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

160A

Description

The UltraGene Assay SARS-CoV-2 Multi Variants Deletions V1 (CE-IVD) is a real-time RT-PCR test (nucleic acid technique (NAT)) intended to be used for 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 patients already diagnosed positive to SARS-CoV-2.

 

Methodology

Real-Time 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.

Complementary Informations

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

More information on the UltraGene Assays – Click here

Intended Use (CE-IVD)

The  UltraGene Assay SARS-CoV-2 Multi Variants Deletions is a real-time RT-PCR test (nucleic acid technique (NAT)) intended to be used for the Identification of:

  • 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”)

The UltraGene Assay SARS-CoV-2 Multi Variants Deletions is NOT intended for the qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens from individuals suspected of COVID-19 by their healthcare provider. The sole purpose of this assay is to identify from positive sample any VOC (including UK, S.-A. and BR).

The UltraGene Assay SARS-CoV-2 Multi Variants Deletions 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.

 

Characteristics and performances

Features

The test has been validated. EUA acknowledgment letter received but FDA’s independent review of this validation is pending. This test has not been FDA authorized, cleared or approved.

CE-IVD marked.

Types of samples

- Nasopharyngeal swab
- Oropharyngeal swab

Compatible extraction methods

- MagNA Pure 24 Total NA Isolation Kit (Roche, #07658036001) with MagNa Pure 24 instrument (Roche, Software version v1.1,#07290519001B)
- MagNA Pure 24 Total NA Isolation Kit (Roche, #07658036001)
- MagNA Pure 24 ProcessingTip Park/Piercing Tool (Roche,#07345585001)
- MagNA Pure Sealing Foil (Roche,#06241638001)

Compatibility with qPCR platforms

Any qPCR instrument compatible with the FAM, HEX, ROX, Cy5 channels.
The following Realtime PCR instruments are validated for use with this test:
- QuantStudio 5 Real-Time PCR Instrument (96-Well 0.2mL Block) (Applied Biosystems, Catalog #A28139, Design & Analysis Software 2.4.3 / Firmware Version 1.3.3)
- UltraGene qPCR 48 (ABL, 149A48, software version 1).

Format / Models

- 50 tests/kit (160A50)
- 1000 tests/kit (160A1000)

Content

- CoV Reaction Solution (RT-PCR Premix)
- N, S and ORF1ab specific primers and probes
- Positive Control
- Negative Control
- Molecular Grade Water

Hands-on-time

20 minutes

Estimated turnaround time

1h30

Analytical sensitivity (Limit of Detection (LoD))

The LoD, for both Targets, is
- 1150 TCID50/mL for the QuantStudio 5 Real-Time PCR instrument
- 115 TCID50/mL with the UltraGene qPCR 48 instrument
for SARS-CoV-2 (ZeptoMetrix SARS-CoV-2 (Isolate: USA-WA1/2020) Culture Fluid (Heat Inactivated) (0.5 mL), Catalog #0810587CFHI, lot# 324887, 1.15 * 107 TCID50/mL))

Inclusivity (in-silico)

In silico analysis concluded that the product would detect all analyzed SARS-CoV-2 targeted deletions (n=47,393 unique sequences by 15th of March 2021)

Cross-reactivity (in-silico)

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

Cross-reactivity (wet testing)

The possible cross-reactivity with the UltraGene Assay SARS-CoV-2 Multi Variants Deletions for each microorganism is listed in the table [cf: IFU "cross reactivity (wet testing) section.

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%)

The UltraGene SARS-CoV-2 Multi Variants Deletions results were 100% correct for the variant detection and variant typing as confirmed by Whole Genome sequencing. On the 30 positive samples, 3 of them (10%) were false results reported by the CE-IVD comparator ViroBOAR Assay.

Workflow

Ordering information

Product

Reference

GTIN

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

160A50

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

160A1000

Downloads

Leaflet

  • Leaflet 160A50/160A1000 (CE IVD)

    EN

    V1

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