Reference laboratory



Overview of laboratory

Beijing Antu Bioengineering Co., Ltd. (Autobio) focuses on the field of clinical biochemical in vitro diagnostic reagents. It is a high-tech enterprise integrating the R & D, production, sales and after-sales of in vitro diagnostic reagents. Beijing Antu has fully invested its diagnostic reagent business portfolio and innovative solutions in the cooperation with end users and partners, demonstrating its firm determination to help and improve the quality of human life and achieve sustainable development. The reference laboratory of Beijing Antu Bioengineering Co., Ltd. was founded in June 2015, with a construction area of 560 square meters and a total fixed assets value of 8 million yuan.

The laboratory has established seven reference measurement procedures for clinical enzymology, four small molecule metabolites and one protein project, and six ion chromatography reference measurement procedures for potassium, sodium, calcium and magnesium and four liquid chromatography tandem mass spectrometry reference measurement procedures are being established.

Responsibilities of laboratory

quality policy

Accurate, standard, efficient and fair

Quality objectives

Get recognition

The reference laboratory of Beijing Antu Bioengineering Co., Ltd. (hereinafter referred to as "laboratory") has successfully passed the preliminary evaluation of China National Accreditation Service for conformity assessment (CNAs), marking that our products have obtained the qualification of "one-time measurement, global mutual recognition".

The laboratory submitted an application for accreditation to CNAs at the end of August 2020 and passed the document review in September. CNAs evaluation expert group conducted on-site evaluation on the laboratory from December 3 to 5 and agreed to pass. CNAs officially issued the "proficiency certificate for testing and calibration laboratory" on January 28, 2021

At present, there are 11 reference measurement projects approved by the laboratory, all of which are spectral platform projects, namely: alanine aminotransferase, aspartate aminotransferase, aspartate aminotransferase, aspartate aminotransferase, aspartate aminotransferase, aspartate aminotransferase, aspartate aminotransferase, aspartate aminotransferase, aspartate aminotransferase, aspartate aminotransferase, aspartate aminotransfera α- Amylase, creatine kinase γ- Glutamyltransferase, lactate dehydrogenase, alkaline phosphatase, glucose, urea, total bilirubin, total protein. The key equipment of the laboratory has been calibrated by the National Institute of metrology of China. At present, the laboratory is building ion chromatography platform and liquid chromatography tandem mass spectrometry platform. In the future, it will develop more reference measurement procedures for various clinical biochemical in vitro diagnosis projects, leading the products to achieve a higher level of traceability and quality control.

Over the years, the laboratory has actively participated in the international reference laboratory external quality assessment program (rela) (laboratory number: 138) and the reference measurement capability verification organized by the clinical laboratory center of the National Health Council, and has achieved good results (see Table 1 for the specific results) :81), It proves the high quality reference measurement level and standard and perfect quality management system (ISO17025 / iso15195).

The laboratory emphasizes the inheritance and development of craftsmanship spirit, is committed to the establishment of reference methods for clinical biochemical products and the standardization of quantity traceability, and provides patients and customers with internationally recognized test results and other related services. Under the leadership and guidance of many experts in the industry, the laboratory strives to promote the rapid development of in vitro diagnosis industry in China, In order to accelerate the process of substituting imported products made in China.

Beijing Antu reference laboratory welcomes all levels of experts, colleagues and partners to visit and exchange, sincerely cooperate and walk side by side.