MXPA06000787A - Quality control device for a blood analyser using whole blood - Google Patents

Abstract

The invention relates to a quality control device for a blood analyser using whole blood. More specifically, the invention relates to a device which can be used to check the correct operation of a blood analyser (9). The inventive device comprises:means (1, 5) for storing control bloods by means of cooling;means for bringing the control bloods back to the temperature specified by the control blood manufacturer;stirring means (1, 12, 13, 14, 16, 17) which are used for the resuspension of the cells;and means for sampling (7) the blood thus prepared. The invention is suitable for use with blood analysers.

Description

QUALITY CONTROL DEVICE FOR A BLOOD ANALYZER USING WHOLE BLOOD DESCRIPTIVE MEMORY The invention relates to intended hematological analyzers for automatically analyzing samples of blood products. It relates more particularly to a quality control device for a blood analyzer than to whole blood. The term "analyzer" will be used below to indicate any apparatus capable of carrying out analyzes from a tube of blood, serum, plasma or urine. The expression "whole blood analyzer" - will be used to measure an analyzer that carries out analyzes on whole blood, that is to say that it contains all the elements of the blood, in contrast to analyzers that operate with plasma or serum. The term "quality control" is used to indicate a procedure that consists of verifying at least daily that the analyzer is working properly before carrying out examinations on patients.

The expression "low, high or normal control blood" is used to indicate blood whose values are selected rather low, high or normal. The intended control bloods for the analyzers are usually presented in a "bottle" or "tube" form and are proposed with low, normal and high values to monitor the instrument on the scale of its measuring capacity. The rules of passage of control blood depend on the legislation. Generally, it is necessary to go through the normal level, plus a low or high level at least once a day. In certain cases, and in particular for devices that operate night and day, it is necessary to pass at least once the normal level when there is a change of operator. If we refer to the NCCLS standard H38-P paragraph 5.7.2, the authors refer to the paramount importance of agitation in the quality control method, in particular in relation to the agitation time and the way of stirring the blood. of control. The official recommendations show that a better control of preanalytical tools is very important for the relevance of quality control. Storage of control blood is carried out by the refrigeration at the temperature recommended by the supplier to guarantee the expiration date provided by the supplier. They should have reset the room temperature and then mix thoroughly before going through the analyzer. The restoration to the temperature is an important factor in the good functioning of the quality control. The control blood is supplied with results sheets given for each level of each blood and for each parameter that is to be obtained from the target value and acceptable limits or tolerances. The expiration date as well as the maximum number of samples taken from the same control blood tube are also given by the manufacturer and should be carefully observed. The results obtained when analyzing blood control should be filed by the laboratory. Frequently they are presented in the form of graphics known as "Levey Jennings" to simplify their interpretation. The procedure of passing blood control in the laboratory consists of fixing the analyzer in operation if necessary, removing blood from control of a refrigerator, leaving the blood in a drainage panel for several minutes to adopt the room temperature, shake the Check bloods carefully, pass the bloods through the analyzer, check if the results are within the limits given by the manufacturer and place again the bloods in the refrigerator. In the process, the expiration date must be verified each time and the maximum number of successive uses of the same tube or vial must be observed.

