Sysmex Partec GmbH is based in Goerlitz, Germany, and is developer and manufacturer of flow cytometer systems for diagnostics and research & industry.
There are 36.9million people living with HIV globally, with Africa bearing the largest number of infected individuals of 25.7 million. *2 CD4 testing is playing important rolls for HIV diagnoses and monitoring process. The CyFlow Counter System is a fully equipped compact and robust desktop flow cytometer counting results in cells/µl blood sample or percentage in three minutes without the need for reference beads.
In recent years, acquiring business in healthcare section was getting more restrictive due to high requirements established by healthcare funding organisations. WHO Prequalification is the certificate for providing high standards, quality control and reliability concerning medical supply of patients. This certificate is a necessary key for access to the Essential Healthcare market especially in resource-limited countries.
With the support of Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) Sysmex Partec GmbH managed successfully to fulfil the requirements for obtaining the WHO Prequalification. Now the CyFlow Counter System is listed on WHO website for prequalified in vitro diagnostic products concerning CD4 assays. This list “helps countries to easily make evidence-based selections when purchasing IVDs that are safe, effective and cost-efficient” (cit. WHO).
The reliable quality management system of Sysmex Partec GmbH, required for prequalification, was audited during a several days lasting on-site inspection. Furthermore, a product dossier with all product-relevant documents for development, production, performance specifications, labelling, trade and approval history, tests and studies as well as manufacturer and management information was prepared. As a third pillar, the WHO performed a laboratory evaluation comparing the Sysmex Partec CyFlow Counter System with another CD4 flow cytometric counting system.
References
*1: WHO Prequalifcation(http://www.who.int/topics/prequalification/en/):
WHO Prequalifcation aims to ensure that diagnostics, medicines, vaccines and immunization-related equipment and devices for high burden diseases meet global standards of quality, safety and efficacy, in order to optimize use of health resources and improve health outcomes.
The prequalification process consists of a transparent, scientifically sound assessment, which includes dossier review, consistency testing or performance evaluation and site visits to manufacturers. This information, in conjunction with other procurement criteria, is used by UN and other procurement agencies to make purchasing decisions regarding diagnostics, medicines and/or vaccines.
*2: http://www.who.int/hiv/en/