Methods and compositions for chlamydial antigens as reagents for diagnosis of tubal factor infertility and chlamydial infection
View Patent ↗The present invention provides Chlamydia proteins and fragments thereof and methods of use in diagnostic assays.
1. A method of identifying an infertile female subject for whom in vitro fertilization or surgical repair of fallopian tube damage is indicated to treat the subject's infertility, comprising:
(a) contacting a biological sample from the subject with a diagnostic panel comprising an antigen of each of Chlamydia trachomatis CT443 or an immunologically reactive fragment thereof, Chlamydia trachomatis CT381 or an immunologically reactive fragment thereof, and Chlamydia trachomatis CT875 or an immunologically reactive fragment thereof;
(b) detecting formation of an antigen/antibody complex with each of the antigen of Chlamydia trachomatis CT443 or an immunologically reactive fragment thereof and the antigen of Chlamydia trachomatis CT381 or an immunologically reactive fragment thereof and detecting the absence of formation of an antigen/antibody complex with the antigen of Chlamydia trachomatis CT875 or an immunologically reactive fragment thereof in the sample, wherein the detection of an antigen/antibody complex with each of the antigen of Chlamydia trachomatis CT443 or an immunologically reactive fragment thereof and the antigen of Chlamydia trachomatis CT381 or an immunologically reactive fragment thereof and detection of the absence of formation of an antigen/antibody complex with the antigen of Chlamydia trachomatis CT875 or an immunologically reactive fragment thereof in the sample identifies the subject as having tubal factor infertility, thereby identifying the subject as a subject for whom in vitro fertilization or surgical repair of fallopian tube damage is indicated to treat the subject's infertility; and
(c) treating the subject identified in step (b) as having tubal factor infertility by in vitro fertilization or surgical repair of fallopian tube damage.
2. The method of claim 1 , wherein the tubal factor infertility is caused by chlamydial infection.
3. The method of claim 1 , wherein the subject is a human female.
4. The method of claim 1 , wherein the biological sample is any body fluid in which antibodies can be detected.
5. The method of claim 1 , wherein the biological sample is diluted 1:1000.
6. The method of claim 1 , wherein the antigen of the CT443 protein or immunologically reactive fragment thereof is a C terminal fragment.
7. The method of claim 1 , further comprising contacting the biological sample of (a) with an additional antigen selected from the group consisting of Chlamydia trachomatis HSP60 or an immunologically reactive fragment thereof, Chlamydia trachomatis CT376 or an immunologically reactive fragment thereof, Chlamydia trachomatis CT557 or an immunologically reactive fragment thereof and any combination thereof, and an antigen/antibody complex is detected in the sample for each of said additional antigen(s).