The same procedure is necessary for the use of a device that operates night and day in an emergency service or intensive care or even in the field of a dispensary of a doctor located outside the hospital, which requires the operator to remove the blood from the refrigerator and carry out the procedure described above. In the field of uses given above, operators are often not well qualified and trained to reproduce the regulatory control procedures necessary for analyzer monitoring. An important phase in the quality control procedure is to place the quality control back in suspension which requires devices designed to carry out the regular and non-aggressive agitation of the bottles. In particular, from US 2002 / 0118594A1, a stirring device is known to have an electromagnet and a small rod contained in the bottle. The movement of the electromagnet causes the rod contained in the bottle to move and cause agitation in the form of a vortex of blood in a bottle. Apart from the fact that this device requires manual operations to be incorporated into a quality control procedure, the agitation principle it implements has a number of associated risks in terms of cells that can be damaged during agitation. In addition to WO 08501797A1, a stirring device is known which operates when oscillating and which is found in particular in the automatic devices of the company Beckman Coulter. In this device, cassettes containing the control tubes are loaded horizontally on a conveyor belt subjected to an oscillatory movement that allows agitation of the blood. Also known from US 5 110 743 is a stirring device that operates by inversion, which consists of a disk that can receive tubes. The disk is composed of two subunits that can start spinning independently of one another. One disk is used for agitation and the other for storage. The processes of agitation using oscillation and inversion can be retained as a principle of agitation for quality control. In no case the patents cited above describe the use of these agitation principles for an integrated quality control function as described in the present application. Numerous patents describe the composition of quality control and place it in the main qualities of stability and for monitoring methods. This applies, for example, to US Patents 5 529 933, US 6 403 377 and US 6 448 085. However, none of the patents describe a method of stirring or passing quality control tubes with which it is possible to reproduce in an optimal way the agitation and storage of the samples of quality control in the analyzer. Given the importance of quality control both in the legislative context and in the context of ensuring the quality of analyzes returned to patients, one of the purposes of the invention is to incorporate quality control into the analyzers and make the process fully automatic to eliminate errors related to the handling. Having been completely released from quality control, the operator can give full attention to the results of the patients. The quality control procedure can then be carried out by the analyzer that performs it automatically, only the frequency of quality controls and the number and selection of control blood levels being programmable by the operator. This object is achieved by the invention proposing an automatic quality control device incorporated in a blood analyzer that operates with whole blood. In order to carry out a quality control to verify the correct functioning of the analyzer, the device according to the invention comprises storage means by cooling the control blood, means for putting the control blood back at the temperature prescribed by the manufacturer of blood control, agitation means for the resuspension of cells and blood sample media thus prepared. In accordance with a first characteristic, the control blood storage means comprise a specified number of tubes closed with a stopper and arranged on a support in contact with the cooling block to regulate the temperature and maintain an optimum temperature for storage of the control blood. In the invention, the cooling of control blood and restoration to the temperature of this form essential operations to achieve quality control under optimal conditions. Conveniently, the cooling block is a cooling block which operates through the Peltier effect which makes it possible to control the temperature of the block by means of electronic control means. It will be remembered that such a block is supplied with electric current and allows precise control of the temperature. It is also sparsely bulky, which favors its incorporation into an analyzer. However, the invention is not limited to the use of a Peltier effect cooling block, and other types of cooling blocks are conceivable within the scope of the present invention. To restore the temperature, several solutions are proposed. First and regardless of the type of cooling block used, the tube holder can be disconnected from the cooling block to restore the temperature of the control blood. In the case of a Peltier cooling block, the current that supplies the cooling block of the Peltier block can be interrupted for a specified period to reset the control bloods to the temperature. The interruption of the current causes a rise in the temperature of the cooling block to the ambient value.

Even in the case of a Peltier effect cooling block, another solution consists of a command to restore and maintain quality control at its operating temperature in accordance with the manufacturer's specifications. Then the Peltier effect is used in reverse to cause heat instead of cooling. The stirring means are preferably agitation means operating by oscillation and / or inversion formed by the tube holder, articulated around a joint of the cooling block. Preferably, the inversion angle is between 100 ° and 180 °. According to a second feature, the blood sampling means are formed by a needle capable of drawing blood from the tubes. The needle is operated by a transversal movement on the blood tubes to be analyzed and blood control as well as on rinsing and mixing tanks and by a vertical movement to penetrate the tubes when piercing the plugs or down to the rinsing and mixing tanks to carry out the rinsing or dilutions of the blood. The perforation of the plugs is carried out when the tubes in their support are in a high and / or high position. The device conveniently comprises programmable processing means for verifying that the values obtained when running each quality control correspond to the limit values and the expected values of the control blood.

The processing means triggers an alarm if the values obtained during the quality control step are out of expected limits. The device further comprises means for driving the quality control procedure either directly by an operator or automatically or by an external connection to a control center. The transfer and analysis of the data is carried out via an internal or external network that implements the currently valid standards, among which HL7, ASTM and XML can be cited. The tubes preferably comprise means for identification and tracking by bar codes, electronic microcircuits and / or magnetic labels. The application of the device according to the invention to whole blood analyzers is novel. It requires the incorporation of storage media for the control and mixing blood and shows from the sample in the analyzer. In another aspect, the invention relates to a blood analyzer comprising a device as defined above. In the description which follows, which is offered by way of example, reference is made to the accompanying drawings, which show: Figure 1, a view in perspective of a tube holder in contact with a cooling block according to the invention.

