BD ProbeTec Manual Del Usario página 4

9. For male urethral and female endocervical swab specimens, specimens must be collected and tested before the
expiration date of the CT/GC Q
10. For vaginal specimens, specimens must be collected and processed before the expiration date of the Vaginal
Specimen Transport. Once expressed, specimens must be tested before the expiration date of the CT/GC Q
tube.
11. For urine specimens, specimens must be tested before the expiration date of the Q
Assay/Reagent:
12. This reagent pack is for testing endocervical and patient-collected vaginal swabs (in a clinical setting), male
urethral swabs, and male and female urine specimens with the BD Viper System in Extracted Mode.
13. The Q x UPT contains NAP Guard™ (approximately 742.5 mM K
skin and respiratory system. In case of contact with eyes, rinse opened eye immediately with plenty of water and
seek medical advice if symptoms persist. After contact with skin, wash immediately with plenty of soap and water.
If inhaled, seek medical attention in case of problems.
14. Use only sample and control tubes with pierceable caps on the BD Viper System in Extracted Mode. Do not remove
pierceable caps prior to running the instrument. Be sure to replace any punctured pierceable caps with new
pierceable caps prior to running the instrument.
15. Do not interchange or mix kit reagents from kits with different lot numbers.
x
16. The CT/GC Q Swab Diluent for the BD ProbeTec CT/GC Q
(DMSO). DMSO is harmful by inhalation, in contact with skin and if swallowed. Avoid contact with eyes. In case of
contact with eyes, rinse immediately with plenty of water and seek medical advice. After contact with skin, wash
immediately with plenty of water.
17. Do not test the CT/GC Q
Collection Kits if received in the laboratory without the swab present. A false negative test result may occur.
18. Use only the BD Viper pipette tips as supplied by BD with the BD Viper System.
19. The Extraction Reagent and Lysis Troughs for the BD ProbeTec CT/GC Q
substances. The use of personal protection equipment, such as nitrile gloves, safety glasses, and lab coats is
strongly recommended when handling these reagents. These solutions have a strong caustic effect, and may
cause severe burns to skin and mucous membranes. Avoid contact with the eyes and skin. Avoid breathing fumes,
vapors, or spray. Harmful if swallowed. Do not eat or drink in the vicinity of these reagents. In case of contact,
immediately remove contaminated clothing, wash the skin with water and soap and rinse thoroughly. In case of
contact with eyes, rinse immediately with plenty of water and seek medical advice.
20. Use only the BD Viper Amplification Plate Sealers (Black) on the Amplification plates with the BD Viper System.
Using the clear sealers for sealing the Amplification plates may cause erroneous results.
21. Reagent pouches containing unused Priming Microwells and Amplification Microwells MUST be carefully resealed
after opening. Verify that desiccant is present prior to resealing the reagent pouches.
22. Because the CT/GC Q
microwell strips is important for final results reporting.
23. The plate containing the Amplification Microwells MUST be properly sealed with the BD Viper Amplification
Plate Sealer (Black) prior to moving the plate from the BD Viper System. Sealing ensures a closed reaction for
amplification and detection and is necessary to avoid contamination of the instrument and work area with
amplification products. Do not remove sealing material from microwells at any time.
24. Priming Microwells with residual fluid (after transfer of liquid from the Priming Microwells to the Amplification
Microwells) represent a source of target contamination. Carefully seal Priming Microwells with plate sealer prior
to disposal.
25. To prevent contamination of the work environment with amplification products, use the disposal bags provided
in the Accessory kit to dispose of tested Amplification Microwells. Make sure the bags are properly closed before
disposal.
26. Although dedicated work areas are not required because the BD Viper design reduces the possibility of amplicon
contamination in the testing environment, other precautions for controlling contamination, particularly to avoid
contamination of specimens during manipulation, are necessary.
27. CHANGE GLOVES if they come in contact with specimen or appear to be wet, to avoid contaminating other
specimens. Change gloves before leaving work area and upon entry into work area.
28. In the event of contamination of the work area or equipment with specimens or controls, thoroughly clean the
contaminated area with 1% (v/v) sodium hypochlorite, DNA AWAY, or 3% (w/v) hydrogen peroxide (do not use
hydrogen peroxide from a bottle that has remained open for longer than 8 days) and rinse thoroughly with water.
Allow surface to dry completely before proceeding.
29. In case of a spill on the BD Viper Lysing Rack, immerse the rack in 1% (v/v) sodium hypochlorite for 1 – 2 min. Do
not exceed 2 min. Thoroughly rinse the rack with water and allow to air dry.
30. Clean the entire work area – counter tops and instrument surfaces – with 1% (v/v) sodium hypochlorite on a daily
basis. Thoroughly rinse with water. Allow surfaces to dry completely before proceeding with additional testing.
31. Contact BD Technical Services in the event of an unusual situation, such as a spill into the BD Viper instrument or
DNA contamination that cannot be removed by cleaning.
SWAB SPECIMEN COLLECTION, STORAGE AND TRANSPORT
For swab specimens, performance data in this package insert have been established with the BD ProbeTec collection
kits listed. Performance with collection devices other than those listed has not been evaluated.
• Female Endocervical Specimen Collection Kit for the BD ProbeTec CT/GC Q
• Vaginal Specimen Transport for the BD ProbeTec CT/GC Q
• Male Urethral Specimen Collection Kit for the BD ProbeTec CT/GC Q
x
diluent tube.
x Swab Diluent tube from the Female Endocervical or the Male Urethral Specimen
x Positive control is used for both CT Q
EDTA). NAP Guard may be irritating to the eyes,
2
x
Amplified DNA Assays contains dimethyl sulFOXide
x Amplified DNA Assays contain corrosive
x and GC Q x testing, correct positioning of the
x Amplified DNA Assays
x
Amplified DNA Assays
x Amplified DNA Assays
3
x
x UPT.
diluent