WO2013064561A1

WO2013064561A1 - Method of sample validation in a biochemical analyser and a biochemical analyser realizing this method

Info

Publication number: WO2013064561A1
Application number: PCT/EP2012/071605
Authority: WO
Inventors: Eric CHARAVEL; Jeanet Randrianarivo
Original assignee: Pz Cormay S.A.
Priority date: 2011-10-31
Filing date: 2012-10-31
Publication date: 2013-05-10
Also published as: PL396830A1

Abstract

The object of the invention is the method of sample validation in a biochemical analyser, in which samples contained in the tubes (5), each of which is marked with an identifier readable by a scanner (3), are arranged in a holder (4), comprising the readout of the said identifier placed on the tube (5) by means of the scanner (3), characterized in that that, behind the holder (4), viewed in the direction of incidence of the light beam (2) of the scanner (3), an additional identifier (1), different from identifiers placed on the tubes (5), is placed. The invention also includes a biochemical analyser realizing this method of sample validation.

Description

Method of Sample Validation in a Biochemical Analyser and a Biochemical Analyser Realizing this Method

The object of the invention is the method of sample validation in a biochemical analyser, in which the samples are placed in the test tubes in a holder, which are marked with an identifier readable by means of a scanner, comprising the readout of the said identifier by means of the scanner. The invention also includes a biochemical analyser realizing this method.

Biochemical analysers are advanced automated devices for testing chemical composition in blood serum and other body fluids (plasma, cerebrospinal fluid, urine). For example, in this manner, the contents of the following is determined in blood serum: glucose, lipids (e.g. cholesterol, triglycerides), enzymes (e.g. amylase, transaminases and phosphatases), ions (e.g. sodium, potassium, lithium), etc.

The central module of the analyser is constituted by a photometer, comprising a light source and a detector, by means of which a colour change of the reaction mixture, placed in a transparent cuvette, can be measured. In a typical, known in the art, analyser, reaction cuvettes are placed on a rotating rack (rotor). In its neighbourhood, there is another rotating rack, which stores reagents used in the test reactions. Special needles and/or automated pipettes collect a portion of the test fluid from the tube to the cuvette and dispense appropriate reagents.

Typically, samples - that is, tubes with fluids intended for tests (e.g. with blood serum, cerebrospinal fluid, other body fluids) are placed in a special holder. Since biochemical analysers are technically very advanced devices, in most cases, they are equipped with suitable automatics, they have a built-in microcomputer or they are normally coupled with a microcomputer. The operator, using a suitable computer program, defines a set of tests to be performed for each sample. Each tube is determined in such a way that the relevant module of the biochemical analyser can read this determination, and, then, on this basis, identify the sample and perform a set of tests assigned to this sample. A suitable set of tests is downloaded from the microcomputer memory on the basis of the read sample identifier. Then, the analyser - usually in an automated way - performs the requested tests. This procedure is called a sample validation. Normally, in the art, tubes are marked with marks readable by means of scanners, especially with one-dimensional (linear) barcodes or with two-dimensional codes. Such marks are read by means of a module equipped with a scanner. Barcodes, readable by standard, well-known in the art scanners, are widespread due to their greatest possible availability, the lowest cost, and simplicity, and the resulting reliability of the readout.

Biochemical analysers constructed in the above-mentioned way and carrying out the above-described test procedure are available in the market, e.g. flexor XL analysers of ELITech), and are subject of numerous patents and patent applications (e.g. JP 8211072 A, JP 10132735 A, JP 2010 33924 A, US 2004 0185549 Al, US 2005 0014274 Al, US 4808380, US 6162399 or US 2007 0065945 Al publications).

Typically, the samples are placed in multi-position holders, i.e. those, into which, at one time, more than one tube can be inserted. This allows the operator to load into the device a few, several or even dozens of samples, and the analyser, after their validation, can operate unattended for long periods, performing the requested tests. Usually, rotating holders in the form of carousels, in which tubes form a circle or circles, are used. Less frequently, linear holders (usually more expensive solution) in which the tubes are arranged in a straight line, in one or several rows, are used. Barcodes placed on the tubes are read by means of the scanner. Such solutions are known, e.g. from the following publications: CN 101806909, EP 0979999 A2, JP 2011 064537 A, US 2007 065945 Al, US 2010 037919 Al or WO 2011 067888 Al . The USA patent application No. US 2005 014274 Al mentions that instead of or in addition to tubes - barcode can also indicate a holder - e.g. to identify a series of samples, as well as to equip the analyser with many modules scanning the barcodes to check and control the movement of the samples along their trajectory in the analyser. On the other hand, application No. US 2011 111522 Al discloses an analyser in which the samples (substantially different than those described here) are applied to special substrates in the form of strips. In these strips, two types of barcodes can be placed - one seen in visible light and read by a standard scanner, and the other - visible in the infrared or UV and read by a spectrometer. Both codes are used to ensure proper automated analysis of samples placed on the substrates by the device. By using two codes that can be placed physically in the same area of the substrate, more of the useful information can be encoded on the substrate.

