R-Biopharm RIDAGENE CMV PG9005 Bedienungsanleitung Seite 38

14. For manual processing, ensure that sample preparation/extraction, PCR
preparation, and PCR are carried out in different rooms in order to prevent false-
positive results.
15. For manual processing, separate clothing and instruments are required for
sample preparation/extraction, PCR preparation, and PCR in order to prevent
false-positive results during the use of this product.
16. Different technologies have inherent differences. Therefore, before changing
over to a new technology, it is recommended that users carry out correlation
studies on the methods in order to assess the differences between the
technologies.
17. Mutations or polymorphisms in the primer or probe binding sites can interfere
with the detection of new or unknown variants and can lead to false negative
results or influence the quantification of the CMV-DNA using RIDA
18. As with all PCR-based in vitro diagnostic tests, extremely low concentrations of
the target sequences under the limit of detection (LoD) can be detected. The
results obtained are not always reproducible.
19. A negative test result means that the CMV-DNA was not detected in the nucleic
acid extracted from the specimen. It cannot be ruled out, however, that the
pathogen load is below the detection limit (see Section 13, Performance
characteristics). In this case, the result can be a false-negative.
20. A positive test result does necessarily indicate the presence of viable organisms.
A positive result indicates that the organism's DNA is present because the
®
RIDA GENE CMV test detects the target genes for CMV (MIEA gene).
21. In rare cases, the test results can be invalid because the internal control failed,
thus necessitating a repeat test. Repeat testing starting with extraction can delay
final test results.
22. As with all diagnostic products, there is a residual risk that the product may
generate invalid, false-positive or false-negative results. This residual risk cannot
be eliminated or further minimized. In some cases, such as in prenatal or
emergency diagnostics, the residual risk can contribute to incorrect decisions
having potentially dangerous consequences for the patient.
13. Performance characteristics
13.1 Clinical performance characteristics
13.1.1 Diagnostic sensitivity
The diagnostic sensitivity of the RIDA
confirmation of positive clinical specimen material, was confirmed using CMV-
positive clinical specimens. Positive plasma and urine specimens (predetermined
using another real-time PCR method) were extracted using Maxwell
38
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GENE CMV real-time PCR test, defined as
2019-05-28
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GENE CMV.
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RSC (Promega)
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RIDA GENE CMV