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Abstract

A method of developing sensitive and discriminatory diagnostic procedures for detecting active bacterial infection in animals, especially humans, basically involves partially digesting the genomic DNA of the infecting bacterial pathogen into a generally large number of ideally random fragments and finding proteins encoded by those fragments which evoke a discriminating response to specimens from viably infected animals. Cloning techniques are used to cause the genes of the multitude of DNA fragments to produce proteins. Groups of proteins encoded by the genes of each fragment are separately tested for the ability to generate an immune response in certain specimens from animals known to have 'viable infection', 'convalescent infection' and 'naive status' with respect to infection by the infecting bacterial pathogen. The protein groups which evoke positive immune responses to viably infected but no immune response to naive specimens are identified as 'selectively responsive proteins'. Similarly, selectively responsive proteins which are found to evoke no immune response from convalescent specimens are identified as 'discriminatingly responsive proteins'. These selectively and discriminatingly responsive protein groups can be cloned in magnitude and used to test unknown patients for status of infection. The method is amenable for developing tests based upon non-invasively obtained specimens, such as peripherally-obtained blood samples. Moreover, rigorous mapping of the pathogen genome is not prerequisite for carrying out the development method. Consequently, the development method can be used to obtain diagnostic procedures particularly suitable for generating individually inexpensive bacterial infection assays capable for screening large scale patient populations.

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