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 Unisex swab specimen collection for Endocervical and Male Urethral specimens in GEN-PROBE transport vial (Blue Shaft Swab)

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 Unisex swab specimen collection for Endocervical and Male Urethral specimens in GEN-PROBE transport vial (Blue Shaft Swab)

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 Unisex swab specimen collection for Endocervical and Male Urethral specimens in GEN-PROBE transport vial (Blue Shaft Swab)

Specimen Volume: Swab

Collection Instructions:

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

2. Insert Blue 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 or Sterile Urine 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) 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 24 hours, keep refrigerated.

Specimen Type: Oral

Container/Tube: GEN-PROBE Unisex swab specimen collection for Endocervical and Male Urethral specimens in GEN-PROBE transport vial (Blue Shaft Swab)

Specimen Volume: Swab

Collection Instructions:

1. Partially open the swab package and remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, laid down, or dropped, discard and get a new Aptima Swab Specimen Collection Kit or.

2.Hold the swab, placing thumb and forefinger in the middle of the shaft covering the black score line. Do not hold the shaft below the score line.

3.Carefully insert the swab into the throat ensuring contact with bilateral tonsils (if present) and the posterior pharyngeal wall, then withdraw the swab without touching the inside of the cheeks or tongue.

4.While holding the swab in hand, unscrew the tube cap. Do not spill the tube contents. If the tube contents are spilled, discard and replace with a new Aptima Swab Specimen Collection Kit. Immediately place the swab into the transport tube so the black score line is at the top of the tube. Align the score line with the top edge of the tube and carefully break the shaft. The swab will drop to the bottom of the tube. Discard the top portion of the swab shaft.

5.Tightly screw the cap onto the tube. When collecting multiple specimens from the same patient, the tube label provides a specimen source field for unique identification for the specimen location.
6. Label vial with patient’s full name, date of birth, date and time of collection, and source of specimen.

Specimen Type: Rectal

Container/Tube: GEN-PROBE Unisex swab specimen collection for Endocervical and Male Urethral specimens in GEN-PROBE transport vial (Blue Shaft Swab)

Specimen Volume: Swab

Collection Instructions:

1. Partially open the swab package and remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, laid down, or dropped, discard and get a new Aptima Swab Specimen Collection Kit.

2.Carefully insert the swab into the rectum about 1-2 inches (3-5 cm) past the anal margin (the outside of the anus) and gently rotate the swab for 5 to 10 seconds. Withdraw the swab without touching the skin.

3.While holding the swab in hand, unscrew the tube cap. Do not spill the tube contents. If the tube contents are spilled, discard and replace with a new Aptima Swab Specimen Collection Kit. Immediately place the swab into the transport tube so the black score line is at the top of the tube. Align the score line with the top edge of the tube and carefully break the shaft. The swab will drop to the bottom of the tube. Discard the top portion of the swab shaft.

4.Tightly screw the cap onto the tube. When collecting multiple specimens from the same patient, the tube label provides a specimen source field for unique identification for the specimen location.

5.Tightly screw the cap onto the tube. When collecting multiple specimens from the same patient, the tube label provides a specimen source field for unique identification for the specimen location.
6. Label vial with patient’s full name, date of birth, date and time of collection, and source of specimen.

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.