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artus HSV-1/2 PCR Kits CE

For detection and differentiation of HSV-1/2 specific DNA using real-time PCR
  • 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)
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.
Cat No./ID: 4500063
artus HSV-1/2 LC PCR Kit (24) CE
For 24 reactions on the LightCycler 1.1/1.2/1.5 Instruments: Master, Mg Solution, 4 Quantitation Standards (HSV-1), 4 Quantitation Standards (HSV-2), Internal Control, Water (PCR grade)
Cat No./ID: 4500065
artus HSV-1/2 LC PCR Kit (96) CE
For 96 reactions on the LightCycler 1.1/1.2/1.5 Instruments: Master, Mg Solution, 4 Quantitation Standards (HSV-1), 4 Quantitation Standards (HSV-2), Internal Control, Water (PCR grade)
Cat No./ID: 4500163
artus HSV-1/2 TM PCR Kit (24) CE
For 24 reactions on the ABI PRISM 7000 and 7900HT SDS: Master, 4 Quantitation Standards (HSV-1), 4 Quantitation Standards (HSV-2), Internal Control, Water (PCR grade)
Cat No./ID: 4500165
artus HSV-1/2 TM PCR Kit (96) CE
For 96 reactions on the ABI PRISM 7000 and 7900HT SDS: Master, 4 Quantitation Standards (HSV-1), 4 Quantitation Standards (HSV-2), Internal Control, Water (PCR grade)
Cat No./ID: 4500263
artus HSV-1/2 RG PCR Kit (24) CE
For 24 reactions on Rotor-Gene Q instruments: Master, Mg Solution, 2 Positive Controls, Internal Control, Water (PCR grade)
Cat No./ID: 4500265
artus HSV-1/2 RG PCR Kit (96) CE
For 96 reactions on Rotor-Gene Q instruments: Master, Mg Solution, 2 Positive Controls, Internal Control, Water (PCR grade)
Cat No./ID: 4500363
artus HSV-1/2 QS-RGQ Kit (24) CE
For 24 reactions on the QIAsymphony RGQ: Master, Mg Solution, 2 Positive Controls, Internal Control, Water (PCR grade)

artus HSV-1/2 PCR Kits CE are intended for in vitro diagnostic use in Europe.


0
Detection of the HSV-1 positive control.
HSV-1 RG PC is detected in fluorescence channel Cycling Green. NTC: No template control (negative control).
1
Detection of the HSV-2 positive control.
HSV-2 RG PC is detected in fluorescence channel Cycling Orange. NTC: No template control (negative control).
2
Herpes simplex virus.
3
Highly sensitive detection of HSV-1 DNA.
Probit analysis: HSV-1 (QIAsymphony RGQ). Analytical sensitivity for HSV-1 of the artus HSV-1/2 QS-RGQ Kit with the QIAsymphony RGQ system.
4
CE-IVD-marked.
5
In vitro diagnostic medical device.
6
Integrated QIAsymphony RGQ system for HSV-1/2 detection.
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)
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
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.

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.

Features
Specifications
Quantitative/qualitative Quantitative/qualitative
Recommended sample prep QIAamp DNA Mini Kit, QIAamp UltraSens Virus Kit, EZ1 DSP Virus Kit
RUO/CE/ASR CE
Sample type Serum, plasma, cerebrospinal fluid (CSF), swabs
Thermal cycler ABI PRISM 7000, 7900HT SDS, LightCycler, Rotor-Gene Q Instruments
What detected Herpes Simplex Virus 1 and 2 DNA

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Protocol Files (1)
For use with QIAsymphony SP/AS instruments (software version 4.0)
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Instrument Technical Documents (1)
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