CN109709324B - Detection method and detection device with compensation function - Google Patents
Detection method and detection device with compensation function Download PDFInfo
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- CN109709324B CN109709324B CN201811197588.9A CN201811197588A CN109709324B CN 109709324 B CN109709324 B CN 109709324B CN 201811197588 A CN201811197588 A CN 201811197588A CN 109709324 B CN109709324 B CN 109709324B
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Abstract
A detection method and a detection device with compensation function are provided, the detection method comprises the following steps. A first trigger command is provided to define a first time point after adding a sample to the first cartridge. Detecting the initial position of the reaction area of the first cassette, and defining a second time point when a first light sensing signal greater than or equal to a preset value is obtained. And obtaining a second light sensing signal from the color generation band of the reaction area after a preset time. The time difference between the first time point and the second time point is calculated as a first residence time. And obtaining a compensation value in the lookup table according to the first retention time and the second optical sensing signal, and compensating the second optical sensing signal by the compensation value.
Description
Technical Field
The present invention relates to a detection method and a detection apparatus, and more particularly, to a detection method and a detection apparatus having a compensation function.
Background
The lateral flow assay (lateral flow assay) technology is convenient to use and mature in process technology, and is widely applied to rapid test (rapid test) products. The lateral flow test paper is mainly formed by alternately attaching a sample pad, a colloidal gold pad, a nitrocellulose membrane and an absorption pad, and can be matched with a cassette, and all the layers of materials are fixed to form a sample port so that a user can conveniently add a test object. When the detection sample is added into the sample port of the cartridge, the detection sample flows on the lateral flow test paper and flows to the nitrocellulose membrane to react with the nitrocellulose membrane to generate different color changes, so that a user can know the detection state of the sample specimen through the color changes.
However, the flowing speed of the test sample in the test cassette affects the reaction result between the test sample and the nitrocellulose membrane, so that the detection state of the sample specimen is affected and misjudged. Therefore, how to effectively improve the accuracy of the test will become the key point of technical improvement for each manufacturer.
Disclosure of Invention
The invention provides a detection method and a detection device with a compensation function, so that the accuracy of the test is improved, and the probability of detection misjudgment is reduced.
The invention provides a detection method with a compensation function, which comprises the following steps. A first trigger command is provided to define a first time point after adding a sample to the first cartridge. Detecting the initial position of the reaction area of the first cassette, and defining a second time point when a first light sensing signal greater than or equal to a preset value is obtained. And obtaining a second light sensing signal from the color generation band of the reaction area after a preset time. The time difference between the first time point and the second time point is calculated as a first residence time. And obtaining a compensation value in the lookup table according to the first retention time and the second optical sensing signal, and compensating the second optical sensing signal by the compensation value.
The invention also provides a detection device with a compensation function, which comprises a first cassette, a trigger unit, a light source unit, a sensing unit and a processing unit. The first cassette is configured for loading a sample such that the sample flows laterally to a reaction area of the first cassette. The trigger unit is configured to generate a first trigger command after the sample is loaded into the first cassette. The light source unit provides light beams to irradiate the reaction area. The sensing unit is configured corresponding to the reaction area, when the sample flows to the initial position of the reaction area, the sensing unit detects the initial position to generate a first light sensing signal, when the sample enters the reaction area from the initial position for a preset time, a colored band is generated in the reaction area, and the sensing unit detects the colored band to generate a second light sensing signal. The processing unit is coupled with the triggering unit, the light source unit and the sensing unit. The processing unit receives the second light sensing signal, obtains a compensation value from the lookup table according to the first retention time and the second light sensing signal, and compensates the second light sensing signal by the compensation value.
The invention discloses a detection method and a detection device with a compensation function, wherein a sample is added into a first cassette, and the initial position and the color band of a reaction area of the first cassette are sensed to generate a first light sensing signal and a second light sensing signal. Then, a first time point is defined according to the first trigger command, a second time point is defined when the first light sensing signal is greater than or equal to a preset value, and a time difference between the first time point and the second time point is calculated to serve as a first retention time. And then, acquiring a corresponding compensation value in the lookup table according to the first retention time and the second optical sensing signal so as to compensate the second optical sensing signal. Therefore, the test data generated by the first cassette is more accurate, so as to reduce the probability of detection misjudgment.
Drawings
Fig. 1A is a schematic diagram of a detection apparatus with compensation function according to an embodiment of the invention.
Fig. 1B is a schematic diagram of a detection apparatus with compensation function according to another embodiment of the invention.
Fig. 1C is a schematic diagram of a detection apparatus with compensation function according to another embodiment of the invention.
Fig. 1D is a schematic diagram of a detection apparatus with compensation function according to another embodiment of the invention.
FIG. 1E is a waveform diagram of a first photo-sensing signal according to an embodiment of the invention.
FIG. 1F is a timing diagram illustrating an operation of a detecting device with compensation function according to an embodiment of the present invention.
Fig. 2A is a schematic diagram of a detection apparatus with compensation function according to another embodiment of the invention.
Fig. 2B is a schematic diagram illustrating a correspondence relationship between the difference value and the second retention time according to an embodiment of the invention.
Fig. 2C is a diagram illustrating a relationship between an interval of the photo sensing signal, a slope of the compensation curve, and an intercept of the compensation curve according to an embodiment of the invention.
Fig. 3 is a flowchart of a detection method with compensation function according to an embodiment of the invention.
Fig. 4 is a flowchart of a detection method with compensation function according to another embodiment of the invention.
Fig. 5 is a flowchart of a detection method with compensation function according to another embodiment of the invention.
Fig. 6 is a detailed flowchart of step S510 of fig. 5.
Fig. 7 is a flowchart of a detection method with compensation function according to another embodiment of the invention.
