BD ProbeTec Manual Del Usario página 10

Table 4: Interpretation of Test Results for the CT Q
Tube Report CT Q
Result MaxRFU
≥125
<125
<125
Any value Extraction Transfer
Any value Liquid Level Failure.
Any value Error. Repeat test from
SPECIMEN PROCESSING CONTROLS
Specimen Processing Controls may be tested in accordance with the requirements of appropriate accrediting
organizations. A positive Specimen Processing Control tests the entire assay system. For this purpose, known positive
specimens can serve as controls by being processed and tested in conjunction with unknown specimens. Specimens
used as processing controls must be stored, processed, and tested according to the package insert instructions. If a
known positive specimen is not available, additional options for Specimen Processing Controls are described below:
ATCC Chlamydia trachomatis:
Assay a stock culture of C. trachomatis LGV2 (ATCC# VR-902B) prepared as described below:
1. Thaw a vial of C. trachomatis LGV2 or C. trachomatis serovar H cells received from ATCC.
2. Prepare 10-fold serial dilutions to a 10
5
3. Place 0.1 mL of 10
pierceable cap.
4. Using the tube layout report, place the Specimen Processing Control(s) in order in the BD Viper Lysing Rack, and
lock into place.
5. Process the controls according to the Pre-warming Procedure and then follow the Test Procedure.
Blackhawk AmpliTrol - Chlamydia trachomatis & Neisseria gonorrhoeae:
1. Thaw a vial of Blackhawk AmpliTrol CT/GC.
2. Add 100 µL of Blackhawk AmpliTrol CT/GC to a BD ProbeTec CT/GC Q
black pierceable cap.
3. Mix the solution by vortexing or with inversion.
4. Using the tube layout report, place the Specimen Processing Control(s) in order in the BD Viper Lysing Rack and
lock into place.
5. Process the controls according to the Pre-warming Procedure and then follow the Test Procedure.
MONITORING FOR THE PRESENCE OF DNA CONTAMINATION
At least monthly, the following test procedure should be performed to monitor the work area and equipment surfaces
for the presence of DNA contamination. Environmental monitoring is essential to detect contamination prior to the
development of a problem.
1. For each area to be tested, use a clean collection swab from the Female Endocervical Specimen Collection Kit for
the BD ProbeTec CT/GC Q
2. Dip the swab into the BD ProbeTec CT/GC Q
motion.
3. Fully insert the collection swab into the CT/GC Q
4. Break the shaft of the swab at the score mark. Use care to avoid splashing of contents.
x
Report
C. trachomatis plasmid
DNA detected by SDA.
C. trachomatis plasmid
DNA not detected by
SDA.
Extraction control
failure. Repeat test
from initial specimen
tube or obtain another
specimen for testing.
Failure. Repeat test
from initial specimen
tube or obtain another
specimen for testing.
Repeat test from
initial specimen tube
or obtain another
specimen for testing.
initial specimen tube
or obtain another
specimen for testing.
5 dilution (at least 4 mL final volume) in phosphate buffered saline (PBS).
dilution in a BD ProbeTec CT/GC Q
x Amplified DNA Assays.
x Assay
Positive for C. trachomatis.
C. trachomatis organism viability and/or infectivity
cannot be inferred since target DNA may persist in
the absence of viable organisms.
Presumed negative for C. trachomatis.
A negative result does not preclude C. trachomatis
infection because results are dependent on
adequate specimen collection, absence of inhibitors,
and the presence of sufficient DNA to be detected.
C. trachomatis, if present, is not detectable.
C. trachomatis, if present, is not detectable.
C. trachomatis, if present, is not detectable.
C. trachomatis, if present, is not detectable.
x Swab Diluent tube and tightly recap using a black
x Swab Diluent tube and wipe the first area* using a broad sweeping
x Swab Diluent tube.
9
Interpretation
x Swab Diluent tube and tightly recap using a
Result
Positive
Negative
Extraction
Control
Failure
Extraction
Transfer
Failure
Liquid Level
Failure
Error