SPECIMEN COLLECTION and HANDLING INSTRUCTIONS for the

BD VIPERâ CHLAMYDIA and GONORRHEA ASSAYS

for ENDOCERVICAL SWAB SPECIMENS -- WSLH Kit 29

Contents

WSLH Kit #29 consists of one Female Endocervical Specimen Collection Kit for the BD ProbeTec™ CT/GC Qx Amplified DNA Assays (VIPER), and contains one swab diluent/specimen transport tube, one white-handled cleaning swab and one pink 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 endocervical swab specimens. No other anatomical sites will be tested. (For male urethral specimens, see WSLH Kit 29M; for urine, use WSLH Kit 27-V.)

2.  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.

3.  Peel open the swab package from the handle end.

4.  After carefully removing the swab from the package, use the polyester fiber-tipped cleaning swab with the white shaft to remove excess blood and mucus from the cervical os.

5.  Discard the used cleaning swab

6.  Remove the PINK collection swab from packaging

7.  Insert the PINK collection swab into the cervical canal and rotate for 15 - 30 seconds

8.  Withdraw the swab carefully, avoiding contact with the vaginal mucosa

9.  Uncap the CT/GC Qx Swab Diluent Tube

10.  Fully insert the PINK collection swab into the CT/GC Qx Swab Diluent Tube

11.  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

12.  Tightly recap the tube

13.  Check to be sure tube is adequately and legibly labeled with patient information.

STORAGE and TRANSPORT

w  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

w  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.

w  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.

w  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: www.slh.wisc.edu Reference Manual: http://www.slh.wisc.edu/wslhApps/RefMan/wslhSearch.php

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

Clinical Orders: (800) 862-1088 or (608) 224-4275 Adopted 091713