Figure 2, a view showing the displacement of the support for the tubes in Figure 1 in their agitation movement; Figures 3A and 3B are respectively perspective and front elevation views of a quality control device incorporated in an analyzer operating with whole blood according to the invention; Figure 4 is a diagram illustrating the modes of operation of the quality control device according to the invention; and Figure 5 is a diagram illustrating in the form of a flow chart the process of interpretation and validation of the results obtained by the device according to the invention. The tube holder having the shape of a rectangular parallelepiped, numbered 1 in FIG. 1, comprises three cylindrical housings with longitudinal axes parallel to each other and in which three control blood tubes 2, 3, 4 are arranged. sealed by plugs 2a, 3a, 4a. The tubes 2, 3, 4 that store control blood are cooled through the support 2 by means of a cooling block 5. The blood contained in the tubes 2, 3, 4 can correspond to low, normal and high control levels but it is It is conceivable that you find two or three identical levels or that only one level is used. The cooling block 5 in the form of a rectangular parallelepiped is in close contact via one of its faces 5a with a face 1a opposite the tube support 1 when the quality control is not in use; that is, in the resting position, to maintain the blood at the temperature recommended by the supplier. Conveniently, the block 5 can be a cooling block that operates in accordance with the principle of the Peltier effect, with which it is possible to control the block temperature by means of electronic regulation that is not shown, the reheating of the tubes takes place for example at interrupting the current that passes through the cooling block. However, any other cooling method can also be used. Thus, it is also possible to use the Peltier effect in reverse to cause heating of the tubes and thereby the restoration of the temperature of the control blood. The tube holder 1 is formed from a metal or any other material that conducts heat so that it can quickly assume the temperature of the cooling block and thereby adjust the temperature of the control bloods to the same temperature as the block temperature. refrigeration. As shown in figure 2, in which the elements corresponding to those of figure 1 are shown with the same references, the agitation of the blood is carried out by repeatedly inverting the tubes 2, 3, 4 around a joint 12, arranged substantially horizontally, from an elevated position for which the tubes are oriented vertically with the plugs 2a, 3a, 4a in an upper to lower position for which the blood tubes 2, 3, 4 are oriented vertically but which have your plugs 2a, 3a, 4a in the background and vice versa. The inversion angle a can be any and can be, for example, between 100 ° and 180 °. The mechanical means that allow this movement are within the reach of the person skilled in the art and are not shown. The reciprocating movement shown by the double arrow 6 is repeated several times to obtain agitation of the blood in accordance with the specifications given by the control blood supplier. In this preferred embodiment, it is obviously possible to take a sample of the blood with the tube in the raised position by sampling means represented by a needle 8 or with the tube in the low position by sample means represented by a needle 7. It can also be It can be seen that a rapid restoration of the control blood temperature can be achieved by disconnecting the tube support 1 from the cooling block 5 by rotation through the angle α around the joint 12. This solution can also be applied to cooling blocks that do not operate by the Peltier effect Now we refer to Figures 3A and 3B which show an example of a quality control device incorporated in an instrument for analyzing whole blood 9. The example relates to a cell counter of the type described by example in the patent FR 97 13503 registered in the name of the applicant.The control device comprises a block of sopo rte and tube 1 in contact with a Peltier effect cooling block 2, a sampling needle 7 and a counting block 10 comprising mixing and rinsing tanks (not shown). Also shown in Figure 3A and 3B is the electricity supply block of the analysis instrument 9. The tube support block 1 is driven in rotation about the hinge shaft 12 which is coupled to a motor 13 via a reduction gear formed by an impulse pulley 14 connected to the motor shaft 13 and via a guided pulley 16 which is connected to the articulation shaft 12, the guided pulley 16 being driven by the impulse pulley 14 via a belt 17. The needle of Sampling that is connected to a carriage 18 that moves in translation on two rails 19 that allows it to move in horizontal movement represented by the two arrows 20, successively on the blood of patients to be analyzed, the blood control contained in the tubes 4, 5, 6 and then the counting block 10 comprising the mixing and rinsing tanks. The displacement of the carriage 18 can be effected by any known means, which is not shown, such as for example a stepped electric motor, incorporated in the carriage 18 controlled by a microprocessor. The sampling needle 7 is also operated in a vertical movement represented by the double arrow 21 which allows it to be lowered into the tubes 2, 3, 4 to sample blood or be lowered in the control block 10 comprising the rinsing and mixing tanks 10 to carry out the rinsing or dilution of the blood. The movement of the needle 7 can be effected by an electric stepped-type motor, which is not shown, suitable for example to a rack supporting the needle 7. An access door not shown allows the control tubes to be replaced when these They are empty or reach their expiration date. The arrangement of the control blood tubes is not limited only to the representation in Figures 3A and 3B, in which the agitation means shown is only provided as an example. One can also use low speed vortex stirring means, those which use oscillation and / or inversion of the tubes, of the types cited in the prior art, by adapting air cooling means when necessary for storage and temperature restoration. of the tubes. The sampling means may make it necessary to have a sampling sample that operates with the inverted tube, that is, with the plug in the lower position. This is also common with analyzers that use a sampling valve. The rotation of all the quality controls in the agitator allow the two puncture configurations, being possible to puncture by moving the needle 7 towards the quality control, or by moving part or all the devices linked to the quality control towards the needle 7. As can be seen in Figure 4, the execution of quality control can be done in three different ways. It can be executed either by means of an operator or automatically by means of a programmable automaton 22 subsequent to the programming which makes it possible, for example, to execute quality control in the morning or at night, or by means of a console 23 via an intranet or Internet 24 network implementing example the network technologies known under the designations HL7, ASTM and XML to allow a central laboratory, of which the whole blood analyzer depends, to execute the quality control procedure. These three execution modules are handled via a unit 25 that enables to operate the quality control mode. The algorithm shown by steps 26 to 33 of the flow chart in Figure 5 makes it easier to interpret and validate the results and generate alarms if the quality control is defective. The procedure initiates step 26 with the launch of the control sequence, which involves the restoration to temperature and agitation of the quality control. The next step 27 shows the measurement and analysis stage. In step 28 a comparison is made between the results of the analysis and the expected values of the quality control. If the results are not correct, they are not validated and stage 29 allows recording data, temporarily stopping the analyzer 9 and triggering an alarm in stage 30. If in stage 28 the results of the analysis are correct, the results are recorded in step 31 and in accordance with a test performed on connection means in step 32, the results are sent to a server via external connection functions 33.

