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

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)

Related Documents

For more information, please view the literature below.

 

Specimen Requirements

Information on collection, storage, and volume

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

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

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.