Cepheid Xpert SWAB/G-50 Mode D'emploi

©2020 Cepheid
302-0175, Rev. C, August 2020
HPC135B Rev. 02 2020.05
English
For in vitro diagnostic use only.
Intended Use
®
The Xpert Swab Specimen Collection Kit is designed to collect,
preserve, and transport endocervical, vaginal, pharyngeal, and
rectal swab specimens. This transport system is used for testing
with Xpert tests.
Summary and Explanation of the Procedure
Endocervical (ES), vaginal (VS), pharyngeal (PS), or rectal (RS)
swab specimens are collected from patients using flocked swabs
included in the specimen collection kit. Swabs are broken off into
the transport reagent tubes to elute organisms and stabilize DNA.
Swab specimens are then transported to the laboratory for testing
on the GeneXpert Instrument Systems.
Materials Provided
Xpert Swab Specimen Collection Kits: (quantity: 50)
Each kit contains a sealed package containing:
• 1 individually wrapped sterile large cleaning swab
• 1 package containing:
• 1 tube containing Xpert Swab Transport Reagent (pink cap)
• 1 individually wrapped sterile flocked collection swab
• Instructions for collection of patient-collected vaginal swabs
(quantity: 50)
• Instructions for collection of endocervical, pharyngeal, and
rectal swabs (quantity: 1of each per kit)
Materials Required but Not Provided
• Disposable gloves
• Adhesive labels or permanent markers for recording specimen
information
Swab Specimens Appropriate for Use
The table below identifies swab specimen types and targets that
are acceptable for use with the Xpert CT/NG and the Xpert TV
tests.
Xpert
Target
Test
Xpert Chlamydia trachomatis and
CT/NG Neisseria gonorrhoeae
Xpert
Trichomonas vaginalis
TV
ES = Endocervical Swab, VS = Vaginal Swab,
PS = Pharyngeal Swab, RS = Rectal Swab
Warnings and Precautions
• For prescription use only.
• Treat all biological specimens, including used cartridges, as if
capable of transmitting infectious agents. Because it is often
impossible to know which might be infectious, all biological
specimens should be treated with standard precautions. Guidelines
for specimen handling are available from the U.S. Center for
Disease Control and Prevention and the Clinical and Laboratory
1,2
Standards Institute.
• Avoid cross contamination during sample handling steps.
• Do not use kit if opened or damaged.
• Spilled or leaking transport reagent tubes should be discarded and
not be used.
Xpert® Swab Specimen Collection Kit
REF
SWAB/G-50
ES VS PS RS
Yes Yes Yes Yes
Yes Yes No No
• Use this collection kit only with the Xpert CT/NG or the Xpert TV
tests.
• Follow your institution's safety procedures for working with
chemicals and handling biological samples.
• With vaginal/endocervical specimens tested with the Xpert CT/NG
test, interference may be observed in the presence of blood
(>1% v/v) or mucin (>0.8% w/v).
• With vaginal/endocervical specimens tested with the Xpert TV
test, interference may be observed in the presence of blood
(>60% v/v).
Kit Storage Requirements
+30
Store collection kit at 2 °C to 30 °C.
+2
Do not use after the expiration date which is clearly
IMPORTANT:
printed on the outer box label.
Product Deterioration
The Xpert Swab Collection Kit should not be used if (1) there
is evidence of damage or contamination to the product, (2)
there is evidence of leakage, (3) the expiration date has passed
on any of the components, o r (4) the swab pouch is open.
Limitations
• Specimens should be handled aseptically.
• The Xpert Swab Collection Kit is intended to be used with the
transport reagent tube and swab provided in the kit. The use of
transport reagent tubes or swabs from any other source could affect
the performance of the product.
• Use this collection kit only with the Xpert CT/NG or the Xpert TV
tests.
Specimen Collection Procedure Patient-
collected Vaginal Swab Specimen Collection
Do NOT expose swab to Xpert Swab Transport Reagent
Caution:
prior to collection.
Wash your hands before starting.
Caution:
If you have any questions about this procedure, please ask your
Note:
doctor, nurse, or care-provider.
1. In the privacy of the examination room or restroom, undress
from the waist down. Comfortably position yourself to maintain
balance during the collection
2. Open the outer peelpack (which contains the two-package kit),
and identify the larger cleaning swab and discard it.
3. Open the package that contains the pink-capped Xpert Swab
Transport Reagent tube and individually wrapped collection
swab. Set the tube aside before beginning to collect sample.
4. Open the collection swab wrapper by peeling open the top of the
wrapper.
5. Remove the swab, taking care not to touch the tip or lay it down.
If the soft tip is touched, the swab is laid down, or the swab is
dropped, request a new collection kit.
6. Hold the swab in your hand, placing your thumb and forefinger in
the middle of the swab shaft across the scoreline.
7. Carefully insert the swab into your vagina about 5 cm (two
inches) inside the opening of the vagina and gently rotate the
swab for 10 to 30 seconds. Ensure the swab touches the walls of
the vagina so that moisture is absorbed by the swab.
8. Withdraw the swab carefully and continue to hold it in your hand.
9. While holding the swab in the same hand, unscrew the pink cap
from the Xpert Swab Transport Reagent tube.
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procedure.