CN112269026A - Method suitable for accurately preparing TSH powdery international standard substance in concentration - Google Patents
Method suitable for accurately preparing TSH powdery international standard substance in concentration Download PDFInfo
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Abstract
The invention discloses a method for accurately preparing the concentration of a TSH powdery international standard substance. The method comprises the following steps: cutting a concave part of an ampoule bottle containing powdered TSH international standard substances; vertically placing the centrifugal tube, enabling the tube opening to be positioned at the cutting part of the ampule, opening the ampule, and enabling powdery standard substances which are possibly sprinkled to fall into the centrifugal tube; washing the inner wall of the ampoule divided into two parts by adopting diluent for many times, and transferring all the liquid into a centrifugal tube; transferring the liquid in the centrifugal tube into a small tube by using a suction tube, and weighing the liquid with the final mass of M1 as a stock solution of the TSH international standard substance; measuring the density of the stock solution of the standard substance to obtain the concentration of TSH in the stock solution, which is marked as C1; and (3) mixing the TSH 0 value with human serum to dilute stock solution of the standard substance to obtain standard series solutions of the standard substance with different concentrations. The method provides method selection for tracing the quantity value of each in-vitro diagnostic reagent manufacturer and also provides reference for preparing the accuracy verification sample.
Description
Technical Field
The invention relates to the field of standard substance use, in particular to a method for preparing TSH international standard substances into different concentrations.
Background
Thyroid Stimulating Hormone (TSH) is a glycoprotein Hormone secreted by adenohypophysis basophils and consists of 211 amino acids, and its molecular structure consists of noncovalent α, β subunit heterodimers, wherein the Hormone is specific for biological and immunological functions and is β subunit, and α subunit is substantially identical to α subunit of Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and Human Chorionic Gonadotropin (HCG). TSH can promote secretion of T3 (triiodothyronine) and T4 (thyroxine), and is the most sensitive index for judging thyroid gland function under negative feedback of T3 and T4, and the level of the index should be closely monitored in the course of thyroid gland disease treatment.
Currently, immunoassays of TSH mainly include Radioimmunoassay (RIA), immunoradiometric Immunoassay (IRMA), Chemiluminescence Immunoassay (CLIA), Electrochemiluminescence Immunoassay (ECLIA), Time-resolved Fluoroimmunoassay (trafia), and Chemiluminescence Enzyme Immunoassay (CLEIA). TSH manufacturers have large detection results, and Beckmann Access 2 is about 20 times higher than Siemens Immunite 2000 in some TSH detection values with low concentration. Recent studies have shown that TSH varies less between methods at normal concentrations and more at abnormal concentrations. The comparison research of 6 TSH detection methods by domestic Malong et al discovers that the methods have different differences, and discovers that the correlation between the radioimmunoassay and the radioimmunoassay with an automatic detection system is poor (r is 0.38-0.41). The reasons for the differences in results between systems are many, such as the difference between different antibodies used by different manufacturers, the difference between the detection personnel and the detection instrument, and the like. But whether each manufacturer can correctly use the universal international standard substance (WHO NIBSC 81/565) and accurately transfer the value is an important influence factor in the assignment process of the calibration products.
Since WHO NIBSC 81/565 is a high-concentration TSH lyophilized powder, each manufacturer must perform a series of multiple dilutions in tracing with the standard. As early as the year 2008, it was,
a study scheme of assignment of a dilution method to a protein test project is proposed by Blirup-Jensen et al. They used CRM 470 to accurately transfer its values to the manufacturer's primary calibrators and working calibrators or quality controls and demonstrated the examples.The first is direct target value transfer between serum matrices, the scheme of which is based on multiple measurements of 6-point dilutions of reference and target substances. The transfer protocol required repeated measurements daily for several days. Both rewet and dilution are controlled by weighing to reduce uncertainty in transfer. In an open system, a reference substance may be used as a calibrator and a target substance as a sample. The ratio of the concentrations of the two species (with or without matrix effect) was directly estimated by a single regression plot. If there is no matrix effect, the regression line will pass through zero with a slope equal to the ratio of the two species concentrations. In closed systems, dedicated commercial calibrators, reference substances and target substances must be used as samples for analysis.
The international standard substance involved in the methods is freeze-dried human serum, and only a balance is needed to accurately add a proper amount of water (1.00ml) into a small bottle which is provided with a rubber stopper and a screw cap and is easy to operate. The international standard substance WHO 81/565 for TSH was lyophilized purified human pituitary extract (about 2 μ g), which was sealed in elongated ampoules and stored at-20 ℃ or below, with a TSH content of 11.5 mIU per ampoule, and a matrix further comprising lyophilized substances of human serum albumin (1mg) without peptidase and lactose (5 mg). Contain the TSH of high concentration in this ampoule, spill easily during the use, the volume of the diluent that adds moreover needs extremely accurate, adopts direct dilution to cause final concentration inaccurate easily. There is therefore a need to provide a simple method by which such high concentrations of international standard substances in powder form can be accurately diluted, thereby providing a dedicated technique for the correct use of such substances.
