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結果 (繁體中文) 1:

粉絲們已經死了

結果 (繁體中文) 2:

Reagent logs, protocol summaries, and run reports for each staining run demonstrate that Requirements 23.2 and 11.4 have been met.
Data was assessed to determine whether requirements have been met.
The PRD Requirement 18.1 for background acceptability states that 90% of slides should have acceptable background scores of less than or equal to 0.5.
However, because this study used TMA slides in addition to full tissue slides, this requirement was expanded to evaluate background acceptability on each individual tissue core for TMA.
Platform to Platform Equivalence Analysis
Overall percent agreement(OPA)between the assays stained on BenchMark ULTRA, XT and GX were calculated.
Unevaluable cores were not included the 2x2 tables or in the following calculations.
Agreement rates are calculated as follows for each platform-to-platform equivalency pairwise comparison(ULTRA to GX, ULTRA to XT and XT to GX):
Negative Percent Agreement(NPA)=(d/(d+b))×100%
An additional analysis was completed on the staining intensity between platforms without acceptance criteria.
Agreement on staining intensity per case will be defined as being 1 score unit away or less between platforms(i.e. if XT has stain intensity of 1.5 and ULTRA has stain intensity of 3.0 then this would result in a disagreement between platforms).
An overall percent agreement(OPA)will be calculated for each platform pairwise comparison:GX vs. ULTRA, ULTRA vs. XT, and GX vs. XT.
The sample size per comparison of 150 cases with a 90% concordance will result in a two-sided, 95% lower bound confidence interval of 84.2%.
This report presents data collected from separate protocols:MLH1-D115042, PMS2-D115044, MSH2- D113867 and MSH6-D112793.
VENTANA anti-MLH1(M1)Data Analysis(Protocol D115042)
Additional analysis looked at the captured stain intensity scores to assess platform-to-platform reproducibility of VENTANA anti-MLH1(M1).
An OPA of 95.0%(441/464)was calculated for VENTANA anti-MLH1(M1)as shown in Table 3.
Reproducibility was previously assessed in a formal verification study using full tissue sections of CRC(D117055)and provided an OPA of 100%(90/90).
Table 2:MLH1 Platform-to-Platform Equivalency(Status Agreement for Each Tissue Case)
Table 3:MLH1 Platform-to-Platform Reproducibility Within 1.0 Staining Intensity for Each Tissue Case
Catalog ID
#of Observations Within 1.0 S.I. for the TMA core
Note:The 95% CIs are included in parentheses using the Wilson(Score)method.
VENTANA anti-MLH1(M1)background analysis demonstrated a 99.7%(630/632)background acceptability rate.
Biostatistics analysis reports for VENTANA anti-MLH1(M1)background acceptability rate may be found in Attachment 13.15.
Agreement on staining intensity per case was defined as being 1 score unit away or less between platforms.
#of Observations Within 1.0 S.I. for the CRC case
Data Analysis:Unevaluable TMA cores(CO8010 and COC1021)
The MMR IHC panel assays provide a unique opportunity to analyze each core across a TMA stained with all MMR m ...

結果 (繁體中文) 3:

風扇來了