CN101726520B - Quality control liquid for non-enzyme type electrochemical detection system and usage thereof - Google Patents

Abstract

The invention relates to a quality control liquid for non-enzyme type electrochemical detection system, which comprises ferrocyanide alkali metal salt and aqueous medium used for dissolving the ferrocyanide alkali metal salt. In addition, the invention also relates to a method for controlling the quality of the non-enzyme type electrochemical detection system.

Description

The control liquid of non-enzyme type electrochemical detection system and its using method

Technical field

The present invention relates to a special quality control liquid and its using method.Particularly, about a kind of storage period limit for length, stability is high, detection is accurate and the control liquid of the non-enzyme type electrochemical detection system of simple process and its using method.

Background technology

Utilize the made electrode examination bar of electrochemical process can be distinguished into two classes, enzyme type electrode examination bar and non-enzyme type electrode examination bar.Because most enzyme electrodes examination bars have the shortcomings such as the restriction of the wet type of being subject to preservation condition, complex process and controlled condition is loaded down with trivial details, cause its cost of manufacture high and cannot produce in a large number.Therefore, in recent years, the research of electrochemical detection system is many towards the development of non-enzyme type electrode examination bar.

The detection of the uric acid in the corpse or other object for laboratory examination and chemical testing such as blood or other body fluid, be for medical circle diagnosis with monitor the different patient's condition during one of instrument.Have at present multiple different mode to can be used for detecting uric acid content, conventional detection method comprises chemical method and enzyme process.But chemical method has easily disturbed, the not good shortcoming of selectivity, and the Expenses of laboratory examination costliness of enzyme process is stored inconvenience, cannot popularize at home and use.Therefore, develop one as United States Patent (USP) the 6th, the non-enzyme type uric acid testing electrode indicator bar disclosing for 258, No. 230B1.

In addition, the center of donating blood all needs to check on by hematin test system for screening of blood and blood donor's security protection, its detection method is numerous, comprise chemical method, gas survey method, hydrometer method and colourimetry etc., the detection method of wherein the most often being used is at present copper sulphate hydrometer method and hematin test instrument.The hematin test instrument Hemocue that graceful to wish (HemoCue) company manufactures again is the most often used.Hemocue is a kind of detector that utilizes optical principle, but its required optical device and consumables cost are higher, and therefore, United States Patent (USP) the 4th, provides a kind of protoheme Electrochemical Detection examination bar for 876, No. 205.

Generally speaking, the main application target of control liquid is to confirm that whether the function of electrochemical detection system is normal, and when occurring having the result of doubt in testing process, and when whether detection system to be confirmed is abnormal, the result that can detect according to control liquid is as basis for estimation, to confirm that whether described detection system is normal.

General commercially available hematin test instrument is the control liquid using animal restructuring blood as correct detection instrument.But, the control liquid that contains animal restructuring blood need to be kept under low-temperature condition, preservation condition is wayward and the effect phase is not long, approximately 1 to 3 months, easily be subject to the impacts such as temperature and operation improper use, the quality of control liquid is polluted, so that the quality of this type of hematin test instrument based on control liquid and cause it to use to be subject to significant limitation.

In view of above-mentioned factors, be necessary to provide a kind of storage period limit for length, stability is high, detection is accurate and the control liquid that is applicable to non-enzyme type electrochemical detection system of simple process, to meet in the demand aspect detection system.

Summary of the invention

Fundamental purpose of the present invention is to provide a kind of control liquid for non-enzyme type electrochemical detection system, can not need for protoheme, uric acid or other use of the quality control of the detection system of the analysans that enzyme detects.

Control liquid of the present invention comprises ferrocyanide alkali metal salt and aqueous medium, and wherein said aqueous medium is used for dissolving described ferrocyanide alkali metal salt.

A kind of method that another object of the present invention is to provide quality of controlling non-enzyme type electrochemical detection system, it comprises:

(a) control liquid of the present invention is contacted with the ferricyanide on described non-enzyme type electrochemical detection system;

(b) to described test macro, apply fixed voltage; With

(c) measure curent change and be converted into the detection reading of described system.

accompanying drawing explanation

Nothing

embodiment

The present invention relates to a kind of control liquid of non-enzyme type electrochemical detection system, the aqueous medium that it comprises ferrocyanide alkali metal salt described in ferrocyanide alkali metal salt and solubilized.

