Hemolytic activity is a requirement to be tested for any blood contacting medical device. The test is based on erythrocyte lysis induced by contact, leachables, toxins, metal ions, surface charge or any other cause of erythrocyte lysis. The current description is based on direct contact of biomaterial and an erythrocyte suspension. The method is based on release of hemoglobin, which can be measured spectrophotometrically. This method is suited to evaluate the hemocompatibility of biomaterials and medical devices according to the international standard ISO 10993-4.
Application
Measuring biomaterial induced hemolysis. This kit is intended for laboratory research use only and is not for use in diagnostic or therapeutic procedures. The analysis should be performed by trained laboratory professionals.
Principle
An erythrocyte suspension is incubated for 24 hours with test material during rotation at 37 ºC. Before and after incubation samples are collected and centrifuged to obtain supernatant, containing free hemoglobin. The hemoglobin concentration is measured by means of a spectrophotometer. Test samples are compared to reference materials. Positive reactive and less-reactive reference materials are included in the kit. It is recommended to include at least two reference materials in each analysis.
The results of the tested materials in relation to the reference materials may be used to evaluate the hemolytic activity. It must be noted that pass/ fail criteria are based on 2% hemolysis. Thus, also the total hemoglobin concentration of the used erythrocyte suspension must be determined.
The kit is designed to determine hemolytic activity of small biomaterial samples. Larger samples can also be used as long as the ratio between erythrocyte suspension and material size is respected.
Video protocol for the Hemolysis test kit.
Storage and Stability
Product is stable at -20 °C for at least six months.
