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Cuvette for an automated analyzer

a cuvette and analyzer technology, applied in the field of automatic analyzers, can solve the problems of limited automation applied, variable test results, high cost, etc., and achieve the effect of high degree of versatility

Inactive Publication Date: 2005-12-01
ALUMINUM PECHINEY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention is an automated analyzer that is a self-contained instrument that can be placed on a laboratory bench. It requires no external connections other than a power line and operates within a temperature range of 18°C to 30°C. The analyzer has several functional units including a process track, sample handling or transport system, reagent handling or transport system, separation and washing system, detection system (luminometer) and data collection / processing system. The reagents and test samples are reacted in disposable cuvettes. The cuvettes are automatically and sequentially dispensed onto a linear process tract which moves each cuvette one cuvette space every 20 seconds. The temperature of the test reaction is controlled by a thermal system which preheats the cuvettes and reagents and maintains an environmental temperature of 37°C, plus or minus one degree, throughout incubation. The analyzer is particularly useful for performing heterogeneous specific bind assays. The analyzer can be run in batch-mode or random access sequence.

Problems solved by technology

Limited automation has been applied to the area of immunoassay testing.
Test results are very often delayed because of the time factor and labor intensity for many of the manual steps, and long incubation or reaction times. These delays can be critical in many clinical situations.
In addition, the manual procedures cause variations in test results and are quite costly.
The causes of such variations include nonuniform testing protocols, technician experience skills and the precision of the apparatus / analyzer.

Method used

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Examples

Experimental program
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Effect test

example 1

Free Thyroxine (FT4)

[0278] A free thyroxine (FT4) assay has been developed for the above described automated analyzer. The FT4 assay is a competitive binding assay in which FT4 in a test sample competes with labeled T4 (tracer reagent) for a limited amount of T4 antiserum covalently coupled to the solid phase. In the preferred format of this assay acridinium ester is the label and paramagnetic particles serve as the solid phase. A test sample (25 uL.) acridininm ester labeled T4 (100 uL.) and anti-T4 paramagnetic particles (450 uL.) are dispensed by the analyzer into a cuvette and incubated for 7.5 minutes at 37° C. After incubation, magnetic separation and washes are performed as described prior to detection of the chemiluminescent signal. The amount of FT4 present in the test sample is determined by the level of the signed detected and is converted to a dose by a two-point data reduction algorithm.

[0279] The test assay has a sensitivity of 0.107 ng / dL. (minimum detectable dose ...

example 2

Human Chorionic Gonadotropin (hCG)

[0282] A human chorionic gonadotropin (hCG) assay has been developed for the above described automated analyzer. The hCG assay is a sandwich assay which utilizes an antibody-coated capture solid phase and a labeled antibody as a tracer reagent. In the preferred format of this assay acridinium ester is the label on a monoclonal antibody and polyclonal antibody coated paramagnetic particles serve as the capture solid phase. A test sample (50 uL.) and tracer reagent (100 uL.) are dispensed into a cuvette by the analyzer and incubated for 5.0 minutes at 37° C. The capture solid phase reagent (450 uL.) is then added to the cuvette followed by an additional incubation of 2.5 minutes. After the second incubation, magnetic separation and washes are performed as described above prior to detection of the chemiluminescent signal.

[0283] All data presented was generated based on a two-point calibration off a full standard master curve, consisting of ten stand...

example 3

Digoxin

[0287] A digoxin assay has been developed for the above described automated analyzer. The digoxin assay architecture is a hapten solid phase with a labeled antibody (tracer reagent). In the preferred format of this assay, the tracer reagent is an acridinium ester labeled monoclonal anti-digoxin antibody; and the solid phase is paramagnetic particles to which digoxin-apoferritin has been immobilized. A test sample (150 uL.) and tracer reagent (50 uL.) are dispensed into a cuvette by the analyzer and incubated for 2.5 minutes at 37° C. The solid phase reagent (250 uL.) is then added to the cuvette followed by an additional incubation of 5.0 minutes. After the second incubation, magnetic separation and washes are performed as described above prior to detection of the chemiluminescent signal.

[0288] All data presented was generated based upon a two-point recalibration off an original master curve. The master curve was generated using eight standards with valves ranging from zer...

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Abstract

An analyzer for performing automated assay testing. The analyzer includes a storage and conveyor system for conveying cuvettes to an incubation or processing conveyor, a storage and selection system for test sample containers, a storage and selection system for reagent containers, sample and reagent aspirating and dispensing probes, a separation system for separating bound from unbound tracer or labeled reagent, a detection system and date collection / processing system. All of the sub-units of the machine are controlled by a central processing unit to coordinate the activity of all of the subunits of the analyzer. The analyzer is specifically suited for performing heterogeneous binding assay protocols, particularly immunoassays.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. application Ser. No. 10 / 022,405, filed Dec. 13, 2001, titled CUVETTE FOR AN AUTOMATED ANALYZER; which is a continuation of U.S. application Ser. No. 09 / 723,231, filed Nov. 27, 2000 now U.S. Pat. No. 6,498,037, titled AUTOMATED ANALYZER; which is a continuation of U.S. application Ser. No. 09 / 438,628, filed Nov. 12, 1999 now U.S. Pat. No. 6,555,062, titled REAGENT CONTAINER FOR AN AUTOMATED ANALYZER; which is a divisional of U.S. application Ser. No. 09 / 238,309, filed Jan. 28, 1999 now U.S. Pat. No. 6,074,615, titled REAGENT CONTAINER FOR AN AUTOMATED ANALYZER which is a continuation of application Ser. No. 08 / 457,702 filed Jun. 1, 1995 now U.S. Pat. No. 6,063,340, titled REAGENT CONTAINER FOR AN AUTOMATED ANALYZER; which is a divisional of application Ser. No. 08 / 222,559, filed Apr. 1, 1994, titled AUTOMATED ANALYZER; which is a continuation of application Ser. No. 07 / 665,196 filed Mar. 4, 1991...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): B01L3/00G01N21/76G01N35/00G01N35/02G01N35/04G01N35/10
CPCB01L3/508Y10T436/114998G01N21/76G01N35/0098G01N35/021G01N35/025G01N35/04G01N35/1002G01N35/1065G01N2035/00386G01N2035/00396G01N2035/00524G01N2035/00752G01N2035/0441G01N2035/0443G01N2035/0465G01N2035/0486G01N2035/1025Y10T436/115831Y10T436/114165Y10T436/11B01L2300/0854
Inventor CAREY, GLENLEWIS, SCOTT C.
Owner ALUMINUM PECHINEY
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