Disclosure of Invention
The invention aims to provide a method for accurately preparing TSH international standard substance (WHO NIBSC 81/565).
The method for diluting the TSH international standard substance comprises the following steps:
(a1) placing an ampoule bottle containing powdered TSH international standard substances at room temperature for at least half an hour, and then cutting a concave part of the ampoule bottle in a non-ventilated environment;
(a2) vertically placing a centrifugal tube and enabling a tube opening to be positioned at a cutting part of the ampoule, and opening the ampoule to enable any powdery TSH international standard substance which can be sprinkled outwards to fall into the centrifugal tube;
(a3) washing the inner wall of the ampoule divided into two parts for many times by using diluent, transferring all the liquid into the centrifuge tube by using a suction tube, and repeating for many times; transferring the liquid in the centrifuge tube into a small tube by using a pipette, repeatedly washing the centrifuge tube for many times, and weighing the centrifuge tube with the final mass of M1 as a stock solution of a TSH (time series of H) international standard substance;
(a4) measuring the density of the stock solution of the TSH international standard substance to obtain the concentration of TSH in the stock solution of the TSH international standard substance, which is marked as C1;
(a5) and (2) diluting the stock solution of the TSH international standard substance by adopting mixed human serum with a TSH 0 value (namely serum with TSH concentration measured by a detection instrument being 0 mu IU/mL) to obtain a series of standard series solutions of the TSH international standard substance with different concentrations, and measuring the concentration of the standard series solutions of the TSH international standard substance to realize the dilution of the TSH international standard substance.
In the above method, in the step (a1), the ampoule bottle is cut sufficiently at the recessed portion, i.e., the neck portion, using a grinding wheel.
In the above method, in step (a2), if there is broken glass, it is ensured that the broken glass falls into the disposable centrifuge tube.
In the above method, in the step (a3), the diluent is Phosphate Buffered Saline (PBS) solution containing bovine serum albumin, and the concentration of the bovine serum albumin is 40-55 g/L, preferably 46 g/L;
and when the liquid in the centrifuge tube is transferred, washing the centrifuge tube by using the diluent.
In the above method, in the step (a4), the density of the stock solution of the TSH international standard substance is measured according to the following steps:
(b1) weighing the total mass of the container and the gun head of the sample adding gun, recording as m1, and repeatedly measuring for 3-5 times;
(b2) absorbing a sample to be measured with the volume v by using the gun head of the sample adding gun, then placing the sample in the container, weighing the whole sample as m2, and repeatedly measuring for 3-5 times;
(b3) calculating the density of the sample to be detected according to a formula (1);
rho is measured as (m2-m1)/v (1).
In the above method, in the step (a4), the volume of the stock solution of the TSH international standard substance is obtained according to the density and mass (M1) of the stock solution of the TSH international standard substance; and obtaining the concentration C1 of the stock solution of the TSH international standard substance according to the mass and the volume.
In the above method, in the step (a5), the concentration of the standard series solution of the TSH international standard substance is obtained according to the following steps:
(A) measuring the density of each diluted solution in a series of standard series solutions of the TSH international standard substances with different concentrations, and recording as rho 2;
(B) obtaining the authentication concentration of each diluted solution in the standard series of solutions of the TSH international standard substances with different concentrations according to the formula (2), and marking as C;
wherein ρ 1 represents the density of the TSH international standard substance; m2 represents the mass of the dilution in the standard series of solutions of the TSH international standard substance.
In the above method, the density ρ 2 of the diluted solution of the TSH international standard substance is measured according to the method of the step (a 4).
The method adopted by the invention dilutes the TSH international standard substance, provides method selection for tracing the quantity value of each manufacturer, and also provides reference for preparing the accuracy verification sample. The method can promote the improvement of the clinical inspection quality of TSH in Beijing area and even nationwide, thereby ensuring that the TSH detection results of various manufacturers are accurate and comparable; the invention can improve the effectiveness of the work of preventing and treating diseases, provide necessary technical support for saving and effectively utilizing sanitary resources, and can generate certain economic benefit and social benefit in the future.
Drawings
FIG. 1 is a physical diagram of the International Standard substance (NIBSC 81/565).
Fig. 2 is a fitting curve 1 of the standard curve authentication value and the detection value.
Fig. 3 is a fitting curve 2 of the standard curve authentication value and the detection value.
