Hemolysis Assay for Biomaterials

Hemolytic activity is a requirement to be tested for any blood contacting medical device

Hemolysis test kit for Biomaterials(30 determinations)

European Union Price: €565,- (As per 01-01-2026).
Inquire for a quotation if you are located outside the European Union.

Order test kit

Description

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.

Storage and Stability

Product is stable at -20 °C for at least six months.

Download

Manual / SDS

References that used the Hemolysis assay for Biomaterials:

1. Bayoumi M, Youshia J, El-Kawy OA, Gaber SAA, Arafa MG, Nasr M, Sammour OA. Folic Acid-Decorated Lipidic Nanocapsules Co-Loaded with Atorvastatin and Curcumin to Enhance Glioma Targeting in Mice. Pharmaceuticals. 2025 Oct 27;18(11):1623.

2. Razaviamri F, Manuel J, Wang K, Zhang Z, Lee BP. Chlorocatechol-functionalized gelatin nanoparticles as a hemostatic agent with antimicrobial properties. Acta Biomater. 2025 Sep 15;204:568-581.

3. Du RL, Hung CH, Leung AS, Ding K, Kong WP, Wang Y, Liang ZG, Chan PH, Wong KY. Development of Broad-Spectrum Antimicrobial Peptides through the Conjugation of FtsZ-Binding and Cell-Penetrating Peptides. ACS Infect Dis. 2025 Aug 8;11(8):2190-2204.

4. Andrade Del Olmo J, Mikeš P, Asatiani N, Alonso JM, Sáez Martínez V, Pérez González R. Alternating Current Electrospinning of Polycaprolactone/Chitosan Nanofibers for Wound Healing Applications. Polymers (Basel). 2024 May 9;16(10):1333.

5. Hung CH, Chan KH, Kong WP, Du RL, Ding K, Liang Z, Wang Y, Wong KY. A Water-Soluble Aggregation-Induced Emission Photosensitizer with Intrinsic Antibacterial Activity as an Antiplanktonic and Antibiofilm Therapeutic Agent. J Med Chem. 2025 Apr 24;68(8):8768-8785.

6. Rahaman MS, Arin A, Farwa U, Park M, Bae SH, Lee BT. ECM derivatized alginate augmenting bio-functionalities of lyophilized mat for skin and liver wound treatment. Biomaterials. 2024 Dec;311:122698.

7. Wang Y, Liang Z, Cao Y, Hung CH, Du R, Leung AS, So PK, Chan PH, Wong WL, Leung YC, Wong KY. Discovery of a novel class of rosmarinic acid derivatives as antibacterial agents: Synthesis, structure-activity relationship and mechanism of action. Bioorg Chem. 2024 May;146:107318.

8. Arin A, Rahaman MS, Farwa U, Gwon J, Bae SH, Kim YK, Lee BT. An agarose-based TOCN-ECM bilayer lyophilized-hydrogel with hemostatic and regenerative properties for post-operative adhesion management. Int J Biol Macromol. 2024 Mar;262(Pt 2):130094.

9. Iancu IM, Schröder V, Apetroaei M-R, Crețu RM, Mireșan H, Honcea A, Iancu V, Bucur LA, Mitea G, Atodiresei-Pavalache G. Biocompatibility of Membranes Based on a Mixture of Chitosan and Lythri herba Aqueous Extract. Applied Sciences. 2023; 13(14):8023.

10. El-Kawy OA, Ibrahim IT, Shewatah HA, Attalah KM. Preparation and evaluation of radiolabeled gliclazide parenteral nanoemulsion as a new tracer for pancreatic β-cells mass. Int J Radiat Biol. 2023;99(11):1738-1748.

11. Andrade Del Olmo J, Pérez-Álvarez L, Sáez Martínez V, Benito Cid S, Ruiz-Rubio L, Pérez González R, Vilas-Vilela JL, Alonso JM. Multifunctional antibacterial chitosan-based hydrogel coatings on Ti6Al4V biomaterial for biomedical implant applications. Int J Biol Macromol. 2023 Mar 15;231:123328.

