VERSANT kPCR Molecular SystemBoosting productivity for respiratory testing.
Molecular laboratories are facing a significant increase in testing for respiratory pathogens due to the COVID-19 global health crisis. Increased testing demands require flexible and automated platforms to enable laboratories to meet respiratory testing needs during the pandemic as well as for routine testing and testing during the flu season.
The VERSANT® kPCR Molecular System1 for PCR testing provides true molecular testing versatility. The VERSANT kPCR Molecular System, delivering accurate and reliable results with maximum productivity and flexibility, enables molecular laboratories to meet emerging challenges as well as routine needs in molecular diagnostic testing.
The VERSANT kPCR Molecular System, along with the VERSANT Sample Preparation 1.0 Reagents Kit, has been validated for use with the FTD SARS-CoV-2 Assay.2 This total solution has been demonstrated to have one of the lowest limits of detection (LoD; sensitivity) when compared to other COVID-19 PCR tests.3
Features & Benefits
The VERSANT® kPCR Molecular System comprises two separate benchtop instruments, each with a separate PC workstation:
- The VERSANT kPCR Molecular System SP1 for sample extraction and PCR plate setup
- The VERSANT kPCR Molecular System AD1,4 for PCR cycling and results analysis and reporting
This design allows for the efficient use of laboratory space, as the instruments can be configured for either one- or two-room operations.
VERSANT kPCR Molecular System SP
Automated extraction of high-quality nucleic acids from specimens
- When used with the VERSANT Sample Preparation 1.0 Reagents Kit, the VERSANT kPCR Molecular System SP isolates RNA and DNA from a wide variety of respiratory specimen types, including nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, nasopharyngeal wash/aspirate, or nasal aspirate as well as bronchoalveolar lavage.
- The system also accommodates specimen types such as plasma, serum, urine, and stool.
- A universal extraction protocol and reagents allow the combination of different sample types in a single batch run.
- Run capacity ranges from 1 to 96 samples per batch.
Optimized workflow options
- The system offers six extraction protocols with varying sample input and eluate output volumes.
- A validated Dynamic Assay Preparation (DAP) protocol for the FTD SARS-CoV-2 Assay combines extraction and PCR plate setup.
- Open DAP protocols are available for laboratory-developed and third-party assays.5
- Eluate splitting, instead of sample splitting, delivers a standardized eluate for use in multiple assays, with up to six PCR master mixes from a single specimen on one PCR plate.
- Eluate storage option saves the eluates on a separate PCR plate for further testing (e.g., for reflex testing).
- Stand-alone automated PCR plate setup from the eluate storage plate is also available.
Accurate sample identification
- System tracks sample ID from primary tube to result.
- Instrument sample carriers are compatible with a variety of primary sample tube types and sizes.
Efficient performance with built-in contamination controls
- Air displacement pipetting (ADP)
- Disposable, filtered pipette tips
- CO-RE tip technology‡ (compressed O-ring expansion)
- Accurate liquid delivery with unique total aspiration and dispense monitoring (TADM) technology‡
- Anti-droplet control (ADC)‡
‡ CO-RE, TADM, and ADC are patented, proprietary technologies of Hamilton Company.
VERSANT kPCR Molecular System AD
- Decoupled, six-color filter set that supports a variety of dyes:
- FAM
- SYBR Green
- VIC
- ABY
- NED
- TAMRA
- JUN
- ROX
- Cy5
- MUSTANG PURPLE
- Supports custom dyes that excite between 455–672 nm and emit between 505–723 nm.6
- Six programmable VeriFlex Zones provide independent temperature zones for enhanced functionality and precise control over the real-time PCR.
- Software options for PCR run preparation and execution, data analysis, and reporting: VERSANT MiPLX Software Solution or QS5 DX software
Assays
Technical Specifications
VERSANT kPCR Molecular System
VERSANT kPCR Molecular System SP
VERSANT kPCR Molecular System AD
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CE-IVD–labeled for diagnostic use in the EU. This instrument has not been FDA-cleared or approved. This instrument has been authorized by FDA under an EUA for use by authorized laboratories. This instrument has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This instrument is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21. U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability varies by country and is subject to local regulatory requirements.
CE-IVD–labeled for diagnostic use in the EU. This test has not been FDA-cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21. U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data
QUANTSTUDIO 5 Dx real-time thermocycler (originally supplied by Thermo Fisher Scientific) modified to run the MiPLX Software Solution (Siemens Healthineers).
Laboratories are responsible for validating assays they develop.
Custom dyes are those dyes not supplied by Siemens Healthineers or dyes not precalibrated with the instrument.
VERSANT, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.