Based on its enhanced dynamic range, SOFIA is able to discriminate levels of analyte in a sample over 10 orders of magnitude, facilitating accurate titering.

Several studies have already demonstrated SOFIA's unprecedented ability to detect naturally occurring prions in the blood and urine of disease carriers.

[1][2][3] This is expected to lead to the first reliable ante mortem screening test for vCJD, BSE, scrapie, CWD, and other transmissible spongiform encephalopathies.

The conventional method of performing laser-induced fluorescence, as well as other types of spectroscopic measurements, such as infrared, ultraviolet-visible spectroscopy, phosphorescence, etc., is to use a small transparent laboratory vessel, a cuvette, to contain the sample to be analyzed.

SOFIA combines the specificity inherent in monoclonal antibodies for antigen capture with the sensitivity of surround optical detection technology.

[citation needed] After amplifying and then concentrating the target analyte, the samples are labeled with a fluorescent dye using an antibody for specificity and then finally loaded into a microcapillary tube.

This tube is placed in a specially constructed apparatus so it is totally surrounded by optical fibers to capture all light emitted once the dye is excited using a laser.

These include clinical applications, such as detecting diseases, discovering predispositions to pathologies, establishing a diagnosis and tracking the effectiveness of prescribed treatments, and nonclinical applications, such as preventing the entry of toxins and other pathogenic agents into products intended for human consumption: SOFIA has been used to rapidly detect the abnormal form of the prion protein (PrPSc) in samples of bodily fluids, such as blood or urine.

Post mortem neuropathological examination of brain tissue from an animal or human has remained the ‘gold standard’ of TSE diagnosis and is very specific, but not as sensitive as other techniques.

Current PrPSc detection methods are time-consuming and employ post mortem analysis after suspicious animals manifest one or more symptoms of the disease.

It has as yet not been possible to detect prion diseases by using conventional methods, such as polymerase chain reaction, serology, or cell culture assays.

Because of the sensitivity of SOFIA, PMCA cycles can be reduced, thus decreasing the chances of spontaneous PrPSc formation and the detection of false-positive samples.

When coupled with limited sPMCA, the methods of the present inventions provide sensitivity levels sufficient to detect PrPSc in blood plasma, tissue and other fluids collected antemortem[citation needed].

The methods combine the specificity of the Mabs for antigen capture and concentration with the sensitivity of a surround optical fiber detection technology.

In addition to prion diseases, the method may provide a means for rapid, high-throughput testing for a wide spectrum of infections and disorders.

The limited numbers of cycles necessary for the present assay platform virtually eliminates the possibility of obtaining PMCA-related false-positive results such as those previously reported (Thorne and Terry, 2008).

To generate an assay for PrPSc in blood that is both highly sensitive and specific, the researchers used limited serial PMCA (sPMCA) with SOFIA.

They did not find any enhancement of sPMCA with the addition of polyadenylic acid, nor was it necessary to match the genotypes of the PrPC and PrPSc sources for efficient amplification.

[2] A 2009 study found SOFIA, in its current format, is capable of detecting less than 10 attogram (ag) of hamster, sheep and deer recombinant PrP.

SOFIA will likely lead to early ante mortem detection of transmissible encephalopathies and is also amenable for use with additional target amplification protocols.

SOFIA represents a sensitive means for detecting specific proteins involved in disease pathogenesis and/or diagnosis that extends beyond the scope of the transmissible spongiform encephalopathies.