Description
PURPOSE
The entry of endotoxins into the bloodstream via injection or implantation can cause fever and/or shock, so the determination of bacterial endotoxins in drugs and medical devices is critical. The LAL test is the most sensitive method for the detection of bacterial endotoxins. Using «ALPYR Test» Gel clot test Standard kit allows to determine the endotoxin of all Gram-negative bacteria by gel clot test. The kit contains a LAL reagent in which carboxymethylcurdlan is lyophilised along with lysate, which prevents activation of the LAL reagent by β-glucans and makes it fully endotoxin-specific.
The kit contains all the necessary components to perform a gel clot test:
| Kit 1 | |
| LAL reagent PYROSTAR ES-F 0.03 EU/ml, 5.2 ml per vial | 6 vials |
| Control Standard Endotoxin 500 ng per vial | 1 vial |
| “ALPYR Water” for BET, 50 ml | 6 vials |
| “ALPYR Tube” apyrogenic test tubes 10×75 mm, 50 pieces per pack | 6 packs |
| “ALPYR Tube” apyrogenic test tubes 13×100 mm, 30 pieces per pack | 6 packs |
| Kit 2 | |
| LAL reagent iBET 0.03 EU/ml, 5.2 ml per vial | 6 vials |
| Control Standard Endotoxin 10 ng per vial | 6 vials |
| “ALPYR Water” for BET, 50 ml | 6 vials |
| “ALPYR Tube” apyrogenic test tubes 10×75 mm, 50 pieces per pack | 6 packs |
| “ALPYR Tube” apyrogenic test tubes 13×100 mm, 30 pieces per pack | 6 packs |
PRINCIPLE OF METHOD
The principle of the method is based on the ability of amoebocyte lysate from the haemolymph of horseshoe crabs (Limulus polyphemus) to react specifically with endotoxins of Gram-negative bacteria (lipopolysaccharides). The reaction of endotoxin and lysate results in a transparent reaction mixture that becomes cloudy or forms a solid gel, which serves as an indicator of the presence of endotoxin. Endotoxins can be detected by limit test or quantitative method.
SAMPLES TO BE TESTED
- pharmaceuticals;
- active pharmaceutical ingredients;
- whashes from medical devices;
- biotech products;
- cell therapy products.
BENEFITS
- does not require the additional use of β-blockers and buffer solutions;
- sensitivity – 0.03 EU/ml;
- contains all necessary reagents and consumables for gel clot test (LAL reagent, control standard endotoxin, apyrogenic tubes, BET water);
- special packaging in a convenient form.
