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(AutoCyte Prep System) with Reflex to Human Papillomavirus (HPV) DNA Probe, High Risk
Test indication: The SurePath (formerly AutoCyte Prep system) liquid-based Pap test produces slides that are intended as replacements for conventional gynecologic. The Pap smear is use in the screening and detection of cervical cancer, precancerous lesions, atypical cells and all other cytologic categories as defined by the Bethesda System for Reporting Cervical Cytology.
Cervicovaginal/ endocervical sampling. Methodology: PrepStain
Slide Processor, FocalPoint (computer assisted pap screening
analysis), routine cytopathologic evaluation, Hybrid Capture®
II DNA Test (Nucleic acid, hybridization assay with signal amplification)
a) To obtain an adequate sampling, scrape
the ectocervix using the Pap Perfect® plastic spatula. Disconnect
the spatula head into the SurePath Preservative vial.
Remarks: This test includes a Cytology, SurePath Liquid-Based Pap Test (AutoCyte Prep, FocalPoint computer assisted screening analysis, Routine cytopathologic evaluation and a Human Papillomavirus (HPV) DNA Probe, recommended High Risk ONLY if the SurePath Liquid-Based Pap Test is interpreted as atypical squamous cells of undetermined significance (ASC-US).
Unacceptable conditions: Frozen, older than 28 days, samples not collected in a SurePath special collection kit provided by lab, Expired SurePath vials will not be processed.
Stability: Ambient: 1 month; Refrigerated: 1 month; Frozen: Unacceptable.
SurePath test reference interval: By Report.
Note: Store SurePath preservative fluid without cytologic samples at 15-30°C in this vials provided. Do not use SurePath solution beyond expiration date marked on the vial. Rotate stock of SurePathTM and use vials with closest expiration date first. No specimen will be accepted in expired solution.
Warning: SurePath preservative contains denatured ethanol which may be fatal if swallowed. Vapor is harmful if inhaled. May cause blindness. SurePath is flammable. Keep away from fire, heat, sparks, and flames. Other solutions must not be substituted for SurePath preservative.
CPT code(s): Refer to the earlier information given in Cytopathology section.
HPV DNA reference interval: High-risk HPV: Not detected.
Hybrid capture II Interpretative Data: Women with atypical squamous cells of undetermined significance (ASC-US) should be managed using a program of either repeat cervical cytology testing, immediate colposcopy or DNA testing for high-risk types of Human Papillomavirus (HPV). Testing for HPV DNA is the preferred approach when liquid-based cytology is used for screening. All women who test positive for high-risk HPV DNA should be referred for colposcopic evaluation. Women with ASC-US who test negative for high-risk HPV DNA can be followed up with repeat cytologic testing at 12 months (2001 ASCCP Guidelines JAMA 2002; 287:2120-2129).
A positive high risk HPV test result indicates that the patient may be infected with one or more of the following HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68; which are associated with cervical cancer and its precursor lesions. However, cross-reactions with other genotypes may occur. Results should be correlated with cytologic/histologic findings.
Note: A negative result does not rule out the presence of an HPV genotype absent from the test panel, a low level infection or specimen sampling error.
CPT code(s): CPT Codes vary based on testing.