Quality Control – Qnostics

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Qnostics

SARS-CoV-2 (COVID-19) Control

In response to the current Coronavirus outbreak, Qnostics, a world leading manufacturer of QC solutions for molecular infectious disease testing has developed a range of products designed to support the validation, verification and performance monitoring of molecular assays used in the testing of SARS-CoV-2 (COVID-19). Accurate and reliable laboratory testing is an essential aspect of COVID-19 disease management and outbreak control. The use of third-party controls will allow laboratories to effectively monitor the performance of diagnostic methods. For more information on Qnostics click here

Features & Benefits

  • Whole Pathogen Controls – Qnostics controls contain the entire SARS-CoV-2 genome meaning they are compatible with the majority of commercial and in-house assays. As whole pathogen controls they target the whole viral genome including CDC and WHO consensus sequences.
  • Full Process Control – Whole pathogen controls are the ideal material for full-process validation, monitoring the testing process from extraction to amplification and detection ensuring ultimate quality assurance in laboratories.
  • Highly Characterised – When the use of time and resources are critical like in COVID-19 testing, the use of highly characterised controls enables laboratories to meet their daily QC needs and accreditation requirements. Qnostics controls are quantified by digital PCR to ensure batch to batch reproducibility and are traceable to an internal reference preparation, to ensure metrological traceability of test results obtained by different diagnostic workflows.
  • True Third Party – An independent, unbiased assessment of assay performance is ensured in line with ISO 15189:2012 regulatory requirements.
  • Superior Manufacturing – Qnostics controls are manufactured under ISO 13485 guidelines to ensure quality and traceability.
  • Liquid for Ease-of-use – Conveniently supplied in a liquid frozen format meaning there is no additional preparation or handling required.
  • Negative Control Available – Negative controls contain human cells/nucleic acids and therefore can be used as part of assay validation.
  • Complete QC Solution – Products available for new assay validation as well as routine performance monitoring.

Complete QC Solutions

Q Controls

Whole pathogen controls designed to monitor assay performance on a run to run basis. As true third party controls, assay drift is detected, monitored and managed helping to ensure accurate and reliable results.

Analytical Q Panels

Designed to span the analytical measuring range of an assay, allowing assessment of linearity, Limit of Detection (LOD) and Limit of Quantitation (LOQ).

Molecular Q Panels

Four individual levels including a negative are provided spanning the assays’ clinical range. Molecular Q Panels may be used to support laboratory training and in the performance assessment and validation of molecular diagnostic assays.

Specification

Target Pathogen – SARS-CoV-2 (COVID-19)

Target – Whole Pathogen

Matrix – Transport Medium

Format – Liquid Frozen

Stability – Single use. Once thawed use immediately.

Regulatory Status – CE, RUO

Ordering Information

Catalogue Number Product Description Pack Size
SCV2QCSARS-CoV-2 Q Control5 x 0.5 ml
TMNQCNegative Q Control 5 x 0.5 ml

Specification

Target Pathogen – SARS-CoV-2 (COVID-19)

Target – Whole Pathogen

Matrix – Transport Medium

Format – Liquid Frozen

Stability – Single use. Once thawed use immediately.

Regulatory Status – CE, RUO

Ordering Information

Catalogue Number Product Description Pack Size
SCV2AQPSARS-CoV-2
Analytical Q Panel
9 x 0.5 ml

Specification

Target Pathogen – SARS-CoV-2 (COVID-19)

Target – Whole Pathogen

Matrix – Transport Medium

Format – Liquid Frozen

Stability – Single use. Once thawed use immediately.

Regulatory Status – CE, RUO

Ordering Information

Catalogue Number Product Description Pack Size
SCV2AQPSARS-CoV-2
Molecular Q Panel
4 x 0.5 ml
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