SARS-CoV-2 · SARS-CoV-2 Products for the detection of SARS-CoV-2 RNA by Real-Time PCR Manufacturer...
Transcript of SARS-CoV-2 · SARS-CoV-2 Products for the detection of SARS-CoV-2 RNA by Real-Time PCR Manufacturer...
SARS-CoV-2Real-Time PCR & Extraction Kits
The Gold Standard Diagnostics (GSD) group now offers its GSD NovaPrime® SARS-CoV-2 (COVID-19) Real-Time PCR kit in combination with the GSD NovaPrime® RNA Extraction kits. Benefit from a complete molecular solution with high sensitivity and efficiency in the overall workflow.
GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR ■ Simultaneous detection of two target sequences ■ Approximately 1 hour turnaround time ■ Sample processing time improved fourfold with 384 run format ■ Reduced reaction mix volume ■ No cross reactivity with common human coronavirus strains ■ Extraction/inhibition control and positive control included
GSD NovaPrime® RNA Extraction kits ■ Easy implementation and improved extraction time ■ Magnetic bead technology for automated extraction of genomic SARS-CoV-2 RNA ■ Respiratory samples from clinical specimens (nasal, nasopharyngeal, oropharyngeal) ■ Validated instruments: King Fisher™ Flex System, Maelstrom 9600 and MGI MGISP-960
SARS-CoV-2
Products for the detection of SARS-CoV-2 RNA by Real-Time PCR
Manufacturer of GSD NovaPrime® RNA Extraction kits: Eurofins GeneScan Technologies GmbH Germany, Engesserstrasse 4, 79108, Freiburg im Breisgau
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For more information on our SARS-CoV-2 product line, please visit: www.goldstandarddiagnostics.com
*RUO: Research use only. Not for use in diagnostic procedures. The kits need to be validated as required by local legislation for their intended use by authorized clinical testing laboratories. A CE-IVD marked version of the kit will be released at a later stage.
Manufacturer of GSD NovaPrime® Real-Time PCR kits: NovaTec Immundiagnostica GmbH Germany, Waldstrasse 23 A6, 63128 Dietzenbach
Real-Time PCR & Extraction Kits
As COVID-19 continues to spread worldwide, diagnostic laboratories face an unprecedented demand for testing capacity. The use of the GSD NovaPrime® RNA Extraction kits enables laboratories to meet this demand with an easy and highly efficient extraction method. The combination with the GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR represents an excellent molecular diagnostic solution.
Extraction & Analysis WorkflowIn order to detect virus particles in human respiratory samples, the virus needs to be isolated and the viral RNA extracted prior to a Real-Time RT-PCR analysis.
Products for the automated extraction of SARS-CoV-2 RNA
Manufacturer of the GSD NovaPrime® RT-PCR kits:NovaTec Immundiagnostica GmbHWaldstrasse 23 A6, 63128 Dietzenbach, Germany+49 6074 4876 0 - [email protected] - www.novatec-id.com
Validated Real-Time PCR cyclers: ABI Prism® 7500 SDS, Fast SDS (Applied Biosystems); AriaMxTM, AriaDxTM (Agilent Technologies); CFX96 Touch (Bio-Rad Laboratories)
SARS-CoV-2 Real-Time PCR & Extraction Kits
Extraction & Analysis Workflow
Lysis and inactivation ofviral particles
Binding and purificationof viral RNA
Elution of RNA from magnetic beads
Analysis with GSD NovaPrime® SARS-CoV-2 (COVID-19)RT-PCR
In order to detect virus particles in human respiratory samples, the virus needs to be isolated and the viral RNA extracted prior to a Real-Time RT-PCR analysis.
GSD NovaPrime® SARS-CoV-2 (COVID-19)
GSD NovaPrime® SARS-CoV-2 (COVID-19)
Product
PCOV6033
PCOV6034
Order No.
96 tests
4 x 96 tests
Format
Products for the detection of SARS-CoV-2 RNA by RT-PCR
5524400701
5524400901
GSD NovaPrime® RNA Extraction AE1
GSD NovaPrime® RNA Extraction AE2
Product Order No.
96 tests
96 tests
Format Validated on
KingFisherTM Flex System*
MGI MGISP-960**
*ThermoFisher Scientific; **MGI Tech. Co., Ltd
Products for the extraction of SARS-CoV-2 RNA
As COVID-19 continues to accelerate worldwide, diagnostic laboratories face an unprecedented demand for testing capacity. The launch of the GSD NovaPrime® RNA Extraction kits enables laboratories to meet this demand with an easy and highly efficient extraction method. The combination with the GSD NovaPrime® SARS-CoV-2 (COVID-19) RT-PCR represents an excellent molecular diagnostic solution.
The kits need to be validated as required by local legislation for their intended use by authorized clinical testing laboratories. A CE-IVD marked version of the kit will be released at a later stage.
Manufacturer of the GSD NovaPrime® RNA Extraction kits:Eurofins GeneScan Technologies GmbHEngesserstrasse 4, 79108, Freiburg im Breisgau, Germany.
Product Order No. Format Validated on
GSD NovaPrime® IVD
RNA Extraction AE15524401101
5524401201
96 reactions
20 x 96 reactions
KingFisher™ Flex System by ThermoFisher ScientificMaelstrom 9600 by Taiwan Advanced Nanotech Inc.
GSD NovaPrime® RNA Extraction AE2*
5524400901 96 reactions MGI MGISP-960 by MGI Tech. Co., Ltd
Product Order No. Format Validated on
GSD NovaPrime® SARS-CoV-2 (COVID-19)
PCOV6033
PCOV6034
PCOV6036
PCOV6037
96 reactions
4 x 96 reactions
1 x 384 reactions
2 x 384 reactions
AriaDxTM / AriaMxTM (Agilent Technologies), ABI Prism® 7500 SDS /Fast SDS / Quantstudio™ 5 (Applied BiosystemsTM), CFX96 TouchTM (Bio-Rad), LightCycler® 480 Instrument II (Roche Diagnostics)
GOLD STANDARD DIAGNOSTICS, INC. 2851 Spafford Street, Davis, CA 95618, United States +1 530 759 8000 +1 530 759 8012
Technical Service 24/7: +1 888 977 GSDX (4739) www.gsdx.us