NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Determining male fertility status
Includes concentration, World Health Organization morphology, and presence of other cellular elements.
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
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.
Patient should have 2 to 7 days of sexual abstinence at the time of semen collection for accurate results.
Include the following information: semen volume, viscosity, pH, appearance (color), and number of days of sexual abstinence.
Submit only 1 of the following specimens:
Semen specimen must arrive within 24 hours of collection. Send specimen Monday through Thursday only and not the day before a holiday. If holiday falls on a Saturday, holiday will be observed on the preceding Friday. Sunday holidays are observed on the following Monday. Specimen should be collected and packaged as close to shipping time as possible. Laboratory does not perform testing on weekends.
Specimen Type: Semen
Container/Tube: Semen Analysis Kit (Supply T178)
Specimen Volume: Total ejaculate
Additional Information: Specimen volume is required.
Specimen Type: Liquefied semen
Specimen Volume: 2 slides-10 microL on each slide
1. If sperm concentration is <10 million/mL, centrifuge the specimen at 300 x G for 10 minutes before making slides.
2. Label 2 frosted slides in pencil with the patient's first and last name and the date of specimen collection.
3. Allow the semen to liquefy for 30 minutes.
4. Place 10 microL of liquefied semen on the labeled end of each slide, and evenly smear the specimen using a plain slide (this process is the same as making a blood smear).
5. Allow the smears to air dry for 15 minutes before placing the slides into a slide holder for shipment.
Additional Information: Total sperm concentration is required.
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.
See instructions above
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
Male fertility can be adversely affected by a number of causes, including sperm with abnormal morphology. The World Health Organization morphology third edition procedure provides a rapid, subjective estimate of sperm shape and size, and reports the presence of WBCs and germinal cells. High numbers of germinal cells and WBCs are indicative of possible disorders in spermatogenesis and genital tract infection, respectively.
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.
Morphology: > or =15% normal oval sperm heads
Germ cells: <4 x10(6)/mL
WBC: <1 x10(6)/mL
Teratospermia, a World Health Organization morphology score of <15% normal oval sperm heads, is associated with impaired fertility. This association is variable and does not rule out normal fertility.
Germinal cells/mL: > or =4.00 x 10(6) indicate a possible disorder in spermatogenesis.
WBC/mL: > or =1.00 x 10(6) indicate a possible genital tract infection.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
A World Health Organization morphology score of <15% normal oval sperm heads does not rule out fertility.
Method Description Describes how the test is performed and provides a method-specific reference
A drop of semen is spread on a microscope slide. The slide is then processed with stains that give different colors to different parts of the sperm. Using high-power microscopy, the shape and size of at least 100 sperm are compared to a normal reference sperm.(The World Health Organization Laboratory Manual for the examination of human semen and sperm-cervical mucus interaction. Fourth edition. Cambridge University Press, 1999)
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; 6:30 a.m. to 3:30 p.m.
Send specimen Monday through Thursday only and not the day before a holiday.
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
Slides are kept for 10 years. Only tests #8893 "WHO Morphology" or #80749 "Strict Criteria Sperm Morphology for Infertility Diagnosis and Treatment, Semen" can be performed on retained slides.
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 was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.
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|
|OVAL3||WHO Morph NL||In Process|
|GERM2||Germ Cells/mL||In Process|