Self-contained swab-based diagnostic systems
First Claim
1. A diagnostic test unit comprising:
- a stem having a first end and a second end, said stem defining at least one flow channel extending between said first end and said second end;
a swab disposed at said first end of said stem, said swab being configured to collect a test sample derived from a biological source that is suspected of containing an analyte;
a fluid chamber configured to contain a fluid, wherein said fluid chamber is in fluid communication with said swab via said flow channel;
a rupturable seal that inhibits leakage of the fluid from said fluid chamber prior to use; and
a test strip for detecting the presence or absence of the analyte in the test sample, said test strip being in fluid communication with said swab, said flow channel, and said fluid chamber.
2 Assignments
0 Petitions
Accused Products
Abstract
A diagnostic test unit is provided. The test unit comprises a stem having a first end and a second end, the stem defining at least one flow channel extending between the first end and the second end. A swab is disposed at the first end of the stem, the swab being configured to collect a test sample derived from a biological source that is suspected of containing an analyte. The test unit also comprises a fluid chamber configured to contain a fluid, wherein the fluid chamber is in fluid communication with the swab via the flow channel. The test unit also comprises a rupturable seal that inhibits leakage of the fluid from the fluid chamber prior to use, and an assay for detecting the presence or absence of the analyte. The assay is in fluid communication with the swab, the flow channel, and the fluid chamber.
85 Citations
46 Claims
-
1. A diagnostic test unit comprising:
-
a stem having a first end and a second end, said stem defining at least one flow channel extending between said first end and said second end; a swab disposed at said first end of said stem, said swab being configured to collect a test sample derived from a biological source that is suspected of containing an analyte; a fluid chamber configured to contain a fluid, wherein said fluid chamber is in fluid communication with said swab via said flow channel; a rupturable seal that inhibits leakage of the fluid from said fluid chamber prior to use; and a test strip for detecting the presence or absence of the analyte in the test sample, said test strip being in fluid communication with said swab, said flow channel, and said fluid chamber. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
-
-
24. A diagnostic test unit comprising:
-
a generally elongated, tubular stem having a first end and a second end, said stem defining at least one flow channel extending between said first end and said second end, said flow channel having a length of from about 1 to about 15 centimeters and at least a portion of said flow channel having a width of from about 0.01 to about 3 millimeters; a swab disposed at said first end of said stem, said swab being configured to collect a test sample derived from a biological source that is suspected of containing an analyte; a fluid chamber configured to contain a fluid, wherein said fluid chamber is in fluid communication with said swab via said flow channel; a rupturable seal that inhibits leakage of the fluid from said fluid chamber prior to use, wherein said seal is formed from film, metallic foil, or combinations thereof, and has a thickness of less than about 0.05 inches; and a test strip for detecting the presence or absence of the analyte in the test sample, said test strip comprising a porous membrane that is in fluid communication with said swab, said flow channel, and said fluid chamber. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33, 34)
-
-
35. A method for detecting the presence or absence or amount of an analyte within a test sample derived from a biological source, said method comprising:
-
i) providing a diagnostic test unit, said test unit comprising; a) a stem having a first end and a second end, said stem defining at least one flow channel extending between said first end and said second end; b) a swab disposed at said first end of said stem; c) a fluid chamber configured to contain a fluid, wherein said fluid chamber is in fluid communication with said swab via said flow channel; d) a seal that inhibits leakage of the fluid from said fluid chamber prior to use; and e) a test strip for detecting the presence or absence of the analyte in the test sample, said test strip being in fluid communication with said swab, said flow channel, and said fluid chamber; ii) collecting the test sample on said swab; iii) rupturing said seal to release said fluid from said fluid chamber, wherein said fluid mixes with the test sample on said swab and then contacts said test strip and generates a detection signal; and iv) further comprising correlating the detection signal to the presence or amount of the analyte. - View Dependent Claims (36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46)
-
Specification