Fig. 4 is a fitting curve 3 of the standard curve authentication value and the detection value.
Fig. 5 is a fitting curve 4 of the standard curve authentication value and the detection value.
Fig. 6 is a standard curve authentication value and detection value fitting curve 5.
Detailed Description
The experimental procedures used in the following examples are all conventional procedures unless otherwise specified.
Materials, reagents and the like used in the following examples are commercially available unless otherwise specified.
A physical diagram of TSH International Standard substance (NIBSC 81/565) is shown in FIG. 1.
Accurately diluting TSH international standard substances according to the following steps:
(a1) the ampoule containing the TSH international standard substance in the form of powder was taken out from a-80 ℃ refrigerator, and left to stand at room temperature for half an hour, and 100ml of a PBS solution (Gibco, cat. 10010023) containing 46g/L bovine serum albumin (SIGMA corporation, cat. B2064) was prepared and prepared.
(a2) To prevent the freeze-dried powder from being blown away by the wind, the ampoule is cut thoroughly with a grinding wheel in a fume hood closed.
(a3) The ampoule bottle containing the powdery substance is vertically tapped on a table top, so that the ampoule bottle is concentrated to one side of the long end of the ampoule tube. Place 50ml centrifuging tube vertically on the desktop, place the cutting part on the mouth of pipe, operating personnel wears cotton gloves and goggles, uses the opening tool who accompanies, opens the ampoule, guarantees that all powder that probably spills outward all falls into the centrifuging tube. If there is broken glass, it is ensured to fall into the centrifuge tube.
(a4) The powder in the ampoule was completely dissolved (in a small amount and multiple times) in the diluent prepared in (a1) and transferred to a centrifuge tube.
(a5) The liquid in the centrifuge tube was transferred once to a vial placed on a balance, the large centrifuge tube was rinsed several times with the diluent in (a4), all the liquid was transferred several times to a vial in a balance, and the mass M1 ═ 9.939g was weighed out as a stock solution of TSH international standard substance.
(a6) The density of the diluted stock solution of the international standard substance is measured according to the following steps:
(b1) weighing the mass of the container and the gun head of the sample adding gun, and recording the mass as m 1;
(b2) sucking a sample to be tested with the volume of constant v (100 μ L) by using the tip of the sample adding gun in (b1), placing the sample to be tested in the container in (b1) (the step of wiping off the sample to be tested adhered to the outside of the tip of the sample adding gun is included in the process), and weighing the whole sample as m 2;
(b3) calculating the density of the sample to be measured according to the following formula: rho is measured as (m2-m 1)/v.
Wherein, the steps (b1) and (b2) can be repeated for 3-5 times according to requirements. Correspondingly, the parameter rho on the left side of the equation equal sign in the step (b3) is to be measured and is taken as an average value of 3-5 times of repetition.
As follows, 0.1025g, 0.1022g, 0.1023g, 0.1019g, 0.1013g and 0.1024g, the density mean value was 1.021.
(a7) From the mass (m-9.939 g) and density (ρ -1.021), the volume v-m/ρ was obtained, the volume 9.734574 mL was obtained, and the concentration of the stock solution of the TSH international standard substance was calculated to be 115000/9.734574-1181.356 μ IU/mL, i.e., C1.
(a8) The stock solutions of the TSH international standard substances were diluted with the TSH 0 value mixed human serum, and formulated as shown in tables 1 and 2, and the density measurement method was the same as in step (a 6).
(a9) The concentration of the authentication value of the international standard substance comprises the following steps:
(A) preparing standard series solutions of TSH standard substances of different concentrations: mixing the diluent and the stock solution of the TSH international standard substance according to different volume ratios (see table 1), thereby obtaining standard series solutions of the TSH international standard substance with different concentrations; in the process of preparing each standard series solution of the TSH international standard substance, the diluted solution of the standard series solution and the stock solution of the TSH international standard substance which form the TSH international standard substance are respectively weighed.
(B) Densitometry of standard series of solutions of different concentrations of TSH international standard substance: the respective densities of the diluted solutions of the TSH international standard substance series prepared in step (a) at different concentrations were measured separately.
(C) Obtaining the theoretical concentration of TSH in standard series solutions of TSH international standard substances with different concentrations: the certified concentration of TSH in each diluted solution in the standard series of solutions of TSH international standard substance at different concentrations was calculated according to the following formula,
wherein C1 represents the concentration of TSH in the stock solution of TSH international standard substance; ρ 1 represents the density of a stock solution of TSH international standard substance; m1 represents the quality of stock solution of TSH international standard substance; m2 represents the mass of the dilution in the standard series of solutions of the TSH international standard substance; ρ 2 represents the density of a standard series solution of TSH international standard substance; c represents the certified concentration of the standard series of TSH international standard substances.
