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Home > Archive>Volume 30, Issue 2, 2020 >27-32. DOI:10. 3969 / j.issn.1671-7856. 2020. 02. 005
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Establishment of a performance verification method for flow cytometer under GLP conditions
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1.Beijing Union-Genius Pharmaceutical Technology Development Co., Ltd., Beijing 100176, China. 2. New Drug Safety Evaluation Center, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100050

Clc Number:

R-33

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    Abstract:

    Objective To establish a method to verify the performance of a flow cytometer under GLP conditions. Methods Based on the industry standard document, YY/ T 0588 - 2017 flow cytometer, a verification method for performance evaluation of a flow cytometer was established using a BD FACSVerseTM flow cytometer, including the commonly used flow detection settings for immunological assessment in drug safety evaluation, forward angular scattering light and lateral angular scattering light resolution, repeatability, carrying pollution rateand instrument stability, among others. Results Under the test conditionsin our laboratory, the performance parameters of the BD FACSVerseTM flow cytometer were in accordance with the technical requirements of the industry standard. Conclusions The above method is accurate and reliable, and can meet the needs of drug safety evaluation. It can provide a useful reference for the performance verification of flow cytometer under GLP conditions.

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History
  • Received:September 19,2019
  • Online: April 01,2020
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