Human Papillomavirus (HPV) (Aptima®) With Reflex to HPV Genotypes 16 and 18,45

CPT: 87624
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Expected Turnaround Time

2 - 5 days



Specimen Requirements


Specimen

Cervical cells in liquid-based cytology transport


Volume

ThinPrep® vial


Minimum Volume

A minimum volume cannot be determined for the ThinPrep® vial because it varies depending on the cellularity of the specimen.


Container

ThinPrep® vial


Collection

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 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 room temperature. Specimens in ThinPrep® vials must be processed within 21 days of collection for HPV.


Patient Preparation

Patient should avoid douches 48 to 72 hours prior to examination. Specimen should not be collected during or shortly after menstrual period.


Causes for Rejection

Improper collection; inadequate specimen; improper labeling; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patient; specimen submitted in vial that expired according to manufacturer's label; frozen specimen; SurePath™ vial. For HPV: specimen more than 21 days old in ThinPrep® vial.


Test Details


Use

High-risk HPV test is used for types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, without differentiation of the individual type. If the initial high-risk test is positive, then the residual specimen will be tested for HPV types 16 and 18,45; type 18 cannot be differentiated from type 45.


Limitations

A negative result does not exclude the possibility of an HPV infection since very low levels of infection or sampling error may produce a false-negative result.


Methodology

Nucleic acid amplification (NAA)


LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
507805 HPV, Aptima High 16/18,45 507801 HPV Aptima 59420-0
507805 HPV, Aptima High 16/18,45 019054 PDF N/A
Reflex Table for HPV Aptima
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507825 HPV Genotypes 16/18,45 507811 HPV Genotype 16 59263-4
Reflex Table for HPV Aptima
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507825 HPV Genotypes 16/18,45 507812 HPV Genotype 18,45 75694-0
Reflex Table for HPV Aptima
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507825 HPV Genotypes 16/18,45 507813 HPV Genotype 16/18,45 Tracking N/A
Reflex Table for HPV Aptima
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 507825 HPV Genotypes 16/18,45 019054 PDF N/A

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The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf