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Specimen Collection Manual: Vaginosis Screen

Instructions

Instructions

• Affirm™ VPIII Ambient Temperature Transport System (ATTS) is a sterile ready-to-use system intended for the collection, preservation, and transportation of vaginal specimens for use only with the Affirm™ VPIII Microbial Identification Test.
• The formulation and design of the ATTS reagent and transport system facilitates nuclei acid preservation and inhibits growth of Candida spp., Gardnerella vaginalis and Trichomonas vaginalis from patient specimens up to 72 hours under ambient and refrigerated conditions.
• Store the Affirm™ VPIII Ambient Temperature Transport System 10 Test Kit at room temperature (20-26°C or 68-78.8°F) prior to usage. Keep away from heat - contents are flammable.

Preparation

• Obtain one plastic bag pouch from the Affirm™ VPIII Ambient Temperature Transport System 10 Test Kit. Each pouch includes the necessary supplies to collect one vaginal specimen and contains the following:
  • Individually wrapped, pre-scored, sterile, polyester-tip swab.
  • Specimen collection tube and cap.
  • Collection label.
  • Ambient Temperature Transport Reagent Dropper (in foil pouch).
    
    
    
  • Caution: The Ambient Temperature Transport Reagent is highly toxic and flammable, and is irritating to the eyes, respiratory system, and skin. Use in a well-ventilated place. Keep away from sources of ignition - no smoking. Wear protective clothing and gloves. Immediately remove any clothing soiled by the product. If inhaled, supply fresh air or oxygen; consult the Material Safety Data Sheet (MSDS) and seek medical advice. After skin contact, immediately rinse with water. After eye contact, rinse immediately with plenty of water, consult the MSDS, and seek medical advice.
• Prepare the Affirm™ VPIII Ambient Temperature Transport System (ATTS) as follows:
  • Open the seal on the outer plastic bag of the ATTS and remove all components. Each plastic bag includes the required supplies for the collection and transport of one vaginal specimen.
  • Write the patient's name and collection date/time on the manufacturer's label. This information can be written with a marker on the tube or "crack and peel" label placed on the tube. Place the label around the top of the specimen collection tube.
    
              
  • Tear open the foil pouch and remove the ATTS Reagent Dropper.
  • Break the glass ampule within the plastic ATTS Reagent Dropper by firmly squeezing the center outer edge of the vial between the finger and thumb one time only. Break the ampule one time only. Do not manipulate the dropper any further, as the broken glass may puncture the plastic vial and result in injury. Do NOT remove the cap from the ampule.
  • Dispense the entire reagent from the ATTS Reagent Dropper into the specimen collection tube.

Specimen Collection Criteria

Patient Preparation & Specimen Collection

• Place the patient in position for a pelvic examination.
• Insert an UNLUBRICATED speculum (WITHOUT JELLY) into the vagina to permit visualization of the posterior vaginal fornix.
• Peel wrapper to expose the patient swab. Remove the swab and discard the wrapper.
• Using the sterile swab from the collection kit, 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.

Specimen Inoculation

• Immediately place the patient swab in the specimen collection tube containing the ATTS Reagent.
• Break the swab shaft at the pre-scored line just above the top of the tube. Discard the remaining shaft into an infectious waste container.
• Place the specimen collection cap over the exposed end of the swab and firmly press the cap onto the specimen collection tube. The cap will "snap" onto the tube when it is properly seated.
• Place the capped specimen collection tube in the outer plastic bag of the ATTS system.

 

Rejection Criteria

• The Affirm™ VPIII Ambient Temperature Transport System 10 Test Kit contents must be used prior to the expiration date printed on the pouches.

Contacts

Last Updated

4/10/2023