CN115308141A - Quality detection method of Adenosine Deaminase (ADA) detection kit - Google Patents
Quality detection method of Adenosine Deaminase (ADA) detection kit Download PDFInfo
- Publication number
- CN115308141A CN115308141A CN202210496816.2A CN202210496816A CN115308141A CN 115308141 A CN115308141 A CN 115308141A CN 202210496816 A CN202210496816 A CN 202210496816A CN 115308141 A CN115308141 A CN 115308141A
- Authority
- CN
- China
- Prior art keywords
- sample
- concentration
- detection
- batch
- value
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
- G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/84—Systems specially adapted for particular applications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/0001—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00 by organoleptic means
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2201/00—Features of devices classified in G01N21/00
- G01N2201/12—Circuits of general importance; Signal processing
- G01N2201/124—Sensitivity
Abstract
The invention belongs to the field of kit detection, and particularly relates to a quality detection method for an Adenosine Deaminase (ADA) detection kit. The quality detection method utilizes multiple dimensions of physical characteristics, chemical characteristics and appearance characteristics to carry out quality detection. The method has high accuracy and sensitivity, and realizes effective control of the quality of Adenosine Deaminase (ADA). Experiments prove that the kit can be used as a conventional method for detecting the quality of an Adenosine Deaminase (ADA) detection kit.
Description
Technical Field
The invention relates to a kit quality detection method, in particular to the technical field of Adenosine Deaminase (ADA) detection kit quality detection methods.
Background
Adenosine Deaminase (ADA) is an important enzyme in purine nucleoside metabolism, is a nucleic acid metabolic enzyme which has an important relation with the immunological activity of body cells, has the activity which is a sensitive index of liver injury, and can be used as one of routine examination items of liver functions.
At present, ADA activity assay in serum can be used to determine acute liver injury and residual pathology; to aid in the diagnosis of chronic liver disease; the diagnosis of hepatic fibers is facilitated; is helpful for the identification of jaundice; ADA activity deficiency is associated with Severe Combined Immunodeficiency Disease (SCID), which can lead to nucleic acid metabolism disorders that affect the development of the thymus, thereby causing immune dysfunction. Cerebrospinal fluid ADA detection can be used as an important index for diagnosis and differential diagnosis of central nervous system diseases.
ADA also has important value in differential diagnosis of exudates with difficult differentiation of benign and malignant diseases. Therefore, the determination of ADA and its isozyme levels in blood and body fluids has been increasingly clinically important for the identification, diagnosis, treatment, and immune function of these diseases.
Although the Adenosine Deaminase (ADA) detection kit has great application value, an effective quality control method for the kit is lacked at present, and effective quality evaluation for the Adenosine Deaminase (ADA) kit on the market is difficult to carry out.
Disclosure of Invention
Aiming at the defects of the existing adenosine deaminase detection kit in the test process, the invention provides the quality detection method of the Adenosine Deaminase (ADA) detection kit, which has the advantages of sensitivity, good accuracy and good stability.
In a first aspect of the present invention, a quality detection method of an Adenosine Deaminase (ADA) detection kit is provided, wherein the quality detection steps are as follows:
(1) Physical detection
(1.1) detecting the appearance of the reagent kit, and checking whether a sealing cover in the reagent kit is tightly covered or not without leakage;
(1.2) checking the clarity and content of the reagent in the reagent kit;
(2) Chemical detection
(2.1) reagent blank absorbance;
(2.2) analytical sensitivity;
(2.3) accuracy detection
(3) Detecting and evaluating calibrator and quality control material
(3.1) appearance inspection
(3.2) accuracy detection
(3.3) detecting the uniformity;
further preferably, in the step (1.2), the reagent container is irradiated by using the same colorless lighting condition to check whether the reagent is colorless clear liquid; the content is measured by a measuring tool, and further, the precision of the measuring tool is not lower than 0.5mL.
Further preferably, in the step (2.1), purified water or distilled water is used as a sample, and the absorbance value of the reaction mixture is measured at 546nm to check whether the absorbance is less than or equal to 1.0000; the requirement of the reagent blank change rate is as follows: the change rate (delta A/min) of blank absorbance of the reagent per minute is less than or equal to 0.0200.
Further preferably, in the step (2.2), when the concentration of ADA in the sample is 90U/L, the absorbance change value delta A/min is more than or equal to 0.0200; if the sample concentration is not 90U/L, other samples with known concentrations can be selected to obtain an approximate absorbance value of 90U/L by conversion for calculation.
Still further preferably, the step (2.3) accuracy detecting step is as follows:
(2.3.1) at least two levels of quality control products with fixed values are selected and measured, and the relative deviation (Bias%) is obtained according to the following formula.
In the formula: bias% — relative deviation;
-sample measurement mean; TV-quality control sample target value.
The relative deviation Bias% is less than or equal to 10.0%;
(2.3.2) adding a certain volume of standard solution or pure product into the human serum sample for testing, repeatedly measuring each sample for 3 times, and calculating the recovery rate R (%) according to the following formula;
in the formula: r-recovery rate; v-volume of standard solution added; v 0 -the volume of the serum sample; c-serum sample additionThe detected concentration after the standard solution; c. C 0 -the detected concentration of the serum sample; c. C s -the concentration of the standard solution; the recovery rate is in the range of 90-110%;
(2.3.3) precision measurement: the same quality control sample is parallelly measured for 10 times by using the same batch of reagents, ADA of the quality control sample is more than or equal to 20U/L, mean value and standard deviation are calculated, and the variation Coefficient (CV) in batch is calculated according to the following formula In batch ) Coefficient of variation in batch CV thereof In batch ≤4.0％；
In the formula:
-sample assay result mean; s-standard deviation; CV of In batch -intra-batch coefficient of variation.
