HPV, cobas high-risk/16/18

Test ID: 

705777

CPT code:

87625, 87624, 88175, 87491

Synonyms:

Gynecologic Pap Test (Image-guided), Liquid-based Preparation and High-risk HPV (Cobas®) With HPV Genotypes 16 and 18

Clinical Use:

Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis and Neisseria gonorrhoeae. The HPV 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.

Test Information:

Failure to obtain adequate ectocervical, endocervical, or vaginal cell population is suboptimal for evaluation. Excessive use of lubricating jelly on the vaginal speculum will interfere with cytologic examination and may lead to unsatisfactory Pap results.
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.

Specimen Type:

Cervical cells in SurePath™ vial and Aptima® device

Requested Volume: 

Entire SurePath™ vial and Aptima® device (for Chlamydia/Gonococcus)

Container Type: 

SurePath™ vial and Aptima® device (for Chlamydia/Gonococcus)

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:

SurePath™ vial – Using a cervical broom: 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.

Required Dedicated Specimen for Chlamydia and Gonococcus: Aptima® vaginal swab or unisex swab collection kit.

Vaginal Swab Kit: Collect vaginal fluid sample using the Gen-Probe® Aptima® swab 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.

Unisex Swab Kit: Clean the cervix using the larger, white- shafted swab supplied in the Gen-Probe® Aptima® swab collection kit and discard. Insert the smaller, blue-shafted swab into the cervix and rotate for 10 to 30 seconds to ensure good sampling. Carefully withdraw the blue-shafted swab, avoiding 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. Break the swab shaft at the scoreline, using care to avoid splashing contents. Recap the swab specimen transport tube tightly.

Storage Instructions:

Room temperature

Rejection Criteria

Improper collection; inadequate specimen; improper labeling; frozen specimen; specimen leaked in transit; quantity not sufficient for analysis; name discrepancies; specimen submitted on male patients. For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than four weeks old in SurePath™ vial; excessively bloody specimens. For Chlamydia andGonococcus: Aptima® specimen more than 60 days old; Gen-Probe® Aptima® collection tube with multiple swabs or white-shafted cleaning swab.

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MCI Diagnostic

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