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. 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/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html).

Other

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

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))
  • QJR code (FDA)

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.

Intended Use (FDA EMERGENCY USE ONLY)) (Version 2 only - models 139B)

  • EUA acknowledgment letter received
  • Pending FDA review under the EUA program
  • This test has not been FDA authorized, cleared or approved

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 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 .

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

  • EUA acknowledgment letter received
  • Pending FDA review under the EUA program
  • This test has not been FDA authorized, cleared or approved

Indication of use

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.

Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Additional laboratory testing (i.e. bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.

Laboratories shall be required to report all positive results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by the test or lower respiratory tract infection that is not detected by a nasopharyngeal swab specimen.

Application - For Research Use Only (RUO)

Except for certain territories (EEA and US) – 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

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.

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

Product

Reference

GTIN

UltraGene Combo2Screen SARS-CoV-2 Assay (50 tests)

139B50

05407007960088

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

139B1000

05407007960095

UltraGene Combo2Screen SARS-CoV-2 Assay (50 tests)

139C50

05407007960118

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

139C1000

05407007960101

Downloads

IFUs

  • IFU 139B50/139B1000 (CE IVD)

    EN

    V1-R5

  • IFU 139B50/139B1000 (FDA pending EUA)

    EN

    V2.0 (draft)

  • IFU 139C50/139C1000 (CE IVD)

    EN

    V1-R0

Request Documentation

Email address
Assay Serial Number