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. 2022 May;24(5):494–502. doi: 10.1016/j.jmoldx.2022.01.003

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.