Description of reference numerals:
100: testing device with compensation function
110: the first cassette
111: reaction zone
112: starting position
113: in the form of a colored tape
114: test strip
115: quality control band
120: test strip
130: upper clamping box
131: sample adding opening
132: a first alignment hole
133: first detection window
140: lower cassette
141: second alignment hole
142: second detection window
150: trigger unit
160: light source unit
170: sensing unit
180: processing unit
190: mobile unit
210_1 to 210_ N: second cassette
211_1 to 211_ N: reaction zone
212_1 to 212_ N: starting position
213_1 to 213_ N: in the form of a colored tape
S11, S12, S21: curve line
T0, T1, T2, T3: point in time
T12: first residence time
T23: predetermined time
S302, S304, S306, S308, S310, S402, S404, S406, S408, S410, S412, S414, S416, S418, S502, S504, S506, S508, S510, S602, S604, S606, S702, S704, S706, S708, S710, S712, S714, S716, S718: step (ii) of
Detailed Description
In each of the embodiments listed below, the same or similar elements or components will be denoted by the same reference numerals.
Fig. 1A is a schematic diagram of a detection apparatus with compensation function according to an embodiment of the invention. Fig. 1B is a schematic diagram of a detection apparatus with compensation function according to another embodiment of the invention. Referring to fig. 1 and fig. 2, the detecting device 100 with compensation function includes a first cassette 110, a triggering unit 150, a light source unit 160, a sensing unit 170 and a processing unit 180. The processing unit 180 is coupled to the triggering unit 150, the light source unit 160 and the sensing unit 170.
The first cassette 110 is configured for adding a sample. Wherein, the sample is introduced into the first cassette 110 and flows laterally to the reaction region 111 (shown by the diagonal lines) of the first cassette 110. In the present embodiment, the first cartridge 110 is, for example, a lateral flow assay (lateral flow assay) test cartridge, and can be used for detecting physiological metabolites or pathogens such as cardiac troponin I (cardiac troponin-I) or Luteinizing Hormone (Luteinizing Hormone). The sample includes, for example, blood, urine, or other liquid specimen.
In addition, the reaction region 111 includes, for example, a nitrocellulose membrane, and the analyte (antigen) in the sample is firstly combined with the colloidal gold-detection antibody complex (colloidal gold-detection antibody conjugation) in the colloidal gold pad of the first cassette 110, and then flows along the reaction region 111 and is combined with the capture antibody (capture antibody) on at least two color bands 113 (e.g., the test band 114 and the quality control band 115) in an aggregation manner, so as to show a color change, so as to perform the detection.
The trigger unit 150 is configured to generate a first trigger command after the sample is loaded into the first cassette 110. In the embodiment, the trigger unit 150 is disposed on the housing of the testing device 100, and after the first cassette 110 is inserted into the testing device 100 and a sample is loaded, a user can press the trigger unit 150, such as a button (not shown), to generate a first trigger command.
In some embodiments, the trigger unit 150 is, for example, a physical sensor, and the trigger unit 150 may be disposed in the housing of the testing device 100, when a user adds a sample to the first cassette 110 and holds the first cassette 110 on a tray, and the tray enters a specific position in the housing of the testing device 100 along a slide rail (not shown) to touch and press the trigger unit 150, the trigger unit 150 generates a first trigger command.
In some embodiments, the trigger unit 150 is, for example, a sensor, and the trigger unit 150 may be disposed at a sample adding position (not shown) of the first cassette 110. After the first cassette 110 is inserted into the testing device 100 and a sample is added, the trigger unit 150 may sense the sample to generate a first trigger command.
The light source unit 160 provides a light beam, and the light beam irradiates at least the start position 112 and the color band 113 of the reaction region 111 of the first cassette 110. In the present embodiment, the light source unit 160 is, for example, a light emitting diode or other light emitting device.
The sensing unit 170 is disposed corresponding to the reaction area 111 of the first cassette 110, and senses a light transmitting state or a light reflecting state of the start position 112 and the color generation band 113 to obtain a first light sensing signal and a second light sensing signal. In the present embodiment, the light source unit 160 and the sensing unit 170 may be disposed in a transmissive manner, that is, the sensing unit 170 is disposed opposite to the light source unit 160. In other words, the light source unit 160 and the sensing unit 170 are respectively disposed on the front and back sides of the first cassette 110. When the light beam provided by the light source unit 160 penetrates the reaction region 111, it reaches the sensing unit 170 located on the opposite side of the first cassette 110 to generate a first light sensing signal and a second light sensing signal.
In some embodiments, the light source unit 160 and the sensing unit 170 may be disposed in a reflective manner, as shown in fig. 1C or fig. 1D, that is, the light source unit 160 and the sensing unit 170 may be disposed on the same side of the first cassette 110. When the light beam provided by the light source unit 160 irradiates the reaction region 111 and is reflected to the sensing unit 170, a first light sensing signal and a second light sensing signal are generated. In addition, the sensing unit 170 is, for example, a photodiode or other light-receiving device.
The processing unit 180 is coupled to the triggering unit 150, the light source unit 160 and the sensing unit 170, and receives the first triggering command, the first light sensing signal and the second light sensing signal. The processing unit 180 defines a first time point T1 (shown as a time point T1 in fig. 1E) according to the first trigger command. And, when the first light sensing signal is greater than or equal to the preset value, the processing unit 180 defines a second time point T2 (time point T2 shown in fig. 1E), and calculates a time difference between the first time point T1 and the second time point T2 as the first retention time. That is, when the processing unit 180 receives the first light sensing signal, the processing unit 180 compares the first light sensing signal with a preset value to determine whether the sample flows to the start position 112 of the reaction region 111. In the present embodiment, the range of the default value is, for example, 2500-2800mV, and the default value can be adjusted according to different detection devices, cartridges or other environmental conditions.