(2.3.4) Linear Range determination:
the kit has a correlation coefficient r of more than or equal to 0.990 in the concentration range of 4-250U/L; the sample concentration is less than or equal to 25U/L, and the absolute deviation is less than or equal to 5U/L; the sample concentration is more than 25U/L, and the relative deviation is less than or equal to 10.0 percent;
in the concentration range of 4-250U/L, taking a high-concentration sample close to the upper limit of the linear range and a low-concentration sample close to the lower limit of the linear range, and mixing to obtain at least 5 diluted concentration samples (x) i ) At least 2 times for each dilution concentration sample, and the mean value (y) of the measurement results is determined i ) (ii) a In diluted concentration (x) i ) As independent variable, the mean value (y) of the results is determined i ) A linear regression equation is obtained for the dependent variable, and the correlation coefficient (r) of the linear regression is calculated according to the following formula. Diluting the concentration (x) i ) Substituting linear regression equation to calculate y i Estimated value of (a) and y i The absolute value is taken as the relative or absolute deviation from the estimated value.
(2.3.5) inter-batch Difference measurement: respectively testing the same quality control sample by using 3 reagents with different batch numbers, wherein the concentration of the quality control sample is more than or equal to 20U/L, and each batch number is repeatedly tested for 3 times; calculate the mean of the results of 3 measurements per batch
And the overall mean of the results of the 3 lot number tests
Calculating the relative range (R) of the mean value of the three batch reagent measurements according to the following formula, wherein the relative range (R) is less than or equal to 8.0 percent;
in the formula: x is the number of max ——
The maximum value of (a) is,
x min ——
minimum value of (1).
Further preferably, in the appearance detection of step (3.1), the freeze-dried product is dissolved and detected, and the dissolved liquid is required to be yellowish; in the step (3.2) of accuracy detection, after calibration is carried out by using the calibrator qualified for detection and the kit, the calibrator to be detected is determined, the determination is repeated for 3 times, and the mean values of the determination results are respectively calculated
Calculating a relative deviation (Bias) according to the following formula;
the relative deviation (Bias) or the deviation of the measured value and the mark is less than or equal to 10.0 percent; in the step (3.3) of uniformity detection, 10 bottles to be detected are takenThe calibrator or quality control material is measured 1 time per bottle, and the mean value of the measured values is calculated respectively
And standard deviation (S) 1 ) (ii) a Taking 1 bottle, repeating the measurement for 10 times, and calculating the mean value of the measured values
And standard deviation (S) 2 ) The standard deviation (S) between bottles was obtained by the following formula Bottle room ) And Coefficient of Variation (CV) Bottle room ) When S1 is less than S2, let CV =0;
its batch precision (CV) Bottle room )≤8.0％。
In a second aspect of the invention, the application of the detection method of the kit in the quality detection of Adenosine Deaminase (ADA) detection kit is provided.
Compared with the conventional kit detection method, the kit has the following beneficial effects:
(1) According to the invention, by optimizing the quality detection method of the kit, the method is not limited to simple appearance detection, physical detection or chemical detection, but rather designs a multi-dimensional detection mode according to the characteristics of a normal Adenosine Deaminase (ADA) kit, which is obviously superior to the prior art.
(2) The invention is not limited to a qualitative detection mode, designs a more accurate detection formula and corresponding parameters, can obviously improve the defect that only a qualitative detection kit is used in the prior art, and can more accurately and quickly determine the quality of the kit to be detected.
Detailed Description
The invention will be further described with reference to specific embodiments, and the advantages and features of the invention will become apparent as the description proceeds. These examples are illustrative only and do not limit the scope of the present invention in any way. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention, and that such changes and modifications may be made without departing from the spirit and scope of the invention.
Example 1
1. Material preparation
Adenosine Deaminase (ADA) detection kit: randomly spot-check multiple batches of kits from the market.
Full-automatic biochemical analyzer: a conventional fully automatic biochemical analyzer, for example, hitachi 7180 fully automatic biochemical analyzer, is used.
2. Quality detection
First time of detection
(1) Physical detection
(1.1) detecting the appearance of the reagent kit, and checking whether a sealing cover in the reagent kit is tightly covered, checking whether a liquid leakage phenomenon exists or not, and finding that the phenomenon does not exist;
(1.2) checking the clarity and content of the reagent in the reagent kit, taking out the reagent in the reagent kit for spot inspection, balancing the reagent to room temperature, irradiating the reagent container by using the same colorless illumination condition, and checking whether the reagent is colorless clear liquid; the content is measured by a measuring tool, the precision of the measuring tool is not lower than 0.5mL, and the batch of sampling kits are found to meet the requirements through inspection.
(2) Chemical detection
And (2.1) opening the full-automatic biochemical analyzer for self-checking or calibration, and setting instrument parameters.
The basic parameters are set as follows.
| Measuring wavelength (Main/auxiliary) | 546nm/700nm | Measuring temperature | 37℃ | Calibration mode | Linearity |
| Ratio of reagent samples (R1: R2: S) | 225：75：6 | Type of reaction | Velocity method | Reaction direction | Up |
| Delay time | 3 minutes | Time of reading | 2 minutes | / | / |
The amount of the reagent sample can be proportionally adjusted according to actual needs, and S is sample.
Using a fully automated biochemical analyzer, calibration (calibration) is performed after loading of reagents, after which the accuracy, precision and linear range are determined. If a semi-automatic biochemical analyzer is used, the ratio of R1 to R2 is 3:1 (V/V) to form a single working solution, and then adding a quality control product and a sample to be detected respectively for determination.
The calculation principle of the measurement result of the full-automatic biochemical analyzer is as follows, and the instrument can automatically display the measurement result.
ADA(U/L)＝C S ×ΔA T /ΔA S (U/L)
In the formula: delta A T Average absorbance change per minute value of sample to be measured
ΔA S Average absorbance change per minute of calibration solution
C S Concentration of ADA in calibration solutions
Measuring a blank sample to ensure that the blank change rate of the reagent is in a required range; using purified water or distilled water as a sample, measuring the absorbance value of the reaction mixed solution at 546nm, checking that the absorbance value is less than or equal to 1.0000, and detecting that the absorbance value of the blank control reagent in the batch is 0.169 to meet the requirements; through actual detection, the change rate (delta A/min) of blank absorbance of the reagent per minute is 0.0009, which meets the requirement (less than or equal to 0.0200);
(2.2) sensitivity of analysis
The qualified requirements are as follows: when the concentration of ADA in the sample is 90U/L, the absorbance change value (delta A/min) of the sample is more than or equal to 0.0200; other samples of known concentration can be selected and converted to approximate absorbance values of 90U/L.
