For automated, simultaneous purification of viral nucleic acids and bacterial DNA from 1–6 or 1–14 human biological specimens using the EZ1 Advanced or the EZ1 Advanced XL
  • CE-marked in compliance with EU IVD Directive 98/79/EC
  • High analytical sensitivity even with low viral titers
  • Rapid and flexible purification of 1–6 or 1–14 samples per run
  • Easy protocol setup with credit-card ease of use
  • Standardized processing ensures reproducible results
 The EZ1 DSP Virus Kit contains all required reagents and labware for automated purification of viral nucleic acids and bacterial DNA from human serum, plasma, cerebrospinal fluid (CSF), urine, whole blood, stool, transport media, respiratory samples, and dried swabs using magnetic-particle technology. Reagents are supplied in prefilled reagent cartridges, which ensures speed and convenience in loading the EZ1 Advanced or the EZ1 Advanced XL. The CE-IVD-marked system provides exact performance specifications, assuring highly reliable viral nucleic acid purification.
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Product Cat. no. List price:
EZ1 DSP Virus Kit (48)
For 48 viral nucleic acid preps: Prefilled Reagent Cartridges, Disposable Tip-Holders, Disposable Filter-Tips, Sample Tubes, Elution Tubes, buffers, carrier RNA
62724
410,00 €

The EZ1 DSP Virus Kit is intended for in vitro diagnostic use.


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Performance
High analytical sensitivity with lower detection limits

The EZ1 DSP Virus Kit provides simultaneous purification of viral nucleic acids and bacterial DNA from human serum, plasma, CSF, urine, whole blood, stool, transport media, respiratory samples, and dried swab. Efficient purification of viral RNA and DNA results in sensitive analytical detection in polymerase chain reaction (PCR), as demonstrated using CE-IVD-marked artus PCR Kits for detection of CMV DNA (see table "Detection limit of CMV DNA using the EZ1 DSP Virus system and artus CMV PCR Kits") and HBV DNA (see table "Detection limit of HBV DNA using the EZ1 DSP Virus system and artus HBV PCR Kits") on a variety of real-time thermal cyclers.

Detection limit of CMV DNA using the EZ1 DSP Virus system and artus CMV PCR Kits
Input titer (copies/ml) Hits (LightCycler) Hits (Rotor-Gene)Hits (ABI PRISM)
1000 18/18 18/18 6/6
316 15/15 15/15 18/18
100 23/24 24/24 18/18
31.6 30/33 27/27 18/18
15.8 10/18 11/12 18/18
10 12/36 21/36 34/36
7.9 8/18 7/18 15/18
5.0 4/18 11/18 13/18
3.16 2/18 6/18 26/36
1 0/18 1/18 4/18
0.316 1/18 0/18 1/18
0.1 1/18 1/18 0/18
0 0/6 0/6 0/18
95% probit value (copies/ml) 67.2 21.8 13.2
Confidence interval (copies/ml) 41.8–142 14.5–44.1 9.0–23.1
The detection limit was determined by the 95 % probit value for the EZ1 DSP Virus system using quantified CMV cell-culture supernatant. The detection limit was determined by processing a dilution series of CMV. The virus was diluted in CMV-negative normal human EDTA plasma pool. Each dilution step was prepared in at least 3 independent runs with at least 6 replicates per dilution. Plasma (400 μl) was used for sample preparation with elution in 60 μl. artus CMV PCR Kits were used for detection of CMV DNA. The samples were analyzed on a LightCycler 1.2 Instrument (Roche), a Rotor-Gene 3000 (Corbett-Research), and an ABI PRISM 7000 SDS (Applied Biosystems).
Detection limit of HBV DNA using the EZ1 DSP Virus system and artus HBV PCR Kits
Input titer (copies/ml) Hits (LightCycler) Hits (Rotor-Gene)Hits (ABI PRISM)
1000 6/6 12/12 18/18
316 18/18 18/18 15/15
100 18/18 18/18 24/24
31.6 18/18 18/18 32/33
15.8 10/18 18/18 16/18
10 13/36 34/36 26/36
7.9 9/18 15/17 13/18
5.0 4/18 13/18 9/18
3.16 5/36 23/36 7/18
1 1/18 5/15 5/18
0.316 0/18 2/17 2/18
0.1 0/18 1/18 2/18
0 0/18 0/18 0/6
95% probit value (copies/ml) 45.7 14.4 38.3
Confidence interval (copies/ml) 28–102 9.5–26.5 21.5–89.8
The detection limit was determined by the 95% probit value for the EZ1 DSP Virus system using HBV WHO international virus standard. The detection limit was determined by processing a dilution series of HBV. The virus was diluted in HBV-negative normal human EDTA plasma pool. Each dilution step was prepared in at least 3 independent runs with at least 6 replicates per dilution. Plasma (400 μl) was used for sample preparation with elution in 60 μl. artus HBV PCR Kits were used for detection of HBV DNA. The samples were analyzed on a LightCycler 1.2 Instrument (Roche), a Rotor-Gene 3000 (Corbett-Research), and an ABI PRISM 7000 SDS (Applied Biosystems).
Linear yields of highly pure viral DNA and RNA

Purification of viral nucleic acids provides linear yields, allowing accurate quantitative analysis for both high and low viral titers. Purified viral nucleic acids give high-performance results in sensitive diagnostic assays, even when starting material contains elevated levels of endogenous inhibitors, demonstrating the robustness of the purification procedure (see table "Robust purification procedure provides unparalleled removal of inhibitors").