12. Chen MJ, Pappas GA, Massella D, Schlothauer A, Motta SE, Falk V, Cesarovic N, Ermanni P. Tailoring crystallinity for hemocompatible and durable PEEK cardiovascular implants. Biomater Adv. 2023 Mar;146:213288.

13. Du RL, Chow HY, Chen YW, Chan PH, Daniel RA, Wong KY. Gossypol acetate: A natural polyphenol derivative with antimicrobial activities against the essential cell division protein FtsZ. Front Microbiol. 2023 Jan 12;13:1080308.

14. Manivasagam VK, Popat KC. Improved Hemocompatibility on Superhemophobic Micro-Nano-Structured Titanium Surfaces. Bioengineering. 2022 Dec 29;10(1):43.

15. Franco AR, Pirraco R, Fernandes EM, Rodrigues F, Leonor IB, Kaplan DL, Reis RL. Untangling the biological and inflammatory behavior of silk-like sutures In vivo. Biomaterials. 2022 Nov;290:121829.

16. del Olmo, JA, et al. Effectiveness of physicochemical techniques on the activation of Ti6Al4V surface with improved biocompatibility and antibacterial properties. Surface and Coatings Technology 447 (2022)

17. Arza CR, Li X, İlk S, Liu Y, Demircan D, Zhang B. Biocompatible non-leachable antimicrobial polymers with a nonionic hyperbranched backbone and phenolic terminal units. J Mater Chem B. 2022 Oct 12;10(39):8064-8074.

18. Virk, HS, Popat, KC. Erythrocyte interaction with titanium nanostructured surfaces. In vitro models. 2022;1:347–363.

19. Li, X, Ilk, S, Liu, Y, Raina, DB, Demircan, D, Zhang, B. Nonionic nontoxic antimicrobial polymers: indole-grafted poly(vinyl alcohol) with pendant alkyl or ether groups. Polym. Chem. 2022;13(16):2307-2319.

20. Swithenbank L, Cox P, Harris LG, Dudley E, Sinclair K, Lewis P, Cappiello F, Morgan C. Temporin A and Bombinin H2 Antimicrobial Peptides Exhibit Selective Cytotoxicity to Lung Cancer Cells. Scientifica (Cairo). 2020 Jun 26;2020:3526286

21. Yu R, Wang J, So LY, Harvey PJ, Shi J, Liang J, Dou Q, Li X, Yan X, Huang YH, Xu Q, Kaas Q, Chow HY, Wong KY, Craik DJ, Zhang XH, Jiang T, Wang Y. Enhanced Activity against Multidrug-Resistant Bacteria through Coapplication of an Analogue of Tachyplesin I and an Inhibitor of the QseC/B Signaling Pathway. J Med Chem. 2020 Apr 9;63(7):3475-3484.

22. Franco AR, Fernandes EM, Rodrigues MT, Rodrigues FJ, Gomes ME, Leonor IB, Kaplan DL, Reis RL. Antimicrobial coating of spider silk to prevent bacterial attachment on silk surgical sutures. Acta Biomater. 2019 Nov;99:236-246.

23. Wersig T, Krombholz R, Janich C, Meister A, Kressler J, Mäder K. Indomethacin functionalised poly(glycerol adipate) nanospheres as promising candidates for modified drug release. Eur J Pharm Sci. 2018 Oct 15;123:350-361.

24. Shi J, So LY, Chen F, Liang J, Chow HY, Wong KY, Wan S, Jiang T, Yu R. Influences of disulfide connectivity on structure and antimicrobial activity of tachyplesin I. J Pept Sci. 2018 Jun;24(6):e3087.

25. Leszczak V, Popat KC. Improved in vitro blood compatibility of polycaprolactone nanowire surfaces. ACS Appl Mater Interfaces. 2014 Sep 24;6(18):15913-24.

26. Nemani KV, Moodie KL, Brennick JB, Su A, Gimi B. In vitro and in vivo evaluation of SU-8 biocompatibility. Mater Sci Eng C Mater Biol Appl. 2013 Oct;33(7):4453-9.