Transport media for clinical specimen collection and molecular diagnostic applications and methods of production and use thereof
A transport medium is disclosed that can be utilized for both sample collection and molecular diagnostic applications. The transport medium can be utilized with multiple types of biological samples and maintains the stability of nucleic acid present in the biological samples so that one or more nucleic acid assay target(s) present in the biological sample is not substantially degraded during storage and shipping. Also disclosed are kits containing the transport medium, mixtures that include a biological sample disposed in the transport medium, and methods of producing and using the medium.
1 . A transport medium for sample collection and molecular diagnostic applications, the transport medium comprising:
guanidine thiocyanate in a sodium acetate buffer, wherein the guanidine thiocyanate is present at a concentration in a range of from about 3M to about 4M;
a polysorbate, wherein the polysorbate is present at a concentration in the range of from about 0.1% to about 20%;
CHAPS (3-((3-cholamidopropyl)dimethylammonio)-1-propanesulfonate), wherein CHAPS is present at a concentration in a range of from about 0.1% to about 5%;
EDTA (ethylenediaminetetraacetic acid);
an alcohol, wherein the alcohol is present at a concentration in a range of from about 1% to about 40%; and
at least one reducing agent selected from the group consisting of TCEP (Tris(2-carboxyethyl) phosphine)), DTT (dithiothreitol), and a combination thereof, wherein the transport medium substantially preserves DNA and/or RNA from the biological sample for a period of at least about 15 days to 30 days at room temperature.
2 . The transport medium of claim 1 , wherein the guanidine thiocyanate is present at a concentration in a range of from about 3M to about 4 M.
3 . The transport medium of claim 1 , wherein the sodium acetate buffer is present at a concentration in a range of from about 50 mM to about 200 mM and at a pH in a range of from about 4 to about 7.
4 . The transport medium of claim 1 , wherein the polysorbate is Polysorbate-20.
5 . The transport medium of claim 1 , wherein the alcohol is ethanol.
6 . The transport medium of claim 1 , further comprising at least one additional ingredient selected from the group consisting of SOS (sodium dodecyl sulfate), polyethylene glycol (PEG), an anti-foaming agent, and combinations thereof.
7 . A kit, comprising:
the transport medium of claim 1 .
8 . The kit of claim 7 , further comprising at least one sample collection device.
9 . The kit of claim 8 , wherein the sample collection device is a single format, multi-collection device.
10 . A mixture, comprising:
a biological sample; and
the transport medium of claim 1 , wherein the biological sample is disposed within the transport medium.
11 . The mixture of claim 10 , wherein the biological sample is selected from the group consisting of urine, stool, sexually transmitted infection (STI) swabs, respiratory collections, blood or any portion thereof, saliva, sputum, cerebrospinal fluid (CSF), surgical drain fluid, intestinal fluid, intraperitoneal fluid, cystic fluid, sweat, interstitial fluid, extracellular fluid, tears, mucus, bladder wash, urine, swabs, semen, pleural fluid, nasopharyngeal fluid, and combinations thereof.
12 . A method, comprising the steps of:
disposing a biological sample in the transport medium of claim 1 to form a mixture.
13 . The method of claim 12 , further comprising at least one step selected from the group consisting of:
shipping the mixture to a clinical facility;
storing the mixture for at least one week; and
performing at least one nucleic acid amplification step on the mixture.