Establishment of industry standards for Y chromosome microdeletion detection kits
Objective To validate the industry standard for Y chromosome microdeletion detec-tion kit.Methods A detection kit for nine types of Y chromosome microdeletions was chosen.Reference ma-terials for Y chromosome microdeletion detection were distributed uniformly.The appearance,detection limit,compliance rate of positive/negative references,and repeatability were verified according to industry standards.Results The test results for all items in the 8 test kits meet the requirements.However,only kit 8 did not de-tect any AZFa microdeletions in the items for detection limit and positive reference rate,which means it did not meet the requirements.Conclusion Most of the validation results meet the requirements of the proposed industry standard,indicating that the indicators of the industry standard are reasonable and feasible.The estab-lishment of an industry standard for Y chromosome microdeletion detection kits will help regulate the develop-ment of such kits,improve quality,and provide technical support for regulation.
NETL
NSTL
万方数据