Robust purification procedure provides unparalleled removal of inhibitors
InhibitorsConcentration Mean log (copies/ml) Standard deviation
Untreated 2.87 0.04
Bilirubin 20 mg/dl 2.83 0.02
Hemoglobin 500 mg/dl 2.80 0.09
Protein 9 g/dl 2.77 0.06
Liposyn 3000 mg/dl 2.80 0.06
HBV (1000 copies/ml [log 3]) was added to panels of recalcified plasma containing elevated levels of endogenous inhibitors. A 3.4 μl aliquot of RealTime HBV Internal Control was combined with carrier RNA for each sample, and viral nucleic acids were extracted from 400 μl samples, in replicates of 5, and eluted in 90 μl elution buffer (AVE). The Abbott RealTime HBV assay  was used for detection of HBV. PCR was carried out on the Abbott m2000rt. 
Exclusion of sample carryover

High process reliability is critical for clinical laboratories that purify nucleic acids for routine testing. Lack of sample-to-sample carryover is a prerequisite for reliable results. To evaluate the risk of sample-to-sample carryover during and between runs, the EZ1 DSP Virus procedure was subjected to rigorous testing using an alternating checkerboard setup of negative and highly positive (1.0 x 108 IU/ml) parvovirus B19 DNA samples. All of the highly positive samples were detected positive using the CE-IVD-marked artus Parvo B19 RG PCR Kit. All negative samples, in the checkerboard runs and the all-negative runs, were unresponsive (see table "Cross-contamination test setup and CT values for detection of parvovirus B19 DNA"). This demonstrates that the EZ1 DSP Virus procedure provides no sample carryover under these conditions.

Cross-contamination test setup and CT values for detection of parvovirus B19 DNA
Position
Run 1 2 3 45 6
1 15.47 X 15.41 X 15.36 X
2 X 15.48  X 15.53 X 15.32
3 X X X X X X
4 15.35 X 15.20 X 15.27  X
5 X  15.21 X 15.13 X 15.42
6 X X X X X X
7 15.X2  X 15.48 15.23  X
8 X  15.31 X 15.83 X 15.62
9 X X X X X X
Nine runs were performed to evaluate the risk of cross contamination events during and between EZ1 DSP Virus procedures. The test was performed using a quantified parvovirus B19 patient sample. The viral load of positive samples used for the carryover tests was 1.0 x 108 IU/ml. For dilution of positive samples and as negative control samples, a human parvovirus B19 negative EDTA plasma pool was used. To detect sample-to-sample carryover, 2 runs were performed with an alternating checkerboard setup of negative and highly positive samples. Every third run was performed using all negative samples to monitor possible run-to-run carryover. This sample setup was repeated three times resulting in a total of nine runs. Parvovirus B19 DNA was detected and quantitated using the CE-IVD-marked artus Parvo B19 RG PCR Kit on the Rotor-Gene 3000. The analytical detection limit of the artus Parvo B19 RG PCR Kit is determined to be 0.2 IU/μl in the eluate (p = 0.05). This indicates that there is a 95 % probability that 0.2 IU/μl in the eluate will be detected. Mean CT value of all samples = 15.40 ± 0.18 (CV = 1.14%) X: Unresponsive after 45 PCR cycles.
Principle

Automated sample preparation enables efficient, standardized purification of nucleic acids. The EZ1 Advanced and the EZ1 Advanced XL enable purification of nucleic acids using proven magnetic-particle technology for use in routine in vitro diagnostic applications. Reagent production is subjected to stringent quality control assuring reliable and robust performance. An easy-to-use instrument, prefilled and sealed reagent cartridges, and simple protocol selection and worktable setup help to prevent handling errors and allow the system to be operated by anyone — from the novice to the expert. Manual handling of potentially infectious samples is minimized, ensuring safety to the user and reliable processing of samples. Purified viral DNA and RNA are ready to use in sensitive downstream diagnostic assays based on enzymatic amplification, such as PCR and reverse transcriptase PCR (RT-PCR) for viral load monitoring.

Procedure

The EZ1 Advanced or the EZ1 Advanced XL in combination with the proven EZ1 DSP Virus Kit enables purification of viral nucleic acids and bacterial DNA from 1–6 (EZ1 Advanced) or 1–14 (EZ1 Advanced XL) samples of human serum, plasma, CSF, urine, whole blood, stool, transport media, respiratory samples, and dried swabs. All processing steps are performed by the instrument, from piercing the reagent cartridge to elution of highly pure nucleic acids. The innovative design of the instrument means that the pipet tips function as separation chambers, increasing the efficiency of magnetic purification and eliminating the need for centrifugation steps. The streamlined procedure provides robust walkaway purification of nucleic acids with minimal hands-on time.

Applications

In combination with the EZ1 Advanced DSP Virus Card and the EZ1 Advanced or the the EZ1 Advanced XL DSP Virus Card and the EZ1 Advanced XL, the EZ1 DSP Virus Kit provides a fully automated procedure for simultaneous purification of viral nucleic acids and bacterial DNA from human serum, plasma, CSF, urine, whole blood, stool, transport media, respiratory samples, and dried swabs. Viral nucleic acids purified using the EZ1 DSP Virus Kit are ready to use in downstream diagnostic assays based on enzymatic amplification, such as PCR and RT-PCR.

Feature
Specifications
Applications PCR, real-time RT-PCR, genotyping
CE/FDA/IVD compatible CE/IVD
Elution volume 75–50 µl
For automated processing BioRobot EZ1
Format Sample tube
Main sample type Serum, plasma
Processing Automated
Purification of total RNA, miRNA, poly A+ mRNA, DNA or protein Viral DNA, viral RNA
Sample amount 100–400 µl
Technology Magnetic particles
Time per run or per prep 40 minutes
Yield Varies

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