Crossover Contamination And The Establishment Of Closed Systems In The Automatic Biochemical Analyzer

In vitro diagnostic(IVD)refers to products and services that obtain clinical diagnostic information and determine disease or body function by measuring human body fluids(blood,urine,cerebrospinal fluid,etc.)in vitro.IVD is a "tool" for laboratory medicine.About 70% of clinical diagnostic information comes from IVD and is an important part of prevention,diagnosis and treatment of human diseases.In recent years,with the development of laboratory medicine and the improvement of testing quality requirements,automatic biochemical analyzers have played an increasingly important role in IVD and have been widely used in hospitals at all levels,Blood stations,physical examination center and other scientific research institutions.The automatic biochemical analyzer is a closed system with the measurement system formed by reagents,calibrators and quality control products of the same manufacturer.The test results are traceable and comparable.However,at present,domestic instrument manufacturers or reagent manufacturers mostly adopt open systems,and it is difficult to ensure traceability and comparability of results,which has become a barrier to mutual recognition of hospitals at all levels.At the same time,the automatic biochemical analyzer will share mechanical parts during the analysis process,so reagents or sample residues from different projects may cause cross-containment pollution to other items.To improve the accuracy and comparability of inspection has become an important issue that needs to be solved today.This paper is divided into two parts to study the above situations:1.The reagent cross-carrying pollution discovery and solution on the Abbott c16000 automatic biochemical analyzer;In order to solve the concealment carryover contamination in clinical chemistry assay,we design a versatile judgment standard and a solution for reagent carryover contamination.The reagent carryover contamination of 930 combinations between 31 types in-vitro diagnostic kits of Bio Sino were evaluated using automatic biochemical analyzer(Abbott c16000)and a new judgment standard was put forward which is conducive to find out those concealed carryover contamination,then a special cleaning procedure were designed.The results show that there are 10 combinations with carryover contamination were identified using traditional standard,and there are 5 more combinations with carryover contamination were picked out using the new standard.Our special cleaning procedure was used to the 15 combinations,in which the contamination rates of the 15 combinations are all significantly reduced and carryover contamination of them are all eliminated.2.The research on the closed system of the Bio Sino in vitro diagnostic reagent and the Bio Sino automatic biochemical analyzer:Study on establishing closed system of Bio Sino in vitro diagnostic reagent and Bio Sino instrument In order to realize the traceability and comparability of the measurement system,a reasonable and universal closed system establishment scheme is proposed.The program adopts Bio Sino Automatic Biochemical Analyzer 340(ZS340),which uses the Bio Sino reagent with high occupancy rate in the IVD market,and optimizes the design of reagent parameters by introducing the principles of reagent parameter setting for 41 clinical routine kits.The parameters,matching calibrators and controls,and comparison with the Abbott c16000 system verify the comparability of the closed system.In an experiment to verify the comparability of closed systems,it was found that the commonly used comparison test comparability criteria did not cover all the items or misjudge,and a new standard for verifying the comparability of closed systems was proposed.The results showed that the closed system verification of 41 clinical routine kits using the new standard can intuitively determine whether the established closed system is comparable.The new standard has also been verified on Beckman and Hitachi instruments.The established closed system achieves traceability and comparability,and provides a basis for mutual recognition of results at all levels of hospitals.