Analyzer throughput featuring through-the-tip analysis

• US 6,013,528 A
• Filed: 07/14/1998
• Issued: 01/11/2000
• Est. Priority Date: 03/11/1997
• Status: Expired due to Term

• Current Assignee: Eastman Kodak Company
• Original Assignee: Ortho-Clinical Diagnostics Incorporated (The Carlyle Group LP (Corporate Private Equity))
• Inventors: Shaw, James David, Freeman, Davis III, Samsoondar, James, Jacobs, Merrit Nyles, Moffett, Thomas
• Primary Examiner(s): Le, Long V.
• Application Number:
  US09/115,366
• Time in Patent Office: 546 Days
• Field of Search: 422/63, 422/64, 422/67, 422/81, 422/82.05, 422/100, 436/43, 436/46, 436/47, 436/49, 436/50, 436/54, 436/164, 436/165, 436/171, 436/174, 436/180, 356/319, 356/320, 356/334, 356/244, 356/326, 356/328, 364/498
• US Class Current: 436/54
• CPC Class Codes: G01N 2035/0432 integrated with measuring devices
• CPC Class Codes: G01N 2035/0434 in the form of a syringe or pipette tip
• CPC Class Codes: G01N 21/03 Cuvette constructions
• CPC Class Codes: G01N 21/11 Filling or emptying of cuvettes
• CPC Class Codes: G01N 21/13 Moving of cuvettes or solid samples to or from the investigating station handling materials for automatic analysis G01N35/00
• CPC Class Codes: G01N 21/359 using near infrared light
• CPC Class Codes: Y10T 436/112499 with sample on test slide
• CPC Class Codes: Y10T 436/119163 with aspirator of claimed structure
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

Apparatus and method for detecting patient sample quality, and/or analytes, in the tip used to aspirate the patient sample liquid and then dispense it onto a slide test element. Spectrophotometric analysis is done on the liquid while still in the tip, by scanning the tip for transmittance in a light-tight enclosure, using NIR and adjacent visible radiation, and detecting the absorbance spectra of the liquid. Thereafter, or prior thereto, the liquid is dispensed onto a dried slide test element for assaying analytes that are not assayed spectrophotometrically, thus enhancing throughput.

Claims

1. A method for improving throughput in a clinical analyzer, said analyzer comprising a dispensing station and at least one test station for detecting a target substance in a patient sample, said dispensing station comprising:

an aspirator probe;

a disposable tip mounted on said probe, for collecting a biological sample liquid from a primary collection container and for dispensing at least a portion of the collected liquid onto or into a test element, said tip comprising an upper mounting portion for mounting on said probe, an exit orifice opposite said mounting portion for taking in and dispensing liquid into and out of, respectively, the tip, and a conical shape extending between said mounting portion and said orifice; and

means for creating a partial pressure or partial vacuum within said probe and said tip;

the method comprising the steps of;

a) aspirating a biological liquid into one of said tips mounted on said probe;

b) while the liquid is within said tip and said tip is on said probe, detecting one or more target substances in said liquid by transmitting light of near infrared and adjacent visible radiation wavelengths at multiple wavelengths through a conical portion of said tip and spectrophotometrically analyzing at said wavelengths the portion of the light transmitted through said tip, by correlating said transmitted light with the concentration of one or more target substances in the liquid, said correlating including the step of calculating a first derivative of the absorbance value as a function of wavelength;

c) dispensing a portion of the liquid from the tip onto a test element; and

d) testing at said test station, said test element plus liquid, for target substances other than said one or more target substances;

so that throughput is increased by the amount of time not required to test said one or more target substances at said test station.

2. A method as defined in claim 1, wherein said liquid is selected from the group consisting of serum, plasma, urine and cerebral spinal fluid and is free of reagent.

3. A method as defined in claim 1, wherein step b) occurs after steps c) and d).

4. A method as defined in claim 1, wherein said step b) comprises transmitting said light through said tip in more than one pass.

5. A method as defined in claim 1, wherein said tip comprises a wide portion and a narrower portion, and said step b) comprises the step of b'"'"') transmitting light through said narrower portion of said tip.

6. A method as defined in claim 5, wherein said step b'"'"') comprises moving said tip within a light-tight enclosure comprising an NIR and adjacent visible radiation emitter, so that the light transmitted by said emitter is directed through only said narrower portion.

7. A method as defined in claim 6, wherein said moving of said step b'"'"') comprises the steps of lowering said tip into a light-tight enclosure comprising an NIR and adjacent visible radiation emitter until said tip is seated therein, scanning said tip and its contents with NIR and adjacent visible radiation emitted from said emitter, and if the contents have a density above a predetermined threshold value, thereafter raising said tip within said enclosure until said emitter is positioned to scan said narrower portion of said tip.

8. A method as defined in claim 1, wherein the target substance is hemoglobin, and wherein said correlating step allows hemoglobin values that are detected, to cover the entire range of from zero to about 35 g/L.

9. A method as defined in claim 8, wherein said correlating step allowing said range of coverage comprises the use of two calibration algorithms, one from zero to about 3 g/L, and the other from 3 to about 35 g/L.

10. A method as defined in claim 9, wherein said other algorithm determines the natural logarithm of hemoglobin from first derivative values of absorbance taken with respect to wavelength.

11. A method as defined in claim 10, wherein said two algorithms comprise the following equations:

For hemoglobin in the range of zero to about

space="preserve" listing-type="equation">500 mg/dL, Hb(g/L)=-75.96(dA.sub.593 /dλ

.sub.593)+81.45(dA.sub.608 /dλ

.sub.608))-0.22;

and

For hemoglobin in the range of about 500 to about 2000 mg/dL,

space="preserve" listing-type="equation">Hb(in g/L)=e.sup.[-14.587(dA.sbsp.593.sup./d.sbsp.λ

593.sup.)-20.458(dA.sbsp.608 .sup./dλ

.sbsp.608.sup.)+0.181].