Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving virus or bacteriophage
Reexamination Certificate
2001-10-17
2004-09-14
Mosher, Mary E. (Department: 1648)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving virus or bacteriophage
C436S501000, C436S518000, C435S007100
Reexamination Certificate
active
06790611
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a method for rapid detection of a Respiratory Syncytial virus (RS virus) related biological cell and/or biological particle contained in a body fluid sample. The method is used for rapidly diagnosing a condition in an individual resulting from an infection by a RS virus.
The method comprises the further steps of detecting a plurality of infection and/or inflammatory response agents, preferably cytokines, and performing a profile of such agents. The profile is a further indication of the condition being diagnosed. The method for detecting a plurality of infection response agents, preferably cytokines, includes the step of performing a profile of such agents.
The methods of the invention are performed by contacting i) a body fluid sample potentially comprising the infectious agent and/or an infection and/or inflammatory response agent, including cytokines, with ii) a targeting species that is preferably quantifiably detectable and capable of specifically recognising a predetermined infectious agent and/or a predetermined infection response agent. It is preferred that the contacting takes place essentially without pretreatment of the body fluid sample.
The targeting species preferably comprises an antibody capable of contacting one or both of an infectious agent and an infection response agent. The targeting species may also comprise a visible label capable of being detected when the complex of the targeting species with either one or both of an infectious agent and an infection response agents is in contact with a solid test area on e.g. a lateral flow device.
BACKGROUND OF THE INVENTION
Antigens from microbial cells have been detected in the prior art. U.S. Pat. No. 4,663,277 relates to a method for detecting a virus by means of an immunoassay in which an extended solid phase coated with antiviral antibody is employed to bind and remove virions from a specimen by forming an immuno-complex with antigens of said virions, a mobile solid phase comprising a dispersion of microspheres coated with the antiviral antibody is used to bind said microspheres to antigens associated with said Immuno-complex, and the presence of bound microspheres is detected. The detection sensitivity is amplified by using microspheres comprising a dye or a label. The extended solid phase may be in the form of a dipstick, syringe, tube or container that can be easily contacted with the specimen. A virus detection kit provides the extended solid phase and mobile solid phases, each coated with antiviral antibodies.
In one embodiment the invention disclosed in U.S. Pat. No. 4,663,277 pertains to a method for detection of viruses in a specimen and comprises the steps of i) treating the specimen to remove undesired components ii) contacting the specimen with a solid phase support having conjugated thereto antiviral antibody capable of forming immuno-complexes with antigens characteristic of the viruses to be detected, iii) separating the solid phase support from the specimen, iv) contacting the separated solid phase support with a mobile solid phase consisting of dispersed microspheres smaller than 0.1 &mgr;m and labelled with metal elements and having conjugated thereto the antiviral antibody that enables the binding of said microspheres to said immuno-complexes, v) separating the unbound mobile solid phase from the solid phase support, and vi) measuring the presence of microspheres bound to said solid phase support by X-ray fluorescence, thereby detecting or determining the presence of viruses in said specimen.
An antispecies antibody is covalently bound to the solid phase support as well as to the mobile solid phase, and an antiviral antibody that forms an immuno-complex with the antispecies antibody is coupled therewith, whereby an antiviral antibody capable of forming immuno-complexes with antigens of viruses to be detected is conjugated to said solid phase support and to said mobile solid phase.
In one embodiment of the invention a plurality of different antiviral antibodies capable of forming complexes with corresponding antigens of different types of viruses are conjugated to the solid phase support as well as to the mobile solid phase, whereby the presence of one or more of a plurality of different types of viruses in the specimen can be detected at the same time.
U.S. Pat. No. 4,740,467 discloses a method for diagnosing syphilis and other treponematoses infections such as yaws and pinta. The method involves admixing i) a biological sample, such as lesion exudate, cerebrospinal fluid, serum, urine, amniofic fluid, synovial fluid or tissue homogenate from a person suspected of having syphilis, yaws or pinta together with ii) a reagent of monoclonal antibodies which are specific for antigens of virulent subspecies of
Treponema pallidum
, including
pertenue, endemicum, carateum
and
pallidum
. If
Treponema pallidum
, the causative organism of syphilis, is present, an immunological specific binding reaction will occur between the monoclonal antibodies and antigenic sites on
T. pallidum
cells. A positive immunoreaction is detected directly by a variety of techniques including radioimmunoassay, fluorescent immunoassay, enzyme linked immunosorbent assay, agglutination reactions, and complement consumption tests.
U.S. Pat. No. 5,290,677 discloses a method for detecting hepatitis A virus by capturing whole virus particles with antibodies specific to hepatitis A virus. In subsequent steps the method comprises generating a cDNA copy of the RNA by reverse transcription in the presence of a primer having a predetermined sequence, amplifying the cDNA by a polymerase chain reaction, and detecting the amplified cDNA by hybridization with probes of a predetermined sequence, or by detection of label bound to the primer, wherein the presence of detectable hybridization or amplification indicates the presence of hepatitis A virus. It is disclosed that samples which contain free virus (for example, stool, environmental samples, or other fomite associated material) may be selectively removed from adventitious material by immunoselection of whole virus using a high titer anti-HAV antibody coated onto a solid phase. The viral RNA is then denatured in the presence of a specific primers, and the viral RNA is reverse transcribed to cDNA using standard methodology.
Further examples of diagnostic methods pertaining to the detection of microbial cells are disclosed e.g. in U.S. Pat. No. 6,077,665 relating to a rapid assay for infection in immunodeficient patients such as neonates or immunocompromised patients (e.g. HIV or transplant patients). The method allows diagnosis at initial evaluation, such that antibiotic treatment and confinement to an intensive care unit can be avoided for uninfected patients. The assay can be used for sepsis diagnosis including the detection of bacterial, viral, or fungal colonization of the blood stream, cerebrospinal fluid (CSF), or urinary tract. The method is based on the measurement of polymorphonuclear leukocyte (PMN, neutrophil) CD11b (Mac-1, CR3) levels by flow cytometry or laser scanning microscopy in whole blood samples.
U.S. Pat. No. 5,965,354 relates to a method and immunodiagnostic test kits for diagnosing herpes simplex virus infection. The methods and kits employ type-specific or type-common antigens in a single-step assay format. In one embodiment the method of the invention comprises the steps of i) contacting a biological sample from a human suspected of containing antibodies to herpes simplex virus with one or more purified herpes simplex virus polypeptides bound to a solid support, under conditions that allow herpes simplex virus antibodies, when present in the biological sample, to bind to said herpes simplex virus polypeptides, and ii) detecting the presence or absence of bound antibodies as an indication of the presence or absence of herpes simplex virus, wherein said detecting is done by using at least one detectably labeled anti-human immunoglobulin antibody.
U.S. Pat. No. 5,939,254 discloses specific primers that amplify a p
Breindahl Morten
Lassen Michael Rud
Besst-Test APS
Cooper Iver P.
Mosher Mary E.
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