SPECIMEN COLLECTION WITH REAGENT LINED COLLECTORS
The present disclosure relates to specimen collection devices comprising stabilizing compositions for the collection, preservation, transport, and analysis of evidence samples for forensic analysis.
1 . A specimen collection device comprising:
a. a specimen collection absorbent;
b. a reagent lined holder, wherein the reagent is a stabilizing composition deposited in the reagent lined holder and wherein the stabilizing composition is able to transfer to the specimen collection absorbent;
c. a means for aligning the specimen collection absorbent with the reagent lined holder;
d. a means for contacting the stabilizing composition with the specimen collection absorbent to deliver the composition to the specimen collection absorbent; and
e. a means for sampling the specimen collection absorbent for further analysis.
2 . The specimen collection device of claim 1 , wherein the device further comprises a means for maintaining the chain of custody of a collected specimen.
3 . The specimen collection device of claim 1 , wherein the stabilizing reagent comprises at least one chelating agent, at least one surface acting agent, at least one antimicrobial agent, and combinations thereof.
4 . The specimen collection device of claim 1 , wherein the stabilizing composition comprises at least one chelating agent and at least one surface acting agent.
5 . The specimen collection device of claim 4 , wherein the stabilizing composition comprises EDTA and Tween®-20.
6 . The specimen collection device of claim 5 , wherein the stabilizing composition comprises 50 mM EDTA and 0.01% Tween®-20.
7 . The specimen collection device of claim 1 , wherein the stabilizing composition comprises at least one chelator, at least one surface acting agent, and at least one antimicrobial agent.
8 . The specimen collection device of claim 7 , wherein the stabilizing composition comprises EDTA, an azide stabilizer, and Tween®-20.
9 . The specimen collection device of claim 8 , wherein the stabilizing composition comprises 50 mM EDTA, 0.1% Sodium Azide, and 0.01% Tween®-20.
10 . The specimen collection device of claim 7 , wherein the stabilizing composition comprises two chelators.
11 . The specimen collection device of claim 10 , wherein the two chelators are EDTA and EGTA.
12 . The specimen collection device of claim 7 , wherein the stabilizing composition comprises two detergents.
13 . The specimen collection device of claim 12 , wherein the two detergents are Tween and SDS.
14 . The specimen collection device of claim 7 , wherein the preservative composition comprises one azide stabilizer.
15 . The specimen collection device of claim 14 , wherein the azide stabilizer is sodium azide.
16 . The specimen collection device of claim 7 , wherein the preservative composition further comprises a salt and a buffering agent.
17 . The specimen collection device of claim 7 , wherein the preservative composition comprises EDTA, EGTA, Tween, SDS, sodium azide, KCl, and Tris-HCl.
18 . The specimen collection device of claim 7 , wherein the preservative composition comprises about 5 to about 15 mM EDTA, about 1 to about 5 mM EGTA, about 0.001% to about 0.1% Tween, about 1 to about 10% SDS, about 0.01 to about 0.1 sodium azide, about 20 to about 30 mM KCl, and about 40 to about 60 mM Tris-HCl.
19 . The specimen collection device of claim 1 , wherein the stabilizing composition is in the form of a stabilizing dissolvable film.
20 . The specimen collection device of claim 19 , wherein the stabilizing dissolvable film comprises at least one film-forming polymer in addition to the stabilizing composition.
21 . The specimen collection device of claim 20 , wherein the at least one film-forming polymer is polyvinylpyrrolidone.
22 . The specimen collection device of claim 21 , wherein the polyvinylpyrrolidone is polyvinylpyrrolidone 40K.
23 . The specimen collection device of claim 21 , wherein the polyvinylpyrrolidone is present in an amount of about 1% to about 10% by weight in a film-forming solution used to prepare the dissolvable film.
24 . The specimen collection device of claim 20 , wherein the at least one water-soluble film-forming polymer is carboxy methyl cellulose.
