According to the “Notice of the State Standardization Administration Committee on the Fourth Batch of National Standards Production and Revision Projects in 2019” issued by SAC [2019] No. 40, the “General Rules for Performance Evaluation of Real-time Fluorescence Quantitative PCR Instruments” with the project code 20194004-T-604 is a national standard development project. The National Technical Committee for Standardization of Industrial Process Measurement Control and Automation (SAC/TC124/SC6)will be in charge of this project.

Mr. Li Yong, Global Marketing Director of Life Sciences of Heal Force Group, with various participants in July

On July 13, 2021, a meeting on the development of the national standard “General Rules for Performance Evaluation of Real-Time Fluorescence PCR Instruments” was held in a hospital laboratory in Suzhou, China. It is worth mentioning that Heal Force had just co-organize the second working meeting of this standard in March 2021.

Mr. Shen Qinhua, Chairman of Heal Force Group, with participants of the conference in March

Heal Force has been developing, producing and manufacturing PCR equipment for nearly 20 years and is a well-known brand in the industry, with a number of products that have received China’s Class III and Class II medical device registration certificates and CE certification.

Among them, the X960 fully automated medical PCR analysis system, with its many features such as good stability, convenient operation, fast running speed which will be time saving, was well received by end-users such as hospitals, CDC and customs at home and abroad during the fight against COVID-19, and made its due contribution to the fight against the epidemic.

This is the same X960 fully automated medical PCR analysis system that Heal Force brings with in this standard performance verification.

X960 Fully Automatic Medical PCR Analysis System

The X960 fully automated medical PCR analysis system is a real time fluorescence PCR analysis system, which maintaining the usual high quality of Heal Force, with two channels and five channels (fifth channel reserved) configurations and a 96-well gold-plated module as standard to meet the needs of different applications.

Hardware design

  • Fluorescence detection system with LED light source and high resolution CCD camera
  • Open reagents and consumables platform with high versatility
  • Acquisition of sample fluorescence signals at the same time

Temperature control system

  • Peltier-Based technology
  • Maximum temperature rise and fall of 5 °C/s, time saving
  • High detection sensitivity, even the smallest individual template could be detected
  • Good uniformity of temperature control, reducing inter-well variation and ensuring accurate data for replicate samples

Data analysis system

  • Independently developed and designed software analysis module with intuitive and clear interface, switchable between English and Chinese
  • Multiple analysis modes, including relative/absolute quantification, melting curve analysis, isothermal amplification, HRM analysis, etc.
  • Built-in statistical analysis and custom formula editing tools, data can be analysed directly in the instrument software without export

The validation of the instrument will focus on the performance of the instrument, such as temperature accuracy, temperature uniformity, temperature fluctuation, temperature rise and fall, fluorescence intensity, fluorescence uniformity, etc.

X960 undergoes various performance tests on site

Heal Force has been invited to participate in the development of national industry standards such as bio-safety cabinet standard and carbon dioxide incubator standard, and was selected to participate in the drafting of the “Digital Operating Room Construction Standard”. This time, Heal Force is honored to participate in the development of China’s national standard for the evaluation of the performance of real-time fluorescence PCR instruments.

Thanks to the organizing committee’s invitation and its recognition of our company, we had the opportunity to have professional and in-depth communication with our peers through this standard meeting, and we believe that we will make progress together and make more contributions to the Chinese PCR industry.

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