Abstract: Rapid methods that identify sepsis-causing bacteria or yeast aid the physician in critical therapeutic decision-making, thus decreasing patient mortality rates. The methods described herein employ plating microorganisms directly on to a MALDI-MS plate, adding concentrated formic acid, and identifying the microorganism by mass spectrometry. Optionally, an organic solvent may be combined with the formic acid, or added to the sample before or after the concentrated formic acid is added thereto. The methods enable direct extraction of proteins from microorganisms without the need for liquid protein extraction methods and yields positive identification results for gram-positive bacteria, gram-negative bacteria and yeast in minutes.

Abstract: An apparatus and associated methods of use for a controlled combination of reagents is disclosed. The apparatus includes a vessel 400, a vessel insert 220, and a cap element 200. The vessel 400 has a body portion 410 for receiving a biological sample. The vessel insert 220 receives at least one reagent therein. Preferably, the vessel insert 220 is received in a portion 420 of the vessel 400. The cap element 200 is attached to the vessel 400 to secure the vessel insert 220 in the vessel 400. During use, the vessel insert 220 is adapted to release its contents when the biological sample is introduced into the body portion 410 of the vessel 400 upon application of an intermixing force to the vessel insert 220. A variety of intermixing forces may be applied, depending upon the embodiment of the present invention and its associated methods of use.

Abstract: The present disclosure provides biomarkers useful for determining the risk of, prognosis of, and/or diagnosis of conditions such as preterm birth in a subject.

Abstract: Various embodiments disclosed herein provide for reagents and methods for rapidly isolating viable microbial cells, including S. pneumoniae, from positive blood culture samples. The resulting microbial pellet can be used for both identification and growth-based methods such as antimicrobial susceptibility testing. The buffers described herein may contain a base solution, non-ionic detergents, thiols, and optionally, ammonium chloride. The disclosed methods provide a process for rapidly isolating and concentrating viable microorganism (s) from PBC samples using only one sample preparation tube and centrifugation while removing cellular debris from the mammalian blood cells that may interfere with identification methods.

Abstract: Methods of the invention include the isolation of intact, viable microorganism(s) from positive blood culture (“PBC”) samples for use in downstream analyses such as identification and antimicrobial susceptibility testing (“AST”). The methods involve collecting a portion of the PBC sample, adding a choline-containing solution, lysing the blood cells, isolating the viable microorganism, and performing downstream analysis of the isolated, viable microorganism. The methods can be applied to a variety of gram-positive bacteria, gram-negative bacteria, and/or yeast, and particularly to strains of S. pneumoniae.

Abstract: The invention provides methods for the rapid determination of the antibiotic susceptibility of a microorganism, such as, an infectious microorganism in a biological sample, using fluorescence in situ hybridization (“FISH”). Methods of the invention may be applied to the rapid identification, typing, antibiotic susceptibility determination, and/or antibiotic minimum inhibitory concentration (MIC) determination for any infectious microorganism, such as a Gram positive bacteria, a Gram negative bacteria, or a yeast.