In a typical case of a multi-position holder all the places in the holder must always be used (i.e. filled with tubes with liquids intended for tests). Additionally, it can happen that the marks of certain tubes, in the case of using one- and two-dimensional codes, may turn out to be unreadable. Such situations are obviously cumbersome and require the presence and intervention of the analyser operator.

It is an essential problem, however, to distinguish between a situation in which, in a given position in the holder, there is a tube with a liquid intended for tests, marked with an unreadable barcode (e.g. a damaged label with a code) and a situation in which, in a given position in the holder, there is simply no tube (and thereby the scanner failed to read the label). It is desirable to distinguish between these two situations automatically and reliably before the beginning of the tests. In another case, it may happen that the sample marked with an unreadable label is taken together with a group of other samples (with the entire holder) to the analyser, the whole test program is executed on the remaining samples, and finally, these samples, together with the sample marked with the unreadable label are returned by the device. Only then does the operator find out that, in the case of one sample, the analysis was not performed due to the unreadable label. This implies the need to repeat the whole procedure for this sample and a significant loss of time. Solutions to this problem known in the art are not satisfactory.

The Japanese patent application No. JP 63098564 A discloses a scanning module mounted in a movable holder. In case the scanner fails to read a barcode placed on the tube - the module can be brought closer to or farther from the label and the readout can be attempted again. The device known from JP 63098564 A can not distinguish between the two situations described above - the lack of sample and the unreadable label on the sample.

According to the US patent application No. US 2010 111765 Al, tubes labeled with barcodes are initially placed on a platform that detects the presence of the tube in a given position, as well as the valid presence of samples in the tube (i.e., a non-empty tube). Labels comprising barcodes, placed on the tubes, are then read out by the scanner. If the readout is successful - the tube is transported to the analyser carousel to perform the tests. The disadvantage of this solution lies in the fact that in the case of a label readout error, the tube will not be transported to the carousel and the test for the given sample will not be performed.

On the other hand, the international application WO 2011008290 A2 discloses a solution, according to which labels with a barcode placed on the tubes are scanned manually by the operator before they are placed in a holder. In the case of a positive label scanning, the operator, every time, defines a test program designed for the sample marked with this label, and then he places such sample in the holder, in a specific position. The holder is equipped with mechanical parts in the form of springs, changing their position in case of removal of the tube from the holder. This allows to detect the removal of the tube from the holder, and the corresponding test program - is removed from the analyser memory. This procedure is not a satisfactory solution to the above-stated problem either.

Therefore, the object of the present invention is to propose a method for sample validation in a biochemical analyser, which allows for simple and reliable distinction between the absence of the sample and the sample marked with an unreadable code, preferably before the beginning of the analysis.

Another object of the invention is to propose a biochemical analyser realizing this method of sample validation.

According to the invention, the method of sample validation in a biochemical analyser, in which the samples contained in the tubes, each of which is marked with an identifier readable by the scanner, are arranged in a holder, comprising the readout of the said identifier placed on the tube by means of the scanner, characterized in that, behind the holder, viewed in the direction of incidence of the light beam of the scanner, an additional identifier, different from the identifiers placed on the tubes, is placed.

Preferably, the said additional identifier is placed on the wall of the biochemical analyser.

Alternatively, preferably, the said additional identifier is placed on the holder, and in particular on a special holder element, such as its rear wall.

Preferably, the said identifier is a one-dimensional (linear) barcode.

Alternatively, preferably, the said identifier is a two-dimensional code, especially a stacked code, e.g. Code49 stacked code or PDF417 stacked code or a matrix code, e.g. Semacode matrix code, MaxiCode matrix code, Aztec Code matrix code or QR matrix code.

The invention also includes a biochemical analyser realizing this method of sample validation. Thanks to the solution according to the invention, a 100% identification of occupied and empty positions in the holder and of the tubes marked with unreadable labels is possible before the beginning of the test cycle. Thanks to the operator being informed in advance (i.e. before the tests, and not after them) about errors in the sample validation - analyser according to the invention provides a much greater speed and efficiency.

The invention will now be further described in a preferred embodiment, with reference to the accompanying drawings, in which:

Figure 1 shows an overall view of the biochemical analyser according to the invention,

Figure 2 shows a drawing of the scanner module and the holder of the biochemical analyser according to the invention,

Figure 3 shows the validation process of the holder with samples according to the invention, and

Figure 4 (a, b, c) illustrates the validation process of samples according to an embodiment of the invention: (a) - readout of the readable barcode on the tube, (b) - an unreadable barcode on the tube, (c) - absence of the tube in a given position of the holder (reading out a barcode in the background).

The following indications were used in the drawings: 1 - embedded barcode placed in the background, 2 - radius of the scanner, 3 - barcode scanner, 4 - holder with the tubes, 5 - tube marked with a barcode, 6 - holder barcode.

