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亞輝龍(688575.SH):乙型肝炎病毒核心抗體測定試劑盒取得醫療器械註冊證

格隆匯5月30日丨亞輝龍(688575.SH)公佈,公司於近日收到了由國家藥品監督管理局簽發的醫療器械註冊證,產品名稱爲乙型肝炎病毒核心抗體測定試劑盒(化學發光法),本產品用於體外定量測定人血清或血漿中乙型肝炎病毒核心抗體(Anti-HBc)的含量。本產品用於乙型肝炎病毒感染的輔助診斷。

乙型肝炎病毒(HBV)由外膜(HBsAg)和內核(HBcAg)組成。肝炎核心抗原由183~185個氨基酸組成。在HBV感染期間,通常會產生針對HBcAg的抗體,這種抗體通常會持續終生。Anti-HBc在HBV感染開始後不久出現,通常在HBsAg出現後不久就可以在血清中檢測到。Anti-HBc會持續存在於HBV感染恢復的人和非活動性攜帶者中。

截至目前,公司已先後取得171項化學發光試劑國內《醫療器械註冊證》(共248個發光試劑國內註冊證)。相較前期已獲證的HBV血清學標誌物的定性檢測產品,本次獲證產品爲新一代產品。本次《醫療器械註冊證》的取得,實現了HBV血清學標誌物的全定量檢測,進一步豐富了亞輝龍傳染病套餐的臨牀應用範圍,爲臨牀診斷提供更精準、更全面的檢測數據,助力乙肝患者更科學的健康管理。

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