For example, after the detection apparatus 100 is turned on, the light source unit 160 and the sensing unit 170 are aligned with the predetermined position of the start position 112 of the first cassette 110, and after the processing unit 180 receives the first trigger command and defines the first time point T1, the sensing unit 170 continuously detects the first light sensing signal of the start position 112. Between the first time point T1 and the second time point T2, since the sample has not flowed to the start position 112, the nitrocellulose membrane at the start position 112 remains dry and has low transmittance, and the first photo-sensing signal sensed by the sensing unit 170 is very low, for example, about 1100-. Accordingly, when the first photo sensing signal is smaller than the predetermined value, it indicates that the first photo sensing signal is not greatly increased, that is, the transmittance of the start position 112 is not greatly increased, the processing unit 180 determines that the sample does not flow to the start position 112, and the processing unit 180 does not define the second time point T2 and continuously receives the first photo sensing signal.
When the first photo sensing signal is equal to or greater than the predetermined value, indicating that the first photo sensing signal is greatly increased, i.e. the transmittance of the initial position 112 is greatly increased, the processing unit 180 determines that the sample has flowed to the initial position 112 and defines a second time point T2.
Next, the processing unit 180 subtracts the first time point T1 (i.e., T2-T1) from the second time point T2, for example, to obtain a first retention time, wherein the first retention time represents the time when the sample is added to the first cassette 110 and flows to the starting position 112 of the reaction region 111.
Then, the processing unit 180 obtains a compensation value from the look-up table according to the first retention time and the second light sensing signal, and compensates the second light sensing signal by the compensation value. Therefore, the test data generated by the first cassette 110 can be more accurate, so as to reduce the probability of detection misjudgment.
In the present embodiment, the first cassette 110 includes a test strip 120, an upper cassette 130, and a lower cassette 140. The test strip 120 has a reaction region 111, and the reaction region 111 has a color ribbon 113, and the color ribbon 113 includes a test ribbon 114 and a quality control ribbon 115. Test strip 120 is, for example, a lateral flow test strip.
The upper cassette 130 is disposed at one side of the test strip 120, and has a sample loading opening 131, a first alignment hole 132 and a first detection window 133. The sample addition opening 131 is used for adding a sample. The first alignment hole 132 exposes the starting position 112 of the reaction region 111, so that the light beam can be irradiated from the alignment hole 132 to the starting position 112. The first detection window 133 exposes at least the color generation band 113 of the reaction region 111. The first alignment hole 132 is located between the sample application opening 131 and the first detection window 133.
The lower cassette 140 is disposed at the other side of the test strip 120, and in some embodiments, if the lower cassette 140 is a penetration test device, the lower cassette 140 has a second alignment hole 141 and a second test window 142, wherein the position of the second alignment hole 141 corresponds to the position of the first alignment hole 132, and the position of the second test window 142 corresponds to the position of the first test window 133. Accordingly, the light beam can be irradiated from the first aligning hole 132 through the start position 112 and then through the second aligning hole 141 to the sensing unit 170.
In some embodiments, the light source unit 160 and the sensing unit 170 are disposed on a side of the upper cassette 130 opposite to the test strip 120, that is, the light source unit 160 and the sensing unit 170 are disposed on the same side, as shown in fig. 1C. In this embodiment, the lower cassette 140 may not have the second alignment hole 141 and the second inspection window 142.
In some embodiments, the light source unit 160 and the sensing unit 170 are disposed on a side of the lower cassette 140 opposite to the test strip 120, that is, the light source unit 160 and the sensing unit 170 are disposed on the same side, as shown in fig. 1D. Also, in this embodiment, the upper cassette 130 may not have the first alignment hole 132 and the first inspection window 133.
In some embodiments, the light source unit 160 is disposed on one side of the upper cassette 130 opposite to the test strip 120, and the sensing unit 170 is disposed on one side of the lower cassette 140 opposite to the test strip 120, that is, the light source unit 160 and the sensing unit 170 are disposed on two opposite sides of the first cassette 110, as shown in fig. 1A and 1B.
In addition, the detection apparatus 100 with compensation function further includes a moving unit 190, as shown in fig. 1A and 1B. The moving unit 190 is coupled to the light source unit 160, the sensing unit 170 and the processing unit 180. In some embodiments, when the detection apparatus 100 is powered on, before the first trigger command is generated, the processing unit 180 controls the moving unit 190 to move the light source unit 160 and the sensing unit 170 to the initial position 112, so that the light beam of the light source unit 160 irradiates the initial position 112 and the sensing unit 170 can sense the light transmittance state of the initial position 112 to generate the first light sensing signal.
In the embodiment, after a predetermined time elapses from the second time point T2, the processing unit 180 controls the sensing unit 170 to generate the second light sensing signal from the color generation band 113 of the reaction region 111, where the predetermined time is, for example, 5 to 20 minutes, but the invention is not limited thereto, so that the analyte of the sample enters the reaction region 111 to perform an immunoreaction to generate a color band (color ban). In the transmissive detection apparatus, after a predetermined time elapses from the second time point T2, the processing unit 180 controls the moving unit 190 to make the light source unit 160, the sensing unit 170 and the first cassette 110 perform relative movement scanning, so that the light beam of the light source unit 160 irradiates the reaction region 111 containing the color ribbon 113, and controls the sensing unit 170 to sense the light transmission state of the color ribbon 113 to generate the second light sensing signal.
In some embodiments, the processing unit 180 controls the moving unit 190 to move the light source unit 160 and the sensing unit 170 to the color band 113 after waiting for a predetermined time, so as to obtain the second light sensing signal.
