CN101995457A - Biological sensing device - Google Patents

Abstract

The invention provides a biological sensing device, which comprises an input unit, an analysis unit, a calculation unit and a setting unit. The biological sensing device is used for setting correction parameters of a test plate in the device, so that correction can be accomplished at relatively low cost and it is more convenient for a user to use.

Description

Biosensing apparatus

Technical field

The invention provides a kind of biosensing apparatus, the correction parameter that it can be set in the test piece in this device makes this correction to finish by lower cost, has more user's convenience (user friendly) simultaneously.

Background technology

Biological sensing instrument has developed into and has been used to detect various biomolecule compounds, comprises oligonucleotides, antibody-antigen reciprocation, hormone-acceptor reciprocation and ferment-matrix reciprocation.Generally speaking, biology sensor is made of two assemblies: height specific identification assembly and molecular recognition event is converted to the converter that quantizes signal, the conversion of signal can be reached by the several different methods that comprises fluorescence method and interferometric method.Use the biological sensing instrument of jettisonable test piece to have higher consumer's acceptance, these instruments are the detections that are used for analyte, as glucose in the blood sample and cholesterol level, and provide the correct value of reading.

Yet, for obtaining testing result accurately, the information relevant with jettisonable test piece (strip) (such as correction parameter, test piece type, and valid period etc.) must input in the biological sensing instrument.Before using biology sensor, at first must finish correction.The test piece of each batch production have batch and batch between the property difference of (lot-by lot), test piece manufacturer must provide correcting code at the test piece of each batch, the user then carries out setting program according to the service manual that manufacturer provided before using test piece, make biology sensor can obtain correct control information.Two kinds of known calibration setup programs are arranged at present: a kind of for selecting one group of built-in (built-in) correcting code in biology sensor according to the correcting code that is indicated on this batch test piece packing by the user; Another kind is the additional correcting code memory card of every batch of test piece, so that correction parameter is accessed in the mnemon.In sensor unit is further proofreaied and correct, will insert formant to proofread and correct the sensitivity of this equipment corresponding to the parameter setting card of the sensor of certain lot number.In sensor unit is further proofreaied and correct,, calibration data is inputed to formant to proofread and correct the sensitivity of biological sensing instrument according to the bar code that is shown on the formant.

United States Patent (USP) the 4th, 637, disclose the pocket portability type of a kind of hand-held medical diagnostic system for No. 403, it is used to check the measurement of blood sugar, urea nitrogen, protoheme, blood constituent or other physical characteristics, a kind of integration system of this previous document description, it is by jabbing patient's finger to obtain blood sample, and then this device utilizes the gained sample that the value of reading of blood sugar or other analyte concentration is provided, and this system uses the reflecting system of a complexity to read the content of analyte in the sample.

No. the 0351891st, European patent discloses a kind of electrochemical sensor system and electrode of measuring the analyte concentration in the humoral sample that be applicable to, this system need use expensive electrode and the reader concentration content with the determination and analysis thing.

United States Patent (USP) the 5th, 053, disclose a kind of integrated circuit carrier and removable slot of vertically taking in this integrated circuit carrier that reaches of comprising for No. 199, it has described a kind of biological sensing meter with pluggable memory key, and this device is to utilize pluggable memory key to control the operation of this instrument.

United States Patent (USP) the 5th, 366 is for No. 609 the biological sensing meter that exists about a kind of analyte that is used for measuring biological sample, in detail, is about control the operation of biological sensing meter via removable pluggable memory module gained data.It has described a kind of biological sensing meter with pluggable ROM (read-only memory), wherein can determine whether close ROM (read-only memory) by ROM (read-only memory) in test procedure in the data that instrument reads the continuous time between the operating period.

Though passed through many improvement, to proofread and correct required cost and complexity and have much room for improvement, the demand that instrumental correction is cooperated with test piece will cause the error of analyte concentration reading.At present, existing correction mechanism need load correcting chip or correcting sheet, or manually imports correcting code to instrument, and these install reusable several, and is not transformed into or imports suitable correcting code as the patient, will cause error.Another problem then is the use of expired test piece, and expired old test piece will cause error and incorrect result.To reduce the use of expired test piece, the patient will must not note the valid period of test piece by someway, and can exempt and use the error that old test piece produced.

