Multipurpose compositions for collecting and transporting biological material

Inventors

Daum, Luke T. • Fischer, Gerald W.

Assignees

Longhorn Vaccines and Diagnostics LLC

Abstract

The invention is directed to compositions and methods for collecting, transporting, and storing, without refrigeration, biological materials, which may comprise samples of biological, clinical, forensic, and/or environmental origin. These compositions preserve the viability of the collected organisms and/or the RNA/DNA and proteins in the sample composition mixture and permit the long-term storage of samples. Compositions are compatible with subsequent manipulation of the sample, including propagation and culture of the collected microorganisms, or isolation, purification, detection, and characterization of proteins, nucleic acids, and other macromolecules. When the compositions containing microorganisms and any polynucleotides therein are further processed, such as by nucleic acid testing, there is an increased ability to detect, isolate, purify and/or characterize select microbes and their components, such as nucleic acids, when compared to conventional microbial transport media that contain interfering substances and RNA/DNA extraction is not required prior to PCR analysis. In particular, the compositions disclosed allow for the collection, transport and storage of biological samples for extended periods at ambient temperature, while maintaining the integrity of the macromolecules of the sample for subsequent extraction, identification, and quantitation.

Core Innovation

The invention provides gelatin-free viral transport medium (VTM) and analyte transport media (ATM) compositions for collecting and transporting biological samples at ambient temperature without refrigeration. The compositions include one or more salts, one or more sugars, including a sugar alcohol, one or more buffers, one or more pH indicators, one or more proteins, peptide or amino acids, and one or more anti-microbial agents.

The compositions contain no gelatin and are defined by a microorganism-specific functional effect. The composition kills or inactivates microorganisms but not viruses, and gelatin-free formulations enable maintaining viral and nucleic-acid-related detectability in transport under ambient conditions.

The disclosed utility supports nucleic acid testing and downstream workflows using nucleic acids, RNA/DNA, and proteins/macromolecules. The document states that the compositions improve performance in NAT workflows, including PCR, qPCR, RT-PCR, and NGS, with improved Ct performance versus conventional UTM, and are compatible with rapid antigen tests and extraction-less workflows.

Claims Coverage

The document includes two independent claims covering a gelatin-free non-refrigerated transport composition framework with microorganism-selective antimicrobial activity and nucleic-acid preservation for detection, and a variant consisting essentially of composition with defined component classes and optional preservation of viruses. Across the independent claims and their dependents, the coverage includes at least six recurring inventive formulation elements, plus the no-gelatin limitation and microbiological selectivity/preservation language.

Overall, the claim set centers on gelatin-free transport compositions that combine salts, sugar or sugar alcohol, buffers, pH indicators, proteins, peptide or amino acids, and anti-microbial agents, while defining selective antimicrobial behavior and, through dependent claims, non-refrigerated transport with substantially all nucleic acid sequences preserved for detection, plus embodiments that preserve viruses.

Stated Advantages

Documented Applications