GENERATION Biotech VoXident Omicron SARS-CoV-2 Variant Detection Kit Instructions

GENERATION Biotech VoXident Omicron SARS-CoV-2 Variant Detection Kit

Instructions

1. Application

The “VoXident” SARS-CoV-2 Omicron Variant Detection Kit is a reagent system, based on quantitative reverse transcriptase (qRT) PCR technology, for the detection of RNA specific to SARS-CoV-2 and to their Variants of Concern (VoC) that cause the Coronavirus Disease 2019 (COVID-19).

VoXident utilizes a set of variant-specific viral mutations to detect the most important current Variant of Concern (VoC): Omicron. For thedetection of other variants than Omicron we recommend to use our follow-up assays.

Quantitative polymerase chain reaction (qPCR) technology utilizes an enzyme (reverse-transcriptase, RT) to convert RNA to complementary DNA (cDNA), from which variant-specific target sequences are then amplified and targeted with specific probes for the detection of their copy number in the initial specimen. For Research Use Only. Not for use in diagnostic procedures. Not FDA approved or CE certified.

2. Equipment and Consumables

3. Kit Components

4. Storage

SARS-CoV-2 Screening & Variant Detection Kits are shipped on -20° C or -80°C ice packs. The components of the kit should arrive frozen. If one or more components are not frozen upon receipt, or if tubes have been compromised during shipment, contact Generation Biotech for assistance.

All components should be stored between -25° C and -15° C upon arrival.
Repeated thawing and freezing of reagents should be avoided, as this might affect the performance of the assay. The reagents should be subdivided and frozen in aliquots if they are to be used intermittently.

Storage between +2° C and +8° C should not exceed a period of two hours.
Protect Primer/Probe Mixes (PPM, blue cap) from light.

5. Product Description

The SARS-CoV-2 DO Variant Detection Kit determines the presence of the Omicron strain of SARS-CoV-2 by discriminating between variant-specific deletions.
The SARS-CoV-2 DO Variant Detection Kit consists of:

• Buffer Mix: Mix of buffer and dNTPs
• Master Mix: Mix of reverse transcriptase and heat-stable polymerase
• Primer / Probe Mix: Mix of primers and probes
• Positive Controls: SARS-CoV-2 RNA of Omicron strain
• Diluent: Nuclease-free Water

The assay consists of three processes in a single reaction tube (one-step qRT- PCR):

• Reverse transcription of target RNA (from SARS-CoV-2) to cDNA
• PCR amplification of target cDNA
• Quantitative detection of PCR amplification products by fluorescent dye labeled probes FAM, HEX, ROX and CY5.

6. Procedure

6.1 Sample Preparation
RNA extracted from the specimen is the starting material for the SARS-CoV-2 Variant Detection Kit.
The quality of the extracted RNA has a profound impact on the performance of the entire test system.
It is recommended to ensure that the system used for nucleic acid (RNA/DNA) extraction is compatible with the characteristics of the sample (i.e. the presence of contaminants, such as in wastewater) and with the desired type of quantitative PCR technology and instrumentation.

If using a spin column-based sample preparation procedure that includes washing buffers containing ethanol, it is highly recommended to perform an additional centrifugation step for 5 min at maximum speed, using a new collection tube and prior to the elution of the nucleic acid, to obtain reliable results.

For additional information and technical support regarding pre-treatment and sample preparation please contact our Technical Support (see Technical Assistance).

6.2 Reaction Setup
All reagents and samples should be thawed completely, mixed (by pipetting or gentle vortexing) and centrifuged briefly before use.

7. Programming the Real-Time PCR Instrument

For basic information regarding the setup and programming of the different real-time PCR instruments, please refer to the user manual of the respective instrument.

7.1 Settings
Define the following settings as described below.

7.2 Fluorescence Detector
Define the fluorescence detectors as described below.

7.3 Temperature Profile

Incubate the reaction as described below.

8. Data Analysis

For basic information regarding data analysis on specific real-time PCR instruments, please refer to the user manual of the respective instrument. For detailed instructions regarding the analysis of the data generated with the SARS-CoV-2 Variant Detection Kit on different quantitative PCR instruments please contact our Technical Support.

Please adjust the threshold of your qPCR instrument for positive detection to be at 10% of the signal intensity of the maximum value of the positive control. Samples that reach less than 10% of the signal intensity of the positive control shall be regarded as negative.

9. Technical Assistance

For customer support, please contact our Technical Support:
e-mail: info@generationbiotech.com
phone: 609-637-0878

10. Disclaimers

For Research Use Only. Not for use in diagnostic procedures. Not FDA approved or CE certified.
Registered names, trademarks, etc. used in this document, even if not specifically marked as such, are not to be considered unprotected by law.

VoXcreen SARS-CoV-2 Screening & Variant Detection Kit · Instructions for Use – 20211231
Generation Biotech
31 Airpark Road
Princeton, NJ 08540
www.gen-bio.com

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References

• Generation Biotech – Generation Biotech, LLC

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