Good news! BSBE reference laboratories successfully passed the CNAs review and extension review!

Published:2021-01-28

Source:[英文]九强生物

From January 13 to 14, 2021, the BSBE reference laboratories successfully passed the re evaluation and extension evaluation of China National Accreditation Service for conformity assessment (CNAs).

The approved items in this expansion are total protein (TP), glucose (Glu), urea (urea), homocysteine (Hcy) and glycosylated hemoglobin (HbA1c). The re evaluated items were alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), creatine kinase (CK), aspartate aminotransferase (AST) γ- There are seven projects of glutamyltransferase (GGT), amylase (Amy) and alkaline phosphatase (ALP), and 12 projects of top nine biological reference laboratories approved by CNAs.


This review is based on following criteria and requirements: cnas-cl01:2018 accreditation criteria for testing and calibration laboratories (ISO / iec17025:2017), cnas-cl07:2018 specific accreditation requirements for reference measurement laboratories in the field of laboratory medicine (ISO / iec15195:2003), cnas-cl07-a001:2018 application of accreditation criteria for testing and calibration laboratories in the field of enzymatic reference measurement Cnas-cl07-a003:2018 "Application of accreditation criteria for medical reference measurement laboratories in the field of reference measurement of metabolites and non peptide hormones".

The BSBE laboratories have been recognized by CNAs medical reference laboratory, which indicates that the company's reference measurement ability has been further recognized by the national authority, which can realize the mutual recognition of reference measurement results in the international scope. The calibration report issued by the laboratory has the identification of CNAs and ILAC, and the calibration data has international authority.


As the leader of China's in vitro diagnosis industry, the BSBE attaches great importance to the construction and application of reference measurement system, hoping to contribute to the mutual recognition and standardization of clinical test results in China. On the one hand, the BSBE reference laboratories build the top traceability system according to iso17511 international standard, and strictly carry out the application research of product traceability, so as to ensure the accuracy of clinical sample determination results. On the other hand, the company actively cooperates with the Chinese Academy of Metrology and the Chinese people's Procuratorate to carry out joint assignment of reference materials, participate in the formulation of industry standards and the compilation of expert consensus, and contribute to the development of the industry.