Through actual detection, the concentration of the calibrator of the kit in the batch is 65U/L, the absorbance values of the primary detection STD are 0.0466 and 0.0466, the average value is 0.0466, the absorbance change value converted into the concentration of 90U/L is 0.0630, and the absorbance change value (delta A/min) is far greater than 0.0200, thereby meeting the requirement.
(2.3) accuracy detection
The accuracy detection steps are as follows:
(2.3.1) the qualification requirements are as follows: at least two levels of quality control products with fixed values are selected for measurement, and the relative deviation (Bias%) is obtained according to the following formula.
In the formula: bias% — relative deviation;
-sample measurement mean; TV-quality control sample target value.
The relative deviation Bias% is less than or equal to 10.0%;
according to the above requirements, the mean value of the measured results of the samples is detected and calculated
16.3 and 32.9, the target value TV of the quality control sample is 17.0 and 34.0, and the relative deviation value Bias% is 3.92% and 3.33% calculated by a formula and meets the qualified requirement.
(2.3.2) adding a certain volume of standard solution or pure product into the human serum sample for testing, repeatedly measuring each sample for 3 times, and solving the recovery rate R (%) according to the following formula;
in the formula: r-recovery rate; v-volume of standard solution added; v 0 -the volume of the serum sample; c, the detection concentration of the serum sample after the standard solution is added; c. C 0 -the detected concentration of the serum sample; c. C s -the concentration of the standard solution;
the qualified requirements are as follows: the recovery rate is in the range of 90-110%;
the volume V of the added standard solution is 20 and the volume V of the serum sample is calculated for the recovery rate of the batch 0 Is 200; the detection concentration c of the serum sample added with the standard solution is 21.1; concentration of serum sample to be detected c 0 Is 16.33; concentration c of the Standard solution s The recovery rate R is calculated to be 105.8 percent and meets the qualified requirement.
(2.3.3) precision measurement: the same quality control sample is parallelly measured for 10 times by using the same batch of reagents, ADA of the quality control sample is more than or equal to 20U/L, mean value and standard deviation are calculated, and the variation Coefficient (CV) in batch is calculated according to the following formula In batch ) Qualification requirement is the coefficient of variation CV in batch In batch ≤4.0％；
In the formula:
-mean value of sample measurements(ii) a S-standard deviation; CV of In batch -intra-batch coefficient of variation.
Detecting the batch of reagents to detect that the sample measurement result values are 23.1, 24.5, 24.3, 23.0, 23.9, 24.2, 24.1, 23.1, 23.6 and 23.2, and the sample measurement result mean value
23.70, standard deviation S of 0.57, coefficient of variation in batch CV In batch 2.4 percent, thereby meeting the qualified requirement.
(2.3.4) Linear Range determination:
the qualified requirements are as follows: in the concentration range of 4-250U/L, the correlation coefficient r is more than or equal to 0.990; the sample concentration is less than or equal to 25U/L, and the absolute deviation is less than or equal to 5U/L; the sample concentration is more than 25U/L, and the relative deviation is less than or equal to 10.0 percent;
in the concentration range of 4-250U/L, taking a high-concentration sample close to the upper limit of the linear range and a low-concentration sample close to the lower limit of the linear range, and mixing to obtain at least 5 diluted concentration samples (x) i ) Each diluted concentration sample is tested at least 2 times, and the mean value (y) of the measurement results is determined i ) (ii) a In diluted concentration (x) i ) As independent variable, the mean value (y) of the results is determined i ) A linear regression equation is obtained for the dependent variable, and the correlation coefficient (r) of the linear regression is calculated according to the following formula. Diluting the concentration (x) i ) Substituting linear regression equation to calculate y i Estimated value of (a) and y i The absolute value is taken as the relative or absolute deviation from the estimated value.
The batch reagent measurements were as follows: mixing and diluting the sample concentration to obtain 5 diluted concentration samples x i The average value of the samples is 0U/L, 62.5U/L, 125U/L, 187.5U/L and 250U/L
At 0.00, 31.8, 64.17, 128.1, 183.07, 249.00, calculated to be r value of 0.9997, the sample concentration is less than or equal to 25U/L, and the absolute deviation is 1.49U/L; the sample concentration is more than 25U/L, and the relative deviation is 1.57%, 2.59%, 1.87% and 0.30%.
(2.3.5) inter-batch Difference measurement: respectively testing the same quality control sample by using 3 reagents with different batch numbers, wherein the concentration of the quality control sample is more than or equal to 20U/L, and each batch number is repeatedly tested for 3 times; calculate the mean of the results of 3 measurements per batch separately
And the overall mean of the results of the 3 lot number tests
The relative range (R) of the mean values of the three batches of reagents is calculated according to the following formula, and the qualified requirements are as follows: the relative range (R) is less than or equal to 8.0 percent;
in the formula: x is the number of max ——
The maximum value of (a) is,
x min ——
minimum value of (1).
Aiming at the batch of reagents, 3 reagents with different batches are used for respectively testing the same quality control sample, and the concentration of the quality control sample is
11.9, 12.3 and 11.8 respectively, so that x is obtained by comparing the three concentrations max Is 12.3,x min The value is 11.8, and the relative range R is calculated to be 4.2%, so the qualified requirement is met.
