Test Code CGPCR Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Probe (Cepheid)
Additional Codes
LAB3226
Performing Laboratory
Bronson Methodist Laboratory
Bronson Battle Creek Laboratory
Bronson Lakeview Laboratory
Bronson South Haven Laboratory
Test Usage
Used to detect genomic DNA from Chlamydia trachomatis and/or Neisseria gonorrhaeae from female and male urine, female vaginal/endocervical, female and male oral and rectal swabs. * Sources other than those approved by the manufacture will be reported with the following disclaimer.
The testing of sample matrices other than those listed in
manufacturer instructions constitutes a modification of an FDA
cleared/approved test. Due to the unavailability of this
sample type, validation of test performance was not
possible. All other test performance characteristics were
determined by Bronson Laboratory in a manner consistent with CLIA
requirements.
Specimen Requirement
Urine (Sterile Container): Refrigerated 4 days
Room Temp: 4 hours
Vag/Cx swab: Ambient 60 days
Specimen Type: Urine (male and female)
Container/Tube: Sterile Urine container
Specimen Volume: First portion
of voided urine
Specimen Minimum Volume: 7 mL
Collection Instructions:
1. Patient should not have urinated for at least 1 hour prior to
specimen collection.
2. Patient should collect first portion of a voided urine (first
part of stream-not midstream) into sterile urine container.
3. Label container with patient’s full name, date of
birth, date and time of collection, and source of specimen.
Submit Sterile Urine container within 3 hours, keep refrigerated
Specimen Type: Cervix
Container/Tube: Cepheid GeneXpert swab in
transport vial
Specimen Volume: Swab
Collection Instructions:
1. Do not use lubricant on speculum.
2. Remove excess mucus from the cervical os and surrounding
mucosa using the cleaning swab (large tip cleaning swab). Discard this swab.
3. Insert the specimen collection swab into the endocervical canal.
4. Gently rotate the swab clockwise for 10 to 30 seconds in the
endocervical canal to ensure adequate sampling.
5. Withdraw the swab carefully; avoid any contact with the
vaginal mucosa.
6. Remove the cap from the swab specimen transport tube and
immediately place the specimen collection swab into the transport
tube.
7. Carefully break the swab shaft against the side of the tube
at the scoreline and discard the top portion of the swab shaft; use
care to avoid splashing of contents.
8. Re-cap (pink cap) the swab specimen transport tube tightly.
9. Label vial with patient’s full name, date of
birth, date and time of collection, and source of
specimen.
Specimen Type: Oral
Container/Tube: Cepheid GeneXpert swab in
transport vial
Specimen Volume: Swab
Collection Instructions:
Caution: Do NOT expose swab to Xpert Swab Transport Reagent
prior to collection.
1. Open the Xpert Swab Specimen collection kit.
2. Open the outer peelpack (which contains the two-package kit),
and identify the larger cleaning swab and discard it.
3. Open the collection swab wrapper by partially peeling open the
top of the wrapper.
4. 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, use a new Xpert Swab Specimen Collection Kit.
5. Instruct the patient to open mouth widely. Position the tongue
toward the bottom of the mouth. Swab areas of the pharynx
(tonsil, posterior wall, uvula, posterior wall).
6. While holding the swab in the same hand, unscrew the cap from
the Xpert Swab Transport Reagent tube.
7. Do not spill the contents of the tube. If the contents of the tube
are spilled, use a new collection kit.
WARNING: If the contents of the tube are spilled on your skin,
wash the affected area with soap and water. If the
contents of the tube are splashed in your eyes,
immediately flush your eyes with water.
8. Immediately place the swab into the transport reagent tube.
9. Identify the scoreline on the collection swab shaft. Carefully
break the swab shaft against the side of the tube at the scoreline
and discard the top portion of the swab shaft; use care to avoid
splashing the contents. Wash with soap and water if exposed.
10. Re-cap (pink cap) the swab specimen transport tube tightly.
11. Label vial with patient’s full name, date of
birth, date and time of collection, and source of
specimen.
Specimen Type: Rectal
Container/Tube: Cepheid GeneXpert swab in
transport vial
Specimen Volume: Swab
Collection
Caution: Do NOT expose swab to Xpert Swab Transport Reagent
prior to collection.
1. Open the Xpert Swab Specimen collection kit.
2. Open the outer peelpack (which contains the two-package kit),
and identify the larger cleaning swab and discard it.
3. Open the collection swab wrapper by partially peeling open the
top of the wrapper.
4. 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, use a new Xpert Swab Specimen Collection Kit.
WARNING: Do not wet or use lubricant on swab.
5. Carefully insert the swab approximately 1 cm beyond the anal
sphincter (so that the fiber tips are no longer visible), and rotate
gently.
6. While holding the swab in the same hand, unscrew the cap from
the Xpert Swab Transport Reagent tube.
7. Do not spill the contents of the tube. If the contents of the tube
are spilled, use a new collection kit.
WARNING: If the contents of the tube are spilled on your skin,
wash the affected area with soap and water. If the
contents of the tube are splashed in your eyes,
immediately flush your eyes with water.
8. Immediately place the swab into the transport reagent tube.
9. Identify the scoreline on the collection swab shaft. Carefully
break the swab shaft against the side of the tube at the scoreline
and discard the top portion of the swab shaft; use care to avoid
splashing the contents. Wash with soap and water if exposed.
10. Re-cap (pink cap) the swab specimen transport tube tightly.
11. Label vial with patient’s full name, date of
birth, date and time of collection, and source of
specimen.
Reference Values
Normal finding: negative for Chlamyida trachomatis and
Neisseria gonorrhoeae
Abnormal finding: positive for Chlamyida trachomatis
and/or Neisseria gonorrhoeae
CPT Code Information
87491
87591
Day(s) Test Set Up
Monday through Sunday
Test Notes
It is recommend to wait at least 3 months before retesting (test
of cure) a positive patient.
Test Availability
Available