Test ID: 83342
ThinPrep Screen with Human Papillomavirus (HPV) Reflex
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Triage of equivocal Pap abnormalities (atypical squamous cells of undetermined significance [ASCUS])
Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| 82100 | Phys Interp of ThinPrep, PAP | No | No |
| 19167 | High Risk HPV DNA Detection | Yes, (order #83344) | No |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
When this test is ordered, a ThinPrep screen will be performed. If the ThinPrep Pap results include atypical cells of undetermined significance (ASCUS), and the patient is > or =21 years old, a high risk HPV test will be performed. If ThinPrep Pap results are abnormal, a pathologist will review the case at an additional charge.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
ThinPrep with Hybrid Capture/Nucleic Acid Hybridization/Signal Amplification
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
STPHPV
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
For optimal interpretation, Pap smears should be collected near the middle of the menstrual cycle. Avoid douching, lubricant use, and sexual intercourse for 24 hours prior to specimen collection.
Submit only 1 of the following specimens:
Specimen Type: Cervical
Container/Tube: Cervix broom (Supply T056)
Specimen Volume: Adequate specimen
Collection Instructions:
1. Specimen containers must be labeled with a minimum of 2 unique identifiers (patient’s name and clinic number).
2. Rinse broom in PreservCyt solution vial by pushing broom into bottom of vial 10 times forcing bristles apart.
3. As final step, swirl broom vigorously to further release material. Discard device.
4. Tighten cap on vial.
5. Record patient's name and identification number on vial.
Specimen Type: Ectocervix and endocervix
Container/Tube: Plastic spatula and cytobrush (Supply T434)
Specimen Volume: Adequate specimen
Collection Instructions:
1. Specimen containers must be labeled with a minimum of 2 unique identifiers (patient’s name and clinic number).
2. Collect specimen from ectocervix using plastic spatula.
3. Rinse spatula in PreservCyt solution by swirling spatula vigorously into vial 10 times. Discard spatula.
4. Next, obtain specimen from endocervix using endocervical brush.
5. Rinse brush in PreservCyt vial by rotating brush 10 times while pushing against side of vial. Swirl brush vigorously as final step to further release material. Discard brush.
6. Tighten cap on vial.
7. Record patient's name and identification number on vial.
Additional Information:
1. An acceptable cytology request form must accompany specimen containers and include the following: Patient's name, medical record number, date of birth, sex, source (exact location and procedure used), date specimen was taken, name of ordering physician and pager number.
2. Submit any pertinent history or clinical information
3. This test is available only to Mayo Rochester and the Mayo Health System Clinics. All other Mayo Medical Laboratories clients need prior laboratory approval.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Cervical | Ambient (preferred) | |
| Refrigerated | ||
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Squamous cell carcinoma of the cervix is believed to develop in progressive stages from normal through precancerous (dysplastic) stages, to carcinoma in situ, and eventually invasive carcinoma. This sequence is felt to develop over a matter of years in most patients.
Follow up of the cervical Pap abnormality "atypical squamous cells of undetermined significance (ASCUS)" is costly and frustrating to patients and clinicians because a large percentage of these patients have normal colposcopic and biopsy findings. Yet, a significant percentage (10% - 15%) will have an underlying high grade squamous intraepithelial lesion (HSIL).
The majority (>99%) of cervical epithelial neoplasms are the result of human papillomavirus (HPV) infection. Some HPV types ("low-risk", types 6 and 11) are associated with low-grade squamous intraepithelial lesions (LSIL) that are benign and do not progress to carcinoma. "High-risk" HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) can result in both LSIL and HSIL, as well as invasive carcinomas. Patients with HSIL have a greater risk for progression to carcinoma.
In the setting of an ASCUS Pap result, the presence of high risk HPV types in cervical specimens, identifies a subgroup of patients with a greater likelihood of having a HSIL.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Satisfactory for evaluation. Negative for intraepithelial lesion.
Note: Abnormal results will be reviewed by a pathologist at an additional charge.
Interpretation Provides information to assist in interpretation of the test results
Cytology:
Standard reporting, as defined by the Bethesda System (TBS) is utilized.
Human papillomavirus (HPV):
A positive test result indicates the presence of one or more of the high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 or 68).
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
A negative human papillomavirus (HPV) test or Pap smear result does not preclude the presence of carcinoma. The false negative rates of the Pap test range from 15% to 30%; the false negative rate of the HPV test (Digene, Hybrid Capture II) is 1.1% to 7.5%.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Solomon D, Schiffman M, Tarone R: Comparison of three management strategies for patients with atypical squamous cells of undetermined significance: baseline results from a randomized trial. J Natl Cancer Inst 2001;93:293-299
2. Soloman D, Davey D, Kurman R, et al: The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA 2002;287:2114-2119
3. Wright TC, Cox JT, Massad LS,et al: 2001 Consensus Guidelines for the management of women with cervical cytological abnormalities. JAMA 2002;287:2120-2129
Method Description Describes how the test is performed and provides a method-specific reference
A ThinPrep Pap specimen is collected, processed on a T2000 or T3000 processor and stained with a Pap stain. Cases are examined microscopically and those with cytologic diagnoses of atypical squamous cells of undetermined significance (ASCUS) are referred to the Virology Laboratory for human papillomavirus (HPV) testing if the patient is 21 or older.(Operator’s Manual: ThinPrep 2000 System, Cytyc, Marlboro, MA; Operator’s Manual: ThinPrep 3000 Processor, Cytyc, Marlboro, MA)
The Digene hc2 High-Risk HPV DNA Test using Hybrid Capture 2 (hc2) technology (Qiagen Inc.) is an In Vitro nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of thirteen high-risk types of human papillomavirus (HPV) DNA in cervical specimens. The HPV types detected by the assay are the high-risk HPV types 16/18/31/33/35/39/45/51/52/56/58/59/68. The hc2 High-Risk HPV DNA Test cannot determine the specific HPV type present. Specimens containing the target DNA hybridize with a specific HPV RNA probe cocktail. The resultant RNA:DNA hybrid is captured onto the surface of a microplate well coated with anti-bodies specific for RNA:DNA hybrids. Immobilized hybrids are then reacted with antihybrid antibodies conjugated to alkaline phosphatase and detected with a chemiluminescent substrate. As the substrate is cleaved by the bound alkaline phosphatase, light is emitted, which is measured as relative light units (RLUs) on a luminometer. The intensity of the light is proportional to the amount of target DNA in the specimen.(Package insert: Digene Hybrid Capture 2 High-Risk HPV DNA Test, Qiagen Inc., Gaithersburg, MD. 2007)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; Varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
G0123 (Government payers)/ThinPrep manual screen
88142 (All other payers)/ThinPrep manual screen
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| 19172 | Accession Number | N/A |
| 19173 | Final Diagnosis | 22637-3 |
| 19174 | Cytotechnologist | In Process |
| 19175 | Revision Description | In Process |
| 19176 | Signing Pathologist | 19139-5 |
| 19188 | Specimen Description: | 33511-7 |
| 19177 | *Previous Report Follows* | N/A |
| 19178 | Addendum | 35265-8 |
| 19191 | Addendum Comment: | 22638-1 |
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