Biological sensing instrument remains in an important demand, promptly develops quick, easy, inexpensive and reliable correcting mode.

Summary of the invention

The invention provides a kind of biosensing apparatus, it comprises the following units:

One input block, it comprises the parameter setting card of test piece and the slot of this biosensing apparatus, wherein this parameter

Setting card is connected with this slot, make the circuit of this parameter setting card and the signal capturing circuit of this biosensing apparatus (signal-acquiring circuit) form a work loop, and by providing voltage or electric current to the circuit of this parameter setting card to produce electric signal;

One analytic unit, it utilizes analogue-to-digital converters (analog-to-digital converter, ADC) signal of circuit conversion gained;

One calculation unit, it imports numerical value maximal value, minimum value and the resolution of this biosensing apparatus by pre-defined desire, and will decipher with the acquisition value data, and determine minimum measurement unit by the maximal value and the minimum value of characterization method by the electric signal of analytic unit gained; And

One setup unit, its data exponent number that stores gained is to be used for the basis of the biosensing apparatus of test piece as correction.

Description of drawings

Fig. 1 is illustrated in the input block of the present invention, the configuration of the signal capturing circuit of biosensing apparatus and the parameter setting card of test piece.

Fig. 2 represents to depend on the coding method of the present invention of a parameter.

Fig. 3 once depends on the synoptic diagram of the method for two or more parameters for expression.

Fig. 4 is illustrated in the input block of the present invention, the configuration of the signal capturing circuit of biosensing apparatus and the parameter setting card of test piece.

Fig. 5 represents that based on voltage strength and relevant parameter, setup unit obtains setting data by coding and correction group.

Fig. 6 is illustrated in the input block of the present invention, the configuration of the signal capturing circuit of biosensing apparatus and the parameter setting card of test piece.

Fig. 7 represents that setup unit obtains setting data by coding and correction group based on the corresponding relation of voltage strength or duration and parameter.

Fig. 8 is illustrated in the input block of the present invention, the configuration of the signal capturing circuit of biosensing apparatus and the parameter setting card of test piece.

Fig. 9 represents input block, analytic unit, calculation unit and the setup unit that the present invention comprises.

Embodiment

The invention provides a kind of biosensing apparatus, the correction parameter that it can be set in the test piece in this device makes this correction to finish by lower cost, has more user's convenience simultaneously.

The invention provides a kind of biosensing apparatus, it comprises the following units:

One input block, it comprises the parameter setting card of test piece and the slot of this biosensing apparatus, wherein this parameter setting card is connected with this slot, make the circuit of this parameter setting card and the signal capturing circuit of this biosensing apparatus form a work loop, and by providing voltage or electric current to the circuit of this parameter setting card to produce electric signal;

One analytic unit, it utilizes the signal of analogue-to-digital converters (ADC) circuit conversion gained;

One calculation unit, it imports numerical value maximal value, minimum value and the resolution of this biosensing apparatus by pre-defined desire, and will decipher with the acquisition value data, and determine minimum measurement unit by the maximal value and the minimum value of characterization method by the electric signal of analytic unit gained; And

One setup unit, its value data that stores gained is to be used for the basis of the biosensing apparatus of test piece as correction.

Biosensing apparatus of the present invention comprises four unit, and these unit are at the test piece that is used in this device and the parameter of setting device, and aforementioned Unit four are input block, analytic unit, calculation unit and setup unit, and it as shown in Figure 9.