In the embodiment, the sensing unit 170 continuously detects the first light sensing signal at the initial position 112 of the reaction region 111 within a predetermined time after the second time point T2, and the processing unit 180 continuously compares the first light sensing signal with a predetermined value within the predetermined time to monitor whether the sample in the first cassette 110 is abnormal. If the detection is misaligned due to a sample abnormality such as hemolysis of the blood sample, the transmittance of the light at the starting position 112 after the second time point T2 may decrease, and the obtained first light sensing signal may decrease, as shown in the curve of S12. If the first light sensing signal is smaller than the preset value, the processing unit 180 may send out an abnormal message to let the user know, and may stop the subsequent detection apparatus 100 or not use the second light sensing signal corresponding to the first light sensing signal.
When the first light sensing signal is continuously greater than or equal to the predetermined value within the predetermined time, as shown in a curve S11 shown in fig. 1E, it indicates that the sample has no abnormal phenomenon, and the processing unit 180 uses a subsequent second light sensing signal corresponding to the first light sensing signal. That is, when the first light sensing signal shows that the sample has no abnormal phenomenon, the processing unit 180 uses the second light sensing signal corresponding to the first light sensing signal, and searches the compensation value in the lookup table for the second light sensing signal with the second light sensing signal and the corresponding first retention time, so as to compensate the second light sensing signal by using the compensation value.
FIG. 1F is a timing diagram illustrating an operation of a detecting device with compensation function according to an embodiment of the present invention. Referring to fig. 1F, at a time point T0, the first cassette 110 is loaded into the detecting device 100 and is turned on. After the sample is loaded into the first cassette 110, the trigger unit 150 generates a first trigger command, so that the processing unit 180 defines a first time point (i.e., time point T1) according to the generation time of the first trigger command.
When the first light sensing signal generated by the sensing unit 170 is greater than the predetermined value, the processing unit 180 defines a second time point (i.e., time point T2) according to a time when the first light sensing signal is greater than the predetermined value. Also, the processing unit 180 sets a time between the first time point (i.e., the time point T1) and the second time point (i.e., the time point T2) as the first residence time T12.
At a time point T3 when a predetermined time T23 passes at the time point T2, the sensing unit 170 senses the reaction region 111 including the colored band 113 to generate a second photo sensing signal, and provides the second photo sensing signal to the processing unit 180. The predetermined time is, for example, the reaction time of the sample in the reaction region 111 including the color bar 113, and the time point T3 is the reaction termination time of the sample.
Further, how the look-up table is created, a plurality of cassettes may be tested by a sample standard. The testing device 100 with compensation function further includes a plurality of second cassettes 210_ 1-210 _ N, wherein N is a positive integer greater than 1, as shown in FIG. 2A. The second cassettes 210_ 1-210 _ N are configured to be loaded with a sample, and the sample flows laterally in the second cassettes 210_ 1-210 _ N and flows to the reaction regions 211_ 1-211 _ N of the second cassettes 210_ 1-210 _ N.
The second cassettes 210_1 to 210_ N are the same cassettes as the first cassette 110, for example, the reaction regions 211_1 to 211_ N are the same as the reaction region 111, the start positions 212_1 to 212_ N are the same as the start position 112, and the color bands 213_1 to 213_ N are the same as the color band 113. Moreover, the structures, internal elements, and the arrangement manners of the second cassettes 210_1 to 210_ N are the same as those of the first cassette 110 in fig. 1A, 1B, 1C, and 1D, and reference may be made to the description of the embodiments in fig. 1A, 1B, 1C, and 1D, so that no further description is provided herein. In addition, the operation timings of the second cassettes 210_1 to 210_ N can also refer to the description of the embodiment of FIG. 1F, and therefore are not described herein again.
In addition, the trigger unit 150 further generates a plurality of second trigger commands after the time when the sample is added to the second cassettes 210_ 1-210 _ N. The light source unit 160 provides light beams to irradiate the initial positions 212_ 1-212 _ N and the color bands 213_ 1-213 _ N of the reaction areas 211_ 1-211 _ N of the second cassettes 210_ 1-210 _ N.
The sensing unit 170 further senses the start positions 212_1 to 212_ N and the light transmitting states or the light reflecting states of the color bands 213_1 to 213_ N to generate a plurality of third light sensing signals and a plurality of fourth light sensing signals. For example, when the sample flows to the start positions 212_1 to 212_ N, the sensing unit 170 further detects the light transmitting state or the light reflecting state of the start positions 212_1 to 212_ N to generate a plurality of third light sensing signals. When the sample enters the reaction regions 211_1 to 211_ N for a predetermined time from the initial positions 212_1 to 212_ N, the color bands 213_1 to 213_ N are generated in the reaction regions 211_1 to 211_ N, and the sensing unit 170 further detects the color bands 213_1 to 213_ N to generate a plurality of fourth photo sensing signals.
The processing unit 180 further defines a plurality of third time points according to receiving a plurality of second trigger commands. The processing unit 180 further receives a third light sensing signal, and when the third light sensing signal is greater than or equal to a preset value, a plurality of fourth time points are defined, and a time difference between the third time point and the fourth time points is calculated as a plurality of second retention times. That is, when the processing unit 180 receives the third light sensing signal, the processing unit 180 compares the third light sensing signal with a preset value to determine whether the sample flows to the start positions 212_1 to 212_ N.
For example, when the third photo sensing signal is smaller than the predetermined value, it indicates that the third photo sensing signal is not greatly increased, i.e., the transmittance of the start positions 212_1 to 212_ N is not greatly increased, the processing unit 180 determines that the sample does not flow to the start positions 212_1 to 212_ N, and the processing unit 180 does not define the generation of the fourth time point and continuously receives the third photo sensing signal of the start positions 212_1 to 212_ N.
