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CE Marking Granted to Quality Control for Newborn Infectious Disease Tests

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ToRCH Quality Controls to support the accuracy and reliability of infectious disease testing in newborns have been granted CE marking.

The controls for ToRCH, which is a blood test screening to detect infectious diseases including toxoplasmosis, rubella, cytomegalovirus, and herpes simplex, are available from global diagnostics company Randox Laboratories, and are used to ensure accurate ToRCH test and system performance.

Manufactured from human plasma, each control is designed to react to the test system in the same manner as the patient sample, helping laboratories to meet ISO 15189:2012 for quality and competence.

Lynsey Adams, Randox Quality Control Manager, commented:

“The CE marking of the ToRCH controls from Randox will be a game-changer for clinicians and patients alike, by facilitating early, accurate and comprehensive diagnoses of infectious diseases in newborns, that allow for the best possible patient outcomes.

“Ultimately, these ToRCH controls will guarantee quality assurance in laboratories performing ToRCH screening in newborns.”

Randox ToRCH Controls are also multi-analyte and therefore, testing can be consolidated to just a small number of vials to save laboratories valuable space and time.

In addition to ToRCH, Randox Infectious Disease Quality Controls also include quality control material for Lyme Disease, Epstein-Barr virus, HIV, Hepatitis A virus, Human T-lymphotropic virus, Cytomegalovirus, and Varicella zoster virus (Chickenpox or Shingles).

Adams continued:

“Unlike analyser-specific tests, these controls can be used across a wide range of laboratory technologies, and complement our already existing RIQAS Serology EQA programmes to provide laboratories with a complete QC solution from a single supplier.

“With a working stability of 60 days at 2°c to 8°c which keeps waste and costs to a minimum, Randox Infectious Disease Controls are set to revolutionise serology testing and provide reliable, accurate results time and time again.”

Randox Infectious Disease Controls are ideal for microbiology and virology laboratories, blood banks, public health laboratories or clinical laboratories performing serology testing.

Key benefits of the Randox Infectious Disease Controls:

  • User-friendly - all samples are provided in a liquid, ready-to-use format
  • Commutable - manufactured from human plasma, each control reacts to the test system in the same manner as a patient sample
  • Versatility - designed to deliver an independent, unbiased assessment of performance with any immunoassay instrument
  • Stability - working stability of 60 days ensures waste and costs are kept to a minimum
  • Multi-marker - helps reduce the number of individual controls required
  • Clinical relevance - designed to challenge clinically-relevant levels, samples will ensure accurate and reliable instrument performance