R-Biopharm RIDAGENE CMV PG9005 Bedienungsanleitung Seite 40

13.2 Analytical sensitivity
13.2.1 Device detection limit
The analytical sensitivity of the individual real-time PCR devices was verified for 10
DNA copies/reaction with 50 replicates on each real-time PCR device. The results
are summarized in Table 13.
Table 13: Confirmation of detection limit of the real-time PCR devices listed
Real-time PCR device
®
LightCycler 480II
Rotor-Gene Q
TM
CFX96
Mx3005P
ABI 7500 Fast Dx
13.2.2 Detection limit with matrix (LoD)
The detection limit of the RIDA
the aid of a dilution series of WHO standards, spiked in EDTA plasma. Seven log
levels of 20 replicates each were tested for the MagNA Pure 96 and LightCycler
480II device combination. The RIDA
limit of 143.7 gEq/ml or 77.6 IU/ml for the specified combination.
The detection limit of the overall process depends on the specimen matrix, the DNA
extraction, and the DNA content.
13.2.3 Linearity
®
The RIDA GENE CMV real-time PCR test is linear in a range of 10
1,000,000) genome equivalents per reaction (gEq/reaction) for all real-time PCR
devices described here.
The lower limit of quantification (LloQ) was determined based on the LoD
determination. The LloQ defines the lowest concentration at which the test achieves
100 % positive results at an accuracy within the specification range. The LloQ is
independent of device and matrix. The RIDA
LloQ of 14.8 gEq/reaction or 185.2 gEq/ml for the MagNA Pure 96, LightCycler
480II, and EDTA plasma combination.
The gEq/reaction was converted to gEq/ml as described in section 11.2, Table 9.
40
N
50
50
50
50
50
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GENE CMV real-time PCR test was determined with
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GENE CMV real-time PCR test has a detection
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GENE CMV real-time PCR test has an
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Positive Negative
0
50
0
50
0
50
0
50
0
50
2
to 10
RIDA
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6
(100 to
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GENE CMV