GeneProof a.s. regularly performs quality verification for all of its products. All products are subject to internal and external quality assessments.
GeneProof PCR kits are regularly tested by QCMD and INSTAND e.V. External Quality Assessment Panels as a part of the used technology continual improvement.
It is the goal of the external assessment programs to aid monitor and improve quality of clinical laboratories by means of assessing the capability of the laboratories to use molecular diagnostics technologies in common clinical operations. The external quality assessment programs are regularly sent to the individual laboratories and subsequently processed and evaluated. Final reports and practical comments provide the participants with the possibility to identify and deal with eventual problems and simultaneously to monitor the efficiency of the quality control processes applied in their laboratories.
|GeneProof Factor II Prothrombin PCR Kit||INSTAND_FII_04.2018||INSTAND_FII_04.2019|
|GeneProof Factor V Leiden PCR Kit||INSTAND_FV_04.2018||INSTAND_FV_04.2019|
|GeneProof Factor XIII V34L PCR Kit|
|GeneProof MTHFR C677T PCR Kit||INSTAND_M677_04.2018||INSTAND_M677_04.2019|
|GeneProof MTHFR A1298C PCR Kit||INSTAND_M1298_04.2018||INSTAND_M1298_04.2019|
|GeneProof PAI-1 Genotyping PCR Kit||INSTAND_PAI-1_04.2019|
|GeneProof Warfarin dose VKORC/CYP2C9 PCR Kit||INSTAND_WARF_04.2018|
Quality Control for Molecular Diagnostics (QCMD) is an independent international organization for external quality assessment located in Glasgow. It provides a wide range of quality assessment services focused in particular on infectious diseases examined by means of molecular diagnostics methods for over 2000 clients in more then 100 countries worldwide. QCMD specializes in improving the molecular diagnostics quality by means of external quality assessment, capability tests and other support activities in the field of quality control.
Quality is extremely important for QCMD, an international quality control organization, and therefore it provides its clients with professional services focused on external quality assessment. QCMD is accredited at ILAC-G13:08/2007/ISO/IEC Guide 43-01:1997 (ISO 17043:2010) and certified according to ISO9001:2008. The QCMD panel quality system guarantees that it is in strict accordance with the ISO17025:2005 and ISO13485:2003 standards.
INSTAND e.V. is an independent international organization for laboratory diagnostics quality control support located in Düsseldorf. Its goal consists in supporting laboratories and medical facilities in the field of quality control and patient care improvements by means of improved disease diagnostics and discovery due to better analyses and their assessments. Internal and external quality assessments and the related improvements in laboratory analyses improvements are the main activities of this organization. INSTAND e. V. offers about 200 external quality assessment programs from various fields of laboratory diagnostics which are practically tested by the External Quality Assessment client laboratories and subsequently evaluated.
The INSTAND e.V. reference laboratory is accredited according to DIN-EN-ISO/IEC 17025:2005 and DIN-EN-ISO 15195:2004 international standards and operates according to DIN-EN-ISO 15193:2004 standard.