(3) Detecting and evaluating calibrator and quality control material
(3.1) appearance inspection
Firstly, dissolving and detecting a freeze-dried product, and observing to find that the dissolved liquid is yellowish and meets the requirement;
(3.2) accuracy detection
In the step (3.2) of accuracy detection, after calibration is carried out by using the calibrator qualified for detection and the kit, the calibrator to be detected is determined, the determination is repeated for 3 times, the determination results are respectively calculated to be 61.6, 62.3 and 60.1, and the average value is obtained
61.33, the calibration standard value is 62.6, and the relative deviation (Bias) is obtained according to the following formula;
the relative deviation (Bias) or the deviation between the measured value and the mark is calculated to be 2.02 percent, which meets the qualified requirement of less than or equal to 10.0 percent; (3.3) detecting the uniformity; in the step (3.3) of uniformity detection, 10 bottles of to-be-detected calibrators or quality control substances are taken, each bottle is measured for 1 time, and the numerical value calibrators are calculated to be 66.2, 63.0, 64.4, 62.5, 65.2, 65.4, 61.3, 62.6, 58.5 and 60.0; the quality control products are 35.1, 30.2, 31.7, 29.4, 34.6, 35.2, 35.6, 35.5, 35.7 and 29.7, and the mean values of the measured values are respectively calculated
The calibration sample is 62.91, the quality control sample is 33.27 and the standard deviation (S) 1 ) The calibration product is 2.35, and the quality control product is 2.54; taking 1 bottle, repeating the measurement for 10 times, and calculating the mean value of the measured values
The calibration material is 64.44, the quality control material is 33.36 and the standard deviation (S) 2 ) The standard deviation (S) between bottles was determined as follows, with a calibrator of 1.40 and a quality control of 1.95 Bottle room ) And Coefficient of Variation (CV) Bottle room ) When S1 is less than S2, let CV =0;
final calculation of the precision (CV) in the batch Bottle room ) 3.00 percent of calibration product and 4.93 percent of quality control product, meets the qualified requirement (less than or equal to 8.0 percent), calculates and counts various data by using a formula according to the requirements of chemical detection steps, detection and evaluation of the calibration product and the quality control product, records the data in an original test record table, fills various judgment results, and meets the requirement of the detection result.
Second detection
(1) Physical detection
(1.1) detecting the appearance of the reagent kit, and checking whether a sealing cover in the reagent kit is tightly covered, checking whether a liquid leakage phenomenon exists or not, and finding that the phenomenon does not exist;
(1.2) checking the clarity and content of the reagent in the reagent kit, taking out the reagent in the reagent kit for spot inspection, balancing the reagent to room temperature, irradiating the reagent container by using the same colorless illumination condition, and checking whether the reagent is colorless clear liquid; the content is measured by a measuring tool, the precision of the measuring tool is not lower than 0.5mL, and the batch of sampling kits are found to meet the requirements through inspection.
(2) Chemical detection
And (2.1) opening the full-automatic biochemical analyzer for self-checking or calibration, and setting instrument parameters.
The basic parameters are set as follows.
| Measuring wavelength (Main/auxiliary) | 546nm/700nm | Measuring temperature | 37℃ | Calibration mode | Linearity |
| Reagent sample ratio (R1: R2: S) | 225：75：6 | Type of reaction | Method of velocity | Reaction direction | Up |
| Delay time | 3 minutes | Time of reading | 2 minutes |
The amount of the reagent sample can be proportionally adjusted according to actual needs, and S is sample.
Using a fully automated biochemical analyzer, a calibration (calibration) is performed after loading the reagents, after which measurements of accuracy, precision and linear range are made. If a semi-automatic biochemical analyzer is used, the ratio of R1 to R2 is 3:1 (V/V) to form a single working solution, and then adding a quality control product and a sample to be detected respectively for determination.
The calculation principle of the measurement result of the full-automatic biochemical analyzer is as follows, and the instrument can automatically display the measurement result.
ADA(U/L)＝C S ×ΔA T /ΔA S (U/L)
In the formula: delta A T Average absorbance change per minute value of sample to be measured
ΔA S Average absorbance change per minute of calibration solution
C S Concentration of ADA in calibration solution
Measuring a blank sample to ensure that the blank change rate of the reagent is in a required range; using purified water or distilled water as a sample, measuring the absorbance value of the reaction mixed solution at 546nm, checking that the absorbance value is less than or equal to 1.0000, and detecting that the absorbance value of the blank control reagent of the batch is 0.0154 to meet the requirements; through actual detection, the change rate (delta A/min) of blank absorbance of the reagent per minute is 0.0008, which meets the requirement (less than or equal to 0.0200);
(2.2) sensitivity of analysis
The qualified requirements are as follows: when the concentration of ADA in the sample is 90U/L, the absorbance change value (delta A/min) of the sample is more than or equal to 0.0200; other samples of known concentration can be selected and converted to approximate absorbance values of 90U/L.
Through actual detection, the concentration of the reagent calibrator of the batch of the kit is 66U/L, the absorbance values of the primary detection STD are 0.0442 and 0.0444, the mean value is 0.0443, and after the absorbance is converted into the absorbance with the concentration of 90U/L, the absorbance change value (delta A/min) is 0.0590 and is far greater than 0.0200, so that the requirement is met.
(2.3) accuracy detection
The accuracy detection steps are as follows:
(2.3.1) the qualified requirements are as follows: at least two levels of quality control products with fixed values are selected for measurement, and the relative deviation (Bias%) is obtained according to the following formula.
In the formula: bias% — relative deviation;
-sample measurement mean; TV-quality control sample target value.
The relative deviation Bias% is less than or equal to 10.0%;
according to the above requirements, the mean value of the measured results of the samples is detected and calculated
17.5 and 34.5, the target value TV of the quality control sample is 17.00 and 34.00, and the relative deviation value Bias% is 3.47% calculated by a formula and meets the qualified requirement.
(2.3.2) adding a certain volume of standard solution or pure product into the human serum sample for testing, repeatedly measuring each sample for 3 times, and calculating the recovery rate R (%) according to the following formula;
in the formula: r-recovery rate; v-volume of standard solution added; v 0 -the volume of the serum sample; c is the detection concentration of the serum sample after the standard solution is added; c. C 0 -the detected concentration of the serum sample; c. C s -the concentration of the standard solution;
the qualified requirements are as follows: the recovery rate is in the range of 90-110%;
the volume V of the added standard solution is 20 and the volume V of the serum sample is calculated for the recovery rate of the batch 0 Is 200; the detection concentration c of the serum sample added with the standard solution is 20.93; detected concentration c of serum sample 0 Is 16.33; concentration c of the Standard solution s The recovery rate R is calculated to be 102.9 percent and is in accordance with the qualified requirement at 65.0.
