10.0 Bacterial Vaginitis Expanded Panel


Title of Manual: Specimen Collection

Version No: 1.1

Title: Bacterial Vaginitis Expanded Panel

Effective Date: 06/01/12
Revised Date: 10/30/13

Document #: GPA.SPC.10.0


I. PURPOSE

To provide the proper collection protocol for bacterial vaginitis panel testing.

II. MATERIALS

Reagents

Supplies

Equipment

• CytoBrush & Spatula or
Broom in ThinPrep or SurePath Liquid Based Collection Vial [Adjunct to Pap]
• APTIMA vaginal specimen
collection swab and tube
• APTIMA unisex specimen
collection swab and tube
• APTIMA urine specimen
collection tube
• BC Affirm Microbial
Transport Swab


III. PROCEDURE

ThinPrep or SurePath Liquid Based Pap Test:
One specimen will be used to provide samples for both the Pap test and/or the Bacterial Vaginitis Expanded Panel (BV) test. Follow the appropriate Pap collection instructions for testing of BV. This test can be performed adjunctively from the Pap vial.

APTIMA Vaginal Swab Collection [Separate from Pap]:
1. Partially peel open the swab package. Do not touch the soft tip or lay the swab down. If the soft tip is     touched, the swab is laid down, or the swab is dropped, use a new Aptima Vaginal Swab Specimen     Collection Kit.

2. Remove the swab.
3. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft.
4. Carefully insert the swab into the vagina about two inches 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.
5. Withdraw the swab without touching the skin.
6. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of
    the tube. If the contents of the tube are spilled, use a new Aptima Vaginal Swab Specimen Collection Kit.
7. Immediately place the swab into the transport tube so that the tip of the swab is visible below the tube label.
8. Carefully break the swab shaft at the scoreline against the side of the tube and discard the top portion of
    the swab shaft. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new
    Aptima Vaginal Swab Specimen Collection Kit.
9. Tightly screw the cap onto the tube.

APTIMA Endocervical/Male Urethra Swab Collection [Separate from Pap]:
Endocervical swab specimens
1. 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. Note: To remove excess mucus from the
    cervical os, a large-tipped swab (not provided) may be used.
2. Insert the specimen collection swab (blue shaft swab in the package with the green printing) into the
    endocervical canal.
3. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure
    adequate sampling.
4. Withdraw the swab carefully; avoid any contact with the vaginal mucosa.
5. Remove the cap from the swab specimen transport tube and immediately place the specimen collection
    swab into the transport tube.
6. 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.
7. Re-cap the swab specimen transport tube tightly.

Male urethral swab specimens:
1. The patient should not have urinated for at least 1 hour prior to sample collection.
2. Insert the specimen collection swab (blue shaft swab in the package with the green printing) 2 to 4 cm
    into the urethra.
3. Gently rotate the swab clockwise for 2 to 3 seconds in the urethra to ensure adequate sampling.
4. Withdraw the swab carefully.

5. Remove the cap from the swab specimen transport tube and immediately place the specimen collection     swab into the transport tube.
6. 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.
7. Re-cap the swab specimen transport tube tightly.

Urine Collection:
1. The patient should not have urinated for at least 1 hour prior to specimen collection.
2. Direct patient to provide a first-catch urine (approximately 20 to 30 mL of the initial urine stream) into
    a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in
    rRNA target dilution that may reduce test sensitivity. Female patients should not cleanse the labial area
    prior to providing the specimen.
3. Remove the cap and transfer 2 mL of urine into the urine specimen transport tube using the disposable     pipette provided. The correct volume of urine has been added when the fluid level is between the black
    fill lines on the urine specimen transport tube label.
4. Re-cap the urine specimen transport tube tightly. This is now known as the processed urine specimen.

Affirm Collection:
1. Open the seal and remove the components. Break the transport reagent ampule and dispense into sample     collection tube.
2. Insert an un-lubricated speculum into the vagina to permit visualization of the posterior vaginal fornix.
3. Using the sterile swab, obtain a sample from the posterior vaginal fornix. Twist or roll the swab against
    the vaginal wall two or three times, ensuring the entire circumference of the swab has touched the
    vaginal wall. Swab the lateral vaginal wall while removing the swab.
4. Immediately place the swab in the sample collection tube.
5. With the swab touching the bottom of the collection tube, grasp the pre-scored handle of the swab just     above the top of the tube and bend until the swab breaks. When the swab is fully inserted into the
    collection tube, the score mark on the swab is approximately 1 cm above the top of the collection tube.
    Discard the broken handle into an infectious waste container.
6. Place the cap over the exposed end of the swab and firmly press the cap onto the tube. The cap will “snap”
    onto the tube when it is properly seated.
7. Label the sample collection tube with the patient name and date of birth, including the time the sample
    was collected.
8. Place in a biohazard bag along with the completed requisition in the side pocket of the specimen bag.

IV. QUALITY CONTROL

Cervicovaginal – ThinPrep/SurePath liquid based Pap vial at 2°C to 30°C.
Vaginal – APTIMA swab specimen transport tube at 2°C to 30°C.
Endocervical – APTIMA swab specimen transport tube at 2°C to 30°C.
Urine – APTIMA urine specimen transport tube at 2°C to 30°C. Fresh at 2°C to 8°C.
Affirm – specimen transport tube at 2°C to 30°C.

V. CALCULATIONS/CALIBRATION

Minimum Volume: 1ml

VI. INTERPRETATIONS

VII. METHOD PERFORMANCE SPECIFICATIONS

Cervicovaginal, Vaginal, & Endocervical – APTIMA swab specimen transport tube or liquid based Pap preservative vial 2 weeks from collection.
Urine – APTIMA urine specimen transport tube 1 week from collection. Urine samples that are still in the primary collection container must be transported to the lab and transferred into the APTIMA urine specimen transport tube within 24 hours of collection. Affirm specimen transport tube within 72 hours of collection.

VIII. REFERENCES

IX. RELATED DOCUMENTS

X. DOCUMENT HISTORY

MINOR REVISION
(Laboratory Director’s Signature on Original Subsequent Document Attached)

X - MAJOR REVISION
(Requires Laboratory Director & Department Director Signature - where applicable)

Reason for Change

10/30/13 New Document Control Format



Laboratory Director

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Date

Natalie Depcik-Smith, MD
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Department Director

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Date


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Designee

Date

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