Pap IG, Ct, rfx HPV all pth

Test ID: 

705843

CPT code:

86003 (x5)

Clinical Use:

Diagnose primary or metastatic neoplasm; detect Chlamydia trachomatis. The high-risk HPV test is used for types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68 without differentiation of the individual types. This assay aids in the diagnosis of sexually-transmitted HPV infection and in the triage of patients with an ASCUS Pap test result.

Specimen Type:

Cervical cells collected by one of the methods described below.

Requested Volume: 

A minimum volume cannot be determined for the ThinPrep® vial, because it varies depending on the cellularity of the specimen. The entire SurePath™ specimen should arrive intact. Specimens collected with the Gen-Probe® Aptima® swab collection kit must arrive intactThinPrep® vial or SurePath™ vial or ThinPrep® vial or SurePath™ vial with optional additional Aptima® swab collection kit (for Chlamydia.

Container Type: 

ThinPrep® vial or SurePath™ vial or ThinPrep® vial or SurePath™ vial and Aptima® swab collection kit (for Chlamydia)

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:

ThinPrep® Vial−Broom Only:

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.

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.

Optional Dedicated Specimen for Chlamydia: Use the Gen-Probe® Aptima® swab collection kit. (Note: Do not use the Gen-Probe® PACE DNA probe collection 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:

Maintain liquid-based cytology and Aptima® swab transport specimens at room temperature. Pap processing must be done within 21 days of collection. SurePath™ vial must be processed for testing within 21 days of collection for HPV. Specimens in ThinPrep® vials must be processed for testing within three months of collection for HPV. Liquid-based cytology specimens must be tested within seven days for Chlamydia trachomatis; if the Aptima® swab transport is used, it must be tested within 60 days.

Rejection Criteria:

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. For Pap: liquid-based cytology specimen more than 21 days old. For HPV: specimen more than 21 days old in SurePath™ liquid-based preservative; specimen more than three months old in ThinPrep® vial. For Chlamydia trachomatis: liquid-based cytology specimen more than seven days old; Aptima® specimen more than 60 days old; Gen-Probe® Aptima® collection tube with multiple swabs, white-shafted cleaning swab, or any swab other than the blue-shafted collection swab.

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