Sperm Antibody, Direct, Semen
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
As the preferred test and specimen type (semen) for males suspected of sperm antibodies, this test is indicated in the investigation of male infertility:
-As a follow-up test when sperm agglutination is noted in the ejaculate
-In men with a history of testicular trauma, biopsy, vasectomy reversal, genital tract infection, or obstructive lesions of the reproductive ductal system
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Antisperm Antibody, Semen
Sperm Antibody Assay
Sperm Antibody Assay
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.
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.
Container/Tube: Fertility-Test Yolk Buffer (Sperm Antibody) Kit (Supply T356)
Specimen Volume: Total ejaculate
1. Patient should have 2 to 7 days of sexual abstinence at the time of semen collection for accurate results.
2. Submit viable semen.
Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.
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.
Variable, based on sperm parameters
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
Sperm antibodies are associated with some cases of infertility. For fertilization to occur, the sperm head must first attach to the zona pellucida of the egg. Sperm antibodies interfere with this binding. While there is consensus that these antibodies play a role in infertility, the percentage of sperm that must be bound by antibodies before fertility is adversely affected is less clear.
<50% total binding
Results are reported as:
-Percentage of sperm with positive binding
-Class of antibody involved (IgG and IgA)
-Site of binding (head, midpiece, tail, and/or tail tip)
Greater than 50% binding is usually required to significantly lower a patient's fertility.
The significance of the percentage binding is inversely related to the patient’s sperm count.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Sperm antibody testing is not recommended for routine infertility testing.
In cases where specimen production presents difficulties, a serum specimen can be tested (see SSA/9502 Sperm Antibody, Indirect, Serum).
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Bronson R, Cooper G, Rosenfeld D: Sperm antibodies: their role in infertility. Fertil Steril 1984;42:171-183
2. Marshburn PB, Kutteh WH: The role of antisperm antibodies in infertility. Fertil Steril 1994;61:799-811
Method Description Describes how the test is performed and provides a method-specific reference
This assay has been developed on the principle that the antigen(s) is a sperm surface protein(s). Such antigens may induce production of antibody in the person himself or his female partner. Direct testing for the presence of antibodies on sperm is accomplished by incubating washed sperm with the immunobeads. The presence of sperm antibodies is indicated by the binding of the polyacrylamide beads to motile sperm. The proportion of sperm bound and the sites of binding are determined by counting a minimum of 100 cells.(Bronson R, Cooper G, Rosenfeld D: Sperm antibodies: their role in infertility. Fertil Steril 1984;42:171-183)
For specimens collected on-site at Mayo Rochester, if patient's sperm count is <5 million/mL or motility is <10%, indirect testing of seminal plasma may be indicated due to insufficient motile sperm for direct testing.
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, Set up at 8:30 a.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
Specimen is discarded the following Monday after testing
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 using an analyte specific reagent. Its performance characteristics were 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|
|TTA||Tail Tip, IgA||38676-3|
|TTG||Tail Tip, IgG||38680-5|