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  2019
GeneProof Hepatitis C Virus (HCV) PCR Kit  QCMD_HCV_C1.2018  
  INSTAND_HCV_03.2018  INSTAND_HCV_03.2019
+Training programme
  INSTAND training programme HCV  
GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit    INSTAND_HCV_03.2019
+Training programme
     QCMD_HCVD_2019.manual
     QCMD_HCVD_2019.croBEE
GeneProof HIV type 1 (HIV-1) PCR Kit     INSTAND_HIV_03.2019
     QCMD_HIV1_C1.2019
     
     
     
     
     
GeneProof Enterovirus PCR Kit QCMD_ENTERO_C1.2018  
  INSTAND_ENTERO_06.2018  
  QCMD_ENTERO_C2.2018  
GeneProof Hepatitis B Virus (HBV) PCR Kit QCMD_HBV_C1.2018  QCMD_HBV_2019.croBEE
  QCMD_HBV_C3.2018  
     
  INSTAND_HBV_03.2018 INSTAND_HBV_03.2019
+Training programme
  INSTAND training programme HBV  
     
GeneProof BK/JC Virus (BK/JC) PCR Kit  QCMD_panel BKV_kit_BKJC.2019 INSTAND_BKV_03.2019 
  QCMD_panel JCV_kit_BKJC.2019 INSTAND_JCV_03.2019
  QCMD_BK.2018  
  QCMD_BK-JC.2018bkv  
     
     
     
GeneProof BK Virus (BKV) PCR Kit  INSTAND_BK_03.2018  -
  QCMD_BK.2018  -
  QCMD_BK-JC.2018bkv  -
     -
GeneProof JC Virus (JCV) PCR Kit  INSTAND_JC_03.2018  -
  QCMD_JC.2018  -
  QCMD_BK-JC.2018jcv  -
GeneProof Cytomegalovirus (CMV) PCR Kit  QCMD_CMV_C1.2018  
  QCMD_CMV_C3.2018  
  INSTAND_CMV_03.2018 INSTAND_CMV.2019
  INSTAND training programme CMV  INSTAND training programme CMV
     
     
     
     
GeneProof Epstein-Barr Virus (EBV) PCR Kit  QCMD_EBV.2018S  QCMD_EBV.2019
     
     
     
     
     
GeneProof Herpes Simplex Virus 1 (HSV-1) PCR Kit     
     
     
     
GeneProof Herpes Simplex Virus 2 (HSV-2) PCR Kit    
     
     
     
GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit INSTAND_HSV_06.2018  QCMD_HSV.2019_manual
  QCMD_HSV.2018  QCMD_HSV.2019_croBEE
     
     
GeneProof Varicella-Zoster Virus (VZV) PCR Kit INSTAND_VZV_06.2018  
  QCMD_VZV_2018  QCMD_VZV.2019
     
     
GeneProof Adenovirus PCR Kit    QCMD_ADV.2019
GeneProof Borrelia burgdorferi PCR Kit  INSTAND_BB_06.2018 INSTAND_BB.2019
  QCMD_BB.2018  
     
GeneProof Aspergillus PCR Kit QCMD_ASP.2018  
GeneProof Neisseria gonorrhoeae PCR Kit QCMD_NG.2018 QCMD_NG.2019+manual
  INSTAND_CHT+NG_06.2018 QCMD_NG.2019+croBEE
     
     
GeneProof Neisseria gonorrhoeae porA variant PCR Kit    
GeneProof Chlamydia trachomatis PCR Kit QCMD_CHT.2018  
  INSTAND_CHT_06.2018 INSTAND_CHT_2019
  INSTAND_CHT+NG_06.2018 INSTAND_CHT+NG.2019
    QCMD_CHT.2019-manual
    QCMD_CHT.2019-croBEE
     
GeneProof Human Papilloma Virus (HPV) PCR Kit QCMD_HPV_PRES.18  QCMD_HPVS.2019
  INSTAND_HPV_06.2018  
GeneProof Mycoplasma genitalium/hominis PCR Kit QCMD_MG.2018  
GeneProof Ureaplasma PCR Kit    
GeneProof Bordetella pertussis/parapertussis PCR Kit QCMD_BP_2018  
  INSTAND_BP_06.2018 INSTAND_BP.2019
     
GeneProof Chlamydia pneumoniae PCR Kit INSTAND_CHP_06.2018 INSTAND_CHP.2019
  QCMD_CHP.2018 QCMD_CHP.2019
     
GeneProof Legionella pneumophila PCR Kit QCMD_LP.2018 QCMD_LP.2019 
  INSTAND_LP_06.2018 INSTAND_LP.2019
     
GeneProof Mycobacterium tuberculosis PCR Kit  QCMD_MT.2018  QCMD_MT.2019+manual
     QCMD_MT.2019+croBEE
     
GeneProof Mycoplasma pneumoniae PCR Kit INSTAND_MP_06.2018 INSTAND_MP.2019
     
     
GeneProof ESBL PCR Kit  -  -
GeneProof VRE PCR Kit INSTAND_VRE_06.2018 INSTAND_VRE.2019
  QCMD_VRE.2018  
GeneProof MRSA PCR Kit QCMD_MRSA.2018  
  INSTAND_MRSA_05.2018 INSTAND_MRSA.2019
     
GeneProof Parvovirus B19 PCR Kit    INSTAND_B19_03.2019
    QCMD_B19_2019
GeneProof CT/NG/MG Multiplex PCR Kit  QCMD_CNMX.2018

QCMD_CNMX.2019-MANUAL

QCMD_CNMX.2019-croBEE

GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit  

QCMD_HHV6.2019

 

Genetic diagnostics  

 Product name  2018 2019
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   
     

 

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.