Biochip, and method for the selective identification of Chlamydia trachomatis infections
Inventors
Simnacher, Ulrike • Forsbach-Birk, Vera • Essig, Andreas • Pfrepper, Klaus-Ingmar
Assignees
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Publication Number
US-8455210-B2
Publication Date
2013-06-04
Expiration Date
Abstract
The present invention relates to a method for the selective identification of Chlamydia trachomatis infections wherein the antigens CT017, CT098, CT318-L1 P, CT431-TARP, CT603-TSAP, and CT664 are used for the specific identification of Chlamydia trachomatis antibodies in samples from mammals. The method according to the invention facilitates the selective identification method of identification of Chlamydia trachomatis infections, in which no false positive results are generated by other Chlamydia species such as, for example, Chlamydia pneumoniae. The invention further relates to a biochip which has the aforementioned Chlamydia trachomatis-specific antigens for the identification of antibodies. The biochip with antigens according to the invention is suitable for multiparameter identification methods in particular.
Core Innovation
The invention relates to a serological diagnostic method, a test kit, and a biochip for the selective detection of Chlamydia trachomatis infections. The approach detects Chlamydia trachomatis-specific antibodies using a defined set of recombinant antigens and supports serological differentiation among acute Chlamydia pneumoniae infection, acute Chlamydia trachomatis infection, and chronic Chlamydia trachomatis infection.
A central aspect is the selection of two to seven antigens from an antigen group defined by SEQ ID NOs, with at least one antigen comprising a Chlamydia trachomatis-specific CT456-TARP antigen selected from a listed subset of SEQ ID NOs. The document emphasizes improved specificity and low cross-reactivity, particularly with Chlamydia pneumoniae.
The disclosure further describes antigen handling as individually immobilized recombinant antigens on a membrane solid support and supports multiparameter testing on a biochip platform. It discusses construction and fluorescent detection formats for biochip-based readouts and references assay formats such as ELISA, Western blot, and line assay.
Claims Coverage
The partial content explicitly provides two independent claims covering a diagnostic test kit and a diagnostic biochip. Both independent claims require selective detection of Chlamydia trachomatis infections and serological differentiation among acute Chlamydia pneumoniae infection, acute Chlamydia trachomatis infection, and chronic Chlamydia trachomatis infection, using two to seven antigens with a mandatory CT456-TARP antigen selection constraint.
Diagnostic test kit for selective serological detection and acute-to-chronic differentiation
A test kit for the selective detection of Chlamydia trachomatis infections and the serological differentiation among acute Chlamydia pneumoniae infection, acute Chlamydia trachomatis infection and chronic Chlamydia trachomatis infection, wherein the kit consists of two to seven antigens selected from the group consisting of SEQ ID NOs: 1-8, 10-15, 19-23, 25, and 28.
Mandatory CT456-TARP inclusion with SEQ ID constrained antigen selection
At least one of said antigens comprises a Chlamydia trachomatis-specific CT456-TARP antigen selected from the group consisting of SEQ ID NO: 5, SEQ ID NO: 21, SEQ ID NO: 22, SEQ ID NO:23 and SEQ ID NO: 25.
Biochip for selective serological detection and acute-to-chronic differentiation
A biochip for the selective detection of Chlamydia trachomatis infections and the serologic differentiation among acute Chlamydia pneumoniae infection, acute Chlamydia trachomatis infection and chronic Chlamydia trachomatis infection, said biochip comprising two to seven antigens selected from the group consisting of SEQ ID NOs: 1-8, 10-15, 19-23, 25, and 28.
Both independent claims are directed to serological selective detection and acute versus chronic differentiation using a constrained antigen set defined by SEQ ID NOs with a mandatory inclusion of a Chlamydia trachomatis-specific CT456-TARP antigen selected from a specified subset of SEQ ID NOs. One claim covers a test kit and the other covers a biochip.
Stated Advantages
Improved specificity with low cross-reactivity with other chlamydial species, especially Chlamydia pneumoniae.
Ability to differentiate serologically among acute Chlamydia pneumoniae infection, acute Chlamydia trachomatis infection, and chronic Chlamydia trachomatis infection.
Suitable for multiparameter testing on biochip platforms.
Capability to differentiate clinically suspected chronic C. trachomatis infection versus seropositive healthy donors.
Documented Applications
Selective serological detection of Chlamydia trachomatis infection using a test kit or biochip based on defined recombinant antigens.
Serological differentiation among acute Chlamydia pneumoniae infection, acute Chlamydia trachomatis infection, and chronic Chlamydia trachomatis infection.
Use in multiparameter testing on biochip platforms (e.g., biochip/Luminex-like multiparameter platforms).
Monitoring infection course via differentiation of infection stage (acute vs chronic/past) as described in the document summary.
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