In this procedure, the identification and tracking of the blood being examined is performed by any means of identification known as a bar code, electronic microcircuit and / or magnetic label that accompanies the tubes.

Claims (18)

NOVELTY OF THE INVENTION CLAIMS

1. - Quality control device for a blood analyzer (9) using whole blood, where it comprises means (1, 5) of storage by means of refrigeration for control blood, means (1, 5) to re-establish at blood temperature control at the temperature prescribed by the manufacturer of the control blood, agitation means (1, 12, 13, 14, 16, 17) for the resuspension of the cells and sampling means (7) of the blood thus prepared, which make it possible to incorporate the device into the blood analyzer.

2. The device according to claim 1, further characterized in that the storage means (1, 5) of control bloods comprise a specified number of tubes (2, 3, 4) sealed by a plug (2a, 3a, 4a,) and arranged in a support (1) in contact with a cooling block (5) that makes it possible to adjust the temperature and maintain an optimum temperature for storing the control blood.

3. The device according to claim 2, further characterized in that the cooling block (5) is a cooling block Peltier effect.

4. The device according to any of claims 2 or 3, further characterized in that the tube support (1) is disconnected from the cooling block (5) to restore the temperature of the control blood.

5. The device according to claim 3, further characterized in that the current supplied by the Peltier effect cooling block (5) is interrupted during a specified period for restoration of the temperature of the control blood.

6. The device according to claim 3, further characterized in that the Peltier effect cooling block (5) is controlled to restore and maintain the quality control at its use temperature in accordance with the manufacturer's specifications.

7. The device according to one of the claims 1 to 6, further characterized in that the stirring means (1, 12, 13, 14, 16, 17) are agitation means that operate by oscillation and / or inversion formed by the tube support (1) articulated around a joint (12) of the cooling block (2).

8. The device according to claim 7, further characterized in that the inversion angle of the inversion means is between 100 ° and 180 °.

9. The device according to one of the claims 1 to 6, further characterized in that the stirring means are low speed vortex stirring means.

10. - The device according to one of claims 1 to 9, further characterized in that the blood sampling means are formed by a needle (7) capable of drawing blood from the tubes.

11. The device according to claim 10, further characterized in that the needle (7) is driven in a transverse movement on the blood tubes to be analyzed and the blood control (2, 3, 4) as well as on a counting block (10) comprising mixing and rinsing tanks and in a vertical movement to penetrate the tubes when piercing the plugs or when descending in the counting block (10) comprising mixing and rinsing tanks to carry out rinsing or blood dilutions.

12. The device according to claim 11, further characterized in that the puncture of the plugs (2a, 3a, 4a) is performed when the tubes in its support (1) are in a high or low position.

13. The device according to one of claims 1 to 12, further characterized in that it comprises programmable processing means (25, ..., 33) to verify that the values obtained when passing through each quality control correspond to the limit values and the expected values of the control blood.

14. The device according to claim 13, further characterized in that the processing means triggers an alarm (30) if the values obtained during the run of the quality control are outside the expected limits.

15. The device according to one of claims 1 to 14, further characterized in that it comprises means (23) for firing the quality control procedure either directly by an operator or automatically (22) or via an external connection to a control unit (25).

16. The device according to one of claims 1 to 15, further characterized in that the transfer of data analysis is carried out via an internal or external network that implements the currently valid standards, among which can be cited HL7, ASTM and XML.

17. The device according to one of claims 2 to 16, further characterized in that the tubes (2, 3, 4) have identification and tracking means by means of bar codes, electronic microcircuits and / or magnetic label.

18. Blood analyzer comprising a device according to one of claims 1 to 17, incorporated in the analyzer.