SurePath™ Pap and HPV mRNA E6/E7

Test Code
15095


CPT Codes
87624, 88142<br><strong>This test is not available for California patient testing.</strong>

Includes
Pap results requiring physician interpretation will be performed at an additional charge (CPT code(s): 88141; HCPCS: G0124)


Preferred Specimen
Pap sample collected in 1 SurePath™ pap vial


Minimum Volume
1 SurePath pap vial


Instructions


Transport Container
1 SurePath pap vial


Transport Temperature
Room temperature


Specimen Stability
SurePath Pap
Room temperature: 28 days
Refrigerated: 90 days
Frozen: Unacceptable

SurePath HPV
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable

SurePath Preservative in Aptima Transfer Tube
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable

Refer to local service area for specimen retention


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
SurePath™ vials without the head of the collection device(s) in the fluid • Swabs • Cervical swabs in Digene® HC cervical sampler • Digene® vials


Methodology

Liquid Based-density Gradient Sedimentation • Transcription-Mediated Amplification (TMA)



Setup Schedule
Set up: Mon-Sat; Report available: 10 days


Reference Range
See Laboratory Report


Clinical Significance
Liquid-based Pap Testing is intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Results of Cervical Cytology. Pap screening is not reliable for the detection of endometrial cancer. HPV DNA testing in conjunction with a Pap test in women 30 years and older can be used adjunctively to assess the presence or absence of high-risk HPV types. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Detection of HPV using the hc2 High-Risk HPV DNA Test does not differentiate HPV types or infection with more than one type, and cannot evaluate persistence of any one type. The use of this test has not been evaluated for the management of women with prior cytologic or histologic abnormalities, hysterectomy, who are postmenopausal, or who have other risk factors (e.g., HIV+, immunocompromised, DES exposure, history of STD).

Gynecologic cytology is a screening test which is subject to both false positive and false negative results. For that reason, the test is most reliable when a satisfactory sample is obtained on a regular repetitive basis. Hence, these results must be interpreted in the context of historic and current clinical information.


Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.