(2.3.3) precision measurement: the same quality control sample is parallelly measured for 10 times by using the same batch of reagents, ADA of the quality control sample is more than or equal to 20U/L, mean value and standard deviation are calculated, and the variation Coefficient (CV) in batch is calculated according to the following formula In batch ) The qualification requirement is the coefficient of variation CV in batch In batch ≤4.0％；
In the formula:
-sample assay resultsMean value; s-standard deviation; CV of In batch -intra-batch coefficient of variation.
Detecting the batch of reagents to detect that the sample measurement result values are 24.1, 24.3, 23.3, 23.0, 24.9, 24.2, 23.1, 24.1, 23.6 and 23.4, and the sample measurement result mean value
23.80, standard deviation S of 0.61, coefficient of variation in batch CV In batch Is 2.57, so the qualified requirement is met.
(2.3.4) Linear Range determination:
the qualified requirements are as follows: in the concentration range of 4-250U/L, the correlation coefficient r is more than or equal to 0.990; the sample concentration is less than or equal to 25U/L, and the absolute deviation is less than or equal to 5U/L; the sample concentration is more than 25U/L, and the relative deviation is less than or equal to 10.0 percent;
in the concentration range of 4-250U/L, taking a high concentration sample close to the upper limit of the linear range and a low concentration sample close to the lower limit of the linear range, and mixing to obtain at least 5 diluted concentration samples (x) i ) At least 2 times for each dilution concentration sample, and the mean value (y) of the measurement results is determined i ) (ii) a In diluted concentration (x) i ) As independent variable, the mean value (y) of the results is determined i ) A linear regression equation is obtained for the dependent variable, and the correlation coefficient (r) of the linear regression is calculated according to the following formula. Diluting the concentration (x) i ) Substituting linear regression equation to calculate y i Estimated value of (a) and y i The absolute value is taken as the relative or absolute deviation from the estimated value.
The batch measured the following: mixing and diluting the sample concentration to obtain 5 diluted concentration samples x i The average values of the samples were 0U/L, 6.5U/L, 125U/L, 187.5U/L, and 250U/L
Calculated to be-0.10, 66.00, 131.47, 195.87, 258.40, r value of 0.9999, the sample concentration is less than or equal to 25U/L, and the absolute deviation is 1.05U/L; the sample concentration is more than 25U/L, and the relative deviation is 0.55%, 0.87%, 0.44% and 0.50%.
(2.3.5) inter-batch Difference measurement: synchronously testing the same quality control sample by using 3 reagents with different batch numbers, wherein the concentration of the quality control sample is more than or equal to 20U/L, and each batch number is repeatedly tested for 3 times; calculate the mean of the results of 3 measurements per batch separately
And the overall mean of the results of the 3 lot number tests
The relative range (R) of the mean value of the three batches of reagents is calculated according to the following formula, and the qualified requirement is as follows: the relative range (R) is less than or equal to 8.0 percent;
in the formula: x is a radical of a fluorine atom max ——
The maximum value of (a) is,
x min ——
minimum value of (1).
Aiming at the batch of reagents, synchronously testing the same quality control sample by using 3 reagents with different batch numbers, wherein the concentration of the quality control sample is
11.9, 12.6 and 13.8 respectively, so that x is obtained by comparing the three concentrations max Is 17.5,x min And 15.3, and further calculating the relative range R to be 14.8%, wherein the value is found to be more than 8%, and the detection does not meet the qualified requirements.
(3) Detecting and evaluating calibrator and quality control material
(3.1) appearance inspection
Firstly, dissolving and detecting a freeze-dried product, and observing to find that the dissolved liquid is yellowish and meets the requirement;
(3.2) accuracy detection
In the step (3.2) of accuracy detection, after calibration is carried out by using the calibrator qualified for detection and the kit, the calibrator to be detected is determined, the determination is repeated for 3 times, the determination results are respectively calculated to be 63.3, 62.6 and 64.5, and the average value is obtained
63.47, the calibration standard value is 62.6, and the relative deviation (Bias) is obtained according to the following formula;
the relative deviation (Bias) or the deviation between the measured value and the mark is calculated to be 1.38 percent, which meets the qualified requirement of less than or equal to 10.0 percent; (3.3) detecting the uniformity; in the step (3.3) of uniformity detection, 10 bottles of to-be-detected calibrators or quality control substances are taken, each bottle is measured for 1 time, and the numerical value calibrators are calculated to be 65.5, 64.9, 65.7, 63.5, 66.3, 63.2, 63.4, 65.1, 63.8 and 63.1; the quality control products are 32.6, 30.0, 34.6, 30.5, 32.8, 32.4, 35.2, 33.1, 35.2 and 31.7, and the mean values of the measured values are respectively calculated
64.45 for calibrator, 32.81 for quality control and standard deviation (S) 1 ) The content of the calibrator is 1.12, and the content of the quality control material is 1.71; taking 1 bottle, repeating the measurement for 10 times, and calculating the mean value of the measured values
The calibrator is 64.65, the quality control is 32.32 and the standard deviation (S) 2 ) The standard deviation (S) between bottles was determined as follows, using a calibrator of 0.85 and a quality control of 1.31 Bottle room ) And Coefficient of Variation (CV) Bottle room ) When S1 < S2, letCV＝0；
Final calculation of the precision (CV) in the batch Bottle room ) The content of the calibrator is 1.13 percent, the content of the quality control product is 3.36 percent, the qualification requirements (less than or equal to 8.0 percent) are met, according to the chemical detection steps, the requirements of the calibrator and the quality control product are detected and evaluated, various data are calculated and counted by using a formula and are recorded in an original test record table, various judgment results are filled, and the detection result meets the requirements.
Third time of detection
(1) Physical detection
(1.1) detecting the appearance of the reagent kit, and checking whether a sealing cover in the reagent kit is tightly covered, checking whether a liquid leakage phenomenon exists or not, and finding that the phenomenon does not exist;
(1.2) checking the clarity and content of the reagent in the reagent kit, taking out the reagent in the reagent kit for sampling inspection, balancing the reagent to room temperature, irradiating the reagent container by using the same colorless illumination condition, and checking whether the reagent is colorless clear liquid; the content is measured by a measuring tool, the precision of the measuring tool is not lower than 0.5mL, and the batch of sampling kits are found to meet the requirements through inspection.