In the present invention, " control " word refers to and confirms that whether the function of non-enzyme type electrochemical detection system is normal, and confirms that whether described detection system is reliable for the measured result data of tested sample.

Being applicable to non-enzyme type electrochemical detection system of the present invention is any known non-enzyme type electrochemical detection system in affiliated field, it includes but not limited to, the U.S. the 6th, 258,230 B1 patents, No. 466344 patent of invention of TaiWan, China and No. 092106502 application for a patent for invention case announcement of TaiWan, China are for detection of the electrode examination of protoheme and uric acid article and its sensor.Be applicable to non-enzyme type electrochemical detection system of the present invention and conventionally comprise non-enzyme type electrochemical examination bar and electrochemical sensor.

Control liquid of the present invention is for example, after utilizing electron mediator (ferricyanide (as the potassium ferricyanide)) on non-enzyme type electrochemical examination bar to react with the ferrocyanide ion (ferrocyanide ion) of ferrocyanide alkali metal salt, electron mediator is reduced into reducing condition by the state of oxidation, again by applying impressed voltage, impel electron mediator to return to the state of oxidation and the principle that produces redox reaction by reducing condition reversed reaction, in described course of reaction, survey the variation of electronic signal, to measure the concentration of ferrocyanide alkali metal salt, whether differentiate described concentration value drops in pre-determined numerical range again, to judge that whether described non-enzyme type electrochemical detection system is normal, and can apply to the measurement of tested sample.

Be applicable to ferrocyanide alkali metal salt in the present invention including but not limited to potassium ferrocyanide (potassium ferrocyanide), sodium ferrocyanide or ferrocyanide lithium.And be applicable to the aqueous medium in the present invention, for any medium that can be used for dissolving ferrocyanide alkali metal salt and provide electronics to shift, it,, including but not limited to water or various damping fluid (as phosphate buffer, citrate buffer solution or citrate buffer), is preferably water.

Those skilled in the art can prepare the control liquid that contains different ferrocyanide alkali metal salt concentrations according to different non-enzyme type electrochemical detection systems, for example, according to the critical field of the normal use of non-enzyme type electrochemical detection system, allocate.In the specific embodiment of the present invention, the content of ferrocyanide alkali metal salt is higher, and the detection reading of described non-enzyme type electrochemical detection system can increase pro rata.

Generally speaking, the content of ferrocyanide alkali metal salt in control liquid is relevant with the kind of tested sample.In a preferred embodiment of the invention, when non-enzyme type electrochemical detection system is during for detection of protoheme, the content of the ferrocyanide alkali metal salt in control liquid is extremely about 0.5w/v% of approximately 0.05 weight/volume percent (w/v%), is preferably about 0.16w/v% to about 0.2w/v%; When non-enzyme type electrochemical detection system is during for detection of uric acid, the content of the ferricyanide in control liquid, be about 0.01w/v% to about 0.05w/v%, be preferably about 0.015w/v% to about 0.03w/v%.

Control liquid of the present invention can optionally further comprise that those skilled in the art knows but unlikely other composition that control liquid of the present invention is had a negative impact, for example xanthans (xanthan gum), glycerine (glycerol) or polyglycol (polyethylene glycols; PEG).

In addition, the invention provides the method for the quality of controlling non-enzyme type electrochemical detection system, it comprises:

(a) control liquid of the present invention is contacted with the ferricyanide on described non-enzyme type electrochemical detection system;

(b) to described test macro, apply fixed voltage; With

(c) measure curent change and obtain ferrocyanide alkali metal salt concentration value.

The method of the quality of control non-enzyme type electrochemical detection system of the present invention further comprises compares measurement result value and pre-determined numerical range, if described measurement result value drops in described pre-determined numerical range, the function that represents described non-enzyme type electrochemical detection system is normal, and can apply to the measurement of tested sample; If measurement result value, higher or lower than described pre-determined numerical range, represents that the function of described non-enzyme type electrochemical detection system is undesired, and cannot apply to the measurement of tested sample.Those skilled in the art can, according to the kind of multi-form non-enzyme type electrochemical detection system and tested sample, adjust described pre-determined numerical range.

