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Sexually Transmitted Infections | Qnostics Molecular Controls

 

Sexually transmitted infections (STIs) remain a major public health concern globally. STIs are the main preventable cause of infertility, particularly in women. However, some STIs remain asymptomatic before leading to serious reproductive complications and congenital infections, therefore appropriate diagnosis and treatment is essential.

Qnostics’ STI Molecular controls comprises a wide range of bacterial targets, including: Chlamydia, Gonorrhea, Trichomonas vaginalis, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, Gardnerella vaginalis, Neisseria gonorrhoea, Chlamydia trachomatis (LGV), Chlamydia trachomatis (LGV) transport and Chlamydia trachomatis (SW).

  • Q Controls
  • Molecular Q Panels
  • Analytical Q Panels
  • Evaluation Panels

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.

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Chlamydia Trachomatis & Neisseria Gonorrhoea (CT/NG) Q Control (Transport Medium)

Pathogen – Chlamydia Trachomatis & Neisseria Gonorrhoea (GT/NG)
Matrix – Transport Medium
Stability – Single use control 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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Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) Q Control
Product code:
CTNGTQC  |  Pack size: 5×1 ml

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Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) Q Control (Urine)

Pathogen – Chlamydia Trachomatis & Neisseria Gonorrhoea (GT/NG)
Matrix – Urine
Stability – Single use control 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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Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) Q Control
Product code:
CTNGUQC  |  Pack size: 5×1 ml

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Human Immunodeficiency Virus (HIV) Q Control

Pathogen – Human Immunodeficiency Virus (HIV)
Target Genotype– Type B
Matrix – Plasma
Stability – Single use control 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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HIV Molecular Q Control
Product code:
HIVMQC|  Pack size:5×1.2 ml

 

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Herpes Simplex Virus 1 (HSV1) Q Control

Pathogen – Herpes Simplex Virus 1 (HSV1)
Genotype– Type 9/84
Matrix – Viral Transport Medium
Stability – Single use control designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE & RUO

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HSV1 Molecular Q Control
Product code:
HSV1MQC|  Pack size: 5×1 ml

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Herpes Simplex Virus 2 (HSV2) Q Control

Pathogen – Herpes Simplex Virus 2 (HSV2)
Genotype – Type 9/84
Matrix – Viral Transport Medium
Stability – Single use control designed to be used immediately minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE & RUO

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HSV2 Molecular Q Control
Product code:
HSV2MQC|  Pack size: 5×1 ml

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Human Papilloma Virus (HPV) Molecular Q Control *

Pathogen – Human Papillomavirus
Matrix – PreservCyt ™
Stability – Single use control 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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Human Papilloma Virus (HPV) Molecular Q Control
Product code:
HPVMQC|  Pack size: 10 x 1.2 ml
*Stored under ambient conditions

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Trichomonas Vaginalis & Mycoplasma Genitalium (TV/MG) Multiplex Q Control *

Pathogen– Trichomonas Vaginalis and Mycoplasma Genitalium
Matrix – Transport Medium
Stability – Single use control 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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TVMG Q Control
Product code:
TVMGQC01-B |  Pack size: 5×1 ml

*To be released in 2024

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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.

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Herpes Simplex Virus 1 (HSV1) Molecular Q Panel

Pathogen – Herpes Simplex Virus 1 (HSV1)
Genotype – Clinical isolate
Matrix – Transport Medium
Stability – Single use, designed to be used immediately after thawing, minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE & RUO

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HSV1 Molecular Q Panel
Product code:
HSV1MQP  | Pack size: 4×1 ml

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Herpes Simplex Virus 2 (HSV2) Molecular Q Panel

Pathogen – Herpes Simplex Virus 2 (HSV2)
Genotype – Type 09
Matrix – Transport Medium
Panel Members – 10
Stability – Single use, designed to be used immediately after thawing, minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – CE & RUO

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HSV2 Molecular Q Panel
Product code:
HSV2MQP  | Pack size: 4×1 ml

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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.

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Herpes Simplex Virus 1 (HSV1) Analytical Q Panel

Pathogen – Herpes Simplex Virus 1 (HSV1)
Genotype – Clinical isolate
Matrix – Transport Medium
Panel Members – 8
Stability – Single use, designed to be used immediately after thawing, minimising the risk of contamination
Shelf Life – Up to 2 years from date of manufacture
Regulatory Status – CE & RUO

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HSV1 Analytical Q Panel
Product code:
HSV1AQP|  Pack size: 8×1 ml

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Herpes Simplex Virus 2 (HSV2) Analytical Q Panel

Pathogen – Herpes Simplex Virus 2 (HSV2)
Genotype – Type 09
Matrix – Transport Medium
Panel Members – 10
Stability – Single use, designed to be used immediately after thawing, minimising the risk of contamination
Shelf Life – Up to 2 years from date of manufacture
Regulatory Status – CE & RUO

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HSV2 Analytical Q Panel
Product code:
HSV2AQP|  Pack size: 10×1 ml

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STI Evaluation Panel

Pathogen – 
Simulated swab: Chlamydia trachomatis, Trichomonas vaginalis, Mycoplasma genitalium, Ureaplasma urealyticum, Mycoplasma hominis, Gardnerella vaginalis
In urine: Neisseria gonorrhoeae, Chlamydia trachomatis
Matrix – Simulated swab or Urine
Panel Members – 10
Stability – Single use, designed to be used immediately after thawing, minimising the risk of contamination
Shelf Life – Up to 2 years after date of manufacture
Regulatory Status – RUO

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STI Evaluation Panel
Product code:
STIEP  |  Pack size: 10×4 ml

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HIV RNA Evaluation Panel

Pathogen – Human Immunodeficiency Virus 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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HIV RNA Evaluation Panel
Product code:
HIVRNAEP|  Pack size: 8 x 1.2ml

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Want to know more?

Contact us or download our Qnostics brochure to learn more.

 

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