# US 12,594,558 B2 · At-home kit for prostate cancer screening and other diseases > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,594,558 B2 - Document ID: US12594558B2 - Status: Granted - Kind: B2 - Application number: 18/007,875 - Filed: 2021-05-28 - Published: 2023-08-10 - Granted: 2026-04-07 - Earliest claimed: 2020-06-02 - Assignees: Sunnybrook Research Institute - Applicants: Sunnybrook Research Institute - Inventors: Hon S. Leong - Web page: https://patentgrep.com/patent/US12594558B2 ## CPC - B01L 3/5023: {with a sample being transported to, and subsequently stored in an absorbent for analysis} - B01L 3/5029: {using swabs} - C12N 15/1003: {Extracting or separating nucleic acids from biological samples, e.g. pure separation or isolation methods; Conditions, buffers or apparatuses therefor} - C12Q 1/6806: Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay (C12Q1/6804 takes precedence) - B01L 3/5082: {Test tubes per se} - B01L 3/50825: {Closing or opening means, corks, bungs} - B01L 2200/16: Reagents, handling or storing thereof - B01L 2200/185: Long distance transport, e.g. mailing - B01L 2300/021: Identification, e.g. bar codes - B01L 2300/123: Flexible; Elastomeric - B01L 2300/126: Paper - C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575) - C12Q 1/701: {Specific hybridization probes} - B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES ## Abstract Thus, the present disclosure provides a kit for collection of biofluids and preservation of any DNA and/or RNA contained in said biofluid. The kit includes a wipe composed of fibers for absorbing a preselected biofluid, the wipe being impregnated with one or more skin-friendly chemicals for preservation of the biofluid absorbed into the wipe. The kit includes a rigid re-scalable tube configured to contain the impregnated wipe therein, a re-scalable bag for sealing the rigid re-sealable tube containing the impregnated wipe for transportation. The kit includes instructions on how to impregnate the wipe with the pre-selected biofluid and seal it in the re-sealable bag, and a return envelope configured to receive therein the re-scalable bag containing the impregnated wipe. ## Claims ### Claim 1 A kit for collection of biofluids and preservation of any DNA and/or RNA contained in the biofluid, comprising: a wipe composed of fibers for absorbing a preselected biofluid, the wipe impregnated with one or more skin-friendly chemicals for the preservation of DNA and/or RNA of the biofluid absorbed into the wipe; a rigid re-sealable tube configured to contain the impregnated wipe therein; a re-sealable bag; instructions on how to impregnate the wipe with the pre-selected biofluid and seal it in the re-sealable bag; and return envelope configured to receive therein the re-sealable bag containing the impregnated wipe, wherein the re-sealable tube is sealed in the re-sealable bag, and wherein the wipe comprises a slit along one edge of the wipe sized to be trapped between a lid on the rigid re-sealable tube and the tube itself during a procedure of DNA/RNA extraction from the absorbed biofluid so the wipe is draped over a lip of the tube and hangs down into the interior of the tube with a bottom edge of the wipe spaced from the bottom of the tube. ### Claim 2 (depends on 1) The kit according to claim 1, wherein the wipe containing fibers is any one of fiber containing paper and fiber containing fabric. ### Claim 3 (depends on 1) The kit according to claim 1, wherein the wipe comprises a machine-readable code sticker attached thereto for associating the wipe with a patient being screened/tested and for protecting patient privacy during a mailing and analysis process. ### Claim 4 (depends on 1) The kit according to claim 1, wherein the biofluid to be collected is semen. ### Claim 5 (depends on 1) The kit according to claim 1, wherein the impregnated wipe is further impregnated with an EDTA solution for inhibiting RNAse/DNAse activity and inducing RNA/DNA binding to the fibers of the wipe. ### Claim 6 (depends on 5) The kit according to claim 5, wherein the EDTA solution comprises about 1 mM to about 5 mM EDT. ### Claim 7 (depends on 1) The kit according to claim 1, wherein the impregnated wipe is further impregnated with a compound configured to preserve protein biomarkers and to prevent growth of bacteria and mold. ### Claim 8 (depends on 7) The kit according to claim 7, wherein the compound is sodium azide, the sodium azide being present in solution at a concentration of less than about 0.2%. ### Claim 9 (depends on 8) The kit according to claim 8, wherein the sodium azide is present in solution in a range from about 0.01% to about 0.2%. ### Claim 10 (depends on 1) The kit according to claim 1, wherein the one or more skin-friendly chemicals comprises at least one general nuclease inhibitor. ### Claim 11 (depends on 10) The kit according to claim 10, wherein the at least one general nuclease inhibitor is any one or a combination of RNase inhibitors and DNase inhibitors. ### Claim 12 (depends on 11) The kit according to claim 11, wherein the at least one general nuclease inhibitor comprises any one or a combination of sodium dodecyl sulfate (SDS), polyvinylsulfonic acid, and diethyl pyrocarbonate. ### Claim 13 (depends on 12) The kit according to claim 12, wherein the at least one general nuclease inhibitor comprises SDS, and wherein the SDS is present at a concentration of about 0.01% v/v to about 2% v/v. ### Claim 14 (depends on 13) The kit according to claim 13, wherein the SDS is present in a concentration of about 0.5% v/v. ### Claim 15 A kit for collection of biofluid from a patient and preservation of any DNA and/or RNA contained in the collected biofluid, comprising: a wipe composed of fibers for absorbing a preselected biofluid, the wipe being selected from a fiber-containing paper or a fiber-containing fabric; a rigid re-sealable tube configured to contain the impregnated wipe therein; a re-sealable bag; instructions on how to impregnate the wipe with the preselected biofluid and seal it in the re-sealable bag; a return envelope configured to receive therein the re-sealable bag containing the impregnated wipe, wherein the re-sealable tube is sealed in the re-sealable bag, wherein the wipe has a slit along one edge of the wipe sized to be trapped between a lid on the rigid re-sealable tube and the tube itself during an extraction procedure of DNA/RNA from the collected biofluid so the wipe is draped over a lip of the tube and hangs down into the interior of the tube with a bottom edge of the wipe spaced from the bottom of the tube, and wherein the wipe is impregnated with an SDS solution having a concentration of about 0.01% v/v to about 2% v/v SDS acting as a general nuclease inhibitor for the preservation of the DNA and/or RNA contained in the absorbed biofluid, an EDTA solution having a concentration from about 1 mM to about 5 mM EDTA for inhibiting RNAse/DNAse activity and inducing RNA/DNA binding to the fibers of the wipe, and a sodium azide solution having a concentration of about 0.01% to about 0.2% sodium azide for preserving protein biomarkers and preventing growth of bacteria and mold.