R-Biopharm RIDAGENE CMV PG9005 Bedienungsanleitung Seite 42

13.3 Analytical specificity

The RIDA GENE CMV real-time PCR test is specific for human CMV from plasma
(EDTA) and urine. A theoretical sequence comparison of the existing nucleotide
databases showed a specificity for CMV and no significant homology with other
organisms such as HHV6 (entire genome).
Furthermore, different organisms were also tested. No cross-reactivities with the
following species were detected (see Table 16):
Table 16: Cross-reactivity testing
Herpes simplex
virus 1 strain
McIntyre
Herpes simplex
virus 2 strain MS
Varicella zoster
virus type B
13.4. Interfering substances
®
The RIDA GENE CMV real-time PCR was validated for human EDTA plasma
samples and urine. No interference with the following substances was detected (see
Table 17 and Table 18):
Table 17: List of substances and concentrations used in the test (EDTA plasma)
Substance/additive
Cholesterol
Azathioprine
Cyclosporine
Ganciclovir
Prednisone 50 mg (Prednisone)
Efavirenz
Ritonavir
Rifampicin
Cotrimoxazole
42
Epstein-Barr
- virus B95-8
strain
Human
- herpesvirus
type 6B
Human
- herpesvirus
type 7
2019-05-28
Human
- herpesvirus
type 8
- JC polyomavirus
- Hepatitis C virus
Concentration
3 mg/ml
4 mg/l
1,125 g/l
32 mg/l
0.5 mg/l
10 mg/l
20 mg/l
100 mg/l
200 mg/l
HIV-1 virus
-
-
-

RIDA GENE CMV
-