R-Biopharm RIDAGENE CMV PG9005 Bedienungsanleitung Seite 37

12. Limitations of the method
1. The diagnosis should not be based on the result of the molecular biological test
alone, but should always take the patient's medical history, symptoms, and all
clinical data into account.
2. This test is validated only for plasma (EDTA) and urine samples.
3. There are no data available on the product's performance when used with
extracted DNA from leukocyte or granulocyte suspensions.
4. The presence of PCR inhibitors can lead to non-evaluable results.
5. This test cannot be used with heparin specimens because heparin inhibits the
amplification reaction.
6. This test cannot be used with samples contaminated with hemoglobin, dextran,
®
Ficoll , ethanol, or 2-propanol.
7. This test cannot be used with extracted DNA that contains a large amount of
human genomic DNA because it can possibly inhibit the amplification reaction.
8. There are exemplary data available on possible inhibitions due to antiviral,
antibiotic, and immunosuppressive medications. No such data are available for
chemotherapeutic medications.
9. The results obtained with this product depend on adequate specimen
identification, extraction, transport, storage, and handling. It is therefore critical to
perform these steps carefully and follow the instructions provided by the
manufacturer of the nucleic acid extraction products. Improper specimen
extraction, transport, storage, and handling can produce false-negative results.
10. Owing to its high analytical sensitivity, the real-time amplification method used in
this test is sensitive to cross-contamination from CMV-positive clinical
specimens, the positive controls, and the same amplification products. Cross-
contamination can produce false-positive results. This product format does limit
cross-contamination; however, only good laboratory practices and adherence to
the instructions for use can prevent cross-contamination.
11. The product may be used only by qualified personnel trained in handling
potentially infectious biological specimens and chemical solutions classified as
hazardous. This requirement should prevent accidents involving possible serious
consequences for the user and other individuals.
12. Use of this product requires work clothing and work areas that are suitable for
handling potentially infectious biological specimens and chemical preparations
classified as hazardous in order to prevent accidents involving possible serious
consequences for the user and other individuals.
13. This product may be used only by qualified personnel trained in performing
molecular biological procedures such as extraction, amplification, and detection
of nucleic acids. This requirement should prevent false results.
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RIDA GENE CMV
2019-05-28
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