The disclosure, in some aspects, provides antigen-specific amino acid sequences for tick-borne relapsing fever Borrelia species.

The present invention relates to an immunoassay for the detection of Borrelia specific IgG, IgM and IgG/IgM antibodies in biological samples suspected of Lyme infection. The immunoassay can be performed via a standard immunoassay format or on an automated platform. In various embodiments, the immunoassay uses one or more Borrelia specific chimeric peptides VlsE-FlaB (designated pFlaB-mV), VlsE-ErpP (designated pErp59-mV), VlsE-P35 (designated pP35-mV) alone or in combination with one or more outer surface protein C (Osp C) types B or I, p58 and DbpA. Other aspects of the invention provide antigen/substrate combinations and compositions comprising combinations of the disclosed peptides and/or proteins for use in the immunoassays described herein.

A device for determining presence or absence of infection due to an infectious agent is described. The device comprises a sample receiving zone configured to receive a liquid sample from a subject suspected of having an infection due to an infectious agent, the sample receiving zone positioned to distribute the sample along a first fluid flow path to a first label zone and along a second fluid flow path to a second label zone. Test lines in each fluid flow path capture a mobile detectable species as an indicator of presence or absence of the infectious agent. The device also comprises a reference line positioned in the one of the fluid flow paths. The bidirectional fluid flow paths emanate from a common sample zone and provide an efficient approach to detection and differentiate two species as indicators of the same infectious agent or as indicators of two different infectious agents.

A multiplexed vertical flow serodiagnostic testing device for diseases such as Lyme disease includes one or more multi-piece cassettes that include vertical stacks of functionalized porous layers therein. A bottom piece of the cassette includes a sensing membrane with a plurality of spatially multiplexed immunoreaction spots or locations. Top pieces are used to deliver sample and/or buffer solutions along with antibody-conjugated nanoparticles for binding with the immunoreaction spots or locations. A colorimetric signal is generated by the nanoparticles captured on the sensing membrane containing disease-specific antigens. The sensing membrane is imaged by a cost-effective portable reader device. The images captured by the reader device are subject to image processing and analysis to generate positive (+) or negative (−) indication for the sample. A concentration of one or more biomarkers may also be generated. The testing device is rapid, simple, inexpensive, and allows for simultaneous measurement of multiple antibodies and/or antigens making it an ideal point-of-care platform for disease diagnosis.

The present invention makes it possible to simply, rapidly, and with high sensitivity detect periodontopathic bacteria at room temperature and in under ten minutes (approximately 2-8 minutes). The arginine-specific peptidase activity of three strains of periodontopathic bacteria, i.e., Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia, are analyzed at room temperature, in under ten minutes, and with high sensitivity. A first compound that has an anti-oxidizing effect and/or a second compound that protects SH groups (mercapto groups) and has a disulfide bond-cleaving effect are present during analysis of a sample. The first compound is at least one among L-ascorbic acid, L-cysteine hydrochloride, and glutathione, and the second compound is at least one among DTT, thioglycolic acid, thioglycerol, mercaptoethanol, and TCEP.

A solid support for detecting the presence of antibodies in a biological sample, where the solid support includes microbial antigens immobilized on the solid support, wherein the microbial antigens include at least one antigen prepared from the group consisting of pleomorphic round bodies of Borrelia genus, for example Borrelia burgdorferi, Borrelia afzelii and Borrelia garinii. Also, a method of detecting a tick-borne microbe in a biological sample, wherein the solid support is contacted with a biological sample.

Compositions and methods for the detection and identification of Tick-Borne Relapsing Fever Borrelia sp. antibodies.

The present disclosure provides a biosignature that distinguishes Lyme disease, including early Lyme disease, from STARI. The present disclosure also provides methods for detecting Lyme disease and STARI, as well as methods for treating subjects diagnosed with Lyme disease or STARI.

This invention relates to a method for the direct detection of tick-borne infections, wherein the human/animal body fluid sample, ideally blood sample to be examined is obtained directly on a specified amount of cell technology medium establishing a partially hostile (semi-hostile) environment, the sample and the cell technology medium are mixed, incubated and stored, if required, meanwhile, the cells and pathogens of the subject are in the semi-hostile environment, then corpuscles and pathogens are separated; a small amount of blood cells from the “buffy coat” layer and blood cells located a few cell layers beneath it are supplemented to and mixed with the gained plasma, the sample is concentrated and the test is finally performed to detect pathogens in the plasma and in blood cells.

The claimed matter covers cell technology medium applied and its application interesting methods.

Reagents that include certain identified peptides derived from B. burgdorferi proteins, or nucleic acid sequences encoding same are useful in the diagnosis of Lyme borreliosis (Lyme Disease) in infected subject are disclosed herein. Such reagents can also include nucleic acid sequences encoding the peptides. Pharmaceutical compositions useful for the treatment or prophylaxis of B. burgdorferi infection include certain peptides derived from B. burgdorferi proteins, or nucleic acid sequences encoding same. Methods of treating or preventing Lyme borreliosis (Lyme Disease) include administering effective amount of such pharmaceutical compositions. An antibody independent prophylactic pharmaceutical composition comprises a sonicate of B. burgdorferi bacterium; and methods of treating or preventing Lyme borreliosis include administering effective amounts of that sonicate composition are also disclosed herein.