Methods of detecting Trichomonas vaginalis
Inventors
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Assignees
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CepheidCepheid is a global leader in molecular diagnostics, dedicated to improving healthcare by developing, manufacturing, and marketing automated, easy-to-use molecular systems and tests. Their mission is to provide rapid, accurate, and actionable genetic testing for a wide range of infectious diseases, oncology, and human genetics. Cepheid's flagship GeneXpert System delivers scalable, sample-to-answer PCR testing for institutions of any size, supporting both centralized and decentralized care. The company is committed to expanding access to high-quality diagnostics worldwide, supporting public health initiatives, driving innovation in molecular testing, and advancing sustainability and responsible business practices.
Cepheid is a global leader in molecular diagnostics, dedicated to improving healthcare by developing, manufacturing, and marketing automated, easy-to-use molecular systems and tests. Their mission is to provide rapid, accurate, and actionable genetic testing for a wide range of infectious diseases, oncology, and human genetics. Cepheid's flagship GeneXpert System delivers scalable, sample-to-answer PCR testing for institutions of any size, supporting both centralized and decentralized care. The company is committed to expanding access to high-quality diagnostics worldwide, supporting public health initiatives, driving innovation in molecular testing, and advancing sustainability and responsible business practices.
Publication Number
US-12221658-B2
Publication Date
2025-02-11
Expiration Date
Abstract
Compositions and methods for detecting Trichomonas vaginalis are provided.
Core Innovation
Compositions and methods for detecting Trichomonas vaginalis are provided. In some embodiments, methods of detecting the presence or absence of Trichomonas vaginalis (TV) in a sample from a subject are provided. In some embodiments, the methods comprise detecting the presence or absence of the TV 40S ribosomal protein (Tv40Srp) gene or RNA in a sample from the subject.
The protozoan Trichomonas vaginalis is responsible for trichomoniasis and improved methods for detection of Trichomonas vaginalis (TV) are needed. In particular, a highly specific, accurate, and sensitive urine- or swab-based diagnostic test is needed.
In some embodiments, detection is performed using PCR, including quantitative PCR, and may include detecting an endogenous control (sample adequacy control) and an exogenous control (sample processing control). In some embodiments, the Tv40Srp gene or RNA, an endogenous control, and an exogenous control are detected in a single multiplex reaction and the present assay can be completed in under 3 hours, and in some embodiments, under 2 hours, using an automated system such as the GeneXpert® system.
Claims Coverage
Two independent claims were identified (claims 1 and 8). Claim 1 discloses three main inventive features. Claim 8 discloses three main inventive features.
Primer regions of at least 20 contiguous nucleotides with ≥90% identity or complementarity to SEQ ID NO:5
A composition comprising a set of primers and a probe for detecting a Trichomonas vaginalis 40S ribosomal protein (Tv40Srp) gene or RNA, wherein the set of primers comprises a first primer comprising a region of at least 20 contiguous nucleotides having a sequence that is at least 90% identical or complementary to a region of at least 20 contiguous nucleotides of SEQ ID NO: 5; and a second primer comprising a region of at least 20 contiguous nucleotides having a sequence that is at least 90% identical or complementary to a region of at least 20 contiguous nucleotides of SEQ ID NO: 5.
Probe capable of selectively hybridizing to a Tv40Srp amplicon and comprising a detectable label
The composition includes a probe that is capable of selectively hybridizing to a Tv40Srp amplicon produced by the first primer and second primer and the probe comprises a detectable label.
Primer pair comprising SEQ ID NO:1 and SEQ ID NO:2
The composition may comprise a primer pair comprising a first primer of SEQ ID NO: 1 and a second primer of SEQ ID NO: 2.
Kit comprising primers and probe for detecting Tv40Srp gene or RNA
A kit comprising a set of primers and a probe for detecting a Trichomonas vaginalis 40S ribosomal protein (Tv40Srp) gene or RNA, wherein the set of primers comprises a first primer comprising a region of at least 20 contiguous nucleotides having a sequence that is at least 90% identical or complementary to a region of at least 20 contiguous nucleotides of SEQ ID NO: 5; and a second primer comprising a region of at least 20 contiguous nucleotides having a sequence that is at least 90% identical or complementary to a region of at least 20 contiguous nucleotides of SEQ ID NO: 5; and wherein the probe is capable of selectively hybridizing to a Tv40Srp amplicon produced by the first primer and second primer and comprises a detectable label.
Kit comprising a second primer pair and second probe for detecting an endogenous control
The kit comprises a second primer pair and second probe for detecting an endogenous control, wherein the primer pair for detecting Tv40Srp and the second primer pair are in the same or different compositions in the kit.
Kit comprising a third primer pair and third probe for detecting an exogenous control
The kit comprises a third primer pair and third probe for detecting an exogenous control, wherein the third primer pair is in the same or different composition from the primer pair for detecting Tv40Srp and the second primer pair, and wherein the exogenous control is a sample processing control.
The independent claims cover (1) compositions comprising a primer pair and a probe that target the Tv40Srp gene or RNA with specified regions of identity/complementarity to SEQ ID NO:5 and a detectable probe, and (2) kits that include those primers and probe and may additionally include primer/probe pairs for endogenous (sample adequacy) and exogenous (sample processing) controls.
Stated Advantages
A highly specific, accurate, and sensitive urine- or swab-based diagnostic test is needed and addressed by the invention.
The present assay can be completed in under 3 hours, and in some embodiments, under 2 hours.
The assay can be carried out in a substantially automated manner using a commercially available nucleic acid amplification system (for example, the GeneXpert® system).
Detection of the Tv40Srp gene or RNA can be performed contemporaneously with an endogenous control and an exogenous control in a single multiplex reaction.
The patent states the further benefit that clinicians need not understand raw data because a computer-based analysis program can translate raw data into information useful for a clinician.
Documented Applications
Detecting the presence or absence of Trichomonas vaginalis in a sample from a subject by detecting the TV 40S ribosomal protein (Tv40Srp) gene or RNA.
Determining whether a subject has a Trichomonas vaginalis infection.
Monitoring treatment for TV infection and monitoring for recurrence of TV infection by measuring the presence of the Tv40Srp gene in samples collected at one or more times from a subject.
Routine and preventative screening of individuals, including asymptomatic individuals, and screening women who are pregnant or attempting to become pregnant.
Testing using urine samples (including first catch urine), endocervical swabs, vaginal swabs (including patient-collected vaginal swabs), and urethral swabs.
Use of the assay in laboratories and communication of results to medical practitioners, including automated analysis and reporting.
Provision of compositions and kits comprising primers and probes for detecting Tv40Srp, including kits that may include reagents such as dNTPs and thermostable polymerase and receptacles for sample collection.
Carrying out the assay on automated nucleic acid amplification platforms such as the GeneXpert® system.
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