Analyte concentration detection devices and methods
Arrangements for the detection of the presence and/or concentration of an analyte in a sample of bodily fluid include diffuse transmission, diffuse reflection and edge or waveguide illumination arrangements. A vertical flow assay arrangement and/or technique is also disclosed, and includes a detection component that can be in the form of an array of optical detection elements. A number of assay pad constructions are described which may include at least one or more of the following components: a prefilter component, a reflective component, a membrane component, a reagent component, a mesh component, and a component to prevent lateral spreading.
1. An arrangement for use in detecting the presence or concentration of an analyte present in bodily fluid, the arrangement comprising:
(a) an assay pad adapted to receive a sample of the bodily fluid, the assay pad containing a reagent;
(b) an array of CMOS detectors, each detector adapted to produce a signal indicative of a reaction between the analyte and the reagent; and
(c) electronics monitoring and interpreting the signals produced by the detectors to estimate the volume of the sample under analysis based on the number of CMOS detectors producing a signal indicative of the reaction between the analyte and the reagent.
2. The arrangement of claim 1 , wherein the electronics further comprise at least one corrective algorithm.
3. The arrangement of claim 1 , wherein the electronics generate an overall reading based on the signals produced by the individual detectors.
4. The arrangement of claim 1 , further comprising a skin penetration member.
5. The arrangement of claim 4 , wherein the skin penetration member comprises a microneedle.
6. The arrangement of claim 1 , further comprising a chamber for receiving the sample of bodily fluid.
7. The arrangement of claim 6 , wherein the assay pad is disposed in the chamber.
8. The arrangement of claim 1 , further comprising at least one light source adapted to provide light incident upon the assay pad.
9. The arrangement of claim 1 , wherein at least one dimension of the linear array is commensurate to at least one dimension of the assay pad.
10. A method useful in detecting the presence or concentration of an analyte present in bodily fluid, the method comprising:
(a) introducing a sample of the bodily fluid onto an assay pad, the assay pad containing a reagent;
(b) monitoring a reaction between the analyte and the reagent, comprising an array of CMOS detectors wherein at least one CMOS detector provides a signal in response to the reaction; and
(c) monitoring and interpreting the at least one signal to provide an estimate of the volume of the sample under analysis based on the number of CMOS detectors producing a signal indicative of the reaction between the analyte and the reagent.
11. The method of claim 10 , wherein step c) further comprises applying at least one corrective algorithm to the at least one signal.
12. The method of claim 10 , wherein step c) further comprises generating an overall reading based on the signals produced by the individual detectors.
13. The method of claim 10 , further comprising providing a skin penetration member.
14. The method of claim 13 , wherein the skin penetration member comprises a microneedle.
15. The method of claim 10 , further comprising providing a chamber for receiving the sample of bodily fluid.
16. The method of claim 15 , wherein step a) further comprises disposing the assay pad in the chamber.
17. The method of claim 10 , further comprising providing light incident upon the assay pad.
18. The method of claim 10 , further comprising providing the linear assay with at least one dimension commensurate to at least one dimension of the assay pad.