EQA Results

Microbiological diagnostics results

Genetic diagnostics results

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.

Microbiological diagnostics 

 Product name
2018  2017
GeneProof Hepatitis C Virus (HCV) PCR Kit   QCMD_HCV_C1.2018 QCMD_HCV_C1/2017
   INSTAND_HCV_03.2018 INSTAND_HCV_06.2017 
   INSTAND training programme HCV  
     
     
     
GeneProof HIV type 1 (HIV-1) PCR Kit     
     
     
     
     
     
     
GeneProof Enterovirus PCR Kit  QCMD_ENTERO_C1.2018 QCMD_EV_C1/2017
   INSTAND_ENTERO_06.2018 INSTAND_EV_06/2017
   QCMD_ENTERO_C2.2018 QCMD_EV_C2/2017
GeneProof Hepatitis B Virus (HBV) PCR Kit   QCMD_HBV_C1/2017
    QCMD_HBV_C3.2017 
    INSTAND_HBV_06/2017 
     
     
     
GeneProof BK/JC Virus (BK/JC) PCR Kit     
     
     
     
     
     
     
GeneProof BK Virus (BKV) PCR Kit     
     
     
     
GeneProof JC Virus (JCV) PCR Kit  INSTAND_JC_03.2018  
     
     
GeneProof Cytomegalovirus (CMV) PCR Kit    QCMD_CMV_C1.2017
    QCMD_CMV_C2.2017
     
     
     
     
     
     
GeneProof Epstein-Barr Virus (EBV) PCR Kit    QCMD_EBV_C1.2017 
    INSTAND_EBV_06/2017 
    QCMD_EBV_C2.2017
     
     
     
GeneProof Herpes Simplex Virus 1 (HSV-1) PCR Kit     INSTAND_HSV1_06/2017
    QCMD_HSV1/2017
     
     
GeneProof Herpes Simplex Virus 2 (HSV-2) PCR Kit   INSTAND_HSV2_06/2017 
    QCMD_HSV2.2017
     
     
GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit  INSTAND_HSV_06.2018 INSTAND_HSV_06/2017 
     
     
     
GeneProof Varicella-Zoster Virus (VZV) PCR Kit  INSTAND_VZV_06.2018 INSTAND_VZV_06/2017 
    QCMD_VZV_2017
     
     
GeneProof Adenovirus PCR Kit   INSTAND_ADV_06/2017 
GeneProof Borrelia burgdorferi PCR Kit  INSTAND_BB_06.2018 INSTAND_BB_05/2017 
  QCMD_BB.2018 QCMD_BB_C1/2017
     
GeneProof Aspergillus PCR Kit    
GeneProof Neisseria gonorrhoeae PCR Kit   QCMD_NG_chC1/2017
    INSTAND_CT.NG_05/2017
    QCMD_NG_C2.2017
     
GeneProof Neisseria gonorrhoeae porA variant PCR Kit    
GeneProof Chlamydia trachomatis PCR Kit  QCMD_CHT.2018 QCMD_CHT_ch01/2017
   INSTAND_CHT_06.2018 INSTAND_CT_05/2017
   INSTAND_CHT+NG_06.2018 INSTAND_CT.NG_05/2017 
    QCMD_CHT_C2/2017
     
     
GeneProof Human Papilloma Virus (HPV) PCR Kit    
   INSTAND_HPV_06.2018 INSTAND_HPV_06/2017 
GeneProof Mycoplasma genitalium/hominis PCR Kit    
GeneProof Ureaplasma PCR Kit    
GeneProof Bordetella pertussis/parapertussis PCR Kit  QCMD_BP_2018 QCMD_BP_2017 
   INSTAND_BP_06.2018 INSTAND_BP_05/2017
     
GeneProof Chlamydia pneumoniae PCR Kit  INSTAND_CHP_06.2018 INSTAND_CP_05/2017 
   QCMD_CHP.2018 QCMD_CP_C1/2017
     
GeneProof Legionella pneumophila PCR Kit  QCMD_LP.2018 QCMD_LP_ch01/2017
   INSTAND_LP_06.2018 INSTAND_LP_05/2017 
     
GeneProof Mycobacterium tuberculosis PCR Kit    QCMD_MT_C1.2017
     QCMD_MT_C2.2017
     
GeneProof Mycoplasma pneumoniae PCR Kit  INSTAND_MP_06.2018 QCMD_MP_C1/2017 
    INSTAND_MP_05/2017 
     
GeneProof ESBL PCR Kit    
GeneProof VRE PCR Kit  INSTAND_VRE_06.2018 INSTAND_VRE_05/2017
    QCMD_VRE_C1.2017
GeneProof MRSA PCR Kit  QCMD_MRSA.2018 QCMD_MRSA_C1/2017
   INSTAND_MRSA_05.2018 INSTAND_MRSA_05/2017 
     
GeneProof Parvovirus B19 PCR Kit   QCMD_B19_C1/2017
GeneProof CT/NG/MG Multiplex PCR Kit   QCMD_CNMX_2017

 

Genetic diagnostics  

 Product name   2017
GeneProof Factor II Prothrombin PCR Kit  INSTAND_FII_04.2018 INSTAND_FII_04.2017
     
     
GeneProof Factor V Leiden PCR Kit  INSTAND_FV_04.2018 INSTAND_FV_04.2017 
     
     
GeneProof Factor XIII V34L PCR Kit    
GeneProof MTHFR C677T PCR Kit INSTAND_M677_04.2018  INSTAND_M677_04.2017 
     
     
GeneProof MTHFR A1298C PCR Kit  INSTAND_M1298_04.2018 INSTAND_M1298_04.2017 
     
     
GeneProof PAI-1 Genotyping PCR Kit   INSTAND_PAI-1_04.2017 
     
     
GeneProof Warfarin dose VKORC/CYP2C9 PCR Kit INSTAND_WARF_04.2018  INSTAND_WARF_04.2017 
     

 

QCMD

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.

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.