(2) Chemical detection
And (2.1) opening the full-automatic biochemical analyzer for self-checking or calibration, and setting instrument parameters.
The basic parameters are set as follows.
| Measuring wavelength (Main/auxiliary) | 546nm/700nm | Measuring temperature | 37℃ | Calibration mode | Linearity |
| Reagent sample ratio (R1: R2: S) | 225：75：6 | Type of reaction | Velocity method | Direction of reaction | Up |
| Delay time | 3 minutes | Time of reading | 2 minutes |
The amount of the reagent sample can be proportionally adjusted according to actual needs, and S is sample.
Using a fully automated biochemical analyzer, calibration (calibration) is performed after loading of reagents, after which the accuracy, precision and linear range are determined. If a semi-automatic biochemical analyzer is used, the ratio of R1 to R2 is 3:1 (V/V) to form a single working solution, and then adding a quality control product and a sample to be detected respectively for determination.
The calculation principle of the measurement result of the full-automatic biochemical analyzer is as follows, and the instrument can automatically display the measurement result.
ADA(U/L)＝C S ×ΔA T /ΔA S (U/L)
In the formula: delta A T Average light absorption per minute of sample to be measuredDegree change value
ΔA S Average absorbance change per minute of calibration solution
C S Concentration of ADA in calibration solutions
Measuring a blank sample to ensure that the blank change rate of the reagent is in a required range; using purified water or distilled water as a sample, measuring the absorbance value of the reaction mixed solution at 546nm, checking that the absorbance is less than or equal to 1.0000, and detecting that the absorbance value of the blank control reagent of the batch is 0.0123, which meets the requirements; through actual detection, the change rate (delta A/min) of blank absorbance of the reagent per minute is 0.0008, which meets the requirement (less than or equal to 0.0200);
(2.2) sensitivity of analysis
The qualified requirements are as follows: when the concentration of ADA in the sample is 90U/L, the absorbance change value delta A/min is more than or equal to 0.0200; other samples with known concentrations can be selected and converted to approximate absorbance values of 90U/L.
Through actual detection, the concentration of the calibrator of the kit in the batch is 66U/L, the absorbance values of the primary detection STD are 0.0446 and 0.0445, the mean value is 0.0446, and after the absorbance is converted into the absorbance with the concentration of 90U/L, the absorbance change value (delta A/min) is 0.06 and is far greater than 0.0200, so that the requirement is met.
(2.3) accuracy detection
The accuracy detection steps are as follows:
(2.3.1) the qualification requirements are as follows: at least two levels of quality control products with fixed values are selected for measurement, and the relative deviation (Bias%) is obtained according to the following formula.
In the formula: bias% — relative deviation;
-sample assay result mean; TV-quality control sample target value.
The relative deviation Bias% is less than or equal to 10.0%;
according to the above requirements, the mean value of the measured results of the samples is detected and calculated
16.6 and 33.6, the target value TV of the quality control sample is 17.00 and 34.00, and the relative deviation value Bias% is 2.16% and 1.18% calculated by a formula and meets the qualified requirement.
(2.3.2) adding a certain volume of standard solution or pure product into the human serum sample for testing, repeatedly measuring each sample for 3 times, and calculating the recovery rate R (%) according to the following formula;
in the formula: r-recovery rate; v-volume of standard solution added; v 0 -the volume of the serum sample; c, the detection concentration of the serum sample after the standard solution is added; c. C 0 -the detected concentration of the serum sample; c. C s -the concentration of the standard solution;
the qualified requirements are as follows: the recovery rate is in the range of 90-110%;
the volume V of the added standard solution is 20 and the volume V of the serum sample is calculated for the recovery rate of the batch 0 Is 200; the detection concentration c of the serum sample added with the standard solution is 20.77; concentration of serum sample to be detected c 0 Is 16.33; concentration c of the Standard solution s Is 65.0, the calculated recovery rate R is 100.15 percent, and the qualified requirement is met.
(2.3.3) precision measurement: the same quality control sample is parallelly measured for 10 times by using the same batch of reagents, ADA of the quality control sample is more than or equal to 20U/L, mean value and standard deviation are calculated, and the variation Coefficient (CV) in batch is calculated according to the following formula In batch ) Qualification requirement is the coefficient of variation CV in batch In batch ≤4.0％；
In the formula:
-sample measurement mean; s-standard deviation; CV of In batch -intra-batch coefficient of variation.
Detecting the reagent batch to detect that the measured result values of the samples are 25.5, 25.6, 25.2, 25.6, 25.7, 25.4, 25.5, 25.4, 25.2 and 25.3, and the mean value of the measured results of the samples is
25.44, standard deviation S of 0.17, coefficient of variation in batch CV In batch Is 0.67 percent, thereby meeting the qualified requirement.
(2.3.4) Linear Range determination:
the qualified requirements are as follows: in the concentration range of 4-250U/L, the correlation coefficient r is more than or equal to 0.990; the sample concentration is less than or equal to 25U/L, and the absolute deviation is less than or equal to 5U/L; the sample concentration is more than 25U/L, and the relative deviation is less than or equal to 10.0 percent;
in the concentration range of 4-250U/L, taking a high-concentration sample close to the upper limit of the linear range and a low-concentration sample close to the lower limit of the linear range, and mixing to obtain at least 5 diluted concentration samples (x) i ) At least 2 times for each dilution concentration sample, and the mean value (y) of the measurement results is determined i ) (ii) a In diluted concentration (x) i ) As independent variable, the mean value (y) of the results is determined i ) A linear regression equation is obtained for the dependent variable, and the correlation coefficient (r) of the linear regression is calculated according to the following formula. Diluting the concentration (x) i ) Substituting linear regression equation to calculate y i Estimated value of (a) and y i The absolute value is taken as the relative or absolute deviation from the estimated value.
The batch reagent measurements were as follows: mixing and diluting the sample concentration to obtain 5 diluted concentration samples x i The average value of the samples is 0U/L, 62.5U/L, 125U/L, 187.5U/L and 250U/L
is-0.2U/L, 66.2U/L and 1344U/L, 199.5U/L and 262.7U/L, and the r value is 0.9999, the sample concentration is less than or equal to 25U/L, and the absolute deviation is 0.88U/L; the sample concentration is more than 25U/L, and the relative deviation is 0.65%, 1.42%, 0.53% and 0.62%.
