The purpose of this trail is to evaluate the performance of Genetron D842V PCR kit in GIST patients using real-time PCR method.
This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron D842V PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. The safety and effectiveness of this kit are confirmed and evaluated.
Study Type
OBSERVATIONAL
Enrollment
1,041
Peking University Cancer Hospital
Beijing, China
Harbin Medical University Cancer Hospital
Harbin, China
Shanghai Tenth People's Hospital
Shanghai, China
Ct Value (Ct Values From PCR Reaction)
the number of PCR cycles where the amplification signal starts to be observed
Time frame: 3 months
PPV
the ratio of true positive in all positive cases
Time frame: 3 months
NPV
the ratio of true negative in all negative cases
Time frame: 3 months
Consistency (the Overall Ratio of True Positive and True Negative)
The overall consistency ratio of true positive and true negative, i.e. (true positive+true negative)/total number of cases
Time frame: 3 months
Kappa coefficient
Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the Genetron D842V PCR kit and sanger sequencing method.
Time frame: 3 months
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