Introduction

Fugen Biomed is an emerging supplier of diagnostic systems and reagents. It was founded by insightful healthcare industry professionals with more than decades of high-performance senior-level experience with professional expertise gained in renowned domestic and multinational organizations.

EQA programs like “EQAsure” are accepted as valuable tools for diagnostic laboratories to assess the quality of test performance results. EQA programs are developed and maintained following requirements of ISO 17043:2010 QMS.  

The EQAsure programs independently operated, providing participants with confidence and assurance of high-quality samples with stability and homogeneity. 

Each laboratory receives a report for each sample that provides the laboratory with an individual performance analysis of submitted results. In the EQAsure report, statistical processes will be based on ISO 13528:2015 – “Statistical methods for use in PT by interlaboratory comparison” for the calculation of robust estimation of the consensus mean and standard deviation, which are used to assess the acceptable performance of each participating laboratory. An individual laboratory performance over the entire cycle is compared with other laboratories in terms of bias for all analytes reported. At the end of the cycle, each laboratory receives a certificate of participation by submitting the required data throughout a program cycle. 

EQAsure offers comprehensive EQA Programs in in-vitro Diagnostic laboratories. The EQAsure program is aims to be known for its high-quality samples, reliability, user-friendliness, and affordable prices. EQAsure programs offer to maintain and improve the quality of in-vitro diagnostics testing, achieving higher patient safety by making healthcare diagnostics more reliable.