The input block of biosensing apparatus of the present invention comprises the parameter setting card of test piece and the slot of this biosensing apparatus, wherein this parameter setting card is connected with this slot, makes the circuit of this parameter setting card and the signal capturing circuit of this biosensing apparatus form a work loop (see figure 1).Work loop shown in Figure 1 is for can be by the voltage-voltage amplifier that provides direct current (DC) voltage or electric current to the circuit of this parameter setting card to produce electric signal, and this electric signal can see through this acquisition circuit and obtain.When biosensing apparatus provides voltage or electric current, it is the electric signal (seeing Fig. 2 and 3) of function that the circuit of this parameter setting card produced with time, this signal is a feature with voltage strength (Δ V), and the voltage that is provided will make voltage change along with the time and form one voltage-function of time.This acquisition circuit can further comprise the multiplexer (multiplexer) of selecting at least one loop, and to obtain two or more signal (see figure 4) on the parameter setting card, the output of signal and corresponded manner thereof are as shown in Figure 5.The form of another kind of parameter setting card can further comprise electric capacity, and it provides a signal that changes according to the time, and for example voltage or strength of current changed along with the time.When based on voltage strength (Δ V) or mistiming (Δ T), parameter value can depend on (see figure 7) thereon.In addition, this acquisition circuit can be one and uses the voltage-to-current amplifier (see figure 8) of reaching identical purpose.As shown in Figure 8, V _OutBe by R _ADetermine and to have V _tBaseline, V _tBe a direct current voltage source, and pass through R _GElectric current then depend on R _ABecause V _OutAnd R _AThe pass be known, can use this circuit to reach as shown in Figure 1 identical purpose.According to the present invention, the parameter setting card comprises the open loop circuit of being made up of at least one group of non-memory module, and this open loop circuit is preferably by the two the combination of serial or parallel connection of resistance, electric capacity or this to be formed.Insert the slot of biosensing apparatus when the parameter setting card of test piece after, the signal capturing circuit by connecting this biosensing apparatus and the circuit of this parameter setting card form the loop of working.

The analytic unit of biosensing apparatus of the present invention utilizes analogue-to-digital converters (ADC) circuit to be changed by the electric signal of input block gained.

Numerical value maximal value (the P of this biosensing apparatus is imported in the calculation unit of biosensing apparatus of the present invention by pre-defined desire _Max), minimum value (P _Min) and resolution (P _Res), and will decipher with acquisition data number by the electric signal of analytic unit gained, and determine minimum measurement unit by the maximal value and the minimum value of characterization method.Utilize voltage strength as making electric signal become the method for eigenwert, this data exponent number (P _n) can obtain by following formula:

$P_n=\frac{P_{\max }-P_{\min }}{P_{\mathrm{res}}}$ (formula 2-1)

In addition, must determine the maximal value (U of employed characterization method _Max) and minimum value (U _Min), and see through following formula and obtain minimum measurement unit (step):

$\mathrm{step}=\frac{U_{\max }-U_{\min }}{P_n}$ (formula 2-2)

The value data that is captured (P) can get (U by following formula calculating _InEigenwert for signal):

$P=P_{\min }+\frac{U_{\mathrm{in}}}{\mathrm{step}}$ (formula 2-3)

The setup unit of biosensing apparatus of the present invention stores the value data of gained, to be used for the basis of the biosensing apparatus of test piece as correction.

Example

Example 1

For the slope value in the test piece characteristic equation (slope) is imported biosensing apparatus, the configuration of the signal capturing circuit of this biosensing apparatus in input block of the present invention and the parameter setting card of test piece as shown in Figure 1.This signal capturing circuit comprises a reference resistance (R at least _f) and an amplifier circuit, by the equiva lent impedance (R on reference resistance and the parameter setting card _A) one fen hydraulic circuit of formation.Slope value with the input correction data is an example, suppose slope value scope on the characteristic equation of test piece be 0.5 to 2.0 and resolution be 0.02 (for example minimum recruitment is 0.02), according to above-mentioned formula 2-1, can obtain data exponent number (mapping data the number) (P of mapping _n) as follows:

$P_n=\frac{P_{\max }-P_{\min }}{P_{\mathrm{res}}}=\frac{2-0.5}{0.02}=75$

Suppose that the ADC reference voltage is 2.5V and reference resistance (R _f) be 10k Ω, and the scope of change in voltage is to be limited between the 0.1v to 2.5v, it is as follows to get minimum measurement unit (step) according to formula 2-2:

$\mathrm{step}=\frac{U_{\max }-U_{\min }}{P_n}=\frac{2.5-0.1}{75}=0.032$

Can calculate the corresponding voltage value and the equivalent impedance (seeing Table 1) thereof of the value data of desire input biosensing apparatus according to formula 2-3.

