TW201719157A - In-vitro diagnostic testpiece and method for in-vitro diagnostic testpiece - Google Patents

Abstract

An in-vitro diagnostic testpiece and a method for in-vitro diagnostic testpiece are disclosed herein, in which the in-vitro diagnostic testpiece includes a testpiece body and an identification unit. The identification unit is disposed on the testpiece body. The testpiece body is configured to contain an analyte for an examination instrument to test the analyte and generate a testing result of the analyte. The identification unit is configured to receive and store the testing result form the examination instrument through the radio frequency identification technology.

Description

In vitro test strips and methods for in vitro test strips law

The present invention is an inspection technique, and particularly relates to an in vitro test strip and a method for in vitro test strips.

In recent years, the In-Vitro Diagnostic (IVD) method has been widely used in the medical field. The common method is to place the object to be tested in a disposable test piece, and then test the object to be tested through the instrument. Presented on paper or stored in a computer host. When the medical staff wants to provide the test results to the testee, they need to use paper or read the test results in the computer host. Whether it is a separate paper or a computer inquiry process, the operation time and burden of medical personnel are increased.

In order to increase the convenience of providing In-Vitro Diagnostic (IVD) results, an aspect of the present disclosure is to provide an in vitro test strip comprising a test strip body and a recognition unit, The other unit is disposed on the test strip body. The test piece body is used for accommodating the object to be analyzed, and the test instrument is used to inspect the object to be analyzed, so that the test instrument produces the test result of the object to be analyzed. The identification unit is configured to receive and store the inspection result from the inspection instrument through radio frequency identification (RFID) technology.

In an embodiment of the present disclosure, the verification result of the identification unit is read by the radio frequency identification technology through the electronic device and stored in the electronic device.

In one embodiment of the present disclosure, wherein the inspection instrument performs an analysis procedure on the analyte to generate an inspection result, the inspection instrument writes an error message to the identification unit when an error occurs in the analysis program.

In an embodiment of the present disclosure, the identification unit stores manufacturing information of the in vitro test strip. The information writing device is used to update manufacturing information through radio frequency identification technology.

In one embodiment of the present disclosure, wherein the identification unit continuously records the ambient temperature of the environment in which the test strip is in vitro.

Another aspect of the present disclosure is to provide a method for testing a test piece in vitro comprising the following steps. The test result is generated according to the analyte. The test results are written and stored in the identification unit of the in vitro test strip by radio frequency identification technology.

In an embodiment of the present disclosure, the method further includes: reading and storing the verification result by using a radio frequency identification technology.

In an embodiment of the present disclosure, the method further includes: performing an analysis program on the analyte to generate a test result. When an error occurs in the analysis program, Write an error message to the identification unit via the inspection instrument.

In an embodiment of the present disclosure, the method further includes: updating, by the writing device, the manufacturing information stored in the identification unit by using a radio frequency identification technology.

In an embodiment of the present disclosure, the method further comprises: continuously recording, by the identification unit, an ambient temperature of an environment in which the test strip is in vitro.

In summary, the disclosure is to store the test result of the analyte in an in vitro test sample for accommodating the analyte, thereby reducing the complexity of the analyte and the test result query, and reducing the analyte and the analyte. The possibility that the test results do not match. In addition, the identification unit of the present disclosure records the accuracy of the environmental temperature improvement test result, and the error code stored in the identification unit also provides information about the failure of the analysis program for further analysis.

The above description will be described in detail in the following embodiments, and further explanation of the technical solutions of the present disclosure is provided.

The above and other objects, features, advantages and embodiments of the present disclosure will become more apparent and understood.

100,200‧‧‧ in vitro test strips

110‧‧‧Slice body

120, 220‧‧‧ identification unit

130‧‧‧Testing instruments

240‧‧‧Information writing device

250‧‧‧Electronic devices

300‧‧‧Methods for in vitro test strips

S302~S304‧‧‧Steps

The above and other objects, features, advantages and embodiments of the present disclosure will become more apparent and understood. 2 is a schematic view showing an in vitro test strip of an embodiment of the present disclosure; and FIG. 3 is a flow chart showing a method for in vitro test strips according to an embodiment of the present disclosure.

To make the description of the present disclosure more detailed and complete, reference is made to the drawings and the various embodiments described below. The examples are not intended to limit the scope of the invention; the description of the steps is not intended to limit the order of execution thereof, and any device having equal efficiency resulting from recombination is covered by the present invention. range.

