Apoenzyme reactivation electrochemical detection method and assay

APOENZYME REACTIVATION
ELECTROCHEMICAL DETECTION
METHOD AND ASSAY

Inventor: Stephen Eliot Zweig, Los Gatos, CA
(US)

Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 1033 days.

This patent is subject to a terminal disclaimer.

Appl. N0.; 11/656,089

Filed: Jan. 22, 2007
Prior Publication Data
US 2007/0289880 A1 Dec. 20, 2007

Related U.S. Application Data

Continuation-in-part of application No. 11/059,841, filed on Feb. 17, 2005, noW Pat. No. 7,166,208, and a continuation-in-part of application No. 10/233,908, filed on Sep. 3, 2002, noW Pat. No. 7,291,698, and a continuation-in-part of application No. 10/308,411, filed on Dec. 3, 2002, noW abandoned.

Provisional application No. 60/549,691, filed on Mar. 3, 2004, provisional application No. 60/317,023, filed on Sep. 4, 2001, provisional application No. 60/339,916, filed on Dec. 6, 2001, provisional application No. 60/389,679, filed on Jun. 17, 2002.

Int. Cl.

G01N 27/327 (2006.01)

U.S. Cl. ................................. .. 205/792; 204/403.01 Field of Classification Search ............... 204/403.01-403.15; 205/777.5,

205/778, 792; 600/345 See application file for complete search history.

(56) References Cited

U.S. PATENT DOCUMENTS

3,542,662 A * 11/1970 Hicks et al. ............ .. 204/403.09

3,817,837 A 6/1974 Rubenstein et al.

4,134,792 A 1/1979 Boguslaski et al.

4,213,893 A 7/1980 Carrico et al.

4,238,565 A 12/1980 Hornby et al.

4,318,983 A 3/1982 Hornby et al.

4,484,987 A * 11/1984 Gough ........................ .. 205/778

4,495,281 A 1/1985 Buckler et al.

4,545,382 A 10/1985 Higgins et al.

4,711,245 A 12/1987 Higgins et al.

4,758,323 A 7/1988 Davis et al.

5,173,165 A * 12/1992 Schmid et al. ........... .. 204/403.1 (Continued)

FOREIGN PATENT DOCUMENTS GB 2188728 A 10/1987 (Continued)

OTHER PUBLICATIONS

Lange et al., “Inhibition of Blood Coagulation Factors by Serine Esterase Inhibitors,” FEBS Letters vol. 24, No. 3, pp. 265-268, Aug. 1972*

(Continued) Primary Examiner * Alex Noguerola

(57) ABSTRACT

The invention discloses a device and method by Which dry reagent enzyme based electrochemical biosensors, Which are in a relatively mature form due to the extensive amount of development pioneered by the blood glucose monitoring industry, may be simply adapted to perform tests for blood coagulation, enzymatic activity, or immunochemical assays for antigens present in a fluid sample. In particular, the utility of combining apoenzyme based dry reagent electrochemical bio sensors With apoenzyme reactivation technology is taught. This combination creates a novel combination test technology capable of detecting a Wide range of different analytes, and operating in a Wide variety of Wet or dry, in vivo or in vitro environments.

20 Claims, 11 Drawing Sheets

U.S. PATENT DOCUMENTS

5,233,025 A * 8/1993 Miyazaki et al. ........ .. 530/388.9 5,264,105 A 11/1993 Gregg etal. 5,320,725 A 6/1994 Gregg et al. 5,336,388 A * 8/1994 Leader et al. .......... .. 204/403.06 5,418,141 A 5/1995 Zweig et al. 5,580,744 A 12/1996 Zweig 5,708,247 A 1/1998 McAleer et al. 5,727,548 A 3/1998 Hill et al. 5,820,551 A 10/1998 Hill etal. 6,352,630 B1 3/2002 Frenkelet al. 6,620,310 B1 9/2003 Ohara et al. 6,673,622 B1 1/2004 Jina 7,006,858 B2* 2/2006 Silver et al. ................. .. 600/345 FOREIGN PATENT DOCUMENTS W0 WO 91/16630 10/1991 OTHER PUBLICATIONS

Heiss et. al. “Dip and read test strips for the determination of trinitrotoluene”, Analytica Chimica Acta 396 (1999) 309-316. Schroeder et. al. “Coupling aminoheyl-FAD to proteins with dimethyladipimidate” Clin. Chim. Sep. 1985; 31(9) 1432-7.

Morris et. al. “Flavin adeinine dinucleotide as a label in homogenous colorimetric immunoassays” Anal Chem 53, 658-665 (1981). Gavalas et. al. “Biosensors based on enzyme polyelectrolyte complex adsobed into a porous carbon electrode” Bio sensors & Bioelectronics 13 (1998) 1205-1211.

Katza et. al. “Glucose oxidase electrodes via reconstitution of the apo -enzyme: tailoring of novel glucose bio sensors” Analytica Chima Acta 385 (1999) 45-58.

Vielstich (ed), Mathias et. al. “Diffusion media materials and characterization”, Handbook of Fuel Cells-vol. 3 (46), p. 3-9, 2003 John Wiley & Sons, Ltd.

Liu and Wang “Improved design for the glucose biosensor”, Food technol. biotechnol. 39 (1) 55-58 (2001).

Hughes et. al. “Allosteric changes in solvent accessibility observed in t11rombin uon active site occupation”, Biochemistry 2004, 43, 5246525 5.

Szynol et. al. “Bactericidal Effects of a Fusion Protein of Llama Heavy-Chain Antibodies Coupled to Glucose Oxidase on Oral Bacteria”, Antimicrobial Agents and Chemotherapy, S.

Yamada et. al. “Mutant Isolation of t11e Escherichia coli Quinoprotein Glucose Dehydrogenase and Analysis ofCrucial . . . ”, J. Biol. Chem. 273 (34), pp. 22021-22027, 1998.

* cited by examiner