Reagents and methods for detecting Neisseria gonorrhoeae

Abstract

This invention provides compositions and methods for detecting Neisseria gonorrhoeae in a sample. This invention also provides related reaction mixtures, kits, systems, and computers.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application Nos. 60 / 530,962, filed Dec. 19, 2003, and 60 / 552,460, filed Mar. 12, 2004, the disclosures of which are each incorporated by reference in their entirety for all purposes.FIELD OF THE INVENTION [0002] The present invention relates to the fields of molecular biology and nucleic acid chemistry. The invention provides methods and reagents for detecting pathogens, such as Neisseria gonorrhoeae and accordingly, also relates to the fields of medical diagnostics and prognostics. BACKGROUND OF THE INVENTION [0003] The genus Neisseria consists of Gram-negative aerobic bacteria including the human pathogen N. gonorrhoeae, which is the causative agent of gonorrhea. N. gonorrhoeae infections, which have a high prevalence and low mortality, are generally acquired by sexual contact and typically affect mucous membranes of the urethra in males and the endocervix in females. However, t...

AI Technical Summary

Benefits of technology

[0008] The present invention provides methods and reagents for the rapid detection of Neisseria gonorrhoeae that are species specific, that is, without substantial detection of other species in the Neisseria genus or species from other genera. For example, the nucleic acid detection reagents of the invention (e.g., probe nucleic acids, sequence specific antibodies, etc.) typically bind to nucleotide sequences present in N. gonorrhoeae but not in other species. Further, since patients infected with N. gonorrhoeae are often also infected with Chlamydia trachomatis, the invention also provides methods of concurrently detecting N. gonorrhoeae and C. trachomatis in samples. This approach minimizes the number of diagnostic procedures to which a patient is subjected, which also typically minimizes the overall cost of diagnosis. In addition to compositions and reaction mixtures, the invention also relates to kits and systems for detecting these pathogenic agents, and to related computer and computer readable media.

Problems solved by technology

For example, a genital infection in males can ascend the urethra and produce symptoms of prostatitis, whereas in females, an N. gonorrhoeae infection of the cervix may spread to the fallopian tubes and ultimately cause sterility among other conditions, if untreated.

Both infections are two known causes of ectopic pregnancy and can also lead to infertility if untreated.

Culture-based methods, while relatively sensitive, are generally slow to perform, often including overnight incubation, and are labor intensive.

The Gram-stain and antibody-based tests typically provide results in less than one hour, but are generally of lower sensitivity than culture-based methods.

Many of these hybridization procedures have depended on the cultivation and / or enrichment of the organism and, thus, are unsuitable for rapid diagnosis.

Many probes used to date lack sufficient specificity to differentiate between pathogenic agents having highly homologous nucleic acid sequences, such as N. gonorrhoeae, N. meningitidis, and the like.

This can lead to biased assay results, including false positives.

One consequence of such misdiagnosis may be the administration of an inappropriate course of treatment to a patient.

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