CN1276973C - Glutamic-pyruvic transaminase quality control product and diluent thereof - Google Patents
Glutamic-pyruvic transaminase quality control product and diluent thereof Download PDFInfo
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- CN1276973C CN1276973C CN 200510023741 CN200510023741A CN1276973C CN 1276973 C CN1276973 C CN 1276973C CN 200510023741 CN200510023741 CN 200510023741 CN 200510023741 A CN200510023741 A CN 200510023741A CN 1276973 C CN1276973 C CN 1276973C
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Abstract
The present invention provides a quality control product of glutamic-pyruvic transaminase. The quality control product uses calf serum as a solvent and contains glutamic-pyruvic transaminase, wherein the mass percentage of albumin is from 10 to 20%, and the volume percentage of glycol is from 30 to 40%. The present invention also provides diluted mother solution of glutamic-pyruvic transaminase. Calf serum is used as a solvent, wherein the mass percentage of albumin is from 20 to 40%, and the volume percentage of glycol is from 60 to 80%. ALT diluted mother solution is used in the implementation mode, and thus, an ALT quality control product can be conveniently prepared. The quality control product prepared from human ALT diluted mother solution of the present invention greatly extends the shelf life of a sample, the quality control sample can be transported at normal temperature, the quality control sample can be directly used without any operation after being received by a user, and the quality of the quality control product can be ensured.
Description
Technical field
The present invention relates to the quality control that the conventional transmissible disease in laboratory detects, relate in particular to a kind of glutamic-pyruvic transaminase quality control product and diluent thereof.
Background technology
The detection relationship between quality in laboratory clarifying a diagnosis of patient and state of illness monitoring, and in blood-borne diseases examination field, the correctness of assay is also closely related with the security of blood.To using reagent to carry out quality examination, carry out the indoor Quality Control that transmissible disease detects and participate in that the quality evaluation system is to ensure the serial of methods that detects quality between suitable chamber.Yet, because quality control product preparation technology's deficiency, the at present domestic stability that is used for carrying out the quality-control sample that matter is commented between reagent examination, indoor Quality Control and chamber is not high, a major reason is because the result error that the degraded of quality-control sample is commented examination, Quality Control and matter is bigger, influenced correct judgement on the one hand to the laboratory detected result, even can directly injure the accuracy of result of laboratory test, then make each hospital clinical check laboratory and laboratory, blood station face the danger of managerial confusion and technical difficulty on the other hand.
Gpt is called for short ALT, is the amino transaminase in the protein metabolism, is the important detection index of the diagnosis of viral hepatitis.The stability of at present domestic ALT quality-control sample commonly used is all not high, usually can only under 4 ℃ of conditions, preserve a couple of days, preserved one to two year under-20 ℃ of conditions, often quality control product is pumped into lyophilized powder when therefore posting or transporting, and the user is after taking lyophilized powder, then need add certain amount of solvent in accordance with regulations, after being redissolved, can use lyophilized powder, because entire operation process complexity and influence factor are too many, the variation of the enzymic activity of ALT is very big in the quality control product, largely influence the stability of quality-control sample, lost the effect of Quality Control sometimes.
The inventor finds that the prescription of diluent plays a part crucial to the Quality Control stability of sample, the inventor improves the ALT diluent, make it to be fit to the stable preservation of quality-control sample, prolonged the time limit of room temperature preservation, 4 ℃ of preservations ,-20 ℃ of preservations greatly.
Summary of the invention
The purpose of this invention is to provide a kind of ALT quality control product.
Another object of the present invention provides a kind of ALT diluent mother liquor.
A first aspect of the present invention is achieved in that a kind of glutamic-pyruvic transaminase quality control product, and as solvent and contain gpt, wherein albuminous mass percent is 10～20% to described quality control product with calf serum, and the volume percent of ethylene glycol is 30～40%.
A second aspect of the present invention is achieved in that a kind of gpt diluent mother liquor, and as solvent, wherein albuminous mass percent is 20～40% with calf serum, and the volume percent of ethylene glycol is 60～80%.This embodiment mainly utilizes ALT diluent mother liquor can prepare the ALT quality control product easily and implement.
ALT diluent mother liquor of the present invention, can be with conventional chemical compound method preparation, promptly with calf serum as solvent, take by weighing mass percent and be 20～40% albumin and dissolve, get volume percent simultaneously and be 60～80% ethylene glycol and dissolve, form ALT diluent mother liquor.
When specifically using as ALT quality-control sample diluent, the ALT diluent mother liquor (2 *) that desirable above-mentioned formulated goes out is a solvent with the calf serum, continuous 2 times of dilution ALT stostes, accurately adjust ALT concentration with calf serum, until desired concn, packing is preserved behind the mixing.In the quality-control sample by the method preparation, albuminous final concentration is 10～20%, and the final concentration of ethylene glycol is 30～40%.
Beneficial effect: because the quality control product of the inventor's ALT diluent mother liquor preparation has prolonged the time limit of the room temperature preservation of quality-control sample, 4 ℃ of preservations ,-20 ℃ of preservations greatly, the effect of test be can preserve under the room temperature situation can preserve a week, 4 ℃ January ,-20 ℃ can preserve two to three years ,-80 ℃ can prolonged preservation.Make quality-control sample to transport at normal temperatures like this, and the user do not add any operation after receiving and just can directly use, and can guarantee the quality of quality control product, made things convenient for each hospital and blood station check section office widely by Express Mail Service.
Embodiment
Further specify the present invention with embodiment below.It should be understood that embodiments of the invention are to be used to illustrate the present invention rather than limitation of the present invention.Essence according to the present invention all belongs to the scope of protection of present invention to the simple modifications that the present invention carries out.The experimental technique of unreceipted actual conditions in the following fact Example carries out according to the normal condition of this area usually.
