CN202119775U

CN202119775U - Limulus kit for endotoxin detection

Info

Publication number: CN202119775U
Application number: CN201120213879XU
Authority: CN
Inventors: 不公告发明人
Original assignee: Co Ltd Of Tachypleus Amebocyte Lysate Trial (demonstration) Plant Of Xiamen City
Current assignee: Xiamen limulus reagent biological Polytron Technologies Inc
Priority date: 2011-06-23
Filing date: 2011-06-23
Publication date: 2012-01-18
Anticipated expiration: 2021-06-23

Abstract

The utility model discloses a limulus kit for endotoxin detection, which comprises a kit body, more than four limulus reagent bottles containing limulus amebocyte lysate and two bacterium endotoxin working standard sample bottles, wherein the limulus reagent bottles and the bacterium endotoxin working standard sample bottles are contained in the kit body. One bacterium endotoxin working standard sample bottle is used for preparing positive control solution, and the other bacterium endotoxin working standard sample bottle is used for preparing positive control solution, three bacterium endotoxin detection water bottles, a pyrogen-free sampling bottle and a pyrogen-free empty ampoule. The limulus kit for endotoxin detection performs fast detection on bacterium endotoxin of samples to be tested such as big transfusion, injection drugs, medical equipment, dislysate, dialysis water and the like according to the principle that components in the limulus amebocyte lysate can form gel under a certain condition when bacterium endotoxin exists, and has the advantage of being accurate and reliable in experimental results.

Description

Endotoxin detects tachypleus amebocyte lysate box

Technical field

The utility model discloses a kind of endotoxin and detects tachypleus amebocyte lysate box, divides by International Patent Classification (IPC) (IPC) to belong to detection kit class manufacturing technology field, especially relates to a kind of detection kit structure of bacterial detection level of endotoxin.

Background technology

Bacterial endotoxin (pyrogen) is the principal ingredient of Gram-negative bacteria bacteria wall.The bacteria endotoxin content that gets into blood of human body round-robin infusion solutions, drug for injection, dislysate or water for dialysis is too high, can cause pyrogen reaction, can cause MODS, endotoxin shock, threat to life when serious.

The bacterial detection level of endotoxin, best way is a LTOY LALT.Contain the C factor responsive in the TAL to bacterial endotoxin, the B factor, proclotting enzyme, coagulagens etc. when bacterial endotoxin exists, can produce a series of agglutinating reaction, form gel at last.

China does not have comprehensive tachypleus amebocyte lysate box at present; Will buy TAL during the bacterial detection endotoxin reaches and the supporting bacterial endotoxin working standard of TAL; Provide apyrogeneity consumptive materials such as apyrogeneity sampling bottle, apyrogeneity test tube, apyrogeneity suction nozzle again for oneself, take time and effort, operation is very loaded down with trivial details.

Summary of the invention

To the deficiency of prior art, the utility model provides a kind of endotoxin easy to use to detect tachypleus amebocyte lysate box, detects fast applicable to the bacterial endotoxin of samples such as infusion solutions, dislysate and water for dialysis.

For achieving the above object, the utility model is realized through following technical scheme:

A kind of endotoxin detects tachypleus amebocyte lysate box, comprising:

One box body, it is the paper shell of ccontaining each reagent bottle and some apyrogeneity suction nozzles;

TAL bottle, quantity are more than four, and TAL is housed in each bottle;

Two bacterial endotoxin working standard bottles, wherein one is used to prepare positive control solution, and another is used to prepare test sample positive control solution;

Water bottle is used in three bacterial endotoxin inspections, is used for dissolving TAL and bacterial endotoxin working standard;

An apyrogeneity sampling bottle;

An empty ampoule of apyrogeneity and some apyrogeneity suction nozzles.

[0007]Further, described TAL bottle is eight TAL ampoules, and the loading amount of TAL is 0.1ml in each ampoule, and wherein two as the test sample pipe, the negative control tube of two flags, and the positive control tube of two flags, two as test sample positive control pipe.

Further, described apyrogeneity suction nozzle is the suction nozzle of two bags, 200 μ l and the suction nozzle of two bags, 1000 μ l.

The utility model is the detection kit of bacterial detection level of endotoxin, wherein two times of the sensitivity that indicates for kit of tiring of bacterial endotoxin working standard.The bacteria endotoxin content of the empty ampoule of apyrogeneity sampling bottle, apyrogeneity suction nozzle and apyrogeneity is less than 0.005EU/ml.The utility model is to utilize composition in the TAL when bacterial endotoxin exists, to produce the principle that a series of agglutinating reaction forms gel at last to carry out LTOY LALT, reaches the purpose of bacterial detection endotoxin content.

The utlity model has following beneficial effect:

1, meet in the usp bacteria endotoxin inspection technique gel method experimental requirements of limiting the quantity of, be equipped with the necessary negative control of LTOY LALT, positive control, and test sample positive control make experimental result accurately and reliably;

2. the TAL in the kit is the TAL special to endotoxin, can not produce false positive reaction to (1,3) callose, and specificity is high;

3. kit comprises the needed apyrogeneity accessory of operation, and the user needn't oneself prepare the apyrogeneity experiment material;

4, easy to use.

Description of drawings

Fig. 1 is the utility model structural representation.

