R-Biopharm RIDAGENE CMV PG9005 Bedienungsanleitung Seite 34

11. Evaluation and interpretation
11.1 Qualitative interpretation
The sample evaluation of the results takes place as per Table 7.
Table 7: Interpretation of the results
CMV
Positive
Negative
Negative
CMV is detected if the sample DNA and the Internal Control DNA (ICD) show an
amplification signal in the detection system.
CMV is also detected if the sample DNA shows an amplification signal but none for
the Internal Control DNA (ICD) in the detection system. Detecting the Internal
Control DNA (ICD) is not necessary in this case because high amplicon
concentrations can cause a weak or absent signal of the Internal Control
DNA (ICD).
CMV is not detected if the sample DNA shows no amplification signal but the
Internal Control DNA (ICD) shows an amplification signal in the detection system
according to the criteria in Table 7. An inhibition of the extraction and/or PCR
reaction can be ruled out by the detection of the Internal Control DNA (ICD).
A sample is invalid if the sample DNA and the Internal Control DNA (ICD) show no
amplification signal or a Ct value of > 35 in the detection system. There are PCR
inhibitors in the specimen, or an error occurred during the extraction process.
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ICD
Positive/negative
Positive/Ct ≤ 35
Negative/Ct > 35
2019-05-28
Result
CMV detected
Target gene is not detected
Invalid
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RIDA GENE CMV