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Abstract
Purpose
The purpose of this study was to evaluate silver in situ hybridization (SISH) as an effective test to identify HER2 gene amplification in patients with breast cancer.
Methods
A systematic literature review was used to evaluate the effectiveness of SISH. The literature review covered from October 27, 2009 to December 1, 2009, and eight domestic databases including KoreaMed and foreign databases including Ovid-MEDLINE, EMBASE, and Cochrane Library were used. Keywords, such as 'silver in situ hybridization' and 'SISH', were used to search 63 documents. Ten studies regarding the evaluation of diagnostics were included in the final evaluation. The Scottish Intercollegiate Guidelines Network (SIGN) tool was used by two evaluators to independently evaluate the quality of the ten studies.
Results
A total of ten studies (nine diagnostic evaluation studies and one correlation study) were identified to evaluate SISH. The effectiveness of this test was evaluated based on diagnostic accuracy, concordance rate, and correlation with fluorescence in situ hybridization (FISH) results. The sensitivity of SISH was 0.81-1.00, and the specificity was 0.82-1.00. The positive predictive value was 0.95-1.00, negative predictive value was 0.81-1.00, and the test accuracy was 0.90-1.00. The concordance rate of SISH was 87.0-100% and two studies reported a correlation with FISH results. The body of evidence as a whole suggests a Grade D for SISH.
Figures and Tables
Figure 1
Documents selected for evaluation of silver in situ hybridization according to the literature search strategy.
Figure 2
Diagnostic meaning of silver in situ hybridization (fixed-effect model).
OR=odds ratio; CI=confidence interval.
Figure 3
Receiver operating characteristics (ROC) curve of silver in situ hybridization (area under the curve [AUC]=0.9872).
Table 3
Levels of evidence (From Scottish Intercollegiate Guidelines Network. SIGN 50: a guideline developer's handbook) (4)
Table 4
Grades of recommendations (From Scottish Intercollegiate Guidelines Network. SIGN 50: a guideline developer's handbook) (4)
References
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