Table 1

slope	V Rn(V)	Ra(Ω)		slope	V Ra(V)	Ra(Ω)		slope	V Ra(V)	Ra(Ω)
											0.50	0.100	417		1.10	1.060	7361		1.70	2.020	42083
0.52	0.116	557		1.12	1.092	7756		1.72	2.052	45804
											0.54	0.132	702		1.14	1.124	8169		1.74	2.084	50096
0.56	0.148	851		1.16	1.156	8601		1.76	2.116	55104
											0.58	0.164	1004		1.18	1.188	9055		1.78	2.148	61023

0.60	0.180	1161		1.20	1.220	9531		1.80	2.180	68125
											0.62	0.196	1322		1.22	1.252	10032		1.82	2.212	76806
0.64	0.212	1489		1.24	1.284	10559		1.84	2.244	87656
											0.66	0.228	1660		1.26	1.316	11115		1.86	2.276	101607
0.68	0.244	1837		1.28	1.348	11701		1.88	2.308	120208
											0.70	0.260	2019		1.30	1.380	12321		1.90	2.340	146250
0.72	0.276	2207		1.32	1.412	12978		1.92	2.372	185313
											0.74	0.292	2401		1.34	1.444	13674		1.94	2.404	250417
0.76	0.308	2601		1.36	1.476	14414		1.96	2.436	380625
											0.78	0.324	2807		1.38	1.508	15202		1.98	2.468	771250
0.80	0.340	3021		1.40	1.540	16042		2.00	2.500	∞
											0.82	0.356	3242		1.42	1.572	16940
0.84	0.372	3470		1.44	1.604	17902
											0.86	0.388	3706		1.46	1.636	18935
0.88	0.404	3951		1.48	1.668	20048
											0.90	0.420	4205		1.50	1.700	21250
0.92	0.436	4468		1.52	1.732	22552
											0.94	0.452	4741		1.54	1.764	23967
0.96	0.468	5024		1.56	1.796	25511
											0.98	0.484	5319		1.58	1.828	27202
1.00	0.500	5625		1.60	1.860	29063
											1.02	0.516	5944		1.62	1.892	31118
1.04	0.532	6276		1.64	1.924	33403

1.06	0.548	6622		1.66	1.956	35956
											1.08	0.564	6984		1.68	1.988	38828

Specify the suitable resistance value can obtain the signal voltage eigenwert of corresponding slope value.Utilize the signal of amplifier circuit acquisition parameter setting card, and can obtain the eigenwert of this signal via the processing of analytic unit.In this example, eigenwert is voltage strength (Δ V).The calculation unit can be deciphered calculation with voltage strength and the parameter that is depended on according to coding rule and obtain set information.Fig. 2 shows that above-mentioned coding method also can be changed into and once depends on two or more parameters, and being applicable to does not need the different types of data imported simultaneously.Figure 3 shows that the method that depends on two or more parameters simultaneously.

Example 2

For slope value in the test piece characteristic equation and values of intercept are imported biosensing apparatus simultaneously, the configuration of the signal capturing circuit of this biosensing apparatus in input block of the present invention and the parameter setting card of test piece is as shown in Figure 4.This signal capturing circuit comprises a reference resistance (R at least _f), an amplifier circuit and signal selection circuit (as multiplexer), via the switching of signal selection circuit, can be by the equiva lent impedance (R on the parameter setting card _aOr R _b) form one minute hydraulic circuit, wherein R with reference resistance _aThe loop be as signal corresponding to the slope value representative of setup parameter, and R _bThe loop be as signal corresponding to the values of intercept representative of setup parameter.Suppose slope value scope on the characteristic equation of test piece be 0.5 to 2.0 and resolution be 0.02, the embodiment of its mapping is shown in example 1.In addition, the scope that values of intercept is possible is that 0.1v to 0.5v and resolution thereof are 0.005, according to above-mentioned formula 2-1, can get the data exponent number (P of mapping _n) as follows:

$P_n=\frac{P_{\max }-P_{\min }}{P_{\mathrm{res}}}=\frac{0.5-0.1}{0.005}=80$

Suppose that the ADC reference voltage is 2.5V and reference resistance (R _f) be 10k Ω, and the scope of change in voltage is to be limited between 0.1 to 2.5, it is as follows to get minimum measurement unit (step) according to formula 2-2:

$\mathrm{step}=\frac{U_{\max }-U_{\min }}{P_n}=\frac{2.5-0.1}{80}=0.03$

Can calculate the corresponding voltage value and the equivalent impedance (seeing Table 2) thereof of the value data of desire input biosensing apparatus according to formula 2-3.