In a preferred embodiment of the invention, the measurable protoheme scope of non-enzyme type electrochemical detection system is that approximately 4 Grams Per Minutes rise to approximately 20 Grams Per Minute liters, and uric acid scope is approximately 3 milligrams/point and rises to approximately 20 milligrams/deciliter.In specific embodiments of the invention, for approximately 12 Grams Per Minutes rise to, approximately 14 Grams Per Minutes rise the protoheme system testing result of use control liquid gained or approximately 16 Grams Per Minutes rise to approximately 19 Grams Per Minute liters; The uric acid system testing result of using control liquid gained rises to approximately 7 milligrams/deciliter or approximately 10 milligrams/point and rises to approximately 12 milligrams/deciliter for approximately 5 milligrams/point.

Following examples are for the invention will be further described, but not are used for limiting the scope of the invention.Any by those skilled in the art can unlabored correction and change be included in the scope of this case instructions disclosure and appended claims.

Embodiment

Embodiment 1: the preparation of control liquid of the present invention

Preparation has the control liquid of different ferrocyanide potassium concns for non-enzyme type electrochemical hematin test system and non-enzyme type electrochemical uric acid detection system two kinds respectively.In hematin test system, the potassium ferrocyanide that comprises about 0.16w/v% when control liquid, when all the other are water, obtained electric signal is converted, the detection number of degrees that rise to obtain approximately 13.2 Grams Per Minutes, and work as the potassium ferrocyanide that control liquid comprises about 0.20w/v%, when all the other are water, obtained electric signal is converted, the detection number of degrees that rise to obtain approximately 18.2 Grams Per Minutes.In uric acid detection system, when potassium ferrocyanide that control liquid comprises about 0.03w/v%, obtained electric signal is converted, to obtain the detection number of degrees of approximately 11 milligrams/deciliter, and when potassium ferrocyanide that control liquid comprises about 0.015w/v%, obtained electric signal is converted, to obtain the detection number of degrees of approximately 6.8 milligrams/deciliter.

As shown in Table 1, in the 1st rank (LEVEL 1), approximately 11 times of using for uric acid detection system of the ferrocyanide potassium concn that hematin test system is used, but system test result has differed 1900 times.This result is clear to be shown, in control liquid of the present invention, the ferrocyanide potassium concn using is not specific, needs to determine according to the non-enzyme type electrochemical detection system of different analysans.In addition, in the detection system of identical analysans, the content of potassium ferrocyanide is higher, and the detection reading of detection system can increase pro rata.

Table 1

According to the above, the present invention is that the conventional animal restructuring blood that utilizes of ferrocyanide alkali metal salt soln replacement that stability in use is higher carries out the quality control of non-enzyme type electrochemical detection system.The control liquid of non-enzyme type electrochemical detection system of the present invention has storage period limit for length, stability is high, detection is accurate and the advantage such as simple process, is suitable for detecting the whether normal operation of multiple non-enzyme type electrochemical detection system.

Although the present invention discloses as above with preferred embodiment; but it is not in order to limit the present invention; any those skilled in the art; not departing from spirit of the present invention and scope; all can do a little change and correction, therefore protection scope of the present invention should be as the criterion so that appending claims is defined.

Claims (4)

1. the whether normal method of function that detects non-enzyme type electrochemical detection system, it comprises:

(a) a kind of control liquid of non-enzyme type electrochemical detection system is contacted with the ferricyanide on described non-enzyme type electrochemical detection system, wherein said control liquid is comprised of following:

Ferrocyanide alkali metal salt; With

For dissolving the aqueous medium of described ferrocyanide alkali metal salt;

Wherein, when described non-enzyme type electrochemical detection system is when measuring protoheme, the content of described ferrocyanide alkali metal salt is that 0.05 weight/volume percent (w/v%) is to 0.5w/v%; And

Wherein, when described non-enzyme type electrochemical detection system is when measuring uric acid, the content of described ferrocyanide alkali metal salt is 0.01w/v% to 0.05w/v%;

(b) to described test macro, apply fixed voltage; With

(c) measure curent change and be converted into the detection reading of described system.

2. method according to claim 1, wherein said ferrocyanide alkali metal salt is potassium ferrocyanide.

3. method according to claim 1, wherein said aqueous medium is selected from the group that water and damping fluid form.

4. according to the method described in any one claim in claims 1 to 3, whether it further comprises compares ferrocyanide alkali metal salt concentration value and pre-determined numerical range, normal to confirm the function of non-enzyme type electrochemical detection system.