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Chlamydia/Gonococcus, NAA With Confirmation
- Chlamydia/Gonococcus, Aptima® TMA
Detection of Chlamydia trachomatis and Neisseria gonorrhoeae (Gonococcus) by nucleic acid amplification technology with confirmation of positive results using a second molecular target
Detect Chlamydia trachomatis and Neisseria gonorrhoeae (Gonococcus)
Note: Specimens cannot be collected and used for Chlamydia/Gonococcus and routine chemistry or urine culture. Chlamydia/Gonococcus NAA requires the use of a first-catch specimen (the initial stream of urine that will wash organisms out of the urethra of men or women). Routine chemistry and bacterial or fungal culture require use of the clean-catch, midstream collection technique.
Nucleic acid amplification (NAA)
Endocervical, vaginal, or male urethral swab; first-void urine (patient should not have urinated for one hour prior to specimen collection); or cervical cells in liquid cytology vial
One swab (endocervical, vaginal, or urethral), 2 mL of a 20 mL to 30 mL urine collection, or entire liquid cytology vial
One swab (endocervical, vaginal, or urethral), 2 mL of a 15 mL urine collection, or entire liquid cytology vial
Gen-Probe® Aptima® swab or Aptima® urine specimen transport; ThinPrep® or SurePath™ liquid cytology vials
Option 1: Gen-Probe® Aptima® Endocervical, Male Urethral, or Vaginal Swab
Endocervical swab: Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white-shaft swab in the package with red printing). Discard this swab. Insert the specimen collection swab (blue-shaft swab in the package with green printing) into the endocervical canal. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling. Withdraw the swab carefully; avoid contact with the vaginal mucosa. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of the contents. Recap the swab specimen transport tube tightly.
Male urethral swab: The patient should not have urinated for at least one hour prior to specimen collection. Insert the specimen collection swab (blue-shaft swab in the package with the green printing) 2 to 4 cm into the urethra. Gently rotate the swab clockwise for two to three seconds in the urethra to ensure adequate sampling. Withdraw the swab carefully. Remove the cap from the swab specimen transport tube and immediately place the specimen collection swab into the specimen transport tube. Carefully break the swab shaft at the scoreline; use care to avoid splashing of contents. Recap the swab specimen transport tube tightly.
Vaginal swab: Care provider specimen: Collect vaginal fluid sample using the Gen-Probe® Aptima® vaginal swab kit by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Patient self-collection: Partially open the package of the Gen-Probe® Aptima® vaginal swab kit. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima® swab specimen collection kit. Remove the swab. Carefully insert the swab into the vagina about two inches past the introitus and gently rotate the swab for 10 to 30 seconds, making sure the swab touches the walls of the vagina so that moisture is absorbed by the swab. Withdraw the swab without touching the skin. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap.
Option 2: Urine Specimen: The patient should not have urinated for at least one hour prior to specimen collection. Direct patient to provide a first-catch urine (approximately 20 to 30 mL of the initial urine stream) into a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity; lesser volumes may not adequately rinse organisms into the specimen. Female patients should not cleanse the labial area prior to providing the specimen. Add urine to the Aptima® Combo 2 urine collection device. The final volume must be between the two black lines on the device (about 2 mL).
Option 3: Liquid-based Cytology Specimen
ThinPrep® Vial − Broom or Brush/Spatula
Broom-like collection technique: Obtain a sample from the cervix using a broom-like device by inserting the brush portion into the cervical os and then rotate the brush five times. Rinse the collection device in the PreservCyt® solution by pushing the brush into the bottom of the vial 10 times, forcing the bristles to bend apart to release the cervical material. As a final step, twirl the brush between the thumb and forefinger vigorously to further release cellular material. Discard the collection device. Tighten the cap on the ThinPrep® vial so that the torque line on the cap passes the torque line on the vial.
Brush/spatula technique: Insert the brush into the endocervical canal until only the bottommost fibers are exposed. Slowly rotate the brush 1/4 to 1/2 turn in one direction. Do not over-rotate the brush. Then, rotate the brush in the PreservCyt® solution 10 times while pushing against the wall of the ThinPrep® vial. Swirl the brush vigorously to release additional material. Discard the brush. Obtain an adequate sample from the ectocervix using a plastic spatula. Swirl vigorously in the ThinPrep® vial 10 times and discard the spatula. Tighten the cap on the ThinPrep® container so that the torque line on the cap passes the torque line on the vial.
SurePath™ Vial: When using the SurePath™ vial, the cervical broom must be used for specimen collection. Insert the broom into the cervical os and rotate five times. Place the broom head into the CytoRich™ preservative fluid in the SurePath™ collection vial. Tightly cap the vial.
Maintain specimen at room temperature or refrigerate (2°C to 30°C).
Causes for Rejection
Specimen with incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions; specimen leaked in transit; specimen in expired transport or incorrect transport device; specimens with inappropriate source for test requested; specimen with fixative or additives; APTIMA® urine transport >30 days from collection; APTIMA® urine transport with incorrect specimen volume; <15 mL urine submitted in sterile container; receipt of urine in sterile container >72 hours from collection; APTIMA® swab transport >60 days from collection; APTIMA® swab specimens with incorrect specimen volume; APTIMA® swab specimen without a swab; cleaning swab (white-shaft swab) in APTIMA® swab transport; any non-Gen-Probe® swab submitted in APTIMA® transport device; wooden-shafted swab in transport device; transport device with multiple swabs; female urethral swab; bloody or grossly mucoid specimens; bacterial swabs; specimen in ProbeTec™ UPT transport; ProbeTec™ Q-swabs; BD ProbeTec™ ET male urethral swab; swab specimen in universal transport media or viral transport media
Submit one specimen per test requested. Specify the exact specimen source/origin (eg, endocervical). Indicate a specific test number on the test request form.
|Order Code||Order Code Name||Order Loinc||Result Code||Result Code Name||UofM||Result LOINC|
|183616||Chlamydia/GC NAA, Confirmation||183617||Chlamydia trachomatis, NAA||43304-5|
|183616||Chlamydia/GC NAA, Confirmation||183618||Neisseria gonorrhoeae, NAA||43305-2|
|Reflex Table for Chlamydia trachomatis, NAA|
|Order Code||Order Name||Result Code||Result Name||UofM||Result LOINC|
|Reflex 1||183620||C. trachomatis NAA, Confirm||183621||C. trachomatis NAA, Confirm||43304-5|
|Reflex Table for Neisseria gonorrhoeae, NAA|
|Order Code||Order Name||Result Code||Result Name||UofM||Result LOINC|
|Reflex 1||183624||N. gonorrhoeae NAA, Confirm||183625||N. gonorrhoeae NAA, Confirm||43305-2|