High-risk HPV With HPV Genotypes 16 and 18 (Cobas®)

CPT: 87624
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Test Details

Use

This test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high-risk types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 without further specific differentiation.

Limitations

Detection of high-risk HPV is dependent on the number of copies present in the specimen and may be affected by specimen collection methods, patient factors, stage of infection, and the presence of interfering substances.

Methodology

Nucleic acid amplification (NAA)

Specimen Requirements

Specimen

Cervical cells in liquid-based cytology transport

Volume

2 mL

Minimum Volume

1 mL (Note: This volume does not allow for repeat testing.)

Container

ThinPrep® vial or SurePath™ vial

Patient Preparation

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

Collection

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 liquid-based cytology specimens at room temperature.

Causes for Rejection

Improper collection; inadequate specimen; improper labeling; specimen more than six months old in ThinPrep® vial; frozen specimen; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patients; specimen more than four weeks old in SurePath™ vial; excessively bloody specimens

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
507385 HPV, cobas high-risk/16/18 507386 HPV other hr types 71431-1
507385 HPV, cobas high-risk/16/18 507387 HPV 16 61372-9
507385 HPV, cobas high-risk/16/18 507388 HPV 18 61373-7

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2018, 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