Experiment one: ALT concentrated solution preparation
A) reference literature (Yang Zhenxiu, Yang Qianying. the preparation of stable GPT liquid quality control serum. Clinical Laboratory magazine, 1985; 3 (4): 185), from Pigs Hearts, extract the ALT concentrated solution
B) the use reitman-frankel method detects the ALT concentration in the ALT concentrated solution
Prepared ALT concentrated solution is used for the effect measuring of preparation of ALT quality control product and ALT diluent.
Experiment two: the effect measuring of preparation of ALT quality control product and ALT diluent
Embodiment 1～6:
A) according to shown in the table 1, with calf serum as solvent, preparation contains mass percent and is respectively the ALT diluent mother liquor that 0%, 20%, 30%, 40%, 40%, 40% albumin and volume percent are respectively 6 kinds of different concns of 0%, 60%, 60%, 60%, 70%, 80% ethylene glycol, i.e. 2 * ALT diluent.
B) according to the ALT concentration in experiment one concentrated solution that obtains, use 2 * ALT diluent, carry out continuous 2 times of dilution ALT stostes, accurately adjust ALT concentration with calf serum, make the ALT concentrated solution be diluted to 35 ± 5 concentration, make that albuminous final concentration is respectively 0%, 10%, 15%, 20%, 20%, 20% in the quality-control sample, the final concentration of ethylene glycol is respectively 0%, 30%, 30%, 30%, 35%, 40%.
C) use reitman-frankel method to detect the good sample of dilution repeatedly, confirm that its concentration reaches 35 ± 5 scopes.
D) the good sample of dilution is preserved in packing, and takes out sample in different preservation conditions and retention period, and reitman-frankel method detects ALT concentration.
E) the results are shown in Table 2～4.
The prescription of table 12 * ALT diluent and quality control product
| Embodiment | 1 | 2 | 3 | 4 | 5 | 6 |
| Albumin concentration in 2 * ALT diluent | 0 | 20％ | 30％ | 40％ | 40％ | 40％ |
| Glycol concentration in 2 * ALT diluent | 0 | 60％ | 60％ | 60％ | 70％ | 80％ |
| Calf serum in 2 * ALT diluent | 100％ | Surplus | Surplus | Surplus | Surplus | Surplus |
| Albumin final concentration in the quality control product | 0 | 10％ | 15％ | 20％ | 20％ | 20％ |
| Ethylene glycol final concentration in the quality control product | 0 | 30％ | 30％ | 30％ | 35％ | 40％ |
| Calf serum in the quality control product | 100％ | Surplus | Surplus | Surplus | Surplus | Surplus |
Table 2 room temperature preservation is to the influence of ALT quality controlled serum stability
| Embodiment | 1 | 2 | 3 | 4 | 5 | 6 |
| Original ALT concentration | 35±5 | 35±5 | 35±5 | 35±5 | 35±5 | 35±5 |
| One week | 20 | 35 | 34 | 36 | 35 | 34 |
| Two weeks | 8 | 27 | 35 | 35 | 36 | 36 |
| Three weeks | 5 | 15 | 30 | 32 | 36 | 35 |
4 ℃ of preservations of table 3 are to the influence of ALT quality controlled serum stability
| Embodiment | 1 | 2 | 3 | 4 | 5 | 6 |
| Original ALT concentration | 35±5 | 35±5 | 35±5 | 35±5 | 35±5 | 35±5 |
| One week | 28 | 36 | 34 | 36 | 34 | 34 |
| January | Muddy (bacterial reproduction) | 34 | 35 | 35 | 36 | 35 |
| February | - | 34 | 33 | 36 | 34 | 35 |
| March | - | 33 | 33 | 35 | 33 | 33 |
| May | - | 30 | 32 | 33 | 32 | 30 |
Table 4-20 ℃ preservation is to the influence of ALT quality controlled serum stability
| Embodiment | 1 | 2 | 3 | 4 | 5 | 6 |
| Original ALT concentration | 35±5 | 35±5 | 35±5 | 35±5 | 35±5 | 35±5 |
| February | 35 | 34 | 35 | 35 | 36 | 37 |
| May | 36 | 34 | 33 | 36 | 36 | 36 |
| October | 33 | 33 | 34 | 35 | 37 | 36 |
| 2 years | 32 | 32 | 34 | 33 | 35 | 35 |
By The above results as can be seen, for the ALT quality control product, the ALT quality controlled serum is stable higher in the concentration range of albumin 10～20% and ethylene glycol 30～40%, can preserve under the room temperature situation week above, 4 ℃ can preserve January in addition longer ,-20 ℃ can preserve two to three years.
Claims (1)
1. glutamic-pyruvic transaminase quality control product, as solvent and contain gpt, wherein albuminous mass percent is 10～20% to described quality control product with calf serum, the volume percent of ethylene glycol is 30～40%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510023741 CN1276973C (en) | 2005-02-01 | 2005-02-01 | Glutamic-pyruvic transaminase quality control product and diluent thereof |
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|---|---|---|---|
| CN 200510023741 CN1276973C (en) | 2005-02-01 | 2005-02-01 | Glutamic-pyruvic transaminase quality control product and diluent thereof |
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| CNB2006101012069A Division CN100541201C (en) | 2005-02-01 | 2005-02-01 | The dilution mother liquor of glutamic-pyruvic transaminase quality control product |
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| CN1673365A CN1673365A (en) | 2005-09-28 |
| CN1276973C true CN1276973C (en) | 2006-09-27 |
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