Description
The UltraGene Assay Combo2Screen SARS-CoV-2 (CE-IVD) 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. It includes an Internal Control.
Methodology
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Intended user
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/
Other
In addition of the PCR amplification reagents, the test utilizes external controls (positive control and a negative control) and an internal control.
CE marking only valid for EEA and territories recognizing it – Otherwise it is for RUO application.
Class of the device
- “Other devices” according EU Directive 98/79/CE
- GMDN code: 64747 (SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT))
More information on the UltraGene Assays – Click here
Intended Use (CE-IVD)
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 intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.
Indication of Use
Version 2 – Models 139B : The amplified DNA result and its interpretation are used to aid the diagnosis of coronavirus disease (Covid-19) infection. Results are for the specific detection of SARS-CoV-2 RNA that are detectable during infection in nasopharyngeal swab samples from patients who meet Covid-19 clinical and/or epidemiological criteria.
Version 3 – Model 139C : The amplified DNA result and its interpretation are used to aid the diagnosis of coronavirus disease (Covid-19) infection. Results are for the specific detection of SARS-CoV-2 RNA that are detectable during infection in nasopharyngeal swab samples and saliva from patients who meet Covid-19 clinical and/or epidemiological criteria.
Application - For Research Use Only (RUO)
This test is not available for sale in the U.S. – 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.
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.
Characteristics and performances
Features
CE-IVD marked.
Performances below are applicable for both version V2 (models 139B) and V3 (models 139C), except where indicated
Types of samples
- Nasopharyngeal swab (139B and 139C models)
- Saliva (139C models only)
Compatible extraction methods
- MagNA Pure 24 Total NA Isolation Kit (Roche, #07658036001) with MagNa Pure 24 instrument (Roche, Software version v1.1)
Compatibility with qPCR platforms
Any qPCR instrument compatible with the FAM, HEX, Cy5 channels.
The following Realtime PCR instruments are validated for use with this test:
- Real-Time PCR System (Tianlong Science & Technology, Cat #Gentier 48E)
- UltraGene qPCR 48 (ABL, 149A48).
Format / Models
Version 2 - 50 tests/kit (139B50) or 1000 tests/kit (139B1000)
Version 3 - 50 tests/kit (139C50) or 1000 tests/kit (139C1000)
Content
CoV Reaction Solution_VLC3
CoV E-N-RNAseP
Primer and Probe Mix
Positive Control
Negative Control
Hands-on-time
20 minutes
Estimated turnaround time
1h45
Analytical sensitivity (Limit of Detection (LoD))
The LoD, for both Targets (E and N), is
1*10-6 TCID50/mL or
0,000001 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)
In silico analysis concluded that the product would detect all analyzed SARS-CoV-2 (n=2415 unique sequences by 21st of May 2020)
Cross-reactivity (in-silico)
No potential unintended cross reactivity is expected based on this in silico analysis
Cross-reactivity (wet testing)
None of the organisms tested interfered with the product performances by generating false positive results (Each micro-organism was tested in triplicates)
Clinical sensitivity
Performance against the expected results are:
• Positive Percent Agreement 30/30 = 100% (95% CI: 88.43%-100.00%)
• Negative Percent Agreement 30/30 = 100% (95% CI: 88.43%-100.00%)
The results interpretation agreement between the product and the FDA EUA / CE-IVD comparators was perfect (Cohen’s Kappa score=1).
Clinical reproducibility
At the QCMD 2020 Coronavirus Outbreak Preparedness (CVOP) EQA Pilot Study (Ref# QAV204214_1), the product obtained the maximal score
All samples were correctly classified.
We obtained 100% clinical accuracy and the results were reproducible.
External validation of Version 2 (models 139B):
- Good agreement with French National Reference Centre (CNR) IP2/IP4 comparator for Covid-19 detection.
- CNR stated for human factors "very easy to use".
- CNR declared the product
can be used for the detection of SARS-CoV-2 in France during the Covid-19 outbreak.
External validation of Version 3 (models 139C):
An international reference academic laboratory did a comparative study of the UltraGene Combo2Screen SARS-CoV-2 Assay version 3 (V3) against the standard of care used at the laboratory (Allplex™ 2019-nCoV Assay, Seegene, KR, # RP10250X / RP10252W, (CE-IVD, FDA-EUA)).
- Concordance of 100% for the detection of viral RNA
- Higher sensitivity of ABL's product (V3) in detecting E-gene
- Product could be positionned in future large scale screening especially where saliva samples woud be introduced in such screening program.
Workflow
Ordering information
Reference
GTIN
UltraGene Assay Combo2Screen SARS-CoV-2 (50 tests) (CE-IVD)
139B50
05407007960088
UltraGene Assay Combo2Screen SARS-CoV-2 (1000 tests) (CE-IVD)
139B1000
05407007960095
UltraGene Assay Combo2Screen SARS-CoV-2 (50 tests) (CE-IVD)
139C50
05407007960118
UltraGene Assay Combo2Screen SARS-CoV-2 (1000 tests) (CE-IVD)
139C1000
05407007960101
Downloads
Leaflet
-
Leaflet 139B50/139B1000 (CEIVD)
