URINE SPECIMEN - Obtain an APTIMA Combo 2 Assay Urine Specimen Collection Kit for Male and Female Urine Specimens. Patients should not have urinated for at least one hour prior to sampling. If they have urinated, please have them wait for 1 hour before collecting the specimen. Direct the patient to provide a FIRST-CATCH URINE (~20-30 ml of the initial urine stream ONLY) into a clean urine collection cup. Collection of larger volumes of urine may reduce test sensitivity. DO NOT COLLECT A CLEAN-CATCH URINE as this may reduce test sensitivity. Female patients should not cleanse the labial area prior to providing the specimen. Remove the cap of the provided urine specimen transport tube and transfer 2.0 ml of urine into the tube using the provided disposable pipette. The correct volume of urine has been added when the fluid level is within the window and between the black lines on the urine specimen transport tube. Tightly recap the urine specimen transport tube so that it does not leak in transport.
Urine specimens should be transported to the laboratory at room temperature in the provided urine specimen transport tube. If received in the primary urine cup, the urine specimen is still acceptable but it must be transferred into the specimen transport tube within 24 hours of collection. Processed urine specimens must be tested within 30 days of collection.
Use only the specimen transport tubes contained in the APTIMA Combo 2 Assay Urine Specimen Collection Kit for Male and Female Urine Specimens. Collection kits are available from Central Laboratory Services or the Clinical Virology Laboratory. Please carefully follow the instructions on the cover of the collection kits to obtain the desired specimen. Specimens not collected as instructed will be rejected.
Specimen not collected using an appropriate GenProbe APTIMA Combo 2 collection kit. Specimens not collected according to the defined collection instructions.
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Test for Neisseria gonorrhoeae is performed in combination with the test for C. trachomatis. Positive results obtained for either C. trachomatis or N. gonorrhoeae when using the GenProbe APTIMA Combo 2 Assay will be confirmed using a second supplemental molecular amplification assay that detects a nucleic acid sequence different from that detected in the initial screening assay.
87801 (Combo) 87491 (CT supplemental) 87591 (GC supplemental)
The GenProbe APTIMA Combo 2 Assay uses transcription-mediated amplification (TMA) to replicate a specific region of the 23S rRNA from C. trachomatis and a specific region of the 16S rRNA from N. gonorrhoeae via DNA intermediates. A unique set of primers is used for each target molecule.
The GenProbe APTIMA Combo 2 Assay is designed to detect the presence of C. trachomatis and N. gonorrhoeae in clinician-collected endocervical, vaginal, and male urethral swab specimens, patient-collected vaginal swab specimens, and in female and male urine specimens. The assay is also intended for use with testing of gynecological specimens collected in the PreserCyt Solution and processed with the Cytyc ThinPrep 2000 System. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital specimens. Alternative specimen sources such as conjunctival, nasopharyngeal and rectal specimens can also be tested using this assay for newborns or infants with suspected conjunctivitis and/or pneumonia due to infection with C. trachomatis during birth and for anorectal infections in women and men. Lastly, the test is applicable for the detection of C. trachomatis and/or N. gonorrhoeae in investigating sexual assault and abuse. Additional testing will be done to confirm any initial positive results in this patient population.
If positive, results are reported as Chlamydia trachomatis rRNA detected or Neisseria gonorrhoeae rRNA detected or both Chlamydia trachomatis rRNA and Neisseria gonorrhoeae rRNA detected.
Negative or no Chlamydia trachomatis rRNA detected.
Negative or no Neisseria gonorrhoeae rRNA detected.
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