In the scope of the embodiments and claims, "one" and "the" may mean a single or plural unless the context specifically dictates the articles.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic illustration of an In-Vitro Diagnostic (IVD) test strip 100 in accordance with an embodiment of the present disclosure. The extracorporeal test strip 100 includes a strip body 110 and an identification unit 120. The test strip body 110 is for accommodating the analyte (for example, blood, urine), and the test instrument 130 checks the analyte. The identification unit 120 is disposed on the test strip body 110.

In practice, the test strip body 110 has a receiving groove for receiving the object to be analyzed, and the shape appearance of the test piece body 110 and the receiving groove is designed according to the inspection category and the inspection instrument 130. For example, to accommodate the centrifugal device within the inspection instrument 130, the test strip body 110 can be designed as a disk or a fan. The identification unit 120 may be a Radio Frequency Identification (RFID) tag. The above-described inspection instrument 130 has a function of radio frequency identification reading and/or writing.

In operation, when a user (such as a medical professional) wants to perform an examination of the analyte, the analyte can be placed in the specimen body 110 and loaded into the inspection instrument 130. Then, the user can operate the inspection instrument 130 to The analysis procedure of the analyte is performed, and when the in vitro test strip 100 carrying the analyte is subjected to the analysis procedure of the test instrument 130, the test apparatus 130 produces the test result. The inspection instrument 130 writes the inspection result to the identification unit 120 via the radio frequency identification technology. In other words, the identification unit 120 receives and stores the verification result from the inspection instrument 130 via the radio frequency identification technology.

In this way, the test result of the analyte is stored on the in vitro test strip 100 containing the analyte. Therefore, the test result of the analyte can be saved and transmitted together with the analyte. Compared with the prior art that saves the test results in paper form or stored in a computer device and is stored separately from the analyte, the present disclosure can reduce the complexity of the analyte and test result query, and also reduce the analyte and test. The result is a mismatch.

In an embodiment, when the inspection instrument 130 performs an error in the analysis program (eg, too much or too little analyte, the test piece is repeatedly used), the verification instrument 130 writes a corresponding error message (eg, an error code) to the identification unit 220. . In this way, different users can use the electronic device to read the error message of the identification unit 220 through the radio frequency identification technology to further understand the information of the analysis program.

Figure 2 is a schematic diagram showing an in vitro test strip 200 of an embodiment of the present disclosure. The in vitro test strip 200 architecture is substantially identical to the in vitro test strip 100 except that the identification unit 220 can interact with the information writing device 240 and the electronic device 250.

The user (eg, medical personnel, test subject) can operate the electronic device 250 to read the test result in the identification unit 220 through the radio frequency identification technology, and the electronic device 250 can also store the test result. In this way, use The electronic device 250 only needs to read the test result of the analyte, and saves the trouble of additionally saving the paper or inquiring the computer device. The electronic device 250 can be a cell phone, a tablet or other electronic device with a radio frequency identification reading function.

In another embodiment, the identification unit 220 of the in vitro test strip 200 can store manufacturing information of the in vitro test strip 200. For example, manufacturing dates, inspection items, or other manufacturer-defined information. When the manufacturer wants to change the information originally stored in the identification unit 220, the manufacturer can update the manufacturing information in the identification unit 220 by the radio frequency identification technology through the information writing device 240. In one embodiment, a user (eg, a manufacturer) can use the information writing device 240 to transmit a single radio frequency signal to update manufacturing information in one or more of the identification units 220. The above information writing device 240 may be an electronic device having a radio frequency identification writing function.

In order to improve the safety of the in vitro test strip 200, in another embodiment, the manufacturer can write a unique identification code into the recognition unit 220 via the information writing device 240. When the user loads the in vitro test strip 200 on the detecting instrument 130 for the analysis program, the testing instrument 130 checks the identification code of the identifying unit 220 to determine whether or not to perform the analyzing program. For example, the inspection instrument 130 checks the identification code of the identification unit 220 and determines that the identification code matches the identification code in the list, and the verification instrument 130 continues to execute the analysis program. On the other hand, if the inspection apparatus 130 checks the identification code of the identification unit 220 and determines that the identification code does not coincide with the identification code in the list, the inspection apparatus 130 stops the analysis program and writes the corresponding error message in the identification unit 220.