Embodiment

Below in conjunction with accompanying drawing the utility model is described further:

Embodiment: see also Fig. 1, a kind of endotoxin detects tachypleus amebocyte lysate box, comprises eight TAL bottles (ampoule) 2 in the box body 1, and wherein two as the test sample pipe, the negative control tube of two flags, and the positive control tube of two flags, two as test sample positive control pipe;

Two bacterial endotoxin working standard bottles (ampoule) 3, wherein one is used to prepare positive control solution, and one is used to prepare test sample positive control solution; Three bacterial endotoxin inspections are used for dissolving TAL and bacterial endotoxin working standard with water bottle (ampoule) 4; An apyrogeneity sampling bottle 5; The empty ampoule 6 of apyrogeneity; Two bag 200 μ

l suction nozzles

71,72 and a bag 1000 μ l suction nozzles 73.The loading amount of TAL is 0.1ml.Two times of the sensitivity that the tiring of bacterial endotoxin working standard indicates for kit.The bacteria endotoxin content of the empty ampoule of apyrogeneity sampling bottle, apyrogeneity suction nozzle and apyrogeneity is less than 0.005EU/ml.

Gel method TAL in the utility model, loading amount are that 0.1ml/ props up, and can is in the apyrogeneity ampoule, and freeze drying is sealed; The bacterial endotoxin working standard is tired to kit indicates two times of sensitivity, and can is in the apyrogeneity ampoule, and freeze drying is sealed; Bacterial endotoxin inspection water, loading amount is that 2ml/ props up, can in the apyrogeneity ampoule, autoclaving; 10ml glass sampling bottle, after depyrogenation is handled at the aseptic condition lower sealing; The empty ampoule of apyrogeneity, the germ-free condition lower sealing; 200 μ l and 1000 μ l suction nozzles after apyrogeneity is handled, place the apyrogeneity polybag, at the aseptic condition lower sealing; At last above-mentioned each component sets is loaded on and forms endotoxin detection tachypleus amebocyte lysate box in the box body.

The method of application of the utility model:

1. need testing solution and contrast preparation

1.1 negative control solution: i.e. bacterial endotoxin inspection water;

1.2 positive control solution: get a bacterial endotoxin working standard, add 1ml detection of bacterial endotoxin water, jolt 2-3min at vortex mixer;

1.3 need testing solution: with an amount of need testing solution of apyrogeneity sampling bottle collection.If sample needs dilution, available bacterial endotoxin inspection water diluted sample in empty ampoule;

1.4 test sample positive control solution: get a bacterial endotoxin working standard, add the 1ml need testing solution, jolt 2-3min. at vortex mixer

2. experimental implementation

2.1 test application of sample

In kit, take out 8 TALs, each adds 0.1ml bacterial endotoxin inspection water, gently jolting dissolving TAL freeze-dried powder.Wherein 2 add the 0.1ml negative control solution respectively, become the negative control pipe; 2 add 0.1ml positive control solution respectively, become the positive control pipe; 2 add 0.1ml test sample positive control solution respectively, become test sample positive control pipe; 2 add the 0.1ml need testing solution respectively, become the test sample pipe;

2.2 application of sample finishes, the sealing mouth of pipe shakes up mixed liquor gently, puts into 37 ℃ ± 1 ℃ constant water bath box or thermostat incubation 60 ± 2min, avoids vibration between incubation period;

3. the result judges

3.1 each pipe is taken out from constant water bath box or thermostat gently, slowly reverses 180 °.If the pipe content is solid gel, and is indeformable, not positive from tube wall slippage person, be recorded as ( +); Though be not gel or generate gel but can not be kept perfectly and negative from tube wall slippage person, be recorded as ( -);

3.2 all negative when negative control duct ligation fruit, positive control pipe and test sample positive control pipe are all positive, experiment is effective, otherwise invalid, maybe be because the experimentation misoperation is answered repeated experiments.

If the test sample pipe is negative, declares the test sample endotoxin content and be less than the sensitivity of kit sign;

If the test sample pipe is positive, declares the test sample endotoxin content and be equal to or greater than the sensitivity of kit sign.

Indicate: be also referred to as sample in the test sample industry that relates in the utility model.

The above record is merely the embodiment that utilizes this origination techniques content, anyly is familiar with modification, the variation that this creation of this art utilization is done, and all belongs to the claim of this creation opinion, and is not limited to embodiment announcement person.

Claims

1. an endotoxin detects tachypleus amebocyte lysate box, it is characterized in that comprising:

One box body;

TAL bottle, quantity are more than four, and TAL is housed in each bottle;

An apyrogeneity sampling bottle;

And an empty ampoule of apyrogeneity and some apyrogeneity suction nozzles.

2. endotoxin according to claim 1 detects tachypleus amebocyte lysate box; It is characterized in that: described TAL bottle is eight TAL ampoules; The loading amount of TAL is 0.1ml in each ampoule, and wherein two as the test sample pipe, the negative control tube of two flags; The positive control tube of two flags, two as test sample positive control pipe.

3. endotoxin according to claim 1 detects tachypleus amebocyte lysate box, it is characterized in that: described apyrogeneity suction nozzle is the suction nozzle of two bags, 200 μ l and the suction nozzle of a bag 1000 μ l.