Self-metering fluid analysis device

• US 5,208,163 A
• Filed: 12/06/1991
• Issued: 05/04/1993
• Est. Priority Date: 08/06/1990
• Status: Expired due to Term

• Current Assignee: Miles, Inc. (Bayer AG)
• Original Assignee: Miles, Inc. (Bayer AG)
• Inventors: Ruetten, Catherine, Charlton, Steven C., Rebec, Mihailo V.
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): REDDING, DAVID A
• Application Number:
  US07/803,076
• Time in Patent Office: 515 Days
• Field of Search: 436/52, 436/63, 436/165, 436/169, 436/171, 436/172, 436/177, 436/178, 436/180, 436/805, 436/807, 436/808, 435/4, 435/810
• US Class Current: 436/63
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/502753 characterised by bulk separation arrangements on lab-on-a-chip devices, e.g. for filtration or centrifugation separation in general B01D; microapparatus for analysis using electrophoresis G01N27/44791; sample preparation G01N1/28
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A method for detecting blood analytes with a sample volume as low as 2 microliters in the hematocrit range of 0% to 60%, or higher. This is accomplished by using a diagnostic device comprising a housing with various chambers and compartments for processing the blood. A sample application port in the housing is used to introduce blood into a metering chamber. From the metering chamber, the blood flows to a reaction chamber for analyzing blood analytes. Blood entering the metering chamber flows into a fluid capillary which indicates that an adequate amount of blood has been received in the metering chamber. The reaction compartment includes a reagent and a filter, the latter of which is disposed between the metering chamber and the reagent so that the reagent reacts with the filtered blood.

Claims

1. A method for analyzing fluid, comprising the steps of:

introducing a sample of fluid into a test device which directs the fluid to a metering chamber that further directs excess fluid to a fluid capillary once the metering chamber has received an ample amount of the fluid;

directing an aliquot of said fluid from the metering chamber to a reaction chamber;

filtering the fluid in the reaction chamber and then directing the filtering fluid into contact with a reagent.

2. A method for analyzing fluid, according to claim 1, further including the step of directing excess fluid into a fluid containment chamber from the fluid capillary.