(2.3.5) measurement of the difference between batches: respectively testing the same quality control sample by using 3 reagents with different batch numbers, wherein the concentration of the quality control sample is more than or equal to 20U/L, and each batch number is repeatedly tested for 3 times; calculate the mean of the results of 3 measurements per batch separately
And the overall mean of the results of the 3 lot number tests
The relative range (R) of the mean values of the three batches of reagents is calculated according to the following formula, and the qualified requirements are as follows: the relative range (R) is less than or equal to 8.0 percent;
in the formula: x is the number of max ——
The maximum value of (a) is,
x min ——
the minimum value of (d).
Aiming at the batch of reagents, synchronously testing the same quality control sample by using 3 reagents with different batch numbers, wherein the concentration of the quality control sample is
13.8, 12.9 and 13.2 respectively, so that x is obtained by comparing the three concentrations max Is 13.8,x min Is 12.9, and then the relative range R is calculated to be 6.8 percent, thereby meeting the qualified requirement.
(3) Detecting and evaluating calibrator and quality control material
(3.1) appearance inspection
Firstly, dissolving and detecting a freeze-dried product, and observing to find that the dissolved liquid is yellowish and meets the requirement;
(3.2) accuracy detection
In the step (3.2) of accuracy detection, after calibration is carried out by using the calibrator qualified for detection and the kit, the calibrator to be detected is determined, the determination is repeated for 3 times, the determination results are respectively calculated to be 63.5, 64.2 and 63.4, and the average value is obtained
63.7, the standard value of the calibrator is 62.6, and the relative deviation (Bias) is obtained according to the following formula;
the relative deviation (Bias) or the deviation between the measured value and the mark is calculated to be 1.76 percent, which meets the qualified requirement of less than or equal to 10.0 percent; (3.3) detecting the uniformity; in the step (3.3) of uniformity detection, 10 bottles of to-be-detected calibrators or quality control products are taken, each bottle is measured for 1 time, the numerical value calibrators are calculated to be 65.5, 63.2, 63.8, 65.9, 63.0, 64.5, 66.4, 65.3, 63.2 and 65.6, the quality control products are calculated to be 35.1, 30.7, 30.0, 31.7, 35.0, 35.6, 34.1, 31.8, 30.6 and 30.1, and the average values of the measured values are calculated respectively
The calibration sample is 64.64, the quality control product is 32.47 and the standard deviation (S) 1 ) The calibrator is 1.20, and the quality control is 2.13; taking 1 bottle, repeating the measurement for 10 times, and calculating the mean value of the measured values
The calibration sample is 64.04, the quality control sample is 33.45 and the standard deviation (S) 2 ) The standard deviation (S) between bottles was determined as follows, using a calibrator of 0.70 and a quality control of 1.53 Bottle room ) And Coefficient of Variation (CV) Bottle room ) When S1 is less than S2, let CV =0;
final calculation of the precision (CV) in the batch Bottle room ) The content of the calibrator is 0.97%, the content of the quality control product is 4.54%, and the qualified product (less than or equal to 8.0%) is detected and evaluated according to the chemical detection steps, the requirements of the calibrator and the quality control product are calculated and counted by using a formula, and the data are recorded in an original test record table, and various judgment results are filled, wherein the detection result meets the requirements.
Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention, and not for limiting the same; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.
Claims (7)
1. A quality detection method of an Adenosine Deaminase (ADA) detection kit is characterized by comprising the following quality detection steps:
(1) Physical detection
(1.1) detecting the appearance of the reagent kit, and checking whether a sealing cover in the reagent kit is tightly covered or not without leakage;
(1.2) checking the clarity and content of the reagent in the reagent kit;
(2) Chemical detection
(2.1) reagent blank absorbance;
(2.2) analytical sensitivity;
(2.3) accuracy detection
(3) Detecting and evaluating calibrator and quality control material
(3.1) appearance inspection
(3.2) accuracy detection
(3.3) uniformity detection.
2. The quality inspection method according to claim 1, wherein in the step (1.2), the reagent container is irradiated by the same colorless illumination condition to check whether the reagent is colorless clear liquid; the content is measured by a measuring tool, and further, the precision of the measuring tool is not lower than 0.5mL.
3. The method of claim 1 or 2, wherein in step (2.1), purified water or distilled water is used as a sample, and the absorbance of the reaction mixture is measured at 546nm to determine whether the absorbance is less than or equal to 1.0000; the requirement of the reagent blank change rate is as follows: the change rate (delta A/min) of blank absorbance of the reagent per minute is less than or equal to 0.0200.
4. A mass spectrometry method according to any one of claims 1 to 3, wherein in the step (2.2), when the concentration of ADA in the sample is 90U/L, the absorbance change value Δ A/min is not less than 0.0200; if the sample concentration is not 90U/L, other samples with known concentrations can be selected to obtain an approximate absorbance value of 90U/L by conversion for calculation.
5. A quality detection method according to any one of claims 1 to 4, wherein said step (2.3) of accuracy detection is as follows:
(2.3.1) at least two levels of quality control products with fixed values are selected and measured, and the relative deviation (Bias%) is obtained according to the following formula.
In the formula: bias% — relative deviation;
-sample measurement mean; TV-quality control sample target value.
The relative deviation Bias% is less than or equal to 10.0%;
(2.3.2) adding a certain volume of standard solution or pure product into the human serum sample for testing, repeatedly measuring each sample for 3 times, and calculating the recovery rate R (%) according to the following formula;
in the formula: r-recovery rate; v-volume of standard solution added; v 0 -the volume of the serum sample; c, the detection concentration of the serum sample after the standard solution is added; c. C 0 -the detected concentration of the serum sample; c. C s -the concentration of the standard solution; the recovery rate is in the range of 90-110%;
(2.3.3) precision measurement: the same batch of reagent is used for parallelly measuring the same quality control sample for 10 times, the ADA of the quality control sample is more than or equal to 20U/L, the mean value and the standard deviation are calculated, and the variation Coefficient (CV) in the batch is calculated according to the following formula In batch ) Coefficient of variation in batch CV thereof In batch ≤4.0％；
In the formula:
-sample assay result mean; s-standard deviation; CV of In batch -intra-batch coefficient of variation.
