Table 2

Results of histological and OSNA tests in different validation series, histology being the gold standard for comparison

Reference (first author)TABHIST+/OSNA+HIST-/OSNA-HIST+/OSNA-HIST-/OSNA+All SLN samplesSENSSPECACCPPVNPVFNRFRR
Tsujimoto 122432762232395.699.398.895.699.34.40.7
Visser247612673833995.397.196.888.498.94.71.1
Schem251310421101533010093.495.587.410000
Tamaki Trial126019101131249597.196.886.49951
Tamaki Trial226107034822044097.294.69577.899.42.80.6
Snook18176631361039591.796.995.986.898.18.31.9
Feldman27191078683020102578.197.795.184.396.721.93.3
Bernet287331381217497.198.698.394.399.32.90.7
Le Frere-Belda14225141351248191.197.296.58198.88.91.2
All9755429355092363191.79796.185.898.38.31.7
  • Case numbers represent lymph node samples, which is slightly higher than the lymph node number, as larger nodes had to be assayed as multiple samples.

  • +, positive (including micrometastases/macrometastases for histology and +/++ results for OSNA); −, negative (including isoltaed tumour cells and copy numbers <250/μl of lysate, respectively); ACC, accuracy (concordance rate of the two tests); FNR, false-negative rate (false-negatives/all positives); FRR, false-reassurance rate (false-negatives/all testing negative); HIST, histological; NPV, negative predictive value; OSNA, one-step nucleic acid amplification; PPV, positive predictive value; SENS, sensitivity; SPEC, specificity; TAB, tissue allocation bias (samples excluded from analysis). Values from SENS to FRR are expressed as percentages.