External dried-reagent control for analytical test devices
First Claim
1. A control device for use in performing a positive control test of a solid-phase analytical test device, said solid-phase analytical test device being one that comprises an indicator and that detects the presence of an analyte in a liquid sample by a change in said indicator, said control device comprising:
- a solid support having a dry control reagent adhering thereto and no components that are chemically reactive with said control reagent, said reagent being arranged on said solid support in a manner permitting removal of said reagent from said support by a wet transfer implement which is either a swab or a sponge, and said reagent being either water-soluble or sufficiently hydrophilic to cause said reagent to be transferred to said wet transfer implement upon contact of said wet transfer implement to said reagent, said reagent being selected as one which when applied to said test device by said wet transfer implement causes an indicator change that is substantially the same as that which occurs in the presence of said analyte.
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Abstract
A control device serving as a source of control reagent for a solid-phase analytical test device is disclosed. The analytical test device analyzes a biological sample for the presence of an analyte such as an enzyme or other chemical species or a particular pH range, and registers the presence or absence of the analyte as a detectable change in an indicator. The control device contains a control reagent that produces the same indicator change and that can be transferred to the analytical test device by a sample implement such as a wet swab. The control reagent is present on the control device as a dry lamina or combination of laminae. A positive control reagent on a control device in accordance with this invention mimics the action of the analyte once it is transferred to the analytical test device, while a negative control reagent on the control device mimics the action of a sample that lacks the analyte.
44 Citations
15 Claims
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1. A control device for use in performing a positive control test of a solid-phase analytical test device, said solid-phase analytical test device being one that comprises an indicator and that detects the presence of an analyte in a liquid sample by a change in said indicator, said control device comprising:
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a solid support having a dry control reagent adhering thereto and no components that are chemically reactive with said control reagent, said reagent being arranged on said solid support in a manner permitting removal of said reagent from said support by a wet transfer implement which is either a swab or a sponge, and said reagent being either water-soluble or sufficiently hydrophilic to cause said reagent to be transferred to said wet transfer implement upon contact of said wet transfer implement to said reagent, said reagent being selected as one which when applied to said test device by said wet transfer implement causes an indicator change that is substantially the same as that which occurs in the presence of said analyte. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
(a) said analytical test device contains a chemical species that is released by said analyte and thus released produces a change in said indicator, and (b) said dry control reagent is a member selected from the group consisting of said chemical species and chemical derivatives thereof that function in substantially the same manner in said analytical test device as said chemical species.
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4. A control device in accordance with claim 1, comprising a plurality of dry control reagents adhering to said solid support, each of said reagents corresponding to a different test among a plurality of tests on said analytical test device for detection of a plurality of analytes, such that a transfer implement bearing said plurality of reagents when applied to said test device causes an indicator change in each of said tests that is substantially the same as those that occur in the presence of said analytes.
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5. A control device in accordance with claim 4 in which said plurality of dried control reagents is combined as a mixture in a single solid composition.
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6. A control device in accordance with claim 4 in which each member of said plurality of dried control reagents is contained in a separate solid composition, thereby forming a plurality of solid compositions arranged in spatially distinct locations on said control device.
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7. A control device in accordance with claim 6 in which said spatially distinct solid compositions are laterally arranged on the surface of said solid support.
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8. A control device in accordance with claim 6 in which said spatially distinct solid compositions are vertically arranged on the surface of said solid support.
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9. A control device in accordance with claim 1 in which said analyte is a species that imparts to said sample a pH exceeding 4.7, said indicator is a compound containing an ionizable phenol group and a negatively charged group dispersed in a polymer containing quaternary ammonium groups, and said dry control reagent is an acid having a pH greater than 5.0.
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10. A control device in accordance with claim 9 in which said dry control reagent is a member selected from the group consisting of 2-(N-morpholino)ethanesulfonic acid and citric acid.
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11. A control device in accordance with claim 1 in which said analyte is a species that releases a volatile amine when placed in said solid-phase test device, said indicator is a substance that undergoes a visual change when contacted with a volatile amine, and said dry control reagent is an acid salt of an amine.
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12. A control device in accordance with claim 11 in which said acid salt of an amine is a member selected from acid salts of methylamine and diaminobutane.
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13. A control device in accordance with claim 3 in which said chemical species is β
- -naphthylamine, said solid-phase analytical test device comprises a conjugate of β
-naphthylamine, said analyte is an enzyme that cleaves said conjugate to release said β
-naphthylamine, said indicator is a compound that undergoes a color change when contacted with β
-naphthylamine thus released, and said dry control reagent is a nonvolatile naphthylamine derivative that produces said color change in said indicator.
- -naphthylamine, said solid-phase analytical test device comprises a conjugate of β
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14. A control device in accordance with claim 13 in which said non-volatile naphthylamine derivative is 3-amino-2-naphthoic acid dispersed in a quaternary amine polymer.
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15. A control device for use in performing a negative control test of a solid-phase analytical test device, said solid-phase analytical test device being one that comprises an indicator and that detects the absence of an analyte by a first change in said indicator and the presence of said analyte by a second change in said indicator, said control device comprising:
a solid support having a dry control reagent adhering thereto and no components that are chemically reactive with said control reagent, said reagent being arranged on said solid support in a manner permitting removal of said reagent from said support by a wet transfer implement which is either a swab or a sponge, and said reagent being either water-soluble or sufficiently hydrophilic to cause said reagent to be transferred to said wet transfer implement upon contact of said wet transfer implement to said reagent, said reagent being selected as one which when applied to said test device by said wet transfer implement causes an indicator change that is substantially the same as said first change.
Specification