| Objective Diagnostic tests were did in this research to evaluate the molecular diagnosis of One-step Nucleic Acid Amplification(OSNA)to evaluate the validity and applicability of the sentinel lymph nodes metastases in breast cancer,to compare with traditional histopathological methods: Touch Imprint Cytology(TIC)and Frozen Section(FS),and to provide the theoretical basis of OSNA in clinical application.Methods1.Indexes were calculate to make use of the evaluation of diagnostic tests principle,including consistency rate,sentivity,specificity,Youden's index,positive predicitive value,negative predicitive value,positive likelihood ratio and negative likelihood ratio,Kappa coefficient.2.To compare the validity and applicability of three different diagnostic methods by McNemar test,the area under the ROC curve and t test.3.Combined dignosis of OSNA and TIC,OSNA and FS were evaluated with serial test and parallel test.Results1.A total 515 patients with breast cancer were enrolled in the present study according with inclusion criteria and exclusion criteria.All of them were female,the range of age was 21~79,the average age was(49.0±12.0).2.For OSNA,the sentivity was 89.8%,the specificity was 89.2%,the consistency rate was 89.3%,the Youden's index was 0.790,the positive predicitive value was 66.2%,the negative predicitive value was 97.4%,the positive likelihood ratio was 8.3,the negative likelihood ratio was 0.114 and the Kappa coefficient was 0.695.For TIC,the sentivity was 83.7%,the specificity was 96.6%,the consistency rate was 94.2%,the Youden's index was 0.803,the positive predicitive value was 85.4%,the negative predicitive value was 96.2%,the positive likelihood ratio was 24.6,the negative likelihood ratio was 0.169 and the Kappa coefficient was 0.809.For FS,the sentivity was 88.8%,the specificity was 98.8%,the consistency rate was 96.9%,the Youden's index was 0.876,the positive predicitive value was 94.6%,the negative predicitive value was 97.4%,the positive likelihood ratio was 74.0,the negative likelihood ratio was 0.113 and the Kappa coefficient was 0.897.3.The difference in performance between OSNA and TIC did not reach significance for sentivity(89.8% vs.83.7%,X~2=1.56,P=0.210).However,significant differences in performance between OSNA and TIC were found in specificity(89.2% vs.96.6%,X~2=21.36,P<0.001).The difference in performance between OSNA and FS did not reach significance for sentivity(89.8% vs.89.0%,X~2=0.00,P=1.000),However,significant differences in performance between OSNA and FS were found in specificity(89.2% vs.98.8%,X~2=33.33,P<0.001).The area under the ROC curve of OSNA,TIC and FS were 0.895,0.902 and 0.938,respectively,significant differences in performance between the area under the ROC curve and the area under the reference line(P <0.001).The difference in performance between OSNA and TIC did not reach significance for area under the ROC curve(Z=0.24,P=0.809),the difference in performance between OSNA and FS did not reach significance for area under the ROC curve(Z=1.92,P=0.054).4.Eliminate first 10 cases,the average time of OSNA was(31.63±4.10)min,the average time of TIC was(32.46±2.60)min,the difference in performance between OSNA and TIC reached significance in detection time(t=-4.09,P<0.001).The average time of FS was(39.98±2.83)min,significant differences in performance between OSNA and FS were found in detection time(t=-38.20,P<0.001).5.The sentivity,specificity,positive predicitive value and negative predicitive value of OSNA and TIC in serial test were 78.6%,98.3%,91.7% and 95.1%,respectively.The sentivity,specificity,positive predicitive value and negative predicitive value of OSNA and TIC in parallel test were 98.0%,88.2%,66.2% and 99.5%,respectively.The sentivity,specificity,positive predicitive value and negative predicitive value of OSNA and FS in serial test were 80.6%,99.8%,98.8% and 95.6%,respectively.The sentivity,specificity,positive predicitive value and negative predicitive value of OSNA and FS in parallel test were 98.0%,88.2%,66.2% and 99.5%,respectively.The area under the ROC curve of four combined tests were 0.884,0.931,0.902 and 0.931,respectively.Significant differences in performance between the area under the ROC curve and the area under the reference line(P <0.001).The difference in performance between OSNA and serial tests did not reach significant differences in performance for area under the ROC curve(P=0.500,P=0.739).The difference in performance between OSNA and parallel tests reached significant differences in performance for area under the ROC curve(P=0.011,P=0.011)?Conclusions OSNA was similar with TIC,FS in sentivity and validity.although OSNA was lower specificity than TIC and FS,OSNA was provided with peculiarity of fast,simple,convenient.Thus OSNA can be an effective rapid intraoperative detection of sentinel lymph nodes metastasis for breast cancer patients. |
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