When the third photo sensing signal is greater than or equal to the predetermined value, it indicates that the third photo sensing signal is greatly increased, i.e., the transmittance at the initial positions 212_1 to 212_ N is greatly increased, and the processing unit 180 determines that the sample has flowed to the initial positions 212_1 to 212_ N to define a fourth time point.
Then, the processing unit 180 subtracts the third time points from the fourth time points to obtain second retention times, wherein the second retention times represent the time when the sample is loaded into the second cassettes 210_1 to 210_ N and flows to the start positions 212_1 to 212_ N of the reaction regions 211_1 to 211_ N, respectively.
Then, the processing unit 180 calculates the slopes and intercepts of the plurality of compensation curves according to the second retention time and the signal value of the fourth light sensing signal to establish a lookup table. In this way, the processing unit 180 can find the corresponding compensation value according to the slope and intercept of the compensation curve of the lookup table, so as to compensate the signal value of the second optical sensing signal corresponding to the first cassette 110 by using the compensation value, so that the test data generated by the first cassette 110 is more accurate, and the probability of detection misjudgment is reduced.
In addition, after the processing unit 180 obtains the plurality of fourth light sensing signals, the processing unit 180 calculates an average value according to the plurality of fourth light sensing signals. For example, the processing unit 180 adds the signal values of the N fourth light sensing signals to obtain a total value, and divides the total value by the number N of the fourth light sensing signals to calculate an average value.
Then, the processing unit 180 generates a plurality of difference values according to the fourth photo sensing signals and the average value. For example, the processing unit 180 subtracts the average value from the signal value of the fourth light sensing signal to generate the difference value. Then, the processing unit 180 generates a compensation curve according to the corresponding relationship between the difference value and the second retention time, as shown in fig. 2B. For example, the processing unit 180 performs a linear regression calculation on the difference value and the second retention time to generate a compensation curve y ═ ax + b. And, the processing unit 180 uses the slope and intercept of the compensation curve to build a look-up table. In some embodiments, the processing unit 180 divides the average value by the fourth light sensing signals to generate a plurality of difference coefficients. Then, the processing unit 180 generates another compensation curve according to the corresponding relationship between the difference coefficient and the second retention time, and can also establish a lookup table.
In an embodiment, when the detection apparatus 100 is powered on, before the second trigger command is generated, the processing unit 180 further controls the moving unit 190 to move the light source unit 160 and the sensing unit 170 to the initial positions 212_1 to 212_ N, so that the light beams are irradiated on the initial positions 212_1 to 212_ N and the light-transmitting states of the sensing initial positions 212_1 to 212_ N to generate the third light sensing signal.
After a predetermined time elapses from the fourth time point, the processing unit 180 further controls the moving unit 190 to move the light source unit 160 and the sensing unit 170 to the color generation bands 213_1 to 213_ N, so that the light beams are irradiated on the color generation bands 213_1 to 213_ N and the light transmission states of the color generation bands 213_1 to 213_ N are sensed to generate a fourth light sensing signal. Wherein the predetermined time is, for example, 5 to 20 minutes, but the present invention is not limited thereto.
That is, when the processing unit 180 defines the fourth time point, the processing unit 180 waits for a predetermined time, and then controls the moving unit 190 to move the light source unit 160 and the sensing unit 170 to the color bands 213_1 to 213_ N, so as to obtain the fourth photo sensing signal.
In addition, in the embodiment, within a predetermined time after the fourth time point, the processing unit 180 continuously compares the third photo sensing signals at the start positions 212_1 to 212_ N with a predetermined value to determine whether the samples in the second cassettes 210_1 to 210_ N have an abnormal phenomenon, such as abnormal or contaminated samples. When any one of the third light sensing signals is smaller than the preset value, the processing unit 180 generates abnormal information indicating that an abnormal phenomenon occurs in the sample, i.e., indicating that the transmittances of the color bands 213_1 to 213_ N are also abnormal. In this case, the fourth light sensing signal corresponding to the third light sensing signal is not used, so as to avoid affecting the establishment of the compensation curve of the lookup table.
When the third light sensing signal is continuously greater than or equal to the preset value within the preset time, it indicates that the sample has no abnormal phenomenon, and the processing unit 180 uses the subsequent fourth light sensing signal corresponding to the third light sensing signal. Then, the processing unit 180 uses the fourth light sensing signals as a basis for generating a compensation curve and building a look-up table. In this regard, the third photo sensing signal obtained from the initial position may be used as a background signal for monitoring the state of the sample.
Table 1 shows the corresponding relationship between the second retention time, the fourth optical sensing signal, the average value, the difference value, and the difference coefficient for a plurality of second cassettes at the same concentration C1 sample. In Table 1, it can be seen that 10 second cassettes 210_1 to 210_10 are tested using the same concentration sample. In table 1, the test result of the second cassette 210_7 does not appear, which indicates that the sample of the second cassette 210_7 has an abnormal phenomenon, so the test data of the second cassette 210_7 is not used by the processing unit 180 to avoid the generated compensation value from being inaccurate.
In addition, after the signal values of the fourth photo sensing signals corresponding to the second cassettes 210_1 to 210_6 and 210_8 to 210_10 are added, the sum is divided by the number of the second cassettes (i.e. 9) to calculate an average value (i.e. 315). Then, the average value is subtracted from the signal values of the fourth photo sensing signals corresponding to the second cassettes 210_1 to 210_6 and 210_8 to 210_10, so as to generate the difference values corresponding to the second cassettes 210_1 to 210_6 and 210_8 to 210_ 10. In some embodiments, the average value is divided by the signal values of the fourth photo sensing signals corresponding to the second cassettes 210_1 to 210_6 and 210_8 to 210_10, respectively, to generate the difference coefficients corresponding to the second cassettes 210_1 to 210_6 and 210_8 to 210_ 10.
