Blood Borne Virus Testing | Qnostics Molecular Controls
Monitoring for the presence of Blood Borne Virus (BBV) nucleic acid is an essential parameter in guiding clinical treatment and patient outcome. The use of appropriate quality control measures is important in ensuring the appropriate daily performance of the molecular assay used in the laboratory independent of the technology.
Qnostics’ Blood Borne Virus Molecular Controls comprises a range of pathogens which are classically detected directly from the blood. This includes pathogens including: B19 Virus, Hepatitis A, Hepatitis B, Hepatitis C, Hepatitis D, Hepatitis H, West Nile Virus and Zika Virus.
Q Controls
Qnostics’ ‘Q’ Controls are positive run controls intended to help laboratories monitor their molecular diagnostic assay on a run-to-run basis within customer derived limits. These third-party independent external controls will ensure that assay drift is detected, monitored and managed allowing the laboratory to continue to provide accurate and reliable results. They also help support a laboratory’s regulatory requirements under the standard ISO 15189.
Hepatitis C (HCV) Control
Pathogen – Hepatitis C Virus (HCV)
Genotype – Type 1B
Matrix – Plasma
Stability – Single use. Once thawed, use immediately
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – RUO
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HCV Medium Q Control
Product code: HCVMQC | Pack size: 5×1.2 ml
Human Immunodeficiency Virus 1 (HIV-1) Control
Pathogen – Human Immunodeficiency Virus (HIV)
Genotype – Type B
Matrix – Plasma
Stability – Single use. Once thawed, use immediately
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – RUO
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HIV Medium Q Control
Product code: HIVMQC | Pack size: 5×1.2 ml
Analytical Q Panels
Analytical ‘Q’ Panels are designed to cover the dynamic range of an assay allowing the laboratory to assess the linearity, LOD and LOQ of their assay. Each panel contains a dilution series covering the analytical range of most assays, in a linear progression, all of which should be treated as a patient sample within an assay run.
Parvovirus B19 (B19) Analytical Q Panel
Pathogen – Parvovirus B19 (B19)
Genotype – Type 1a
Matrix – Plasma
Number of Levels – 9
Stability – Single use Q-Panel designed to be used immediately minimising risk of contamination
Shelf Life – Up to 2 years from date of manufacture
Regulatory Status – RUO
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B19 Analytical Q Panel RUO
Product code: B19AQP | Pack size: 9×1.5 ml
Molecular Q Panels
Molecular Q Panels consist of four individual levels, including a negative, and are intended to evaluate the assays’ clinical range. Molecular Q Panels can also be used to support laboratory training and in the assessment and development of molecular diagnostic assays from extraction phase through amplification and finally detection.
Parvovirus B19 (B19) Molecular Q Panel
Pathogen – Parovirus B19 (B19)
Genotype – Type 1a
Matrix – Plasma
Stability – Single use Q-Panel designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – RUO
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B19 Molecular Q Panel
Product code: B19MQP | Pack size: 4 x 1.2 ml
Evaluation Panels
Evaluation panels are designed to assist laboratories with development of their molecular assays, establish the assay parameters of the molecular method and determine its fitness for purpose. The evaluation panels for blood-borne viruses contain a duplicate vial of one concentration which allows laboratories to asses reproducibility of their workflow for these targets.
Hepatitis B (HBV) Genotype Evaluation Panel
Pathogen – Types A, B, C, D and H
Matrix – Plasma
Panel Members – 6 (including a negative)
Stability – Single use Evaluation Panel designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – RUO
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HBV Genotype Evaluation Panel
Product code: HBVGTEP | Pack size: 6×1.2 ml
Hepatitis B (HBV) Evaluation Panel
Pathogen – Types A and D
Target Genotype – Whole Pathogen
Matrix – Plasma
Panel Members – 8
Stability – Single use Evaluation Panel designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – RUO
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HBV Evaluation Panel
Product code: HBVDNAEP | Pack size: 8×1.2 ml
Hepatitis C (HCV) Genotype Evaluation Panel
Pathogen – Types 1a,1b, 2b, 3a, 4a, 5a and 6a
Matrix – Plasma
Panel Members – 8
Stability – Single use Evaluation Panel designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – RUO
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HCV Genotype Evaluation Panel
Product code: HCVGTEP | Pack size: 8×1.2 ml
Hepatitis C (HCV) Evaluation Panel
Pathogen – Types 1b and 3a
Matrix – Plasma
Panel Members – 8
Stability – Single use Evaluation Panel designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – RUO
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HCV Evaluation Panel
Product code: HCVRNAEP | Pack size: 8×1.2 ml
Human Immunodeficiency (HIV1) Evaluation Panel
Pathogen – Types B and C
Matrix – Plasma
Panel Members – 8
Stability – Single use Evaluation panel designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – RUO
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HIV1 Evaluation Panel
Product code: HIVRNAEP | Pack size: 8×1.2 ml
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