Device and apparatus for conducting an assay

• US 6,300,142 B1
• Filed: 05/26/2000
• Issued: 10/09/2001
• Est. Priority Date: 11/28/1997
• Status: Expired due to Term

• Current Assignee: Provalis Diagnostics Limited
• Original Assignee: Provalis Diagnostics Limited
• Inventors: Griffiths, David, Attridge, John Worthington, Odell, John Anthony, Gresswell, Mark, Vessey, John Phillip, Curtis, John, Fernando, Felix, Percival, David Alan, Stevenson, Anthony, Andrewes, David
• Primary Examiner(s): Chin, Christopher L.
• Assistant Examiner(s): Padmanabhan, Kartic
• Application Number:
  US09/555,472
• Time in Patent Office: 501 Days
• Field of Search: 210/321.6, 210/321.61, 210/321.62, 210/321.63, 210/321.64, 210/321.65, 210/321.66, 210/321.67, 210/650, 210/651, 210/782, 356/426, 356/427, 366/208, 385/12, 385/15, 385/33, 385/129, 414/754, 422/44, 422/63, 422/64, 422/68.1, 422/82.05, 422/82.11, 422/101, 422/102, 424/530, 435/717.92, 435/293.1, 435/962, 435/967, 435/287.1, 435/6, 435/3, 435/7, 435/288--28, 436/43, 436/45, 436/63, 436/66, 436/67, 436/88, 436/164, 436/172, 436/174, 436/177, 436/518, 436/536, 436/538, 436/539, 436/805, 436/807, 436/808, 436/809, 530/363, 530/380, 530/412, 530/417
• US Class Current: 436/518
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/045 whereby the whole cover is slidable
• CPC Class Codes: B01L 2300/046 Function or devices integrated in the closure
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2400/0644 rotary valves
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: Y10S 435/962 Prevention or removal of interfering materials or reactants or other treatment to enhance results, e.g. determining or preventing nonspecific binding
• CPC Class Codes: Y10S 435/967 Standards, controls, materials, e.g. validation studies, buffer systems
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/809 Multifield plates or multicontainer arrays
• CPC Class Codes: Y10T 436/11 Automated chemical analysis
• CPC Class Codes: Y10T 436/111666 Utilizing a centrifuge or compartmented rotor
• CPC Class Codes: Y10T 436/25 including sample preparation
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

Abstract

A apparatus for assaying glycated proteins and other analytes in biological samples such as blood, in which a sample is presented to the apparatus, includes an inlet port between moveable between first and second inlets, such that the inlet can be brought into liquid communication with each inlet in turn. The inlet port accommodates a filter or binder. The apparatus also includes a microprocessor operable via a key pad, at least one light emitter and at least one light detector, a display and driver, and an A to D converter, and is operatively connected to a power source.

Claims

1. An apparatus for use in an assay in which a sample is separated into component fractions for presentation to an instrument, said apparatus comprising:

a carousel, including,

(1) a base portion having

(a) a first inlet and a first component fraction collection chamber defined therein, said first inlet being in fluid communication with said first component fraction collection chamber, and

(b) a second inlet and a second component fraction collection chamber defined by said base portion, said second inlet being in fluid communication with said second component fraction collection chamber, wherein said first and second component collection fraction chambers are not in fluid communication with each other, and

(2) a top portion; and

a funnel portion including an outlet port, said funnel portion being adapted to receive a filter means or a binder means,

wherein said carousel is rotatably mounted about said funnel portion such that when said carousel is rotated, said outlet port is brought into selective liquid communication with each first and second inlet in turn.

2. An apparatus in accordance with claim 1 wherein the filter means or binder retaining means is a frit.

3. An apparatus in accordance with claim 1 wherein said first and second inlets include optical chambers.

4. An apparatus in accordance with claim 1 further comprising a third inlet.

5. An apparatus in accordance with claim 4 further comprising an absorbent or wicking material positioned in said third inlet.

6. An apparatus in accordance with claim 1 wherein the funnel portion further comprises:

means for locating the funnel portion relative to an optical instrument.

7. An apparatus in accordance with claim 1 wherein the funnel portion further comprises:

a guide member about which the carousel rotates.

8. An apparatus in accordance with claim 7 wherein the guide member includes an annular ring.

9. An apparatus in accordance with claim 8 wherein the annular ring includes a recessed portion.

10. An apparatus in accordance with claim 1, wherein the carousel is adapted to house a plurality of tubes and the top portion includes a plurality of holes formed therein adapted for removal of said tubes from the apparatus.

11. An apparatus in accordance with claim 1 wherein the first and second inlets are optical chambers.

12. An apparatus in accordance with claim 11 wherein the optical chambers have curved optical surfaces.

13. An apparatus in accordance with claim 12 wherein the optical chambers are recessed.

14. An apparatus in accordance with claim 1, further comprising:

an instrument adapted for receiving the carousel, comprising;

a microprocessor operable via a key pad,

at least one light emitter;

at least one light detector;

a display and driver;

an analog to digital converter; and

means for connecting the instrument to a power source.

15. An apparatus in accordance with claim 14, further comprising an annularly shaped recessed portion in said instrument for receiving said carousel, said recessed portion defined by a floor, an annular innermost side wall extending from said floor and an annular outermost sidewall extending from said floor, said outermost side wall comprising a channel member running about its circumference and a connecting channel extending from a top surface of the instrument to the channel member.

16. A method for assaying a sample with an apparatus having

(A) a carousel which includes

(1) a base portion having

(a) a first inlet and a first component fraction collection chamber defined therein, said first inlet being in fluid communication with said first component fraction collection chamber, and

(b) a second inlet and a second component fraction collection chamber defined by said base portion, said second inlet being in fluid communication with said second component fraction collection chamber, and

(2) a top portion having

(B) a funnel portion including an outlet port adapted to receive a filter means or a binder means, said carousel being rotatably mounted about said funnel portion such that as said carousel is rotated, said outlet port is moveable relative to each of said first and second inlets and is brought into selective liquid communication with each first and second inlet in turn, said method comprising the steps of:

collecting a first component fraction of the sample into the first component fraction collection chamber,

rotating said carousel about said funnel portion;

collecting a second component fraction of the sample into the second component fraction collection chamber; and

assaying the first and second component fractions to determine the presence or absence of one or more analytes in said component fractions.

17. A method of assaying in accordance with claim 16, wherein the sample is blood, the first component fraction contains one or more non-glycated proteins, and the second component fraction contains one or more glycated proteins.

18. A method of assaying in accordance with claim 17, wherein the one or more glycated proteins are selected from the group consisting of glycated hemoglobin, glycated human serum albumin and glycated apo lipoprotein.

19. A method of assaying in accordance with claim 18 further comprising the following steps of:

obtaining a blood sample containing blood cells from a subject;

lysing blood cells of the blood sample; and

separating the blood sample into two components using a method which involves binding an analyte to a solid phase to obtain a first component fraction and then releasing the analyte to obtain the second fraction.

20. A method of assaying in accordance with claim 19, further comprising the steps of:

separating the analyte from the sample; and

detecting the analyte by immunoassay or spectrophotometry.