Then, linear regression calculation is performed on the difference values corresponding to the second cassettes 210_1 to 210_6 and 210_8 to 210_10 and the second retention time (as shown in the compensation curve S21 shown in fig. 2B), so as to obtain the slope a1 and the intercept B1 of the compensation curve 1 in the signal interval 1, as shown in table 2 and fig. 2C. In some embodiments, the difference coefficients corresponding to the second cassettes 210_1 to 210_6 and 210_8 to 210_10 and the second retention time are linearly regressed to obtain another set of slope and intercept of the signal interval 1.
TABLE 1 corresponding relationship table of the second cassette, the second detention time, the fourth light sensing signal, the average value, the difference value and the difference coefficient
In the above embodiment, the samples added to the second cassettes 210_1 to 210_10 are samples of the same concentration, and the slope a1 and the intercept b1 of the signal interval 1 are obtained. Then, another sample of the concentration C2 is added to each of the second cassettes 210_11 to 210_20 for detection, and the operations can be performed as described in the above embodiments to obtain the slope a2 and the intercept b2 of a set of compensation curves 2 in the signal interval 2; in other words, the slope aM and the intercept bM of the compensation curve M of the M groups are generated by performing the above operations on the samples with different concentrations C1-CM. Accordingly, a look-up table is established as table 2, which is a table of the corresponding relationship between the slope and intercept of the signal intervals 1-M and the compensation curve of the optical sensing signal interval.
When a sample with unknown concentration is detected by the first cassette, the processing unit obtains a first retention time and a second light sensing signal, confirms that the second light sensing signal belongs to a certain signal interval in the lookup table, and according to the slope and intercept of the signal interval, the processing unit brings the first retention time into a compensation curve of the slope and intercept to calculate, so as to obtain a compensation value to compensate the second light sensing signal.
TABLE 2 corresponding relationship table of interval of light sensing signal, slope of compensation curve, and intercept of compensation curve
In this embodiment, the lookup table is established by performing linear regression according to the difference value and the second retention time, and the compensation value calculated according to the lookup table is subtracted from the second light sensing signal to obtain the compensated light sensing signal, so as to more approximate to the real concentration of the object to be measured. In some embodiments, the lookup table is established by performing a linear regression according to the difference coefficient and the second retention time, and the compensated optical sensing signal can be obtained by multiplying the second optical sensing signal by the compensation value calculated according to the lookup table to more approximate the actual concentration of the object to be measured.
Through the description of the above embodiments, a detection method having a compensation function can be generalized. Fig. 3 is a flowchart of a detection method with compensation function according to an embodiment of the invention.
In step S302, a first trigger command is provided after adding a sample to a first cassette to define a first time point. In step S304, the initial position of the reaction area of the first cassette is detected, and when the first photo sensing signal greater than or equal to the predetermined value is obtained, a second time point is defined.
In step S306, a second photo sensing signal is obtained from the color generation band of the reaction region after a predetermined time. In step S308, a time difference between the first time point and the second time point is calculated as a first residence time. In step S310, a compensation value is obtained from the look-up table according to the first retention time and the second light sensing signal, and the second light sensing signal is compensated by the compensation value.
Fig. 4 is a flowchart of a detection method with compensation function according to another embodiment of the invention. In step S402, a first trigger command is provided after adding a sample to a first cassette to define a first time point. In step S404, the initial position of the reaction area of the first cassette is detected, and when the first photo sensing signal greater than or equal to the predetermined value is obtained, a second time point is defined.
In step S406, the first photo sensing signal within a predetermined time after the second time point is continuously obtained. In step S408, a second light sensing signal is obtained from the color generation band of the reaction region after a predetermined time. In step S410, the first light sensing signal within a predetermined time after the second time point is compared with a preset value. In step S412, when the first light sensing signal within the predetermined time after the second time point is less than the preset value, abnormal information is generated, and the second light sensing signal corresponding to the first light sensing signal is deleted.
In step S414, when the first light sensing signal within the predetermined time after the second time point is continuously greater than or equal to the preset value, a second light sensing signal corresponding to the first light sensing signal is adopted. In step S416, a time difference between the first time point and the second time point is calculated as a first residence time.
In step S418, a compensation value is obtained from the look-up table according to the first retention time and the second light sensing signal, and the second light sensing signal is compensated by the compensation value.
Fig. 5 is a flowchart of a detection method with compensation function according to another embodiment of the invention. In step S502, after adding the sample to the plurality of second cassettes, a plurality of second trigger commands are provided to respectively define a plurality of third time points. In step S504, the start position of the reaction area of the second cassette is detected, and a plurality of fourth time points are defined when a plurality of third photo sensing signals greater than or equal to a predetermined value are obtained.
In step S506, a plurality of fourth photo sensing signals are obtained from the color generation bands of the reaction regions of the second cartridge after a predetermined time has elapsed. In step S508, a time difference between the third time point and the fourth time point is calculated as a plurality of second residence times.
In step S510, the slopes and intercepts of the plurality of compensation curves are obtained according to the second retention time and the fourth light sensing signal to establish a lookup table. That is, FIG. 5 may be a flow of building a look-up table. Next, after step S510 is executed, step S302 of fig. 3 may be entered, and the flow of fig. 3 is executed.
Fig. 6 is a detailed flowchart of step S510 of fig. 5. In step S602, an average value is calculated according to the fourth photo sensing signal. In step S604, a plurality of difference values or a plurality of difference coefficients are generated according to the fourth photo sensing signal and the average value. In step S606, a lookup table having a plurality of signal intervals and corresponding slopes and intercepts is established according to the difference value or the difference coefficient and the compensation curve of the second retention time.
