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In general, the TRAK assay gave results that were identical to the TSI, although one or two of the three calibrators in the critical area of the curve (0 IU/L, 1 IU/L, and 2 IU/L) had to be adjusted in all three of the TRAK assays.
Overall, the TRAK reagents produced results most comparable to the TSI assay.
The other TSI-negative (just below the cutoff) Graves patient was positive in the TRAK assay and the ELISA index.
Because the presence of hematuria is sometimes associated with false-positive BTA TRAK results, it is recommended that upon detection of hematuria by dipstick, that voided urine cytology be performed as well as the BTA TRAK test.
Because only symptomatic patients with clinical signs of bladder cancer or patients with known bladder cancer were included in this study, the decision threshold of an earlier clinical evaluation of the BTA TRAK assay was used to select patients with a bladder tumor.
The precision of the BTA TRAK assay was determined according to the procedures recommended by the NCCLS (13) by testing two controls and five urine samples in duplicate in each of 20 independent analytical runs (1 analytical run/day) at three different laboratories.