(a10) The instrument used for detection is Architec i2000sr, cat # 7K62-35, lot # 91052UI00, quality Control substance is Berle Immunoassay Plus Control (lot # 40340), and indoor quality Control is performed.
TABLE 1 TSH International Standard substance Standard series concentration preparation
Remarking: the stock solution used for the solutions numbered 1 to 5 is the solution numbered 6
Table 2 TSH international standard substance series densitometry (volume v ═ 100 μ L)
Second, result in
As shown in Table 3, the relative bias mean was 4.1%, less than the biological variability-derived medium allowable bias (7.82%), and the absolute bias mean was-0.2. The correlation coefficient for each correlation line is 1.000, the slope is close to 1, and the intercept is close to 0, as shown in table 4.
TABLE 3 deviation of each point from the certification value after dilution with TSH International Standard substance (WHO 81/565)
TABLE 4 Standard Curve after dilution of TSH International Standard substance (WHO 81/565)
The application method of the powdery TSH international standard substance can be used for assignment of a manufacturer calibrator and accuracy verification of a room evaluation organization. The international standard substance in powder form is dissolved by adopting a proper diluent, the whole process adopts a weighing method, and a detection system which is commonly used in clinic is adopted for detection. The experimental result proves that the method of the invention has strict design and easy implementation, and is a new method for correctly utilizing the constant value international standard substance sealed in the ampoule bottle.
Claims (6)
1. A method for diluting TSH international standard substance, comprising the following steps:
(a1) placing an ampoule bottle containing powdered TSH international standard substances at room temperature for at least half an hour, and then cutting a concave part of the ampoule bottle in a non-ventilated environment;
(a2) vertically placing a centrifugal tube, enabling a tube opening to be positioned at a cutting part of the Ann-cut bottle, opening the Ann-cut bottle, and enabling powdery TSH international standard substances which are possibly sprinkled to fall into the centrifugal tube;
(a3) washing the inner wall of the ampoule divided into two parts by using diluent for multiple times, transferring all the liquid into the centrifuge tube by using a suction tube, and repeating the steps for multiple times; transferring the liquid in the centrifuge tube into a small tube by using a pipette, repeatedly washing the centrifuge tube for many times, and weighing the centrifuge tube with the final mass of M1 as a stock solution of a TSH (time series of H) international standard substance;
(a4) measuring the density of the stock solution of the TSH international standard substance to obtain the concentration of TSH in the stock solution of the TSH international standard substance, which is marked as C1;
(a5) and (3) diluting the stock solution of the TSH international standard substance by adopting TSH 0 value mixed human serum to obtain standard series solutions of the TSH international standard substance with different concentrations, and measuring the concentration of the standard series solutions of the TSH international standard substance to realize the dilution of the TSH international standard substance.
2. The method of claim 1, wherein: in the step (a3), the diluent is a PBS solution containing bovine serum albumin, and the concentration of the bovine serum albumin is 40-55 g/L;
and when the liquid in the centrifuge tube is transferred, washing the centrifuge tube by using the diluent.
3. The method according to claim 1 or 2, characterized in that: in the step (a4), the density of the stock solution of the TSH international standard substance was measured according to the following procedure:
(b1) weighing the total mass of the container and the gun head of the sample adding gun, and recording as m 1;
(b2) absorbing a sample to be detected with the volume v by using the gun head of the sample adding gun, then placing the sample in the container, and weighing the sample as m 2;
(b3) calculating the density of the sample to be detected according to a formula (1);
rho is measured as (m2-m1)/v (1).
4. The method according to any one of claims 1-3, wherein: in the step (a5), the certified concentration of the standard series solution of the TSH international standard substance is obtained according to the following steps:
(A) measuring the density of each diluted solution in the standard series solutions of the TSH international standard substances with different concentrations, and marking as rho 2;
(B) obtaining the authentication concentration of each diluted solution in the standard series solutions of the TSH international standard substances with different concentrations according to the formula (2), and marking as C;
wherein ρ 1 represents the density of the stock solution of the TSH international standard substance; m2 represents the mass of the dilution in the standard series of solutions of the TSH international standard substance.
5. The method of claim 4, wherein: measuring the density of the standard series solution of the TSH international standard substance according to the method of step (a 4).
6. The method according to any one of claims 1-5, wherein: the TSH international standard substance is WHO NIBSC 81/565.
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| CN114200139A (en) * | 2021-12-01 | 2022-03-18 | 首都医科大学附属北京朝阳医院 | Method for accurately assigning carcinoembryonic antigen reference substance |
| CN115093499A (en) * | 2022-08-03 | 2022-09-23 | 北京活力源科技有限责任公司 | Stokes equivalent diameter standard substance and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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