Fig. 7 is a flowchart of a detection method with compensation function according to another embodiment of the invention. In step S702, after adding the sample to the plurality of second cassettes, a plurality of second trigger commands are provided to respectively define a plurality of third time points. In step S704, the start position of the reaction area of the second cassette is detected, and a plurality of fourth time points are defined when a plurality of third photo sensing signals greater than a predetermined value are obtained.
In step S706, the third light sensing signal within the predetermined time after the fourth time is continuously obtained. In step S708, a plurality of fourth photo sensing signals are obtained from the color generation bands of the reaction regions of the second cartridge after a predetermined time has elapsed.
In step S710, the third light sensing signal within a predetermined time after the fourth time point is compared with a preset value. When any one of the plurality of third light sensing signals within a predetermined time after the fourth time point is smaller than the preset value, the process proceeds to step S712, abnormal information is generated, and the fourth light sensing signal corresponding to any one of the third light sensing signals is deleted.
In step 714, when the third light sensing signal within a predetermined time after the fourth time point is continuously greater than or equal to the preset value, a fourth light sensing signal corresponding to the third light sensing signal is adopted. In step S716, a time difference between the third time point and the fourth time point is calculated as a plurality of second residence times. In step S718, the slopes and intercepts of the plurality of compensation curves are obtained according to the second retention time and the fourth light sensing signal to establish a lookup table.
In summary, the testing method and the testing apparatus with compensation function disclosed in the present invention add the sample into the first cassette, and sense the initial position and the color bar of the reaction area of the first cassette to generate the first photo sensing signal and the second photo sensing signal. Then, a first time point is defined according to the first trigger command, a second time point is defined when the first light sensing signal is larger than a preset value, and a time difference between the first time point and the second time point is calculated to serve as a first retention time. And then, acquiring a corresponding compensation value in the lookup table according to the first retention time and the second optical sensing signal so as to compensate the second optical sensing signal. In addition, the detection can be performed on a plurality of second cassettes to generate a plurality of slopes and intercepts of compensation curves, and the lookup table is established by using the slopes and intercepts of the compensation curves. Therefore, the test data generated by the first cassette is more accurate, so as to reduce the probability of detection misjudgment.
Although the present invention has been described with reference to the above embodiments, it should be understood that the scope of the present invention is not limited to the above embodiments, and those skilled in the art can make various changes and modifications without departing from the spirit and scope of the invention.
Claims (11)
1. A detection method with compensation function, comprising:
(a) adding a sample into a first cassette and then providing a first trigger command to define a first time point;
(b) detecting an initial position of a reaction area of the first cassette, and defining a second time point when a first light sensing signal greater than or equal to a preset value is obtained;
(c) obtaining a second light sensing signal from a color generation band of the reaction area after a preset time;
(d) calculating the time difference between the first time point and the second time point as a first residence time; and
(e) obtaining a compensation value in a lookup table according to the first retention time and the second optical sensing signal, and compensating the second optical sensing signal by the compensation value;
(f) providing a plurality of second trigger commands to respectively define a plurality of third time points after adding the sample to a plurality of second cassettes;
(g) detecting an initial position of a reaction area of the second cassettes, and defining a plurality of fourth time points when a plurality of third light sensing signals which are greater than or equal to the preset value are obtained;
(h) respectively obtaining a plurality of fourth light sensing signals from a color generation band of the reaction area of the second cassettes after the preset time;
(i) calculating time differences between the third time points and the fourth time points as a plurality of second residence times; and
(j) and obtaining slopes and intercepts of a plurality of compensation curves according to the second residence times and the fourth light sensing signals so as to establish the lookup table.
2. The detection method with compensation function according to claim 1, wherein between steps (b) and (c) further comprising:
continuously acquiring the first light sensing signal within the preset time after the second time point; and
wherein, further include between step (c) and (d):
comparing the first light sensing signal in the preset time after the second time point with the preset value;
when the first light sensing signal in the preset time after the second time point is smaller than the preset value, generating abnormal information, and deleting the second light sensing signal corresponding to the first light sensing signal; and
and when the first light sensing signal in the preset time after the second time point is continuously greater than or equal to the preset value, adopting the second light sensing signal corresponding to the first light sensing signal.
3. The detection method with compensation function according to claim 1, wherein the step (j) comprises:
calculating an average value according to the fourth light sensing signals;
generating a plurality of difference values or a plurality of difference coefficients according to the fourth light sensing signals and the average value; and
and establishing the lookup table with a plurality of signal intervals and the corresponding slopes and intercepts according to the difference values or the difference coefficients and the compensation curves of the second residence times.
4. The detection method with compensation function according to claim 3, wherein between steps (g) and (h) further comprising:
continuously acquiring the third light sensing signals within the preset time after the fourth time points; and
wherein, step (h) and (i) between still include:
comparing the third light sensing signals in the preset time after the fourth time points with the preset value;
when any one of the third light sensing signals within the preset time after the fourth time points is less than the preset value, generating abnormal information, and deleting the fourth light sensing signal corresponding to the third light sensing signal; and
and when the third light sensing signals within the preset time after the fourth time points are continuously greater than or equal to the preset value, adopting the fourth light sensing signals corresponding to the third light sensing signals.
