Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Herpes Simplex Virus (HSV) Types 1 and 2, NAA

CPT: 87491; 87529(x2); 87591; 87661
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Test Details

Use

Diagnosis of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections; detect and type active HSV shedding.

Limitations

This test is intended for use as an aid in the diagnosis of herpes simplex virus (HSV) infections with active viral shedding; it also differentiates HSV-1 from HSV-2. Negative HSV NAA results indicate lack of viral shedding but do not confirm absence of previous infection.

Methodology

Nucleic acid amplification (NAA)

Specimen Requirements

Specimen

Vaginal or endocervical cells collected by one of the methods described below

Volume

One Aptima® swab or entire liquid cytology vial

Minimum Volume

One Aptima® swab or entire liquid cytology vial

Container

Aptima® unisex or Aptima® vaginal swab transport or ThinPrep® or SurePath™ liquid cytology vial

Collection

Vaginal swab: Care provider specimen: Collect vaginal fluid sample using the GenProbe® 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 GenProbe® 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 vaginal opening 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.

Endocervical swab in Aptima®: Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white-shafted swab in the package with red printing). Discard this swab. Insert the specimen collection swab (blue-shafted 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 using care to avoid splashing of the contents. Recap the swab specimen transport tube tightly.

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 rotating 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 release additional 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.

Storage Instructions

Maintain specimen at room temperature.

Causes for Rejection

Urine specimen; specimen transported under inappropriate conditions; bacterial swabs; unlabeled specimen or discrepancy between specimen label and test request form; Aptima® COMBO 2 (AC2) swab specimen transport tube with two swabs or swab not supplied by Gen-Probe® or no swab; ProbeTec™ swabs; female urethral swab. For Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis: Aptima® swab transports >60 days from collection. For HSV: Aptima® swab transports >7 days from collection. Note: Specimens collected from children younger than 13 years of age or specimens submitted without the age of the patient or date of birth may be tested and will be reported with a disclaimer.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
188070 Ct Ng TV HSV by NAA 183161 Chlamydia by NAA 43304-5
188070 Ct Ng TV HSV by NAA 183162 Gonococcus by NAA 43305-2
188070 Ct Ng TV HSV by NAA 188053 Trich vag by NAA 46154-1
188070 Ct Ng TV HSV by NAA 188057 HSV 1 NAA 16130-7
188070 Ct Ng TV HSV by NAA 188058 HSV 2 NAA 16131-5

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