Table 3.
Results of discordant case investigation between OSNA and histology (H&E Staining and CK19 IHC
| No. | Stage UICC |
Histology | OSNA | qRT-PCR | Conclusion | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| size | description | original run copies/μL | +/- | second run1 copies/μL | +/- |
beta-actin +/- |
CK19 +/- |
CEA +/- |
|||
| 1 | IV | 8 mm | Macrometastasis, only in slice b, not d | <250 | - | 5470 | ++ | + | + | + | Discordant Sample mix-up |
| 2 | III | m | Macrometastasis, calcified tissue | <250 | - | 0 | - | + | + | - | Discordant Beta-actin and CK19 value near the cut-off level |
| 3 | IV | 3 mm | Macrometastasis, only level 2 | <250 | - | <250 | - | + | - | - | Tissue allocation bias |
| 4 | IIA | - | negative | 540 | + | <250 | - | + | - | - | Discordant Low copy |
| 5 | IIA | - | negative | 1300 | + | <250 | - | + | - | - | Discordant |
| 6 | IV | negative | 1300 | + | 290 | + | + | - | + | Tissue allocation bias | |
| 7 | IIIA | 3.5 mm | Positive with IHC in level 1 | 25000 | ++ | 53700 | ++ | + | + | + | Tissue allocation bias |
| 8 | IB | - | negative | 27000 | ++ | <250 | - | + | - | - | Discordant Sample mix-up |
OSNA: ++: CK19 mRNA copies/μL higher than 5000, +:CK19 mRNA between 250 - 5000 copies/μL, -: CK 19 mRNA copies/μL less than 250, 1The indicated copy number is the mean of three OSNA runs, QRT-PCR: +: positive, -: negative.