# US 7,611,670 B2 · Quantitative analysis of a biological sample of unknown quantity

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- Number: US 7,611,670 B2
- Document ID: US7611670B2
- Status: Granted
- Kind: B2
- Application number: 10/706,321
- Filed: 2003-11-12
- Published: 2005-06-16
- Granted: 2009-11-03
- Earliest claimed: 2002-04-23
- Assignees: Home Access Health Corporation
- Inventors: Michael Wandell; Ilia Vinogradov; Barbara Godsey
- Web page: https://patentgrep.com/patent/US7611670B2

## CPC

- G01N 33/57555: of the prostate
- G01N 33/54393: {Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding}
- G01N 33/92: involving lipids, e.g. cholesterol {, lipoproteins, or their receptors (steroid hormones G01N33/743)}
- G01N 33/96: involving blood or serum control standard
- G01N 2333/91188: transferring nitrogenous groups (2.6)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Disclosed is a method for testing a modified specimen such as a dried blood spot, plasma or serum specimen, for an analyte of interest, such as cholesterol. In accordance with the disclosed subject matter, the level of the analyte of interest in the medium from which the modified specimen was obtained (e.g., from a patient's blood) is determined based on the level of an analyte in a solution formed from the modified specimen and on the level of at least one normalizing analyte. The analyte and normalizing analyte each may be an ion, compound, biochemical entity, or property of the specimen. Also disclosed are a fluid collector and a fluid collection device.

## Claims

### Claim 1

A kit comprising a fluid collection device comprising a pair of fluid collectors, each comprising an absorbent substrate coated with a saccharide, said substrate comprising a mat of glass fibers at least substantially coated with polyvinyl alcohol, said fibers defining a plurality of pores, the pores in said mat having a pore size effective to at least substantially prevent lysing of red blood cells while permitting at least substantial separation of serum from red blood cells via differential wicking and a single superstrate, said fluid collectors ordinarily not being in fluidic contact with one another and each being generally fixed with respect to said superstrate, said superstrate having a pair of apertures, each defining a blood receiving opening and permitting access to a respective one of said fluid collectors, and further comprising a dessicant, said dessicant being present in an amount effective to provide a dessicating protective effect on a blood fluid specimen.

### Claim 2 (depends on 1)

A fluid collection device according to claim 1, said superstrate comprising a second pair of apertures, each of said fluid collectors having a first end and a second end, said blood receiving openings permitting respectively fluidic access to the first end of one of said fluid collectors, said second pair of apertures each being respectively relatively proximal said second end of one of said fluid collectors thereby defining a pair of gangs.

### Claim 3

A kit comprising: a fluid collection device having a fluid collector with an absorbent substrate coated with a saccharide, said substrate comprising a mat of glass fibers at least substantially coated with polyvinyl alcohol, said fibers defining a plurality of pores, the pores in said mat having a pore size effective to at least substantially prevent lysing of red blood cells while permitting at least substantial separation of serum from red blood cells via differential wicking and a superstrate, said fluid collector being generally fixed with respect to said superstrate, said superstrate having an aperture defining a blood receiving opening and permitting access to said fluid collector, and further comprising a dessicant, said dessicant being present in an amount effective to provide a dessicating protective effect on a blood fluid specimen.

### Claim 4 (depends on 3)

A kit according to claim 3, further comprising instructions for using the fluid collection device.

### Claim 5 (depends on 4)

A kit according to claim 4, wherein said instructions are integral with said device.

### Claim 6 (depends on 4)

A kit according to claim 4, wherein said instructions are separate from said device.

### Claim 7 (depends on 3)

A kit according to claim 3, further comprising a requisition form, said requisition form permitting indication of the type of test to be conducted on the fluid to be collected by the device.

### Claim 8 (depends on 7)

A kit according to claim 7, wherein said requisition form lists a plurality of test types.

### Claim 9 (depends on 3)

A kit according to claim 3, wherein said dessicant comprises silica.

### Claim 10 (depends on 9)

A kit according to claim 9, wherein said dessicant is contained in a porous pouch.

### Claim 11 (depends on 3)

A kit according to claim 3 further comprising a lancet, instructions for using the kit, a dessicant, said dessicant being present in an amount effective to provide a dessicating protective effect on a blood fluid specimen collected in said device, and a barrier film pouch sized for receiving said fluid collection device and said dessicant.

### Claim 12 (depends on 11)

A kit according to claim 11, further comprising a requisition form permitting indication of the type of test to be conducted in the fluid to be collected by the device.
