N Selvakumar1, K Silambuchelvi2, M Gomathi Sekar2, A Syam Sunder2, S Anbarasu2, V Banu Rekha3, C Ponnuraja4, Vanaja Kumar2. 1. Department of Mycobacteriology, National Institute for Research in Tuberculosis (ICMR), Chetpet, Chennai 600031, India. Electronic address: selvakumar.nagamiah@gmail.com. 2. Department of Mycobacteriology, National Institute for Research in Tuberculosis (ICMR), Chetpet, Chennai 600031, India. 3. Department of Clinic, National Institute for Research in Tuberculosis (ICMR), Chetpet, Chennai 600031, India. 4. Department of Statistics, National Institute for Research in Tuberculosis (ICMR), Chetpet, Chennai 600031, India.
Abstract
BACKGROUND: Documentation of structured quality indicators for mycobacteriology laboratories supporting exclusively controlled clinical trials in pulmonary tuberculosis (PTB) is lacking. OBJECTIVE: To document laboratory indicators for a solid (Lowenstein-Jensen medium) culture system in a mycobacteriology laboratory for a period of 4years (2007-2010). METHODS: The sputum samples, collected from PTB suspects/patients enrolled in clinical trials, were subjected to fluorescence microscopy, culture and drug sensitivity testing (DST). Data was retrospectively collected from TB laboratory registers and computed using pre-formulated Microsoft Office Excel. Laboratory indicators were calculated and analyzed. RESULTS: The number of samples processed in a calendar year varied from 6261 to 10,710. Of the samples processed in a calendar year, specimen contamination (4.8-6.9%), culture positives (78.4-85.1%) among smear positives, smear positives (71.8-79.0%) among culture positive samples, smear negatives among culture negative samples (95.2-96.7%), and average time to report DST results (76-97days) varied as shown in parentheses. CONCLUSION: Values of quality indicators in mycobacteriology laboratories supporting exclusively clinical trials of PTB have to be defined and used for meaningful monitoring of laboratories.
BACKGROUND: Documentation of structured quality indicators for mycobacteriology laboratories supporting exclusively controlled clinical trials in pulmonary tuberculosis (PTB) is lacking. OBJECTIVE: To document laboratory indicators for a solid (Lowenstein-Jensen medium) culture system in a mycobacteriology laboratory for a period of 4years (2007-2010). METHODS: The sputum samples, collected from PTB suspects/patients enrolled in clinical trials, were subjected to fluorescence microscopy, culture and drug sensitivity testing (DST). Data was retrospectively collected from TB laboratory registers and computed using pre-formulated Microsoft Office Excel. Laboratory indicators were calculated and analyzed. RESULTS: The number of samples processed in a calendar year varied from 6261 to 10,710. Of the samples processed in a calendar year, specimen contamination (4.8-6.9%), culture positives (78.4-85.1%) among smear positives, smear positives (71.8-79.0%) among culture positive samples, smear negatives among culture negative samples (95.2-96.7%), and average time to report DST results (76-97days) varied as shown in parentheses. CONCLUSION: Values of quality indicators in mycobacteriology laboratories supporting exclusively clinical trials of PTB have to be defined and used for meaningful monitoring of laboratories.