KeratinoSens试验在医疗器械致敏性检测中的应用研究

doi:10.3969/j.issn.1004-616x.2021.06.010

Abstract

Abstract: OBJECTIVE: This article introduces a new in vitro human-derived cell line as an alternative method (KeratinoSens assay) of evaluation for delayed-type hypersensitivity to,KeratinoSens assay,and discusses its application in the detection of two medical devices. METHODS: Plasmid pGL4.17-AKR1C2-ARE-SV40 was constructed to transfect the human immortalized keratinocytes HaCaT,and the stablye transfected cell line KeratinoSens was obtained by screening with G418. TheUsing KeratinoSens assaywas used to evaluateprocess sensitizers with different sensitization ranks and non-sensitizers. By calculating the Variabilities of gene activity induction variability ofin the negative control were used to identify cell stability. The data were,compared toing the test results with the sensitization properties of the compounds in the literature,and were used to indicateget the predictability of the sensitization of the cell line. After the successful cell transfection is identified,the KeratinoSens assay wasis used to test the medical devices with more clinical sensitization reports,medical natural latex gloves and nickel-containing metals. RESULTS: The negative control hads a variation of 18.6% which meets the stability requirements,and the synthesized cell hadve good sensitization predictability. KeratinoSens assay rResults fromof the two medical devices were are negative. CONCLUSION: The KeratinoSens was successfully constructed and used to initially applied to medical device testing to provide empirical data for itsthe method to be transformationed into a medical device testing method.

Key words: sensitization test, alternative in vitro, KeratinoSens assay, medical device

CLC Number:

R331

CHEN Hong, HUANG Yuanli, WANG Han, LIAN Huan, HAN Qianqian, WANG Chunren. Research on KeratinoSens assay applied to medical devices[J]. Carcinogenesis, Teratogenesis & Mutagenesis, 2021, 33(6): 455-460.

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Research on KeratinoSens assay applied to medical devices

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