Test Details
Methodology
Nucleic acid amplification (NAA)
Result Turnaround Time
2 - 4 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
This test is used to 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.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Specimen Requirements
Specimen
Vesicular fluid, ulcerated lesions, vaginal, or endocervical cells collected by one of the methods described below
Volume
One swab or entire liquid cytology vial
Minimum Volume
One swab or entire liquid cytology vial
Container
Aptima® unisex or Aptima® vaginal swab transport or swab in Universal or Viral Transport Media (UTM/VTM) or ThinPrep® liquid cytology vial
Collection Instructions
Lesion/vesicle swab: Unroof or scrape the lesion with an Aptima® swab (for Aptima® collections) or with a synthetic swab for UTM/VTM collections.
Vaginal swab: Collect vaginal fluid sample using the 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.
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 ¼ to ½ 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.
Storage Instructions
Maintain specimen at ambient or refrigerated 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 Hologic or no swab; ProbeTec™ swabs; female urethral swab; SurePath™ vial; Aptima® swab transports >7 days from collection; specimens submitted in non-FDA cleared UTM or VTM
LOINC® Map
Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
---|---|---|---|---|---|---|
188056 | HSV NAA | 188057 | HSV 1 NAA | 16130-7 | ||
188056 | HSV NAA | 188058 | HSV 2 NAA | 16131-5 | ||
Order Code | 188056 | |||||
Order Code Name | HSV NAA | |||||
Order Loinc | ||||||
Result Code | 188057 | |||||
Result Code Name | HSV 1 NAA | |||||
UofM | ||||||
Result LOINC | 16130-7 | |||||
Order Code | 188056 | |||||
Order Code Name | HSV NAA | |||||
Order Loinc | ||||||
Result Code | 188058 | |||||
Result Code Name | HSV 2 NAA | |||||
UofM | ||||||
Result LOINC | 16131-5 |