BD ProbeTec Manual Del Usario página 9

Running one plate on a BD Viper System:
The first two positions (A1 and B1) are reserved for the positive (A1) and negative (B1) controls, respectively. The first
available position for a patient sample is C1.
Running two plates on a BD Viper System:
For plate one, the first two positions (A1 and B1) are reserved for the positive (A1) and negative (B1) controls, respectively.
The first available position for a patient sample is C1. For plate two (full plate) the last two positions (G12 and H12) are
reserved for the positive (G12) and negative (H12) controls, respectively. For plate two (partial plate) the last two positions
after the last patient sample are automatically assigned as the positive and negative controls, respectively.
Interpretation of Quality Control Results:
The CT/GC Q x Positive Control and the CT/GC Q
order to obtain patient results. If controls do not perform as expected, the run is considered invalid and patient results
will not be reported by the instrument. If either of the controls does not provide the expected results, repeat the
entire run using a new set of controls, new extraction tubes, new extraction reagent trough, new lysis trough and new
microwells. If the repeat QC does not provide the expected results, contact BD Technical Services.
If the C. trachomatis-specific signal is greater than or equal to a threshold of 125 Maximum Relative Fluorescent Units
(MaxRFU), the EC fluorescence is ignored by the algorithm. If the C. trachomatis-specific signal is less than a threshold
of 125 MaxRFU, the EC fluorescence is utilized by the algorithm in the interpretation of the result.
Table 3: Interpretation of Quality Control Results
Control Type
CT Q x Positive Control
CT Q x Positive Control
CT Q x Positive Control
CT Q x Negative Control
CT Q x Negative Control
CT Q x Negative Control
Refer to the Interpretation of Test Results for a description of Tube Result Report symbols.
INTERPRETATION OF TEST RESULTS
x
The BD ProbeTec CT Q
the presence of C. trachomatis in clinical specimens. All calculations are performed automatically by the BD Viper
software.
The presence or absence of C. trachomatis DNA is determined by calculating the peak fluorescence (MaxRFU) over
the course of the amplification process and by comparing this measurement to a predetermined threshold value. The
magnitude of the MaxRFU score is not indicative of the level of organism in the specimen. If the C. trachomatis-specific
signal is greater than or equal to a threshold of 125 MaxRFU, the EC fluorescence is ignored by the algorithm. If the
C. trachomatis-specific signal is less than a threshold of 125 MaxRFU, the EC fluorescence is utilized by the algorithm
in the interpretation of the result. If assay control results are not as expected, patient results are not reported. See the
Quality Control section for expected control values. Reported results are determined as follows.
Tube Result Report Symbol
or
or
Amplified DNA Assay uses fluorescent energy transfer as the detection method to test for
x Negative Control must test as positive and negative, respectively, in
OK
or
OK
or or
8
CT Q x MaxRFU
≥125
<125
Any value
<125
≥125
Any value
QC Disposition
QC Pass
QC Failure
QC Failure
QC Pass
QC Failure
QC Failure