Table 1.
MTBDRsl Performance on a Dilution Series of Drug-Susceptible-TB and XDR-TB Strains (104, 103, and 102 CFU/mL) at Ramp Rates of 2.2°C/second (Manufacturer-Recommended) or 4.0°C/second (3 Replicates in Triplicate for Each Ramp Rate; 18 Total MTBDRsl Results)
Ramp rate (°C/second) | TUB-band–positive | TUB-band–positive |
|||
---|---|---|---|---|---|
Indeterminate for any gene locus | Incorrect banding call | Incorrect drug class diagnostic call | Valid result | ||
2.2 | 16/18∗ (89) | 2/16† (13) | 22/400‡ (6) | 2/32§ (6) | 14/16† (88) |
4.0 | 17/18∗ (94), P = 0.547 | 3/17† (18), P = 0.680 | 33/425¶ (8), P = 0.193 | 2/34‖ (6), P = 0.950 | 14/17† (82), P = 0.680 |
Data are expressed as n/N (%). Accuracy for M. tuberculosis–complex-DNA (TUB-band) and then further analysis of indeterminate rates, incorrect banding calls, and incorrect drug class diagnostic calls were done. No significant differences were seen between ramp rates using dilution series. P values are for within-column comparisons between different ramp rates. CFU, colony-forming units; Incorrect banding call, the presence or absence of a band deviating from the true banding call; Incorrect drug class diagnostic call, the presence or absence of banding patterns resulting in deviation of the true susceptibility to a drug class; Indeterminate, one or more gene locus control is absent; MTBDRsl, GenoType MTBDRsl VER 2.0; TB, tuberculosis; TUB-band–positive, positive for Mycobacterium tuberculosis–complex-DNA; Valid result, TUB-band–positive, determinate for all gene locus controls, thus having diagnostic calls for both drug classes; XDR, extensively drug resistant.
Two strains × 3 replicates × 3 dilutions.
TUB-positive strips.
Sixteen TUB-band–positive strips × 25 bands per strip.
Sixteen TUB-band–positive strips × 2 drug class diagnostic calls.
Seventeen TUB-band–positive strips × 25 bands per strip.
Seventeen TUB-band–positive strips × 2 drug class diagnostic calls.