Diagnostic kits to detect SP22 and SP22 antibodies
Inventors
Assignees
US Environmental Protection Agency
Publication Number
US-8497135-B2
Publication Date
2013-07-30
Expiration Date
2027-02-13
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Abstract
Oral, topical and injectable contraceptives, which are based on sperm protein 22 kDa (SP22) polypeptides and antibodies and infertility diagnostics and kits are provided.
Core Innovation
The invention provides oral, topical, and injectable contraceptives based on sperm protein 22 kDa (SP22) polypeptides and antibodies, as well as infertility diagnostics and kits. It features methods for detecting infertility in male subjects by measuring SP22 levels in sperm samples, where decreased SP22 indicates infertility. Immunoassays are preferred for determining SP22 levels.
Additionally, the invention includes methods for determining the fertilization potential by isolating a motile subset of sperm and detecting SP22 presence on them. It also encompasses methods for monitoring fertility in subjects vaccinated with SP22 by detecting SP22 antibody levels, where increased antibody levels indicate protection against fertilization. Pharmaceutical compositions comprising spermicidal SP22 antibodies, vaccines with SP22 polypeptides, and kits for detection of SP22 or its antibodies are described.
The background outlines the problem addressed: conventional sperm analysis based on sperm count and motility is not reliably predictive of male fertility, with thresholds being uncertain and some males with normal counts still infertile. Approximately one in six couples experience infertility and 16% of infertile couples have unexplained causes. There is a need for accurate and easy-to-use diagnostic tests to determine male fertility.
Claims Coverage
The patent includes one independent claim directed to a diagnostic kit for detecting SP22 on motile sperm in a semen sample, featuring specific structural components and SP22 antibody targeting functional peptide regions.
Kit structure comprising distinct zones for sperm sample processing and detection
The kit comprises an application zone for adding a sperm sample and a detection zone containing an SP22 antibody that identifies the presence of SP22 polypeptide on motile sperm.
Incorporation of a barrier zone to isolate motile sperm subset
The kit optionally includes a barrier zone separating the application and detection zones, which isolates a subset of sperm having higher average motility than the overall sperm sample.
Barrier filter characteristics
The barrier zone may include a porous barrier filter, such as a nylon mesh with specified pore sizes, allowing motile sperm to pass through to the detection zone.
SP22 antibody specific binding to defined peptide regions
The SP22 antibody in the detection zone binds to a portion of SP22 polypeptide selected from amino acid sequences 40-57, 58-72, 88-102, 80-102, 118-132, 160-174, or 47-102 of SEQ ID NO: 2.
Antibody conjugation to detectable markers
The SP22 antibody may be conjugated to detectable markers, including chemiluminescent labels, facilitating direct detection of SP22 presence.
Provision of ports for solution handling
The kit may include one or more ports allowing addition or removal of solutions directly to or from the detection zone, possibly separated by filters that prevent sperm passage.
Instructions for use and quantitative detection
The kit may comprise instructions and optionally a color-coded scale for visual or instrument-based evaluation of the SP22 detection and its correlation with sperm fertility.
The claims collectively cover kits for identifying SP22 on motile sperm involving compartmentalized structures with zones for sample application, motile sperm barrier separation, specific SP22 antibody detection against defined epitopes, optional conjugated detectable markers, fluid handling ports, and user instructions for fertility assessment.
Stated Advantages
The invention provides diagnostic tests that are accurate and easy to use for determining male fertility, improving upon conventional sperm analysis which is unreliable.
The SP22-based assays permit prediction of fertility with high correlation and predictive value, useful in clinical, toxicological, and epidemiological settings.
The kits and methods enable detection of sperm quality and fertility potential by assessing SP22 presence on motile sperm subsets, offering enhanced fertility evaluation.
Antibody-based contraceptives and vaccines targeting SP22 functional fragments effectively reduce fertility, providing novel contraceptive methods.
Formulations are adaptable to various routes of administration and include combinations with other active agents and adjuvants to enhance immunogenicity and protective effects.
Documented Applications
Diagnosis of male infertility by detecting SP22 levels in sperm samples
Determination of fertilization potential by isolating motile sperm subsets and assessing SP22 presence
Monitoring fertility status in subjects vaccinated with SP22 by measuring SP22 antibody levels
Use of SP22 antibodies as spermicides delivered via creams, gels, foams, suppositories, lubricants, or impregnated in vaginal devices
SP22 polypeptide-based vaccines administered orally, intravaginally, or by injection for contraception
Screening kits for clinical evaluation of fertility and effectiveness of SP22-based vaccination
Determining sperm quality for assisted reproductive technologies and artificial insemination in humans and animals
Use in toxicological studies screening reproductive toxicants that affect SP22 levels and fertility
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