Table 2

Intercept	V RbV)	Rb(Ω)		?Intercept	V Rb(V)	Rb(Ω)		?Intercept	V Rb(V)	Rb(Ω)
											0.100	0.100	417		0.250	1.000	6667		0.400	1.900	31667
0.105	0.130	438		0.255	1.030	7007		0.405	1.930	33860
											0.110	0.160	460		0.260	1.060	7361		0.410	1.960	36296
0.115	0.190	482		0.265	1.090	7730		0.415	1.990	39020
											0.120	0.220	504		0.270	1.120	8116		0.420	2.020	42083
0.125	0.250	526		0.275	1.150	8519		0.425	2.050	45556

0.130	0.280	549		0.280	1.180	8939		0.430	2.080	49524
											0.135	0.310	571		0.285	1.210	9380		0.435	2.110	54103
0.140	0340	593		0.290	1.240	9841		0.440	2.140	59444
											0.145	0.370	616		0.295	1.270	10325		0.445	2.170	65758
0.150	0.400	638		0.300	1.300	10833		0.450	2.200	73333
											0.155	0.430	661		0.305	1.330	11368		0.455	2.230	82593
0.160	0.460	684		0.310	1.360	11930		0.460	2.260	94167
											0.165	0.490	707		0.315	1.390	12523		0.465	2.290	109048
0.170	0.520	730		0.320	1.420	13148		0.470	2.320	128889
											0.175	0.550	753		0.325	1.450	13810		0.475	2.350	156667
0.180	0.580	776		0.330	1.480	14510		0.480	2.38	198333
											0.185	0.610	799		0.335	1.510	15253		0.485	2.41	267778
0.190	0.640	823		0.340	1.540	16042		0.490	2.44	406667
											0.195	0.670	846		0345	1.570	16882		0.495	2.47	823333
0.200	0.700	870		0.350	1.600	17778		0.500	2.50	∞
											0.205	0.730	893		0.355	1.630	18736
0.210	0.760	917		0.360	1.660	19762
											0.215	0.790	941		0.365	1.690	20864
0.220	0.820	965		0.370	1.720	22651
											0.225	0.850	989		0.375	1.750	23333
0.230	0.880	1013		0.380	1.780	24722
											0.235	0.910	1038		0.385	1.810	26232
0.240	0.940	1062		0.390	1.840	27879
											0.245	0.970	1086		0.395	1.870	29683

Specify the suitable resistance value can obtain the signal voltage eigenwert of corresponding slope value.Select circuit, R by controlling signal _a, reference resistance and biosensing apparatus can form the loop output signal waveform, utilizes the signal of amplifier circuit acquisition parameter setting card and decoding computing gained data can obtain slope value.After finishing, signal selection circuit will be selected R _bBe operating resistance, R _aPresent open-circuit condition, capture with R by amplifier circuit again _bBe the signal that the basis generated, then can get the eigenwert of voltage strength (Δ V) via the processing of analytic unit.The calculation unit can be deciphered calculation with voltage strength and the parameter that is depended on according to coding rule and obtain the set information (see figure 5).

Example 3

The test piece build date can input to biosensing apparatus and the effect phase of active management test piece, and characterization method of the present invention is then represented time and all numbers respectively.In input block of the present invention, the configuration of the signal capturing circuit of biosensing apparatus and the parameter setting card of test piece is as shown in Figure 6.This signal capturing circuit comprises a reference resistance (R at least _f), an and amplifier circuit, by the impedance (R on reference resistance and the parameter setting card _aAnd C _A) one fen hydraulic circuit of formation in parallel.The equivalent resistance of this parameter setting card changes with parameter value is different.Because C _ABe a kind of assembly based on time or frequency function, voltage strength (Δ V) and mistiming (Δ T) all can be used for the Code that separates of parameter input.Utilize the signal of amplifier circuit acquisition parameter setting card, then can obtain the eigenwert of this signal waveform again via the processing of analytic unit.In this example, eigenwert is voltage strength (Δ V) and mistiming (Δ T).The calculation unit can be deciphered calculation with voltage strength and the parameter that is depended on according to coding rule and obtain the set information (see figure 7).

