Identification of a new ehrlichia species from a patient...

Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...

Reexamination Certificate

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C424S130100, C424S164100, C424S184100, C435S006120, C435S243000, C435S252100, C435S260000, C536S023700, C536S024320, C536S024330

Reexamination Certificate

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06524590

ABSTRACT:

This invention relates to the identification and characterization of a new microorganism isolated from a patient suffering from ehrlichiosis. The new organism, designated herein as
Ehrlichia chaffeensis
, is similar to but distinct from
Ehrlichia canis.
BACKGROUND OF THE INVENTION
Human ehrlichiosis is a newly recognized disease characterized by fever, headache, malaise, thrombocytopenia, leukopenia, and elevated liver enzymes (Anon.,
M.M.W.R
. 37, 270, 275, 1988; Fishbein, et al.,
JAMA
257, 3100, 1987; Fishbein, et al.,
J. Infect. Dis
. 160, 803,1989; Eng, et al.,
JAMA
264, 2251, 1990). Often the patients also have a history of tick exposure. The only Ehrlichia species known to infect humans is
Ehrlichia sennetsu
, the agent responsible for sennetsu rickettsiosis, a disease that has been reported only in Japan and Malaysia (Ristic, in
Microbiology
1986, L. Leive, Ed., American Society for Microbiology, Washington, D.C., 1986, pp. 182-187). Since recognition of a human form of ehrlichiosis in the United States in 1986, laboratory-based surveillance has led to the identification of about 215 persons with variable antibody titer to
E. canis
in 20 states, predominantly in southeastern and south central areas of the United States (Fishbein, et al.,
J. Infect. Dis
., 160, 803, 1989; Eng, et al.,
JAMA
264, 2251, 1990). It may be noted, however, that despite such serologic evidence, the causative agent of human ehrlichiosis remained unidentified and the etiology of the disease also remained undetermined.
SUMMARY OF THE INVENTION
It is, therefore, an object of the present invention to isolate, identify and characterize the agent associated with human ehrlichiosis, the agent thus isolated having been designated herein as “
Ehrlichia chaffeensis
” or “human Ehrlichian”.
It is noted that if the scientific community accepts the change of nomenclature of
E. chaffeensis
to
E. homosapiensis
or other designation, then of course it should be recognized accordingly.
It is another object of the present invention to grow the
Ehrlichia chaffeensis
isolate in a cell culture.
It is also an object of the present invention to provide a recombinant molecule or construct containing
E. chaffeensis
nucleotide sequence or
E. chaffensis
-specific fragment thereof.
A further object of the present invention is to prepare antibodies having specificity particularly against
E. chaffeensis.
A still further object of the present invention is to provide cloned genes of
E. chaffeensis
that encode
E. chaffeensis
-specific antigens.
An additional object of the present invention is to provide a composition comprising an immunogenic amount of
E. chaffeensis
antigen, either naturally produced or recombinantly made, to induce antibodies against
E. chaffeensis
in a host susceptible to infection by
E. chaffeensis.
A further object of the present invention is to provide an immunoassay for detecting human ehrlichiosis employing
E. chaffeensis
or a fragment derived therefrom as an antigen.
Another object of the present invention is to provide a diagnostic kit comprising a container containing
E. chaffeensis
-specific antigen or antibody.
Yet another object of the present invention is to provide a method for screening the toxicity of a drug against
E. chaffeensis
by comparing the growth of
E. chaffeensis
in the presence and absence of the drug in a cell culture environment.
Also provided herein is an immunoassay for detecting
Ehrlichia chaffeensis
or an antigen of
Ehrlichia chaffeensis
, comprising reacting a sample suspected of containing
Ehrlichia chaffeensis
or an antigen of
Ehrlichia chaffeensis
, with an antibody having specific binding affinity to an antigen of
Ehrlichia chaffeensis
, and determining the occurrence of an immunological reaction between said sample and the antibody.
Various other objects and advantages will become evident from the following detailed description of the invention.


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