Objectives: To evaluate the performance of FASTPlaqueTB™, phage-based test, for the rapid diagnosis of Mycobacterium tuberculosis (TB) in individuals with clinically suspected mycobacterial urinary tract infection with no previous history of Anti Tuberculosis Treatment, presenting at Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India, a tertiary care hospital. Methods: This comparative study between conventional methods and rapid FAST-PlaqueTB™ assay was performed for Urine samples of 50 patients with clinical suspicion of tubercular etiology of Urinary tract infection of immunocompromised patients [Diabetes mellitus (14), AIDS (13), Renal transplant recipient (9), Malignancies (7), End stage renal disease/Chronic renal failure (6), Systemic lupus erythematosus (1)]. Microscopy (Ziehl- Neelsen staining), Culture (Lowenstein Jensen Medium and BACTEC medium), NAP test, in-house IS6110-based PCR and FAST-PlaqueTB™ were performed. Results: The sensitivity, specificity and overall accuracy of Ziehl-Neelsen stain were 71.42%, 90.69% and 88% respectively. The sensitivity, specificity and overall accuracy of PCR were 80%, 100% and 98% respectively. The sensitivity, specificity and overall accuracy of FASTPlaqueTB™ were 100%. Conclusions: FAST-PlaqueTB™ is a rapid, manual test for the diagnosis of Mycobacterium tuberculosis. This test has significantly higher sensitivity compared with smear microscopy. The 100% sensitivity of FAST-PlaqueTB™ was higher than that of the corresponding values for PCR (80%). The FAST-PlaqueTB™ test is easy to perform, requires no dedicated equipment, and results are read by eye within 48 hours. This test can be useful for the diagnosis of TB in developing countries with a high incidence of TB where other rapid diagnostic tests may not be appropriate. FASTPlaqueTB™ test shows promising performance for urinary TB and could be chosen as the method of choice for rapid diagnosis of urinary TB.
Jain, S., Nag, V. L., Marak, R. S. K., Prasad, N., & Dhole, T. N. (2010). PP-225 Evaluation of a rapid FAST-PlaqueTBTM, phage-based test for the detection of Mycobacterium tuberculosis in urine samples. International Journal of Infectious Diseases, 14, S93. https://doi.org/10.1016/s1201-9712(10)60293-7