Preferred embodiment of the invention

Figure 1 shows an overall view of a preferred embodiment of the biochemical analyser according to the present invention. On the other hand, Figure 2 shows a construction schema of the scanner module and of the biochemical analyser holder according to the invention, and Figure 3 illustrates the validation process of the holder with samples according to the invention, and according to the preferred embodiment of the present invention.

Tubes 5 containing blood serum samples intended for tests are placed in positions of the ten-position holder 4. Some positions of the holder 4 can remain empty. Tubes 5 are marked with labels with linear barcodes. Alternatively, two-dimensional codes may be used, e.g. a stacked code, Semacode, MaxiCode, Aztec Code, QR matrix codes, etc. Behind the holder 4, viewed in the direction of incidence of the light beam 2 of the scanner 3, an additional long label with a barcode 1 is placed. In the discussed case, the label 1 is of the same length as the holder 4, but it can also be longer or shorter, and at least of such a length, so that the barcode 1 placed on it be always situated behind the places in the holder 4 designed for the tubes 5. Moreover, in the discussed case, the label 1 is placed on the analyser housing, but it can also be placed in other places, particularly on the holder 4 which can be provided, for this purpose, with a rear wall. It is important that the barcode, located on the back, be always placed behind the places in the holder designed for the tubes.

As shown in Figure 4a, the tube 5 in the tenth position of the holder 4 is marked with a readable, valid barcode that is read out by the scanner 3. As a result of the valid readout, the sample validation takes place, i.e. in the computer memory connected to the analyser (not shown in the drawing), the test program set for this sample is found and its execution by the analyser begins. The analyser proceeds to the tube validation in a subsequent position in the holder 4.

As shown in Figure 4b, the tube 5 in the tenth position of the holder 4 is marked with an unreadable (damaged) barcode. An attempt to read out the code by the scanner 3 ends with an error. The scanner 3 repeats the attempt to read out the label, then repeats the attempt for the third time. All of the three attempts end with an error. The barcode from the label 1, located on the back, behind the holder 4 is not read out at the same time because it is obscured by a damaged label pasted on the tube 5. The readout error, in relation to not reading out the code 1 located behind the holder 4, means that in the given position of the holder 4, the sample 5 is located, which is marked with an unreadable barcode. The computer connected to the analyser (not shown in the drawing) records this fact and immediately notify the operator about it with an appropriate message. Then, the operator has the possibility of intervention, e.g. by removing the tube 5 from the holder 4 and starting the tests for the other tubes, or by correcting (reprinting) the damaged label, or by a manual validation of the tube in the system, etc.

As shown in Figure 4c, the tenth position of the holder 4 is empty (contains no tube). In this case, the scanner 3 reads correctly the barcode from the label 1 located behind the holder 4, on the analyser housing. Reading out the barcode 1 means that in the given position of the holder 4, there is no tube. The computer connected to the analyser (not shown in the drawing) records this fact, informs the operator about it with an appropriate message and proceeds to the tube validation in a subsequent position in the holder 4.

In the discussed embodiment of the invention, the holder 4 has two parallel rows of holes intended for placing the tubes 5, wherein the holes in the rear row (i.e., farther away from the scanner) are offset relative to the holes in the front row (i.e., closer to the scanner) by a distance equal to the sum of ½ of the tube diameter and ½ of the distance between the tubes 5. Thanks to this, the scanner 3 can read the barcodes located on the tubes 5 in the two rows of the holder 4.

After validation of the entire holder 4 (i.e., validation of all tubes placed in the holder) the first reagents are administered into the cuvettes (not shown in the drawing), then, the temperature stabilization is awaited for and the requested test cycle begins.

Claims

1. A method of sample validation in a biochemical analyser, in which samples contained in the tubes, each of which is marked with an identifier readable by a scanner, are arranged in a holder, comprising the readout of the said identifier placed on the tube by means of the scanner, characterized in that, behind the holder, viewed in the direction of incidence of the light beam 2 of the scanner 3, an additional identifier 1, different from identifiers placed on the tubes 5, is placed.

2. The method according to claim 1, characterized in that, the said additional identifier 1 is placed on the wall of the biochemical analyser.

3. The method according to claim 1, characterized in that, the said additional identifier 1 is placed on the holder 4.

4. The method according to claim 3, characterized in that, the said additional identifier 1 is placed on a special element of the holder 1, preferably on its rear wall.

5. The method according to any one of the preceding claims, characterized in that, the said identifier is constituted by a one-dimensional (linear) barcode.

6. The method according to any one of the preceding claims 1 to 4, characterized in that, the said identifier is constituted by a two-dimensional code.

7. The method according to claim 6, characterized in that, the said identifier is constituted by a stacked code, preferably Code49 stacked code or PDF417 stacked code.

8. The method according to claim 6, characterized in that, the said identifier is constituted by a matrix code, preferably Semacode matrix code, MaxiCode matrix code, Aztec Code matrix code or QR matrix code.

9. The biochemical analyser realizing the method of sample validation according to any one of the preceding claims.