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Becton, Dickinson and Company L009847 Instrucciones De Uso página 2

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Female Endocervical Specimen Collection
B
Kit for the BD ProbeTec
trachomatis/Neisseria gonorrhoeae
(CT/GC) Q
English:
pages
1 – 2
Dansk:
side
2 – 3
Deutsch:
Seiten
3 – 5
Español:
páginas 5 – 6
INTENDED USE
The Female Endocervical Specimen Collection Kit for the BD ProbeTec CT/GC Q
collect and transport patient endocervical specimens to the laboratory for testing with the BD ProbeTec CT/GC Q
Amplified DNA Assays on the BD Viper™ System in Extracted Mode.
SUmmAry AND ExPlANATIoN
The Female Endocervical Specimen Collection Kit for the BD ProbeTec CT/GC Q
sterile cleaning swab with a white shaft, a sterile collection swab with a pink shaft that is scored for breaking and
a tube of CT/GC Q
x
Swab Diluent for specimen transport. The polyester fiber-tipped cleaning swab is provided to
clean the cervical os of blood and mucus prior to specimen collection. The polyurethane foam-tipped swab with
the pink-colored shaft is used to collect the specimen for testing. After the specimen is collected, the cap of the
diluent tube is removed, the swab is placed into the CT/GC Q
score mark. The tube is recapped and transported to the testing facility.
rEAGENTS
materials Provided: Each Female Endocervical Specimen Collection Kit for the BD ProbeTec CT/GC Q
DNA Assays contains one sterile polyester fiber-tipped cleaning swab with a white shaft, one sterile polyurethane
foam-tipped collection swab with a pink shaft and one tube of CT/GC Q
approximately 2 mL of potassium phosphate/potassium hydroxide buffer with DMSO and preservative.
materials required But Not Provided: Gloves
Storage Instructions: Store collection kit at 2 – 33°C. Do not use beyond the expiration date. Swab sterility is
guaranteed if primary swab container is intact.
Warnings and Precautions:
For in vitro Diagnostic Use.
1. Do not pre-wet the swab with the CT/GC Q
2. Pathogenic microorganisms including hepatitis viruses and Human Immunodeficiency Virus may be present in
clinical specimens. "Standard Precautions"
items contaminated with blood and other body fluids.
3. Optimal performance of the BD ProbeTec CT/GC Q
handling and transport.
4. Use only collection and transport systems labeled for use with the BD ProbeTec CT/GC Q
Assays.
5. The polyester fiber-tipped swab with the white shaft is for cleaning the cervical os and should not be used for
collecting the patient specimen.
6. Proper labeling should accompany each specimen to the laboratory.
7. The CT/GC Q
x
Swab Diluent contains dimethyl sulfoxide (DMSO). DMSO is harmful by inhalation, in contact
with skin and if swallowed. Keep container in a well-ventilated place. 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. Wear suitable protective clothing and gloves.
8. When breaking the shaft of the swab, take care to avoid splashing of contents.
9. Dispose of unused CT/GC Q
10. Take care to avoid cross-contamination during the specimen handling steps. Specimens can contain high
levels of organisms. Ensure that specimen containers do not contact one another, and discard used materials
without passing over open containers. If gloves come in contact with specimen, change gloves to avoid cross-
contamination.
11. Specimens must be collected and tested before the expiration date of the CT/GC Q
SPECImEN CollECTIoN AND TrANSPorT
1. Remove the cleaning swab from packaging.
2. Using the polyester fiber-tipped cleaning swab with the white shaft, remove excess blood and mucus from the
cervical os.
3. Discard the used cleaning swab.
4. Remove the pink collection swab from packaging.
5. Insert the collection swab into the cervical canal and rotate for 15 – 30 sec.
6. Withdraw the swab carefully. Avoid contact with the vaginal mucosa.
x
Amplified DNA Assays
Français :
pages
Norsk:
sider
Svenska:
sidan
x
Swab Diluent prior to collecting specimen.
1-4
and institutional guidelines should be followed in handling all
x
Swab Diluent tubes according to the Material Safety Data Sheet.
Chlamydia
6 – 7
8 – 9
9 – 10
x
Swab Diluent tube and the shaft is broken at the
x
Swab Diluent. The Swab Diluent contains
x
Amplified DNA Assays requires proper specimen collection,
U
0086
x
Amplified DNA Assays is used to
x
Amplified DNA Assays consists of a
x
x
Amplified DNA
x
diluent tube.
L009847
2009/01
x
Amplified

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