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

Table 2.

MTBDRsl Performance on Smear-Negative Sputa at Ramp Rates of 2.2°C/second (Manufacturer-Recommended) or 4.0°C/second (52 Isolates)

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 52/52 (100) 0/52 (0) 0/1300 (0) 0/104§ (0) 52/52 (100)
4.0 51/52 (98), P = 0.315 7/51 (14), P = 0.006 54/1275 (4), P < 0.001 6/102 (6), P = 0.013 41/51 (80), P = 0.001

Data are expressed as n/N (%). Accuracy for Mycobacterium tuberculosis–complex-DNA, and then further analysis of indeterminate rates, incorrect banding calls, and incorrect drug class diagnostic calls were done. The number of valid results [52 of 52 (100%) versus 41 of 51 (80%)] improved by 21% (95% CI, 8–34; P < 0.001). P values are for within-column comparisons between different ramp rates. Significant P values are marked in bold. 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.

Total number of clinical specimens.

TUB-positive strips.

Fifty-two TUB-band–positive strips × 25 bands per strip.

§

Fifty-two TUB-band–positive strips × 2 drug class diagnostic calls.

Fifty-one TUB-band–positive strips × 25 bands per strip.

Fifty-one TUB-band–positive strips × 2 drug class diagnostic calls.