Molecular Quality Control

Molecular Quality Controls for diagnostic laboratories

In laboratories everything can have an error range, yet variables are not a problem as long as they are being monitored and managed. For this monitoring and validation of the samples, the Randox quality controls can be used. This Randox testing is suitable for validation and ISO certification. As well to support training and monitoring (new) lab technicians over the full process.  This third party quality control provides extra ensurance of your quality besides the first party internal controls and the EQAS (external quality assurance services). As a third party control the Qnostics quality control meets the ISO 15189:2021 regulatory requirements.

Benefits of the Randox Quality Control

Approved quality control

Qnostics SARS CoV-2 Quality Controls

The Qnostics SARS CoV-2 quality control  contains the whole viral genome of an inactivated SARS-CoV-2. This sample is inactivated by heat and gamma irradiation. The inactive SARS-CoV- 2 is diluted in a transport medium containing background human cells, no additional preparation is needed. It is a positive control to monitor molecular assays on commercial scale. For molecular assays from extraction phase through amplification the Qnostics SARS-CoV-2 Quality Controls can be used. 

  • Qnostic Q Control
    • 5x 0.5mL positive or negative samples
  • Qnostic Molecular Q Panel
    • 4x 0.5mL: 3 Positive (low, medium, high) and 1 negative sample
  • Qnostic Analytical Q Panel
    • 9x 0.5mL: Concentration range of 8 positive and 1 negative sample
    • LOD/LOQ measurements

Other Quality Control Applications

  • Transplant Associated Diseases
    • Adenovirus, BK Virus, Cytomegalovirus, Epstein-Barr Virus, Human Herpes Virus 6, Herpes Simplex Virus 1/2, JC Virus, Pneumocystist jirovecii pneumonia and Varicella Zoster Virus
  • Respiratory Infections
    • Adenovirus, Influenza A/B Virus, Parainfluenza Virus, Respiratory Syncytial Virus A/B, Respiratory Triplex and Rhinovirus
  • Sexually Transmitted Infections
    • Chlamydia trachomatis and Neisseria gonorrhoea
  • Blood Borne Viruses
    • Parvovirus B19 and Hepatitis A Virus
  • Gastrointestinal Infections
    • Norovirus

ACUSERA 24-7

Improve analytical performance with an easy-to-use and affordable Statistical Data Analysis tool to track QC results, theAcusera 24-7

  • Manage daily QC activities to ensure accurate patient results.
  • Detect possible errors immediately (systemand reagent issues) anytime and anywhere.
  • We deliver true assessment of analytical performance according to ISO 26289:2012.

KEY BENEFITS

  • Reduce time and money spent on troubleshooting: Peer group statistics:labs can compare statistics to their peers and identify any unique or widespread issues.
  • Highly flexible: Establish your own performance limits, multi-rules, consensus groups and target values for each instrument or lot of QC.
  • Comprehensive reports:easy-to-read and customisable reports.
  • Access anywhere and anytime with a 24-7 access. 
  • Advanced Statistical Analysis: %Bias, Total Error and Sigma Metrics to enhance performance assessment.
  • Automated Data Import: Upload QC data directly to Acusera 24•7 via LIMS and middleware.
  • Technical support: Contact us for any technical support you might need. 

Ensure the right diagnosis for STI

We offer evaluation panels for STI diseases, which cover up to 10 bacterial and protozoan target infections:

Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, and Gardnerella vaginalis. 

  • Shelf life of 2 years from manufacture.
  • Simple and easy to use molecular controls.

 

Request a quotation

Request a quotation for your selection of laboratory instruments, reagents, kits or consumables. 

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Contact information

+31 30 6880771
support@isogen-lifescience.com

Our office

Veldzigt 2A
3454 PW De Meern

ISOgen office