In an embodiment, the test strip body of the test strip 200 is tested in vitro The test substance is contained in 110, and the test substance (for example, an enzyme) is used to assist the test instrument 130 in performing an analysis procedure of the analyte, and must be stored in a special temperature (for example, 2 to 8 degrees Celsius (° C.)). The identification unit 220 can continuously record the ambient temperature at which the test strip 200 is in vitro. When the user uses the in vitro test strip 200 to analyze the analyte, the assay instrument 130 can read the temperature information recorded in the identification unit 220 and select appropriate parameters to optimize the analysis procedure to produce the correct test results. For example, when the in vitro test strip 200 is at a temperature other than the above-described special temperature environment, the inspection apparatus 130 reads the temperature history recorded by the identification unit 220, and judges the temperature value of the in vitro test strip 200 leaving the appropriate storage environment and continues. time. Next, the inspection instrument 130 appropriately adjusts the parameters of the analysis program to correct the situation in which the in vitro test strip 200 leaves the storage environment while maintaining the accuracy of the test result. Alternatively, when the inspection instrument 130 determines that the temperature value and duration of the in vitro test strip 200 leaving the appropriate storage environment will seriously affect the accuracy of the test result, the test apparatus 130 stops the analysis program and writes a corresponding error message to the identification unit. Within 220.

3 is a flow chart showing a method 300 for in vitro test strips in accordance with an embodiment of the present disclosure. The method 300 for in vitro test strips has a plurality of steps S302-S304 that can be applied to the in vitro test strips 100, 200 as described in Figures 1 and 2. Those skilled in the art should understand that the steps mentioned in this embodiment can be adjusted according to actual needs, and can be performed simultaneously or partially simultaneously, unless the order is specifically stated. The specific implementation manner is as disclosed above, and will not be repeatedly described herein.

In step S302, a test result is generated according to the analyte.

In step S304, the verification result is written and stored in the identification unit of the in vitro test strip by the radio frequency identification technology.

Through the above embodiments, the present disclosure can store the test result of the analyte in an in vitro test sample for accommodating the analyte, thereby reducing the complexity of the sample to be analyzed and the query result, and reducing the analyte and the test. The result is a mismatch. In addition, the identification unit of the present disclosure records the accuracy of the environmental temperature improvement test result, and the error message stored in the identification unit also provides information about the failure of the analysis program for further analysis.

Although the present disclosure has been disclosed in the above embodiments, it is not intended to limit the invention, and the present invention may be modified and retouched without departing from the spirit and scope of the present disclosure. The scope of protection is subject to the definition of the scope of patent application.

100‧‧‧In vitro test strips

110‧‧‧Slice body

120‧‧‧ Identification unit

130‧‧‧Testing instruments

Claims (10)

An in vitro test strip comprising: a test strip body for accommodating an analyte to be tested, for a test instrument to inspect the analyte, such that the test apparatus produces a test result of the analyte; and a recognition unit And being disposed on the test strip body for receiving and storing the test result from the inspection instrument through radio frequency identification technology. The in vitro test strip according to claim 1, wherein the test result of the identification unit is read by an RFID device and stored in the electronic device. The in vitro test strip according to claim 1, wherein the test apparatus performs an analysis program on the analyte to generate the test result, and when the analysis program has an error, the test instrument writes an error message to the identification. unit. The in vitro test strip according to claim 1, wherein the identification unit stores manufacturing information of one of the in vitro test strips, and an information writing device is configured to update the manufacturing information by radio frequency identification technology. The in vitro test strip of claim 1, wherein the identification unit continuously records an ambient temperature of an environment in which the in vitro test strip is placed. A method for testing a test piece in vitro comprises: generating a test result according to an analyte; and writing and storing the test result to one of the in vitro test pieces by a radio frequency identification technology. The method of claim 6, further comprising: reading and storing the verification result by radio frequency identification technology through an electronic device. The method of claim 6, further comprising: performing an analysis procedure on the analyte to generate the inspection result; and writing an error message to the identification unit through the inspection instrument when an error occurs in the analysis program. The method of claim 6, further comprising: updating the manufacturing information stored in the identification unit by the radio frequency identification technology through a writing device. The method of claim 6, further comprising: continuously recording, by the identification unit, an ambient temperature of an environment in which the in vitro test strip is located.