Specimen Requirements

 Please call Bronson Laboratory Services at 269-341-6440 to
obtain a GEN-PROBE Collection Kit for specimen collection. Take
care to read instructions provided with kit before sampling.

Specimen Type: Cervix

Container/Tube: GEN-PROBE swab in
GEN-PROBE 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 (white shaft swab in the package
with red printing). Discard this swab.

3. Insert the specimen collection swab (blue shaft swab in the
package with the green printing) 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 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: Cervix

Container/Tube: Broom collection device;
PreservCyt solution vial

Collection Instructions:

1. Obtain adequate specimen of cervix.

2. Rinse broom into PreservCyt solution vial by pushing
broom into bottom of vial 10 times, forcing bristles apart.

3. As final step, swirl broom vigorously to further release
material.

4. Discard broom.

5. Tighten cap on vial.

6. Label vial with patient’s full name, date of
birth, date of collection, and source of specimen.

Additional Information: Causes for
rejection include improper labeling or vial leakage due to
insufficient cap tightening.

Specimen Type: Vaginal

Container/Tube: GEN-PROBE swab in
GEN-PROBE transport vial

Specimen Volume: Swab

Collection Instructions:

1.Carefully insert the blue shaft
swab into the vagina about 2 inches (5 cm) past the introitus and
gently rotate the swab for 10 to 30 seconds. Make sure the swab
touches the walls of the vagina so that moisture is absorbed by the
swab and then withdraw the swab without touching the
skin.

2. Remove the cap from the swab specimen transport tube and
immediately place the specimen collection swab into the transport
tube.

3. 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.

4. Re-cap the swab specimen transport tube tightly.

5. Label vial with patient’s full name, date of
birth, date and time of collection, and source of
specimen.

Specimen Type: Urethra (males)

Container/Tube: GEN-PROBE swab in
GEN-PROBE transport vial

Specimen Volume: Swab

Collection Instructions:

1. Collect discharge specimen ≥1 hour after urination
using swab.

2. Insert swab 2 to 4 cm into urethra.
3. Rotate swab so that it comes into contact with all urethral
surfaces. Leave swab inserted 2 to 3 seconds before removing.
4. Place swab in transport vial.
5. Label vial with patient’s full name, date of birth, date
and time of collection, and source of specimen.

Specimen Type: Urine (male and female)

Container/Tube: GEN-PROBE collection
container

Specimen Volume: First portion
of voided urine

Specimen Minimum Volume:  2 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).
3. Label container with patient’s full name, date of
birth, date and time of collection, and source of specimen.

NOTE:  Sources other than cervical and vaginal have not
been FDA approved for this methodology.  Non approved sources
will be performed and resulted using 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 limited availability
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.

Patients under 14 years of age:

The testing of patient populations other than those listed in
manufacturer instructions constitutes a modification of an FDA
cleared/approved test.  Testing performed on patients less
than 14 years of age is not specified in the manufacturer’s
instructions, and is classified as a Laboratory Developed
Test. 

Due to the unavailability of samples, validation of test
performance on patients in this age group was not possible. 
All other test performance characteristics were determined by
Bronson Laboratory in a manner consistent with CLIA
requirements.