Suppose to utilize voltage strength (Δ V) and the eigenwert of mistiming (Δ T) to represent all numbers and time respectively each all data input biosensing apparatus in 2007 to 2011.Aspect all number encoders,,, can get the data exponent number (P of mapping according to above-mentioned formula 2-1 owing to comprised for 52 weeks in 1 year _n) as follows:

$P_n=\frac{P_{\max }-P_{\min }}{P_{\mathrm{res}}}=\frac{52-1}{1}=51$

Suppose that the ADC reference voltage is 2.5V and reference resistance (R _f) be 470k Ω, and the scope of change in voltage is to be limited between the 0.2v to 1.73v, it is as follows to get minimum measurement unit (step) according to formula 2-2:

$\mathrm{step}=\frac{U_{\max }-U_{\min }}{P_n}=\frac{1.73-0.2}{51}=0.03$

Can calculate the corresponding voltage value and the equivalent impedance (seeing Table 3) thereof of the value data of desire input biosensing apparatus according to formula 2-3.

Table 3

Table 3 (continuing)

In addition, at the time encoding context, because the time scope of desire input can get the data exponent number (P of mapping by 2007 to 2012 according to formula 2-1 _n) as follows:

$P_n=\frac{P_{\max }-P_{\min }}{P_{\mathrm{res}}}=\frac{2011-2007}{1}=4$

Suppose that the ADC reference voltage is 2.5V and reference resistance (R _f) be 470k Ω, and the scope that the mistiming changes is to be limited between 0.5 to 0.1, it is as follows to get minimum measurement unit (step) according to formula 2-2:

$\mathrm{step}=\frac{U_{\max }-U_{\min }}{P_n}=\frac{0.5-0.1}{4}=0.1$

Can calculate the corresponding mistiming (Δ T) and the equivalent capacitance value (C thereof of the value data of desire input biosensing apparatus according to formula 2-3 _A) (seeing Table 3).

Claims (9)

1. biosensing apparatus, it comprises the following units:

One input block, it comprises the parameter setting card of test piece and the slot of this biosensing apparatus, wherein this parameter setting card is connected with this slot, make the circuit of this parameter setting card and the signal capturing circuit of this biosensing apparatus form a work loop, and by providing voltage or electric current to the circuit of this parameter setting card to produce electric signal;

One analytic unit, it utilizes the signal of analogue-to-digital converters (ADC) circuit conversion gained;

One calculation unit, it imports numerical value maximal value (Pmax), minimum value (Pmin) and the resolution (Pres) of this biosensing apparatus by pre-defined desire, and will decipher with the acquisition value data, and determine minimum measurement unit (step) by the maximal value (Umax) and the minimum value (Umin) of characterization method by the electric signal of analytic unit gained; And

One setup unit, its value data that stores gained is to be used for the basis of the biosensing apparatus of test piece as correction.

2. biosensing apparatus as claimed in claim 1, it is a direct current (DC) power supply that the voltage of the circuit that gives this parameter setting card or electric current wherein are provided.

3. biosensing apparatus as claimed in claim 1, wherein power supply is built in this biosensing apparatus in being.

4. biosensing apparatus as claimed in claim 1, wherein this feature electric signal is voltage strength, mistiming or both combinations.

5. biosensing apparatus as claimed in claim 1, wherein this parameter setting card comprises the circuit that at least one group of non-memory module formed.

6. biosensing apparatus as claimed in claim 5, the wherein circuit formed by the combination of resistance, electric capacity, inductance or this three's serial or parallel connection of this circuit.

7. biosensing apparatus as claimed in claim 1 wherein utilizes voltage strength as characterization method, and the feature electric signal that this value data can utilize this voltage strength to produce reaches and obtains by following formula or its relation:

$P_n=\frac{P_{\max }-P_{\min }}{P_{\mathrm{res}}}.$

8. biosensing apparatus as claimed in claim 1 wherein must determine the maximal value (Umax) and the minimum value (Umin) of employed characterization method, and sees through following formula and obtain minimum measurement unit (step):

$\mathrm{step}=\frac{U_{\max }-U_{\min }}{P_n}.$

9. biosensing apparatus as claimed in claim 1, wherein this value data can be calculated and be got by following formula or its relation:

$P=P_{\min }+\frac{U_{\mathrm{in}}}{\mathrm{step}},$

Wherein this Pmin and step be such as claim 1 definition, and Uin is the eigenwert of signal.

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