Recently, the Shenzhen Cell Quality Testing Platform that serves the Shenzhen Comprehensive Cell Bank and the Shenzhen (Beike) Regional Cell Preparation Center received the 2015 "External Quality Assessment Certificate" issued by the National Center for Clinical Laboratories of the Ministry of Health, with all assessment items passing. This indicates that the testing technology and capabilities of the Shenzhen Cell Quality Testing Platform built and operated by Beike Biotech have reached top domestic levels, and will play a positive role in further standardizing the quality of cell testing, effectively safeguarding cell quality and the safety of cell storage and clinical use.
External quality assessment (EQA) is a process in which multiple laboratories analyze the same samples and an external independent body collects and feeds back the results reported by the laboratories, thereby evaluating laboratory performance. Through inter-laboratory comparison, EQA assesses laboratory calibration and testing capability and monitors its ongoing competence. The role of EQA is to use inter-laboratory comparison to assess laboratory capability — in practice, it is a verification activity that examines, supervises and confirms a laboratory's competence to ensure it maintains a high level of testing.
To standardize external quality assessment activities for clinical testing and align with internationally accepted EQA practice, the National Center for Clinical Laboratories of the Ministry of Health has, since 2003, issued certificates each year to participating institutions at the conclusion of all EQA programs, listing the items that have passed.
The items in which the Shenzhen Cell Quality Testing Platform operated by Beike Biotech participated in this EQA included blood-screening enzyme immunoassay testing, blood-screening nucleic acid testing, blood typing, and complete blood count. Blood-screening enzyme immunoassay testing items include hepatitis B virus surface antigen, hepatitis B virus core antibody, hepatitis C virus antibody, HIV antibody, and Treponema pallidum antibody. Blood-screening enzyme immunoassays and blood typing are conducted three times per year, with each item scored out of 100 each round. Blood-screening nucleic acid testing items include hepatitis B virus (HBV-DNA) and hepatitis C virus (HCV-RNA). Blood-screening nucleic acid testing and complete blood count are conducted twice per year, with each item scored out of 100 each round.
Beike Biotech has long upheld the management principle and operating philosophy of "putting quality first," and has consistently performed quality control of testing results in a comprehensive, high-standard manner in strict accordance with ISO 9001 and AABB requirements, maintaining the smooth operation of its quality management system, actively participating in the EQA programs of the National Center for Clinical Laboratories of the Ministry of Health, and treating EQA participation as an opportunity to improve and assess the testing capability of the cell quality testing platform, integrating EQA into year-round quality control to ensure cell quality and safety in all respects.
To date, since 2011, Beike Biotech has participated in four EQA programs organized by the National Center for Clinical Laboratories of the Ministry of Health, and has obtained passing "External Quality Assessment Certificates" each time. Going forward, the Shenzhen Cell Quality Testing Platform will continue to participate in EQA programs and provide safer guarantees for customer-stored cells and clinical-grade cells produced.
