SPECIMEN COLLECTION and HANDLING Instructionsfor The

SPECIMEN COLLECTION and HANDLING Instructionsfor The

SPECIMEN COLLECTION and HANDLING INSTRUCTIONSfor the

BD VIPER CHLAMYDIA and GONORRHEA ASSAYS

for URETHRAL SWAB SPECIMENS -- WSLH Kit 29M

Contents

WSLH Kit #29M consists of one Male Urethral Specimen Collection Kit for the BD ProbeTec™ CT/GC QxAmplified DNA Assays (VIPER), and contains one swab diluent/specimen transport tube, one white-handled cleaning swab and one blue specimen collection swab. Store kits at room temperature prior to use. Note: These collection kits are not intended for collection of specimens from patients less than 12 (twelve) years old or cases of sexual assault.

SPECIMEN COLLECTION

  1. This kit may only be used for the collection of urethral swab specimens from male patients. No other anatomical sites will be tested.
  1. Remove the collection tube from the packaging. Label the tube with 2 patient identifiers (such as name and date of birth or patient number), and the date/time collected. Do not leave excess label wrapped around or sticking off of the tube, or covering the cap.
  1. Peel open the swab package from the handle end.
  2. Remove the BLUE collection swab from packaging
  3. Insert the BLUE collection swab 2-4 cm into the urethra and rotate for 3 - 5 seconds
  4. Uncap the CT/GC Qx Swab Diluent Tube
  5. Fully insert the BLUE collection swab into the CT/GC QxSwab Diluent Tube
  6. Break the shaft of the swab at the score mark, using care to avoid splashing of contents. DO NOT CUT the swab with scissors, the shaft must be the length indicated by the scored break
  1. Tightly recap the tube
  2. Check to be sure tube is adequately and legibly labeled with patient information.

STORAGE and TRANSPORT

Store and transport swab specimens at 2 – 30ºC if tested within 30 days. Specimens may also be stored at -20°C (frozen) for up to 180 days.

For domestic and international shipments, specimens should be packaged and labeled in compliance with applicable state, federal, and international regulations covering the transport of clinical specimens and etiologic agents/infectious substances. Time and temperature conditions for storage must be maintained during transport. Shipping studies have been performed with seeded urine specimens to demonstrate that temporary exposure to extreme temperatures (-20°C and 60°C) during transport does not reduce UPT product performance.

REQUISITION & TRANSPORT INFORMATION

Please be certain patient name and second unique identifier (such as date of birth) is clear on specimen label and matches exactly the information on the requisition form.

Requisition must also include (minimum): patient date of birth and sex, clinician name and UPIN, date of collection and specimen type/site of collection, test request(s), and address for reporting results.

All liquid specimens must be transported to WSLH using pressure resistant secondary packaging (bags) and rigid outer containers (boxes) in accordance with US Postal regulations. Multiple specimens may be placed in one pressure bag.

Contacts:

WSLH: Reference Manual:

Customer Service: (800) 862-1013 or (608) 224-4272

Clinical Orders: (800) 862-1088 or (608) 224-4275