artus HSV-1/2 PCR Kits CE

For detection and differentiation of HSV-1/2 specific DNA using real-time PCR

Products

artus HSV-1/2 PCR Kits CE are intended for in vitro diagnostic use in Europe.
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artus HSV-1/2 RG PCR Kit (24) CE

Cat. No. / ID:   4500263

For 24 reactions on Rotor-Gene Q instruments: Master, Mg Solution, 2 Positive Controls, Internal Control, Water (PCR grade)
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artus HSV-1/2 QS-RGQ Kit (24) CE

Cat. No. / ID:   4500363

For 24 reactions on the QIAsymphony RGQ: Master, Mg Solution, 2 Positive Controls, Internal Control, Water (PCR grade)
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artus HSV-1/2 RG PCR Kit (96) CE

Cat. No. / ID:   4500265

For 96 reactions on Rotor-Gene Q instruments: Master, Mg Solution, 2 Positive Controls, Internal Control, Water (PCR grade)

Features

  • Complete CE-IVD-compliant workflow (QIAsymphony RGQ)
  • High reliability using the internal control and positive controls
  • Highly sensitive detection of as few as 43.2 copies/ml (QS-RGQ kit)
  • Same temperature profile for multiple viruses (RG and QS-RGQ kits only)

Product Details

artus HSV-1/2 PCR Kits are ready-to-use molecular detection kits for real-time PCR. The kits provide all necessary reagents optimized for rapid and sensitive detection of HSV-1/2 specific DNA isolated from CSF (RG kits), CSF and plasma (QS-RGQ kits), or from serum, plasma, CSF, and swabs (LC and TM kits) for in vitro diagnostic use. The artus HSV-1/2 LC, RG, and TM PCR Kits use automated or manual sample preparation and manual asssay setup techniques. The artus HSV-1/2 RG PCR Kit is also available as EASYartus HSV-1/2 RG PCR Kits, combined with the EZ1 DSP Virus Kit for automated viral nucleic acid purification. The artus HSV-1/2 QS-RGQ Kit is part of the QIAsymphony RGQ, the complete automated system from sample to pathogen detection, and is not for use with manual assay setup.

Performance

To ensure highest sensitivity, artus HSV-1/2 Kits have been optimized to detect low numbers of HSV-1/2 DNA. The analytical sensitivity of the artus HSV-1/2 QS-RGQ Kit is 57.3 copies/ml for HSV-1 and 65.7 copies/ml for HSV-2 in consideration of the purification from CSF and assay setup using the QIAsymphony RGQ (see figure " Highly sensitive detection of HSV-1 DNA").

Performance characteristics of artus HSV-1/2 RG PCR Kit and artus HSV-1/2 QS-RGQ Kit
Kit artus HSV-1/2 RG PCR Kit artus HSV-1/2 QS-RGQ Kit
Validated sample types Human cerebral spinal fluid (CSF) Human cerebral spinal fluid (CSF) or EDTA plasma
Analytical sensitivity 0.12 copies/μl HSV-1
0.16 copies/μl HSV-2
in the PCR
57.3 copies/ml HSV-1 (CSF)
65.7 copies/ml HSV-2 (CSF)
37.2 copies/ml HSV-1 (plasma)
43.2 copies/ml HSV-2 (plasma)
in consideration of the purification
Specificity Tested with HSV-1 (HF, KOS, MacIntyre strains) and HSV-2 (HG-52, G, and MS strains) Tested with HSV-1 (HF, KOS, MacIntyre strains) and HSV-2 (HG-52, G, and MS strains)
See figures

Principle

artus HSV-1/2 PCR Kits are based on the amplification and simultaneous detection of a specific region of the HSV-1 and HSV-2 genome using real-time PCR. The kits provide high levels of specificity, sensitivity (see figure " Highly sensitive detection of HSV-1 DNA"), and reproducibility.

The kits provide positive controls for HSV-1 and HSV-2 (see figures " Detection of the HSV-1 positive control" and " Detection of the HSV-2 positive control"). In addition, the kits contain a second heterologous amplification system to identify possible PCR inhibition. This is detected as an internal control (IC) in a different fluorescence channel from the analytical PCR.

Specifications of artus HSV-1/2 RG PCR Kit and artus HSV-1/2 QS-RGQ Kit
Kitartus HSV-1/2 RG PCR Kit artus HSV-1/2 QS-RGQ Kit
Validated sample types Human cerebral spinal fluid (CSF) Human cerebral spinal fluid (CSF) or EDTA plasma
Amplicon 154 bp region of the UL5 gene 154 bp region of the UL5 gene
See figures

Procedure

artus  HSV-1/2 PCR Kits provide all necessary reagents optimized for reliable HSV-1/2 DNA detection and differentiation. Simply add template DNA to the ready-to-use PCR master mix and Mg solution, and start the reaction on the appropriate real-time cycler using the optimized cycling program described in the kit handbook.

Common temperature profiles for multiple assays in one run

The temperature profiles of artus HSV-1/2 LC PCR, RG PCR, and QS-RGQ Kits correspond to the profiles of the artus LC PCR, RG PCR, and QS-RGQ Kits for CMV, EBV, VZV, and (RG and QS-RGQ kits only) BK virus. Therefore, these PCR assays can be performed and analyzed in a single run.

Complete automated system from sample to HSV-1/2 detection

The QIAsymphony RGQ workflow solution for HSV-1/2 detection comprises the QIAsymphony SP for sample preparation, the QIAsymphony AS for assay setup, and the artus HSV-1/2 QS-RGQ Kit on the Rotor-Gene Q. The system enables reliable pathogen detection with a complete CE-IVD-compliant workflow (see figure " Integrated QIAsymphony RGQ system for HSV-1/2 detection").

Recommendations for viral DNA purification when using artus LC, RG, and TM PCR Kits 

For DNA purification, the EZ1 DSP Virus Kit for automated viral nucleic acid purification is to be used. The artus HSV-1/2 RG PCR Kit is also available as CE-IVD-marked EASYartus HSV-1/2 RG PCR Kits, which include the EZ1 DSP Virus Kit for automated viral nucleic acid purification.

See figures

Applications

artus HSV-1/2 PCR Kits enable rapid and sensitive detection of HSV-1/2 DNA from EDTA plasma. The kits enable discrimination of HSV-1 and HSV-2 using genotype specific probes.

The artus HSV-1/2 QS-RGQ Kit is designed to be used with the QIAsymphony RGQ system, providing a complete CE-IVD-compliant workflow from sample to HSV DNA detection and discrimination of HSV-1 and HSV-2.

Supporting data and figures

Specifications

FeaturesSpecifications
Quantitative/qualitativeQuantitative/qualitative
Sample typeSerum, plasma, cerebrospinal fluid (CSF), swabs
RUO/CE/ASRCE
Recommended sample prepQIAamp DNA Mini Kit, QIAamp UltraSens Virus Kit, EZ1 DSP Virus Kit
Thermal cyclerABI PRISM 7000, 7900HT SDS, LightCycler, Rotor-Gene Q Instruments
What detectedHerpes Simplex Virus 1 and 2 DNA

Resources

Instrument Technical Documents (1)
Information document for software version 4.0
Additional Resources (1)
Protocol Files (1)
For use with QIAsymphony SP/AS instruments (software version 4.0)
Safety Data Sheets (1)
Certificates of Analysis (1)