(2.3.4) Linear Range determination:
in the concentration range of 4-250U/L, the correlation coefficient r is more than or equal to 0.990; the sample concentration is less than or equal to 25U/L, and the absolute deviation is less than or equal to 5U/L; the sample concentration is more than 25U/L, and the relative deviation is less than or equal to 10.0 percent;
in the concentration range of 4-250U/L, taking a high-concentration sample close to the upper limit of the linear range and a low-concentration sample close to the lower limit of the linear range, and mixing to obtain at least 5 diluted concentration samples (x) i ) At least 2 times for each dilution concentration sample, and the mean value (y) of the measurement results is determined i ) (ii) a In diluted concentration (x) i ) As independent variable, the mean value (y) of the results is determined i ) A linear regression equation is obtained for the dependent variable, and the correlation coefficient (r) of the linear regression is calculated according to the following formula. Diluting the concentration (x) i ) Substituting linear regression equation to calculate y i Estimated value of (a) and y i The absolute value is taken as the relative or absolute deviation from the estimated value.
(2.3.5) inter-batch Difference measurement: respectively testing the same quality control sample by using 3 reagents with different batch numbers, wherein the concentration of the quality control sample is more than or equal to 20U/L, and each batch number is repeatedly tested for 3 times; calculate the mean of the results of 3 measurements per batch separately
And the overall mean of the results of the 3 lot number tests
Calculating the relative range (R) of the mean value of the three batch reagent measurements according to the following formula, wherein the relative range (R) is less than or equal to 8.0 percent;
in the formula: x is the number of max ——
The maximum value of (a) is,
x min ——
minimum value of (1).
6. The quality inspection method according to claim 5, wherein in the step (3.1) of appearance inspection, the freeze-dried product is dissolved and inspected, and the liquid after dissolution is required to be yellowish; in the accuracy detection of the step (3.2)Calibrating with qualified calibrator and kit, measuring calibrator, repeating the measurement for 3 times, and calculating mean value of measurement results
Calculating a relative deviation (Bias) according to the following formula;
the relative deviation (Bias) or the deviation of the measured value and the mark is less than or equal to 10.0 percent; in the step (3.3) of uniformity detection, 10 bottles of to-be-detected calibration materials or quality control materials are taken, each bottle is measured for 1 time, and the average value of the measured values is calculated respectively
And standard deviation (S) 1 ) (ii) a Taking 1 bottle, repeating the measurement for 10 times, and calculating the mean value of the measured values
And standard deviation (S) 2 ) The standard deviation (S) between bottles was obtained by the following formula Bottle room ) And Coefficient of Variation (CV) Bottle room ) When S1 is less than S2, let CV =0;
its batch precision (CV) Bottle room )≤8.0％。
7. The use of the quality detection method according to any one of claims 1 to 6 in the quality detection of Adenosine Deaminase (ADA) detection kit.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210496816.2A CN115308141A (en) | 2022-05-09 | 2022-05-09 | Quality detection method of Adenosine Deaminase (ADA) detection kit |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210496816.2A CN115308141A (en) | 2022-05-09 | 2022-05-09 | Quality detection method of Adenosine Deaminase (ADA) detection kit |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN115308141A true CN115308141A (en) | 2022-11-08 |
Family
ID=83854808
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210496816.2A Pending CN115308141A (en) | 2022-05-09 | 2022-05-09 | Quality detection method of Adenosine Deaminase (ADA) detection kit |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN115308141A (en) |
-
2022
- 2022-05-09 CN CN202210496816.2A patent/CN115308141A/en active Pending
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Glick et al. | Unreliable visual estimation of the incidence and amount of turbidity, hemolysis, and icterus in serum from hospitalized patients. | |
| CN110146477B (en) | Preparation method of concentration gradient calibration chip and calibration method thereof | |
| US3795484A (en) | Automated direct method for the determination of inorganic phosphate in serum | |
| CN112083175A (en) | Method for correcting biochemical index by hemolytic index measured by full-automatic dry biochemical analyzer | |
| NIshi et al. | Three turbidimetric methods for determining total protein compared. | |
| US5258308A (en) | Method, kit and apparatus for verifying calibration and linearity of vertical photometers | |
| US3890099A (en) | Colorimetric assay for urea | |
| CN106442355A (en) | Determination reagent for heart-type fatty acid binding protein and preparation method of determination reagent | |
| EP0097472A1 (en) | Method of determining calcium in a fluid sample | |
| CN108613976A (en) | Bilirubin direct detection kit | |
| CN111721934A (en) | Improved specific growth factor detection kit and application thereof | |
| CN115308141A (en) | Quality detection method of Adenosine Deaminase (ADA) detection kit | |
| CN105842437A (en) | Kit for detecting D-3-hydroxybutyric acid and preparation method of kit | |
| CN106018401A (en) | Method for determining content of chlorine ions in water | |
| Park | Improvement of biosensor accuracy using an interference index detection system to minimize the interference effects caused by icterus and hemolysis in blood samples | |
| CN104833807A (en) | Quantitative measurement method, reagent and kit of retinol conjugated protein | |
| Passey et al. | Evaluation of the Beckman" System TR Enzyme Analyzer" | |
| CN114924079A (en) | Anti-glutamate decarboxylase antibody determination kit and detection method | |
| JPS6118982B2 (en) | ||
| CN112129949A (en) | Retinol binding protein detection kit, preparation method and use method thereof | |
| CN111593091A (en) | Kit for detecting homocysteine | |
| CN111175242A (en) | Lipoprotein phospholipase A2 detection kit and application thereof | |
| Gambino et al. | Comparison of serum calcium measurements obtained with the SMA 12/60 and by atomic absorption spectrophotometry | |
| CN110564894B (en) | Method for evaluating interference of interferent on fluorescence quantitative PCR detection HBV DNA | |
| Klugerman et al. | Commercial control sera in the clinical chemistry laboratory |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination |