IP Library Granted Patent US 8,425,843
Granted Patent B2
US 8,425,843 · App. 12/373,012 · Granted Apr 23, 2013

Integrated apparatus and method to detect inflammatory states present in a sample of whole blood

Inventors: Alfredo Ciotti (Udine, IT); Paolo Galiano (Padua, IT)
Assignee: Alifax Holding SpA
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Quick Facts
Patent No.
US 8,425,843
App. No.
12/373,012
Granted
Apr 23, 2013
Kind
B2
Abstract

Integrated apparatus and method for hematological analyses, wherein the apparatus, comprises, arranged substantially in line and integrated substantially in a single machine, a device ( 14 ) of the optical type to detect substantially instantaneously the speed of blood sedimentation (ESR) by measuring the optical density, or absorbance, of the blood sample, and a measuring assembly ( 18 ) with a cell-counter function or suchlike.

Claims (33)

1. An integrated apparatus for detecting inflammatory states present in a single sample of whole blood and derived from metabolic damage, physical damage or behavioral damage, the apparatus comprising:

a detection unit to detect the erythrocyte sedimentation rate (ESR) of said sample, in order to obtain a preliminary indication of a possible inflammatory state present in said sample;

a first dispensing unit connected downstream of said detection unit, the first dispending unit comprising a first microvalve suitable to dispense a predetermined amount of said sample at least to a pre-treatment unit suitable to perform a pre-treatment in order to substantially eliminate the content of red corpuscles in at least a part of said sample subjected to detection of the erythrocyte sedimentation rate (ESR);

a second dispensing unit connected downstream to said pre-treatment unit, the second dispensing unit comprising a second microvalve suitable to dispense a predetermined amount of said part of the sample pre-treated in the pre-treatment unit to each of a plurality of reactors of a reaction group for performing at least an immunological and/or coagulative reaction between said predetermined amount of the sample and each of a plurality of latexes dispensed in a predetermined amount to each of the reactors by a third dispensing unit, each of said latexes being suitably sensitized so as to cause said immunological and/or coagulative reaction,

wherein the plurality of reactors includes a reactor for reacting a portion of said predetermined amount of the sample pre-treated in the pre-treatment unit and one of the latexes comprising an anti C-reactive protein antibody, and another reactor for reacting another portion of said predetermined amount of the sample pre-treated in the pre-treatment unit and another one of the latexes sensitized to detect a rheumatic factor; and

an optical device able to measure the kinetics of said immunological and/or coagulative reaction, indicative of said inflammatory states present in said sample.

2. The apparatus as in claim 1 , wherein said first dispensing unit comprises a first photometric sensing device suitable to detect the volume of said predetermined amount of the sample.

3. The apparatus as in claim 1 , wherein said second dispensing unit comprises a second photometric sensing device suitable to detect a dispensed volume of said predetermined amount of said sample pre-treated in the pre-treatment unit.

4. The apparatus as in claim 1 , wherein said third dispensing unit comprises a third microvalve suitable to dispense the predetermined amount of each of the latexes and a third photometric sensing device suitable to detect a dispensed volume of said predetermined amount of each of the latexes.

5. The apparatus as in claim 1 , further comprising a command and control unit at least suitable to coordinate a functioning of the second dispensing unit and of the third dispensing unit in order to maintain a value of a ratio of a dispensed predetermined amount of the sample pre-treated in the pre-treatment unit to a dispensed predetermined amount of the latex in a determined range, correlated to a kind of the immunological and/or coagulative reaction.

6. The apparatus as in claim 1 , wherein said pre-treatment unit comprises a lysis reactor able to achieve a lysis reaction of a part of said sample in order to obtain a lysed sample.

7. The apparatus as in claim 1 , wherein said pre-treatment unit comprises a centrifuge device able to centrifuge a part of said sample in order to obtain a centrifuged sample wherein the red corpuscles are separated from the whole blood.

8. The apparatus as in claim 1 , wherein said detection unit is also able to measure the equivalent hematocrit factor of said sample.

9. The apparatus as in claim 1 , further comprising a coagulation reactor of the reaction group able to perform at least a coagulation reaction between a part of said sample and a coagulation reagent.

10. The apparatus as in claim 9 , wherein the third dispensing unit is also able to dispense a predetermined amount of the coagulation reagent to the coagulation reactor, a command and control unit being able to maintain a ratio of said part of said sample or a dispensed predetermined amount of the sample pre-treated in the pre-treatment unit to a dispensed predetermined amount of the coagulation reagent in a determined range, correlated to the coagulation reaction.

11. The apparatus as in claim 1 , wherein said reaction group comprises an additional reactor for reacting an additional portion of said predetermined amount of the sample pre-treated in the pre-treatment unit and an additional one of the latexes comprising streptolysin “O”.

12. The apparatus as in claim 1 , wherein said reaction group comprises a fourth reactor, in which a fourth reaction is able to occur between a fourth portion of said predetermined amount of the sample pre-treated in the pre-treatment unit and a fourth latex comprising an anti-fibrinogen antibody, to measure the content of fibrinogen in said sample.

13. The apparatus as in claim 9 , wherein said reaction group comprises another reactor, in which a reaction is able to occur between a portion of said sample or a portion of said predetermined amount of the sample pre-treated in the pre-treatment unit and said coagulation reagent.

14. The apparatus as in claim 5 , wherein the command and control unit is also able to command and control said detection unit and said reaction group.

15. The apparatus as in claim 1 , wherein the optical device comprises a photometer having a measurement cell with an optical path comprised between about 0.4 mm and 0.9 mm.

16. A method for detecting inflammatory states present in a single sample of whole blood and derived from metabolic damage, physical damage or behavioral damage, the method comprising the steps of:

measuring a value of an erythrocyte sedimentation rate (ESR) of said sample, in order to obtain a preliminary indication of a possible inflammatory state present in said single sample;

producing a pre-treated sample by subjecting to a pre-treatment, in a pre-treatment unit, a part of said single sample subjected to measurement of the value of the erythrocyte sedimentation rate (ESR) in order to substantially eliminate a content of red corpuscles, wherein a predetermined amount of said single sample subjected to measurement of the value of the erythrocyte sedimentation rate (ESR) is dispensed to the pre-treatment unit by using a first dispensing unit comprising a microvalve suitable to dispense said predetermined amount of said sample subjected to measurement of the value of the erythrocyte sedimentation rate (ESR) to the pre-treatment unit;

performing an immunological and/or a coagulative reactions between a predetermined amount of the pre-treated sample and a plurality of latexes, by using a plurality of reactors of a reaction group, wherein portions of the predetermined amount of the pre-treated sample is dispensed to each of the reactors by using a second dispensing unit comprising a second microvalve suitable to dispense said portions of the predetermined amount of the pre-treated sample to each of the reactors, and wherein each of the latexes is dispensed by using a third dispensing unit, wherein the performing step includes reacting in one of the reactors one of the portions of the predetermined amount and one of the latexes comprising an anti C-reactive protein antibody, and reacting in another one of the reactors another one of the portions of the predetermined amount and another one of the latexes sensitized to detect a rheumatic factor; and

measuring at least the kinetics of said reaction, indicative of said inflammatory states present in said sample.

17. The method as in claim 16 , further comprising:

measuring a value of an equivalent hematocrit factor of said sample, wherein the pre-treatment includes a lysis reaction step of a part of said sample in order to obtain a lysed sample; and

correcting a measurement of a kinetics of said reaction performed with a portion of the lysed sample, by said equivalent hematocrit factor.

18. The method as in claim 16 , wherein the pre-treatment includes a centrifuge step in order to obtain a centrifuged sample wherein the red corpuscles are separated from the whole blood.

19. The method as in claim 16 , further comprising:

performing at least a coagulation reaction between a part of said sample or a portion of the sample pre-treated in the pre-treatment unit and a coagulation reagent, by using a coagulation reactor of the reaction group, wherein a predetermined amount of the coagulation reagent is dispensed by using the third dispensing unit.

20. The method as in claim 16 , further comprising: maintaining a ratio of a dispensed predetermined amount of the sample pre-treated in the pre-treatment unit to a dispensed volume of each of the latexes in a determined range, correlated to a kind of the immunological and/or coagulative reaction, by using a command and control unit.

21. The method as in claim 20 , further comprising: maintaining a ratio of said part of said sample or said portion of the sample pre-treated in the pre-treatment unit to a dispensed predetermined amount of a coagulation reagent in a determined range, correlated to a coagulation reaction, by using the command and control unit.

Assignments (3)
CORRECTIVE ASSIGNMENT TO CORRECT THE CONVEYANCE TYPE PREVIOUSLY RECORDED AT REEL: 045609 FRAME: 0310. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT Recorded Apr 26, 2018
From: ALIFAX HOLDING SPA
To: ALIFAX S.R.L.
Reel/Frame 046022/0763 →
CHANGE OF NAME Recorded Mar 16, 2018
From: ALIFAX HOLDING SPA
To: ALIFAX S.R.L.
Reel/Frame 045609/0310 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 8, 2009
From: CIOTTI, ALFREDO; GALIANO, PAOLO
To: ALIFAX HOLDING SPA
Reel/Frame 022087/0929 →
Priority Claims (1)
IT UD06A0177 · Jul 14, 2006 · national
Continuity (1)
Related Publication 20090311736A1 · Dec 17, 2009