Qnostics

Respiratory Target Multiplex (RTX) 1 Control

This multiplex control has been designed in response to the current Coronavirus pandemic. The control can be used to support the validation, verification and performance monitoring of molecular assays used in SARS-CoV-2 testing and other respiratory pathogens.

Meeting the requirements of various testing strategies, this 4-plex control covers multiple viral pathogens that cause respiratory diseases in various patient cohorts, in line with public health testing and the test menu of most syndromic assays.

Having a multiplex control, like the Qnostics RTX1, gives great flexibility to laboratories and allows them to meet laboratory requirements in terms of respiratory pathogens covered whilst keeping QC tests to a minimum.

Features & Benefits

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    Whole Pathogen Control

    Containing the entire SARS-CoV-2 genome, the RTX1 Control is compatible with the majority of commercial and in-house assays. As a whole pathogen control, it targets the whole viral genome.

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    Full Process Control

    Whole pathogen controls are ideal for full-process validation, monitoring the testing process from extraction to amplification and detection ensuring ultimate quality assurance in laboratories.

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    Highly Characterised

    Using highly characterised controls enable labs to meet their daily QC needs and accreditation requirements. Qnostic controls are quantified by digital PCR to ensure batch-to-batch reproducibility.

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    True Third Party

    An independent, unbiased assessment of assay performance is ensured in line with ISO 15189:2012 regulatory requirements.

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    Liquid for Ease-of-Use

    Conveniently supplied in liquid frozen format meaning there is no additional preparation or handling required.

Specification

Target Pathogen – Influenza A (H1N1), Influenza B (Victoria), Respiratory Syncytial Virus (A), Coronavirus (SARS-CoV-2)

Target – Whole Pathogen

Matrix – Transport Medium

Format – Liquid Frozen

Stability – Single use. Once thawed use immediately.

Regulatory Status – RUO

Ordering Information

Catalogue Number Product Description Pack SizePackage Insert
RTX1QCRTX1 Q Control5 x 0.6 mlKit Insert

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

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    Whole Pathogen Control

    Qnostics controls contain the entire SARS-CoV-2 genome meaning they are compatible with the majority of commercial and in-house assays.

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    Full Process Control

    Whole pathogen controls are ideal for full-process validation, monitoring the testing process from extraction to amplification and detection ensuring ultimate quality assurance in laboratories.

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    Negative Control Available

    Negative controls contain human cells/nucleic acids and therefore can be used as part of assay validation.

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    True Third Party

    An independent, unbiased assessment of assay performance is ensured in line with ISO 15189:2012 regulatory requirements.

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    Complete QC Solution

    Products available for new assay validation as well as routine performance monitoring.

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

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.

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

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).

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

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.

Ordering Information

Catalogue Number Product Description Pack Size
SCV2MQPSARS-CoV-2
Molecular Q Panel
4 x 0.5 ml

Specification

Target Pathogen – Novel Coronavirus SARS-CoV-2, SARS-CoV-2 (Delta, Alpha, Beta, Gamma, Eta, Alpha N variant, Omicron)

Matrix – Transport Medium (TM)

Format – Liquid Frozen

Stability – Single use. Once thawed use immediately

Regulatory Status – Research Use Only (RUO)

Evaluation Panel

Intended for research use only, this evaluation panel is designed to help laboratories develop their molecular procedures.

Suitable for use with most commercial and in-house molecular methods, this panel is characterised using real-time PCR and NGS. The panel contains variants of whole pathogen inactivated SARS-CoV-2 and is supplied in a liquid-frozen format.

Ordering Information

Catalogue Number Product Description Pack Size
SCV2TEPSARS-CoV-2
Typing Evaluation Panel
8 x 1.0 ml
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