.

Although the sensitivity and specificity of nucleic acid amplification assays are high with smear-positive samples, the sensitivity with smear-negative and extrapulmonary samples for the diagnosis of tuberculosis in suspicious tuberculosis cases still remains to be investigated. This study evaluates the performance of the GenoType Mycobacteria Direct (GTMD) test for rapid molecular detection and identification of the Mycobacterium tuberculosis complex and four clinically important nontuberculous mycobacteria (M. avium, M. intracellulare, M. kansasii, and M. malmoense) in smear-negative samples. A total of 1,570 samples (1,103 bronchial aspiration, 127 sputum, and 340 extrapulmonary samples) were analyzed. When we evaluated the performance criteria in combination with a positive culture result and/or the clinical outcome of the patients, the overall sensitivity, specificity, and positive and negative predictive values were found to be 62.4, 99.5, 95.9, and 93.9%, respectively, whereas they were 63.2, 99.4, 95.7, and 92.8%, respectively, for pulmonary samples and 52.9, 100, 100, and 97.6%, respectively, for extrapulmonary samples. Among the culture-positive samples which had Mycobacterium species detectable by the GTMD test, three samples were identified to be M. intracellulare and one sample was identified to be M. avium. However, five M. intracellulare samples and an M. kansasii sample could not be identified by the molecular test and were found to be negative. The GTMD test has been a reliable, practical, and easy tool for rapid diagnosis of smear-negative pulmonary and extrapulmonary tuberculosis so that effective precautions may be taken and appropriate treatment may be initiated. However, the low sensitivity level should be considered in the differentiation of suspected tuberculosis and some other clinical condition until the culture result is found to be negative and a true picture of the clinical outcome is obtained.Acid-fast smear examination and culture (liquid-and solidbased media, automated and semiautomated systems) are conventional techniques for microbiological detection of mycobacteria causing tuberculosis (TB) (14, 24). However, the sensitivity of smear has been variable (range, 20 to 80%) (1). In some smear-negative cases, TB might be difficult to differentiate from a number of other clinical pictures. Therefore, invasive medical procedures are necessary for sampling of patients from whom a qualified sputum sample cannot be obtained or in case of extrapulmonary TB, which requires histopathological, cytopathological, and microbiological examination of tissue specimens and body fluids. Nucleic acid amplification (NAA) techniques have been used for early detection of causative mycobacteria in clinical samples and also to support the clinical and radiological diagnosis in patients with presumptive Mycobacterium tuberculosis infection (3,19,33). Although the specificity values obtained with both smear-positive and smear-negative samples are high, the sensitivities of molecular assays are rather less w...

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AIM: The aim of the present study was to evaluate pre-treatment concentrations of leptin in patients with advanced lung cancer and to investigate possible associations between their levels and clinicopathological variables, response to therapy and overall survival. MATERIAL AND METHODS: There are 71 previously untreated patients with cytological or histological evidence of primary lung cancer who were admitted to the oncology department between November 2013 and August 2014. Forty-fi ve healthy individuals with age, sex and BMI matching the lung cancer patients, were recruited to take part in the study as a control group. Leptin levels were measured quantitatively by using a microELISA kit. RESULTS: The serum leptin levels at diagnosis were signifi cantly lower in lung cancer patients than those in control subjects (4.75 ± 4.91 ng/ml, 9.67 ± 8.02 ng/ml; p < 0.001). We did not fi nd any signifi cant difference in leptin values related to clinicopathological parameters such as ECOG PS, weight loss, histological type, disease stage and TNM classifi cation. Nevertheless, we demonstrated a signifi cant correlation between serum leptin levels and BMI in lung cancer patients (correlation coeffi cient: 0.303; p > 0.010). The analysis of serum leptin values did not show any association with the overall survival of the patients. CONCLUSION: Our results showed that the serum leptin level has no prognostic indications in advanced lung cancer patients. Leptin is decreased in lung cancer, and there is lack of correlation with tumour-related factors including prognosis. Therefore, leptin is not a useful clinical marker in lung cancer (Tab. 2, Fig. 2, Ref. 22). Text in PDF www.elis.sk.