25 . The specimen collection device of claim 24 , wherein the carboxy methyl cellulose is present in an amount of about 0.1% to about 1% by weight in a film-forming solution used to prepare the dissolvable film.
26 . The specimen collection device of claim 19 , wherein the thickness of the film is about 5μ to about 5 mm.
27 . The specimen collection device of claim 19 , wherein the preservative composition is present in the film formulation in an amount sufficient to deliver an amount of stabilizing composition sufficient to stabilize a collected sample.
28 . The specimen collection device of claim 19 , wherein the film formulation dissolves in about 5 minutes upon contacting a wet sample.
29 . The specimen collection device of claim 19 , wherein the dissolvable film comprises a liner.
30 . The specimen collection device of claim 29 , wherein the liner is selected from the group consisting of S&S® 903™ paper, S&S® IsoCode® paper, and S&S® 900™, Whatman FTA paper, RAETON™ 16 paper, RAETON™ 26 paper, RAETON™ 96 paper, RAETON™ 7 paper, RG paper, LL72 paper, and B-85 paper.
31 . A specimen collection device comprising:
a. a specimen collection absorbent;
b. a reagent lined holder, wherein the reagent is a stabilizing composition deposited in the reagent lined holder and wherein the stabilizing composition is able to transfer to the specimen collection absorbent;
c. a means for aligning the specimen collection absorbent with the reagent lined holder;
d. a means for contacting the stabilizing composition with the specimen collection absorbent to deliver the composition to the specimen collection absorbent; and
e. a means for sampling the specimen collection absorbent for further analysis;
wherein the stabilizing composition comprises 50 mM EDTA and 0.01% Tween®-20.
32 . The specimen collection device of claim 31 , wherein the stabilizing composition is in the form of a stabilizing dissolvable film.
33 . A specimen collection device comprising:
a. a specimen collection absorbent;
b. a reagent lined holder, wherein the reagent is a stabilizing composition deposited in the reagent lined holder and wherein the stabilizing composition is able to transfer to the specimen collection absorbent;
c. a means for aligning the specimen collection absorbent with the reagent lined holder;
d. a means for contacting the stabilizing composition with the specimen collection absorbent to deliver the composition to the specimen collection absorbent; and
e. a means for sampling the specimen collection absorbent for further analysis;
wherein the stabilizing composition comprises 50 mM EDTA, 0.1% Sodium Azide, and 0.01% Tween®-20.
34 . The specimen collection device of claim 33 , wherein the stabilizing composition is in the form of a stabilizing dissolvable film.
35 . A specimen collection device comprising:
a. a specimen collection absorbent;
b. a reagent lined holder, wherein the reagent is a stabilizing composition deposited in the reagent lined holder and wherein the stabilizing composition is able to transfer to the specimen collection absorbent;
c. a means for aligning the specimen collection absorbent with the reagent lined holder;
d. a means for contacting the stabilizing composition with the specimen collection absorbent to deliver the composition to the specimen collection absorbent; and
e. a means for sampling the specimen collection absorbent for further analysis;
wherein the stabilizing composition comprises about 5 to about 15 mM EDTA, about 1 to about 5 mM EGTA, about 0.001% to about 0.1% Tween, about 1 to about 10% SDS, about 0.01 to about 0.1 sodium azide, about 20 to about 30 mM KCl, and about 40 to about 60 mM Tris-HCl.
36 . The specimen collection device of claim 35 , wherein the stabilizing composition is in the form of a stabilizing dissolvable film.
37 . A method of collecting a specimen for analysis comprising the steps of:
a. providing a specimen collector having a specimen collection absorbent and a reagent lined cassette;
b. contacting the specimen collection absorbent to a specimen for collection;
c. closing the specimen collector, wherein the sample collection absorbent is moved into a position that aligns the specimen collection absorbent with the reagent lined cassette;
d. contacting the specimen collection absorbent to the reagent lined cassette to deliver the reagent to the specimen collection absorbent;
e. storing the specimen collector; and
f. sampling the specimen collection absorbent for analysis.