5. A detection apparatus having a compensation function, comprising:
a first cartridge configured for loading a sample to flow laterally to a reaction area of the first cartridge;
a trigger unit configured to generate a first trigger command after the sample is loaded into the first cassette;
a light source unit for providing a light beam to irradiate the reaction area;
a sensing unit, configured corresponding to the reaction area, when the sample flows to an initial position of the reaction area, the sensing unit detects the initial position to generate a first light sensing signal, when the sample enters the reaction area from the initial position for a predetermined time, a color generation band is generated in the reaction area, and the sensing unit detects the color generation band to generate a second light sensing signal; and
a processing unit coupled to the triggering unit, the light source unit and the sensing unit, wherein the processing unit receives the triggering command to define a first time point, the processing unit receives the first light sensing signal, defines a second time point when the first light sensing signal is greater than or equal to a preset value, calculates a time difference between the first time point and the second time point as a first retention time, receives the second light sensing signal, obtains a compensation value in a lookup table according to the first retention time and the second light sensing signal, and compensates the second light sensing signal by the compensation value,
a plurality of second cassettes, configured to be loaded with the sample, respectively, such that the sample flows laterally to a reaction area of the second cassettes;
wherein the trigger unit further generates a plurality of second trigger commands after the sample is added into the second cassettes;
wherein, the light source unit further provides the light beam to irradiate the reaction areas of the second cassettes;
when the sample flows to an initial position of the reaction areas of the second cassettes, the sensing unit detects the initial position of the reaction areas of the second cassettes to generate a plurality of third light sensing signals, and when the sample enters the reaction areas of the second cassettes from the initial position of the reaction areas of the second cassettes for the preset time, a colored band is generated in the reaction areas of the second cassettes, and the sensing unit detects the colored band of the reaction areas to generate a plurality of fourth light sensing signals;
the processing unit further receives the second trigger commands to define a plurality of third time points, the processing unit further receives the third light sensing signals, defines a plurality of fourth time points when the third light sensing signals are greater than or equal to the preset value, calculates time differences between the third time points and the fourth time points to serve as a plurality of second detention times, and further receives the fourth light sensing signals, and calculates slopes and intercepts of a plurality of compensation curves according to the second detention times and the fourth light sensing signals to establish the query table.
6. The detecting device with the compensation function as claimed in claim 5, wherein the processing unit further compares the first light sensing signal with the preset value, and when the first light sensing signal is smaller than the preset value, the processing unit generates an abnormal message.
7. The detecting device with the compensation function as claimed in claim 5, wherein the first cassette comprises:
a test strip having the reaction area, and the reaction area having the color ribbon;
an upper card box, which is arranged at one side of the test strip and is provided with a sample adding opening, a first alignment hole and a first detection window, wherein the sample adding opening is used for adding the sample, the first alignment hole exposes the initial position of the reaction area, the first detection window corresponds to the reaction area containing the color ribbon, and the first alignment hole is positioned between the sample adding opening and the first detection window; and
and the lower cassette is arranged on the other side of the test strip and is provided with a second alignment hole and a second detection window, wherein the second alignment hole corresponds to the first alignment hole, and the second detection window corresponds to the first detection window.
8. The detecting device with the compensation function as claimed in claim 7, wherein the light source unit and the sensing unit are disposed on a side of the upper cassette opposite to the test strip, or disposed on a side of the lower cassette opposite to the test strip.
9. The detecting device with the compensation function as claimed in claim 7, wherein the light source unit is disposed on a side of the upper cassette opposite to the test strip, and the sensing unit is disposed on a side of the lower cassette opposite to the test strip.
10. The detecting device with the compensation function according to claim 5, further comprising:
a mobile unit coupled to the light source unit, the sensing unit and the processing unit;
before the first trigger command, the processing unit controls a moving unit to move the light source unit and the sensing unit to the initial position, so that the light beam of the light source unit irradiates the initial position and the sensing unit senses the initial position to generate the first light sensing signal;
and the processing unit controls the moving unit to move the light source unit and the sensing unit to the color generation band in the preset time after the second time point, so that the light beam of the light source unit at least irradiates the color generation band and the sensing unit senses the color generation band to generate the second light sensing signal.
11. The detecting device with the compensating function as claimed in claim 5, wherein the processing unit calculates an average value according to the fourth photo sensing signals, generates a plurality of difference values or a plurality of difference coefficients according to the fourth photo sensing signals and the average value, and establishes the lookup table having a plurality of signal intervals and the corresponding slopes and intercepts according to the compensation curves of the difference values or the difference coefficients and the second retention times.
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| DE4041905A1 (en) * | 1990-12-27 | 1992-07-02 | Boehringer Mannheim Gmbh | TEST CARRIER ANALYSIS SYSTEM |
| HU222809B1 (en) * | 1997-10-03 | 2003-10-28 | 77 Elektronika Műszeripari Kft. | Method and apparatus for detecting chemical component from sample mostly for detecting glucose content of blood from blood sample |
| US20070143035A1 (en) * | 2005-12-19 | 2007-06-21 | Petruno Patrick T | Diagnostic test reader with disabling unit |
| US7763454B2 (en) * | 2004-07-09 | 2010-07-27 | Church & Dwight Co., Inc. | Electronic analyte assaying device |
| CN102539735A (en) * | 2010-11-12 | 2012-07-04 | 美艾利尔圣地亚哥有限公司 | Test device and system with integrated quality assurance label |
| WO2013163342A1 (en) * | 2012-04-24 | 2013-10-31 | Abbott Diabetes Care Inc. | Methods of lag-compensation for analyte measurements, and devices related thereto |
| TWI513978B (en) * | 2012-06-08 | 2015-12-21 | Hmd Biomedical Inc | Test strip, detecting device and detection method |
| CN103712693A (en) * | 2012-09-28 | 2014-04-09 | 亚旭电脑股份有限公司 | Color recognition method and device |
| US10371660B2 (en) * | 2013-05-17 | 2019-08-06 | Lifescan Ip Holdings, Llc | Accurate analyte measurements for electrochemical test strip based on multiple calibration parameters |
| US9625385B2 (en) * | 2015-02-24 | 2017-04-18 | Tokitae Llc | Photothermal spectroscopy systems for offset synchronous testing of flow assays and methods of using same |
| CN105044087B (en) * | 2015-05-28 | 2019-02-01 | 北京丰拓生物技术有限公司 | Urine examination device for fast detecting and method |
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