UltraGene Assay SARS-CoV-2 Triplex, Screening, Multi-Variants and Typing V1.x (CE-IVD)

Description

The UltraGene Assay SARS-CoV-2 Triplex (CE-IVD) is a screening, Multi-Variants and Typing V1 is a RT-PCR test intended to be used for the qualitative detection of RNA from the SARS-CoV-2 and the qualitative detection of SARS-CoV-2 deletions HV 69/70 (Δ69), Y144 (Δ144) and 242-244 (Δ242) on the Spike (S) gene and the deletion SGF 3675-3677 (Δ3675) on the ORF1ab gene in upper respiratory specimens from individuals suspected of COVID-19 by their healthcare provider.

Assay results are for the Detection/Identification of:

  • RNA from the SARS-CoV-2
  • UK Variant : the Spike Δ69 and Spike Δ144 and ORF1ab Δ3675 indicate an infection with SARS-CoV-2 lineage B.1.1.7 (i.e. United Kingdom VOC 202012/01, VOC 202102/02; “UK”)
  • South Africa variant : the Spike Δ242 and ORF1ab Δ3675 indicate an infection with SARS-CoV-2 lineage B.1.351 (i.e. South Africa VOC 202012/02; “SA”)
  • Brazil Variant : the ORF1ab Δ3675 alone indicates an infection with SARS-CoV-2 lineage P.1 (i.e. Brazil VOC 202101/02; “BR”)

Methodology

Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Intended user

The product is intended to be used by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

Other

In addition of the PCR amplification reagents, the test include external controls (positive control and a negative control) and an internal control.

More information on the UltraGene Assays – Click here

Workflow

 

 

 

Characteristics and performances

Features


CE-IVD marked.

Types of samples

Upper respiratory specimens (nasal, mid-turbinate, nasopharyngeal, oropharyngeal swab specimens and nasopharyngeal wash/aspirate or nasal aspirate and bronchoalveolar lavage (BAL) fluid specimens)

Compatible extraction methods

Magnetic beads

Compatibility with qPCR platforms

Any qPCR instrument compatible with the FAM, HEX, ROX, Cy5 channels. Validated for use with:
- QuantStudio 5 Real Time PCR Instrument
- UltraGene qPCR 48 Instrument

Format / Models

- 1000 tests screening / 50 tests multi-variants) (160A1000_50)
- (1000 tests screening / 1000 tests multi-variants) (160A1000_1000)

Content

- CoV Reaction Solution_VLC3 (RT-PCR Premix)
- E, N, and RNaseP gene specific primers and probes
- Positive Control
- Negative Control
- Water

Hands-on-time

- Less than 20 minutes for up to 48 samples
- Less than 40 minutes for up to 96 samples
- Automation capacity (liquid handling robots available upon request)

Estimated turnaround time

~1h10

Analytical sensitivity (Limit of Detection (LoD))

- 1150 TCID50/mL for the QuantStudio 5 Real-Time PCR instrument
- 115 TCID50/mL for SARS-CoV-2 with the UltraGene qPCR 48 instrument

Inclusivity (analytical reactivity)

No mismatches on >96.5% of the 47,393 sequences in the Inclusivity dataset

Cross-reactivity (in-silico)

No potential unintended cross reactivity is expected based on this in silico analysis

Cross-reactivity (wet testing)

For cross-reactivity wet testing, the UltraGene Assay SARS-CoV-2 Triplex, Screening, Multi-Variants and Typing V1 did not react (i.e., tested positive) when tested with the microorganisms that are commonly found in upper respiratory specimens and tested at the indicated concentration, both for the Screening and the Variant detection and typing steps

Clinical sensitivity

Performance against the expected results are:
• Positive Percent Agreement 30/30 = 100% (95% CI: 88.65%-100.00%)
• Negative Percent Agreement 30/30 = 100% (95% CI: 88.65%-100.00%)

Clinical reproducibility

EQA Pilot Study: 100% clinical accuracy

Ordering information

Product

Reference

GTIN

UltraGene SARS-CoV-2 Multi Variants Deletions V1 (CE IVD) (50 tests)

160A1000_50

05407007960187

UltraGene SARS-CoV-2 Multi Variants Deletions V1 (CE IVD) (1000 tests)

160A1000_1000

05407007960194

Downloads

Leaflet

  • Leaflet 160A1000_50/160A1000_1000 (CE IVD)

    EN

    V1

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