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.

artus HSV-1/2 LC PCR Kit (96) CE

Cat. No. / ID. / ID. 4500065

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)

artus HSV-1/2 RG PCR Kit (24) CE

Cat. No. / ID. / ID. 4500263

For 24 reactions on Rotor-Gene Q instruments: Master, Mg Solution, 2 Positive Controls, Internal Control, Water (PCR grade)

artus HSV-1/2 TM PCR Kit (96) CE

Cat. No. / ID. / ID. 4500165

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)

artus HSV-1/2 LC PCR Kit (24) CE

Cat. No. / ID. / ID. 4500063

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)

artus HSV-1/2 QS-RGQ Kit (24) CE

Cat. No. / ID. / ID. 4500363

For 24 reactions on the QIAsymphony RGQ: Master, Mg Solution, 2 Positive Controls, Internal Control, Water (PCR grade)

artus HSV-1/2 RG PCR Kit (96) CE

Cat. No. / ID. / ID. 4500265

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

artus HSV-1/2 TM PCR Kit (24) CE

Cat. No. / ID. / ID. 4500163

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)

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

Highly sensitive detection of HSV-1 DNA.

Detection of the HSV-1 positive control.

Detection of the HSV-2 positive control.

Integrated QIAsymphony RGQ system for HSV-1/2 detection.

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
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
Amplicon	154 bp region of the UL5 gene	154 bp region of the UL5 gene

See figures

Highly sensitive detection of HSV-1 DNA.

Detection of the HSV-1 positive control.

Detection of the HSV-2 positive control.

Integrated QIAsymphony RGQ system for HSV-1/2 detection.

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

Integrated QIAsymphony RGQ system for HSV-1/2 detection.

Highly sensitive detection of HSV-1 DNA.

Detection of the HSV-1 positive control.

Detection of the HSV-2 positive control.

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

Detection of the HSV-1 positive control.

HSV-1 RG PC is detected in fluorescence channel Cycling Green. NTC: No template control (negative control).

Specifications

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

Resources

Information document for software version 4.0

For use with QIAsymphony SP/AS instruments (software version 4.0)

Download Safety Data Sheets for QIAGEN product components.

FAQ

In general and especially for extraction from cerebrospinal fluid, serum or plasma, QIAGEN recommends the use of carrier RNA during nucleic acid extractions to increase the yield of extracted pathogen DNA. QIAGEN recommends to use Poly(A) RNA homopolymers from GE Healthcare (Cat. no. 27- 4110-02).

FAQ ID -1530

The artus HSV-1/2 RG PCR kit detects HSV-1/2 specific DNA. Other Herpes viruses are not detected. The LOD is 0.12 copies/µl for HSV-1 and 0.16 copies/µl for HSV-2

-1

Only CSF is validated within the CE mark for the artus HSV-1/2 RG PCR Kit.

-1

No. The artus HSV-1/2 RG PCR Kit is highly specific and shows no cross-reactivities. Sample materials with the following pathogens tested negative: EBV, VZV, CMV, HHV6, HAV, HBV, HCV, HIV, WNV, Parvo B19, Enterovirus.

-1

The artus^® HSV-1/2 LC PCR Kit contains probes for both the HSV-1 and HSV-2 detection. Yet, the hybridization properties of these probes differ with the template DNA (HSV-1 or -2) to allow for a melting curve based virus type discrimination. The probes which match HSV-1 perfectly carry a few mismatches for HSV-2 leading to decreased fluorescence signal.

-2

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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

Products

artus HSV-1/2 LC PCR Kit (96) CE

artus HSV-1/2 RG PCR Kit (24) CE

artus HSV-1/2 TM PCR Kit (96) CE

artus HSV-1/2 LC PCR Kit (24) CE

artus HSV-1/2 QS-RGQ Kit (24) CE

artus HSV-1/2 RG PCR Kit (96) CE

artus HSV-1/2 TM PCR Kit (24) CE

Features

Product Details

Performance

See figures

Principle

See figures

Procedure

Common temperature profiles for multiple assays in one run

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

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

See figures

Applications

Supporting data and figures

Detection of the HSV-1 positive control.

Specifications

Resources

FAQ

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