Immunoassay fluorometer

• US 6,830,731 B1
• Filed: 01/05/1998
• Issued: 12/14/2004
• Est. Priority Date: 01/05/1998
• Status: Expired due to Term

• Current Assignee: Quidel Cardiovascular, Inc. (Quidel Corporation)
• Original Assignee: BIOSITE INCORPORATED (Abbott Laboratories Incorporated)
• Inventors: McPherson, Paul H., Anderberg, Joseph M, Buechler, Kenneth F.
• Primary Examiner(s): LUDLOW, JAN M
• Application Number:
  US09/003,090
• Time in Patent Office: 2,535 Days
• Field of Search: 422/67, 422/82.05, 422/82.08, 436/46, 436/50, 364/528.01, 600/300, 702/31
• US Class Current: 422/82.08
• CPC Class Codes: G01N 21/645 Specially adapted constructive features of fluorimeters
• CPC Class Codes: Y10T 436/112499 with sample on test slide
• CPC Class Codes: Y10T 436/115831 Condition or time responsive

Abstract

A fluorometer for sensing the fluorescence of a sample utilizes an optical energy source for exciting a sample to be tested and an optical energy detector for detecting the emitted energy from the excited sample. Drive electronics are used for positioning the sample with respect to the optical components allowing a plurality of sample regions to be tested. A processor is utilized to control the operation of the test in accordance with test instructions and for processing the emitted energy detected from the sample to determine test results. A ROM chip socket accepts a plurality of ROM chips, wherein each ROM chip stores test data sets for one or more test types to be performed. ROM chips can be swapped to allow the fluorometer to be configured and reconfigured to perform a plurality of different tests. A communications interface facilitates the sharing of test information between the fluorometer and external entities.

Claims

1. A fluorometer for taking fluorometric readings of a sample, comprising:

an assay device for carrying the sample to be tested;

an optical energy source for exciting the assay device carrying the sample by irradiating the assay device with optical energy;

an optical energy detector for detecting energy emitted from the excited assay device due to the irradiation;

an encoded label disposed on the assay device to provide encoded sample information relating to the sample carried in the assay device;

an encoder reader for reading the encoded label;

drive electronics for positioning the assay device, with respect to the optical energy source and the optical energy detector, so that at least one of a plurality of assay zones within the sample can be tested;

a processor for controlling the operation of the test in accordance with test instructions and for processing the emitted energy detected from a given zone or plurality of zones in order to determine test results;

a ROM chip socket for accepting at least one of a plurality of ROM chips

at least one ROM chip for insertion into the ROM chip socket, that stores information related to at least one of;

instrument specific operational software for one or more tests;

test specific evaluation curves;

control solution;

calibrator solution;

the accessibility of a user to change fluorometer parameters; and

expected values measured by a QC simulator; and

a bi-directional communications interface for transferring test information between the fluorometer and an external entity.

2. The fluorometer of claim 1, wherein said sample information includes at least one of the group of a patient identification, a sample identification, a sample type, and an identification of a type of test to be performed on the sample.

3. The fluorometer of claim 1, wherein said encoded label includes at least one of the group of an optical bar code, a magnetic stripe, an inductive circuit, and alphanumeric characters.

4. The fluorometer of claim 1, further comprising a power source and wherein said fluorometer is packaged in a hand-held portable case.

5. The fluorometer of claim 1, further comprising a user interface.

6. The fluorometer of claim 1, further comprising a storage device for maintaining a record of one or more samples tested and test results for said one or more samples.

7. The fluorometer of claim 6, wherein said record comprises at least one of the group of patient identification, sample identification, identification of a test performed on said sample, a date and time at which the tests were conducted, and test results.

8. The fluorometer of claim 7, wherein the record is part of the test information exchanged over the bi-directional communication interface.

9. The fluorometer of claim 1, wherein said optical energy source excites said assay with energy at a first wavelength and said optical energy detector senses energy emitted from said assay device at a second wavelength, wherein said first wavelength is different from said second wavelength.

10. The fluorometer of claim 9, wherein said first wavelength is approximately 670 nanometers and said second wavelength is approximately 760 nanometers.

11. The fluorometer of claim 9, further comprising a first filter to cutoff frequencies emitted from said optical energy source which are near said second wavelength, and a second filter to filter frequencies at said first wavelength from being received by said optical energy detector, thereby decreasing the effect of said optical energy source as a source of background for said optical energy detector.

12. The fluorometer of claim 11, wherein said first filter cuts off frequencies at wavelengths longer than approximately 690 nanometers and said second filter cuts off frequencies at wavelengths shorter than approximately 710 nanometers.

13. The fluorometer of claim 1, wherein external entity includes at least one of the group comprised of a hospital, a physician'"'"'s office, a testing clinic, and a laboratory.

14. The fluorometer of claim 13, wherein the test information communicated to the external entity includes at least one of the group of test results, patient identification, sample identification, a date and time at which the tests were conducted, and an identification of the test or tests performed on a sample.

15. The fluorometer of claim 13, wherein information related to at least one of:

instrument specific operational software for one or more tests;

test specific evaluation curves;

control solution;

calibrator solution;

the accessibility of a user to change fluorometer parameters; and

expected values measured by a QC simulator is supplied as the test information communicated from the external entity and used as an alternative to storing the data in the ROM chip.

16. The fluorometer of claim 1, wherein test specific information includes calibration information for one or more tests.

17. The fluorometer of claim 1, wherein control solution information includes concentrations and ranges of analytes and expiration dating of control solutions.

18. The fluorometer of claim 1, wherein calibrator solution information includes concentrations and ranges of analytes and expiration dating of calibrator solutions.

19. The fluorometer of claim 1, wherein information relating to the accessibility of a user to change fluorometer parameters includes information relating to at least one of the group comprised of addition and deletion of user passwords, normal ranges for analytes being measured, frequencies of measuring control solutions, and information relating to the QC simulator.

20. The fluorometer of claim 1, wherein the ROM chip is also used as a storage device for maintaining a record of one or more samples tested and test results for said one or more samples.

21. The fluorometer of claim 1, wherein drive electronics includes a motor to position the assay device, a motor controller to control the motor and a friction drive or gear drive for translating the rotation of the motor into motion of the assay device.

22. The fluorometer of claim 21, wherein the testing can be automated under the control of the processor directing the drive electronics to position the assay device in accordance with operational instructions stored in ROM.

23. The fluorometer of claim 1, wherein the encoder reader automatically reads the encoded label by operating in conjunction with the drive electronics and a position encoder.

24. The fluorometer of claim 1, wherein the fluorometer can be reconfigured, by selection of a new operational software, to test at least one of the group comprised of fecal extract, food product extract, chemical composition, ground extract, environmental sample, and a biological fluid selected from the group consisting of blood, serum, plasma, and urine.