BD ProbeTec Manual Del Usario página 8

2. Swirl the urine cup to mix the urine specimen and open carefully.
NOTE: Open carefully to avoid spills which may contaminate gloves or the work area.
3. Uncap the tube and use a pipette to transfer the urine specimen into the tube. The correct volume of urine has
been added when the fluid level is between the black lines on the fill window located on the label. This volume
corresponds to approximately 2.0 – 3.0 mL of urine. DO NOT overfill or under fill the tube.
4. Tighten a black pierceable cap securely on each tube.
5. Repeat steps 1 through 4 for each urine specimen. Use a new pipette or pipette tip for each sample.
6. Using the tube layout report, place the neat urine specimens in order in the BD Viper Lysing Rack and lock into
place.
7. Specimens are ready to be pre-warmed.
8. Change gloves before proceeding to avoid contamination.
NOTE: The pre-warm step must be started within 30 h of collection if the urine has been stored at 2 – 30°C; within
7 days of collection if stored at 2 – 8°C; or within 180 days if stored frozen at -20°C.
QUALITY CONTROL PREPARATION
NOTE: Do not re-hydrate the controls prior to loading in the BD Viper Lysing Rack.
1. Using the tube layout report, place CT/GC Q
Lysing Rack.
2. Using the tube layout report, place CT/GC Q
Lysing Rack.
3. Controls are ready to be pre-warmed with the specimens, if desired.
PRE-WARM PROCEDURE FOR SWAB AND URINE SPECIMENS
NOTE: The pre-warm procedure must be applied to all swab and urine specimens to ensure that the specimen matrix
is homogeneous prior to loading on the BD Viper System. Failure to pre-warm specimens may have an adverse
impact on performance of the BD ProbeTec CT/GC Q
be pre-warmed; however, pre-warming of the controls is optional.
NOTE: Refrigerated or frozen specimens must be brought to room temperature prior to pre-warming.
1. Insert the BD Viper Lysing Rack into the BD Viper Lysing Heater.
2. Pre-warm the specimens for 15 min at 114 +/- 2ºC.
3. Remove the Lysing Rack from the Lysing Heater and let specimens cool at room temperature for a minimum of
15 min before loading into the BD Viper instrument.
4. Refer to the Test Procedure for testing specimens and controls.
5. After pre-warming, specimens may be stored for 7 days at 2 – 30ºC or for 180 days at -20°C without additional pre-
warming prior to testing on the BD Viper System.
TEST PROCEDURE
Refer to the BD Viper Instrument User's Manual (Extracted Mode Operation) for specific instructions for operating and
maintaining the components of the system. The optimum environmental conditions for the CT Q
be 18 – 27°C and 20 – 85% Relative Humidity.
QUALITY CONTROL
Quality control must be performed in accordance with applicable local, state and/or federal regulations or
accreditation requirements and your laboratory's standard Quality Control procedures. It is recommended that the
user refer to pertinent CLSI guidance and CLIA regulations for appropriate Quality Control practices.
The Control Set for the BD ProbeTec CT/GC Q
Negative Control must be included in each assay run and for each new reagent kit lot number. Controls must
be positioned according to the BD Viper Instrument User's Manual. The CT/GC Q
for substantial reagent failure only. The CT/GC Q
contamination. Additional controls may be tested according to guidelines or requirements of local, state, and/or
federal regulations or accrediting organizations. Refer to CLSI C24-A3 for additional guidance on appropriate internal
quality control testing practices.
pGCint3 linearized plasmids.
The Extraction Control (EC) oligonucleotide is used to confirm the validity of the extraction process. The EC is dried
in the Extraction Tubes and is re-hydrated by the BD Viper System upon addition of the specimen and extraction
reagents. At the end of the extraction process, the EC fluorescence is monitored by the instrument and an automated
algorithm is applied to both the EC and C. trachomatis-specific signals to report specimen results as positive, negative,
or EC failure.
General QC Information for the BD Viper System:
The location of the microwells is shown in a color-coded plate layout screen on the LCD Monitor. The plus symbol
(+) within the microwell indicates the positive QC sample. The minus symbol (-) within the microwell indicates the
negative QC sample.
A QC pair must be logged in for each reagent kit lot number and for each plate to be tested. If QC pairs have not been
properly logged in, a message box appears that prevents saving the rack and proceeding with the run until complete.
A maximum of two QC pairs per rack is permitted. Additional control materials may be added provided they are
logged in as samples.
NOTE: The BD Viper System will re-hydrate the controls during the assay run. Do not attempt to hydrate the assay
controls prior to loading them into the BD Viper Lysing Rack.
x
Negative Controls into the appropriate positions in the BD Viper
x Positive Controls into the appropriate positions in the BD Viper
x assays and/or BD Viper System. Swab and urine specimens must
x
Amplified DNA Assays is provided separately. One Positive and one
x Negative Control monitors for reagent and/or environmental
14 The Positive Control contains approximately 2400 copies per mL of pCTB4 and
x Positive Control will monitor
7
x assay were found to