Swab specimen: Endocervical, vaginal or male urethral specimen using Gen-Probe APTIMA Combo 2 Assay Unisex Swab Specimen Collection Kit. When collecting a male urethral specimen, patient should not have urinated for at least one hour prior to specimen collection. Carefully follow the instructions printed on the collection kit. Urine specimen: Collect 20-30 mL first catch urine specimen into a sterile plastic urine container. Urine specimen can be transferred to the Gen-Probe APTIMA Combo 2 Assay Urine Specimen Collection Kit for transport or the sterile urine container may be sent. When collecting a urine specimen, patient should not have urinated for at least one hour prior to specimen collection. Carefully follow the instructions printed on the collection kit. ThinPrep PreservCyt™ Solution: Cervical brush in ThinPrep PreservCyt™ Solution.
Handling:
Urine specimen can be transported to the laboratory at 2-30 degrees C in either the primary collection device (urine cup) or in the urine specimen transport tube. Urine specimen must be maintained at 2-30 degrees C and must be transferred into the specimen transport tube within 24 hours of collection. ThinPrep PreservCyt™ specimen can be transported to laboratory at 2-30 degrees C. NOTE: Test for Neisseria Gonorrhoeae cannot be done if the specimen has already been processed for the PAP.
Stability:
Swab specimen stable 60 days at ambient temperature, 60 days refrigerated, or 90 days if frozen at -20 to -70 degrees C. Urine specimen in the Collection Kit stable 30 days at ambient temperature, 30 days refrigerated, or 90 days if frozen at -20 to -70 degrees C. Do not freeze a urine specimen that has not been added to the collection kit. ThinPrep PreservCyt™ specimen stable 14 days ambient, 30 days refrigerated, or 3 months frozen.
Standard Volume:
20-30 mL urine.
Minimum Volume:
2 mL urine.
Transport:
Ambient temperature, refrigerated, or frozen if in collection kit.
Comments:
This method has been tested using endocervical and male urethral swab specimens, vaginal swab specimen, ThinPrep PreservCyt™ liquid PAP specimens, and female and male urine specimens only. Performance with other specimens has not been assessed. Specimens other than those collected with the APTIMA Combo 2 Assay Unisex Swab Specimen Collection Kit for Endocervical and Urethral Swab Specimens or the APTIMA Combo 2 Assay Urine Collection Kit for Male and Female Urine Specimens, and ThinPrep PreservCyt™ Solution have not been evaluated.
Rejection Criteria:
ThinPrep PreservCyt™ specimen already processed for the PAP; urine specimen older than 24 hours that has not been transferred to the Urine Specimen Collection Kit; Unisex Swab Specimen Collection Kit received containing white cleaning swab (the large white swab is for preparatory cleaning of the endocervix and is unacceptable for testing), or received containing no swab; frozen urine specimen that has not been transferred to the Urine Specimen Collection Kit; catheterized urine specimens; urine specimen collection with urine preservatives; specimens received in any transport media other than those mentioned above.
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