Quality indicators in a mycobacteriology laboratory supporting clinical trials for pulmonary tuberculosis.


Selvakumar, N.; Silambuchelvi, K.; Gomathi, S.; Syam Sunder, A.; Anbarasu, S.; Banu Rekha, V.; Ponnuraja, C.;  Kumar, V.


International Journal of Mycobacteriology; 2012; 1; 185-189.   


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 4 years (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 (76–97 days) 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.


Keywords: Quality assurance; Mycobacterium tuberculosis ; Laboratory indicator; Pulmonary tuberculosis




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