Cervical Papanicolaou Smear, Screening Without Physician Interpretation
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Cervical carcinoma and a number of infectious conditions of the female genital tract such as herpes, Candidiasis, human papillomavirus infection, trichomonas, etc.
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
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Cervical Pap Smear w/o Interp
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.
Container/Tube: Glass slide
Specimen Volume: Circular scrape of cervical os
1. Specimen containers must be labeled with a minimum of 2 unique identifiers (patient’s name, and medical record number or date of birth). Containers should also be labeled with specimen source, and date collected.
2. Glass slides may be labeled with a single unique identifier, but 2 identifiers are preferred. If multiple slides are submitted, each slide must have proper identification. Glass slides should be identified with the following: patient’s name and a second patient identifier that is also on the accompanying paperwork (ie, medical record number or date of birth)
3. Fix slides immediately in 95% alcohol or treat with commercially available spray fixative.
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 clinical information, including date of last menstrual period.
3. This test is available only to Mayo Rochester and the Mayo Health Systems Clinics. All other Mayo Medical Laboratories clients need prior laboratory approval.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
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 pre-cancerous (dysplastic, intraepithelial neoplastic, stages II in situ carcinoma, and eventually invasive carcinoma). This sequence is felt to develop over a matter of years in most patients.
The etiology of cervical carcinoma is unknown but the disease is believed to be related to sexual activity and possibly sexually transmitted viral infections such as human papilloma virus.
Most cervical carcinomas and precancerous conditions occur in the transformation zone (squamo-columnar junction), therefore, this area needs to be sampled if optimum results are to be obtained.
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 physician at an additional charge.
Standard reporting, as defined by the Bethesda System (TBS) is utilized.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
If endocervical cells have not been obtained (less than optimal smears), the results may be unreliable.
There is a false-negative rate of 10% to 20% in the presence of cervical intraepithelial neoplasia or invasive squamous cell carcinoma.
The Pap test is unreliable for endometrial carcinoma (at least 50% false-negative rate).
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Wright TC Jr, Cox JT, Massad LS, et al: ASCCP-Sponsored Consensus Conference. 2001 Consensus Guidelines for the management of women with cervical cytological abnormalities. JAMA 2002 April;287(16):2120-9
2. Solomon D, Davey D, Kurman R, et al: The 2001 Bethesda System: terminology for reporting results of cervical cytology-Consensus Statement. JAMA 2002 April;287(16):2114-9
Method Description Describes how the test is performed and provides a method-specific reference
Papanicolaou-stained slides are microscopically examined by a cytotechnologist. Abnormal findings are reviewed and reported by a pathologist (charged separately).(Unpublished Mayo method)
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, 8 a.m.-5 p.m.
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.
This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
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.
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|
|18596||Revision Description:||In Process|
|18599||SP Signing Pathologist:||N/A|
|18600||*Previous Report Follows*||N/A|