UltraGene Combo2Screen SARS-CoV-2 Assay

Description

The UltraGene Combo2Screen SARS-CoV-2 Assay is a real-time RT-PCR test (nucleic acid technique (NAT)) intended to be used for the qualitative detection of nucleic acids from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) and directed against the E and N genes of SARS-CoV-2 virus.

Methodology

Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

More information on the UltraGene Assays – Click here

Application - For Research Use Only (RUO)

Except for certain territories – For Research Use Only (RUO). Not for use in diagnostic procedures. No claim or representation is intended to provide information for the diagnosis, prevention, or treatment of disease.
The ABL’s UltraGene Combo2Screen SARS-Cov-2 Assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test for the qualitative detection of RNA from SARS-CoV-2. The test is targeting E (Envelop) and N (Nucleocapsid) regions of the viral genome.
The product is intended for use by professional users in laboratories able to work with biohazardous material like hospital laboratories, reference laboratories, private laboratories or government laboratories.

The current laboratory biosafety guidance for the 2019 novel coronavirus (SARS-CoV-2) shall be followed (https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html).
Results are for the identification of SARS-CoV-2 from extracted RNA samples. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal and oropharyngeal swabs during the acute phase of infection.

INTENDED USE - FDA-EMERGENCY USE ONLY

The UltraGene Combo2Screen SARS-CoV-2 Assay is a real-time RT-PCR test (nucleic acid technique (NAT)) intended to be used for the qualitative detection of nucleic acids from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen to aid the diagnosis of coronavirus disease (Covid-19) infection.

The UltraGene Combo2Screen SARS-CoV-2 Assay is for use only under Emergency Use Authorization (EUA) in U.S. laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate complexity tests, and in U.S. laboratories certified under CLIA to perform high complexity tests.

The UltraGene Combo2Screen SARS-CoV-2 Assay is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

The current laboratory biosafety guidance for the 2019 novel coronavirus (SARS-CoV-2) shall be followed (https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html).

The UltraGene Combo2Screen SARS-CoV-2 Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Characteristics and performances

Features

The test has been validated but FDA’s independent review of this validation is pending.
CE-IVD marking is pending.

Types of samples

Nasopharyngeal swab

Compatible extraction methods

Roche® MagNA Pure 24 System and related reagents for RNA extraction (protocol Pathogen 1000)( https://diagnostics.roche.com/global/en/products/systems/magna-pure-24-system.html)

Compatibility with qPCR platforms

Any system compatible with the FAM channel. System validated for the TianLong Gentier48R qPCR instrument and related reagents for RT-PCR (http://e.medtl.com/?page_id=227)

Format

100 tests/kit (139A100) or 1000 tests/kit (139A1000)

Content

CoV Reaction Solution_VLC3, CoV E Primer and Probe Mix, CoV N Primer and Probe Mix, Water, Positive Control, Negative Control

Hands-on-time

20 minutes

Estimated turnaround time

1h45

Analytical sensitivity (Limit of Detection)

The concentration level, for both Targets (E and N), was 1*10-6 TCID50/mL for SARS-CoV-2 (ZeptoMetrix SARS-CoV-2 (Isolate: USA-WA1/2020) Culture Fluid (Heat Inactivated) (0.5 mL), 3,16 * 106 TCID50/mL))

Inclusivity (in-silico)

When allowing for 1 mismatch, we aligned all primers and probes of the UltraGene Combo2Screen SARS-CoV-2 Assay to 100% of the inclusivity study sequences (n=413)

Cross-reactivity (in-silico)

For the N gene primers and probe, we identified no potentially unintended targets. Even though the forward and reverse primers may amplify a target region in SARS coronavirus, the probe would not bind to the amplicon.
The primers and probe of the E gene may amplify and detect the SARS and Bat coronaviruses and were not specific with an 80% identity threshold. Few other nonspecific bindings were found but would not result in either an amplification or detection
The primers and probe for the N gene were specific to SARS-CoV-2.

Cross-reactivity (wet testing)

All 12 upper respiratory microorganisms ((ZeptoMetrix NATtrol™ Pneumonia Panel – Atypical Bacteria & Viruses (NATPPA-BIO)) were undetectable with the UltraGene Combo2Screen SARS-CoV-2 Assay.

Clinical evaluation

For each target, E and N genes of the SARS-CoV-2, sixty samples (n=60) were randomly and blindly distributed over 3 instrument-runs by a person, different from the technician who handled the specimens and processed them.
All negative samples (n=30) yielded negative results (100%)
All samples at 1,5*LoD (n=20) and 4*LoD (n=10) were positive (100%)

Clinical sensitivity

Forty-four (44) extracted RNA from NPS samples were processed in parallel with the UltraGene Combo2Screen SARS-CoV-2 Assay and a comparator test (CE-IVD marked, ORF1a/b and N SARS-CoV-2 targets with a claimed LoD of 200 copies/mL or 5 GEC/reaction) : 22 clinical samples were initially reported positive and 22 negative by validated LDT results.
The UltraGene Combo2Screen SARS-CoV-2 Assay performance against the expected results of the LDT are:

Positive Percent Agreement 22/22 = 100% (95% CI: 84.56%-100.00%)
Negative Percent Agreement 22/22 = 100% (95% CI: 84.56%-100.00%)

The results interpretation agreement between the UltraGene Combo2Screen SARS-CoV-2 Assay and the CE-IVD comparator was perfect (Cohen’s Kappa score=1).

Clinical reproducibility

100% clinical reproducibility obtained for the 8 tests of the QCMD 2020 Coronavirus Outbreak Preparedness (CVOP) EQA Pilot Study (Ref# QAV204214_1)

Workflow

Ordering information

Product

Reference

GTIN

UltraGene Combo2Screen SARS-CoV-2 Assay (100 tests)

139A100

05407007960064

UltraGene Combo2Screen SARS-CoV-2 Assay (1000 tests)

139A1000

05407007960071

Downloads

IFUs

  • IFU for Emergency Use Authorization (USA and its territories ONLY)

    EN

    V1-R2

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