39.0 Vaginitis Panel (Affirm)


Title of Manual: Specimen Collection

Version No: 1.1

Title: Vaginitis Panel (Candida species,
Gardnerella vaginalis
and Trichomonas vaginalis)

Effective Date: 11/01/09
Revised Date: 01/02/14

Document #: GPA.SPC.39.0


I. PURPOSE

To provide the protocol for proper collection of the Affirm test.

II. MATERIALS

Reagents

Supplies

Equipment

Vaginal sampling:
BD Affirm Microbial
Transport Swab (ATTS)


III. PROCEDURE

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

• Minimum Volume:
    • 1 mL
• Storage Requirements:
    • Room Temperature
• Stability Requirements:
    • 72 hours

V. CALCULATIONS/CALIBRATION

VI. INTERPRETATIONS

VII. METHOD PERFORMANCE SPECIFICATIONS

VIII. REFERENCES

IX. RELATED DOCUMENTS

BD Affirm Collection Swab E:11-1-09

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

1/02/14 New Document Control Format



Laboratory Director

(Signature)

Date

Natalie Depcik-Smith, MD
(Print)



Department Director

(Signature)

Date


(Print)



Designee

Date

(Print)

(Signature)

(Print)

(Signature)

(Print)

(Signature)

(Print)

(Signature)

(Print)

(Signature)



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