Allplex™ 2019-nCoV Assay

Overview

The Allplex™ 2019-nCoV Assay is an in vitro diagnostic (IVD) real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the qualitative detection of SARS-CoV-2 viral nucleic acids.

It is a multiplex, real-time PCR assay for simultaneous detection of 3 target genes of SARS-CoV-2 in a single tube. The assay is designed to detect RdRP and N genes specific for SARS-CoV-2, and E gene for all of Sarbecovirus including SARS-CoV-2.

Analytes
  • Sarbecovirus (E gene)
  • SARS-CoV-2 (N gene)
  • SARS-CoV-2 (RdRP gene)
  • Internal Control (IC)
Samples
  • Sputum
  • Nasopharyngeal swab
  • Oropharyngeal swab
  • Anterior nasal swab
  • Mid-turbinate

Ordering Information

Product        

Allplex™ 2019-nCoV Assay                                             

Cat No. / Size    

RP10252W / 124 rxns

Features / Benefits / Proof

Features
Benefits
Proof
MULTIPLEX REAL-TIME PCR – Detection and identification of target genes (E gene, RdRP gene, N gene) specific for COVID-19 in a single tube
Delivers results faster at a lower cost and more accurately
See Instructions for Use (IFU)
MANUFACTURABILITY
Consistent supply
Seegene has delivered more than 100 million tests
SHORT TAT – Results within 1 hour and 50 minutes after extraction
Delivers results faster to your customers for a faster treatment implementation
See Instructions for Use (IFU)
POWERFUL PERFORMANCE – PCR with high sensitivity and specificity
Delivers accurate results for better patient care and peace of mind
See IFU LOD: 4,167 Copies/mL
USER-FRIENDLY WORKFLOW – Convenient workflow using Seegene’s automated one platform
Implement Seegene’s solution in your laboratory faster with minimum training
AUTOMATIC DATA ANALYZER – Automated data interpretation and LIS interlocking with Seegene Viewer
Easily retrieves results and eliminates interpretation and clerical errors
UDG SYSTEM – Utilization of the UDG system to prevent carry-over contamination
Prevents carryover contamination and false positive results found in PCR for more accurate results
WHOLE PROCESS VALIDATION – From extraction to PCR by whole process control
Prevent or detect human errors for more accurate results

Results

Automated data analysis for multiplex real-time PCR

Seegene Viewer is designed to enable users simple access to automated data analysis for Seegene’s high multiplex real-time PCR assays. The software allows identification and differentiation for both Ct value of multiple targets in a single channel as well as melting curve analysis.

The highlighted result represents positive results for E gene of Sarbecovirus in FAM channel, RdRP  gene and N gene of COVID-19 in Cal Red 610 and Quasar 670, respectively.

Instructions for Use (IFU)

PCR controls

The PCR controls below are provided with the Allplex™ 2019-nCoV Assay to confirm the validity of each PCR run on the same plate.

Prior to determining of the validity of each PCR run, the user must confirm the results of the negative control and positive control.

Negative Control (NC)

Used as a PCR control to confirm test validity, and the absence of any contaminants during testing. The “No template” control is prepared using RNase-free water added to the Master Mix prior to PCR. NC must be included in each test run. No signal should be detected with the NC.

Positive Control (PC)

Used to confirm test validity, and functions as the validation control for PCR amplification and the test detection steps. The PC includes plasmids encoding Allplex™ 2019-nCoV Assay target sequences and must be included in each test run.

Internal Control

The Allplex™ 2019-nCoV Assay includes a full process Internal Control (RP-V IC) which is composed of MS2 phage genome. This Internal Control material verifies all steps of the analysis process, including sample extraction, reverse transcription, and PCR to demonstrate proper sample processing and test validity of each sample.

Nucleic Acid Extraction

The assay was validated with the extraction options listed below.

Manufacturer
Instrument
Extraction Kit
Reaction No. / Catalog No.
Seegene
Seegene STARlet (65415-03)
STARMag 96 X 4 Universal Cartridge Kit
384 reactions (744300.4.UC384)
Seegene
Seegene STARlet (65415-03)
STARMag 96 X 4 Viral DNA/RNA 200 C Kit
384 reactions (EX00013C)
Hamilton
Microlab STARlet IVD (173000-075)
STARMag 96 X 4 Universal Cartridge Kit
384 reactions (744300.4.UC384)
Hamilton
Microlab STARlet IVD (173000-075)
STARMag 96 X 4 Viral DNA/RNA 200 C Kit
384 reactions (EX00013C)
Seegene
Seegene NIMBUS (67930-03)
STARMag 96 X 4 Universal Cartridge Kit
384 reactions (744300.4.UC384)
Seegene
Seegene NIMBUS (67930-03)
STARMag 96 X 4 Viral DNA/RNA 200 C Kit
384 reactions (EX00013C)
Hamilton
Microlab NIMBUS IVD (65415-02)
STARMag 96 X 4 Universal Cartridge Kit
384 reactions (744300.4.UC384)
Hamilton
Microlab NIMBUS IVD (65415-02)
STARMag 96 X 4 Viral DNA/RNA 200 C Kit
384 reactions (EX00013C)
LG Chem
AdvanSure E3 System (YETS0001EG)
AdvanSure NA EX Kit
96 reactions Reagent Plate (RPE0001K01)
LG Chem
AdvanSure E3 System (YETS0001EG)
AdvanSure NA EX Kit
Proteinase K Tube (RPK0001K01)
LG Chem
AdvanSure E3 System (YETS0001EG)
AdvanSure NA EX Kit
Strip (E3 System) (YSTP0500KG)
GeneAll
N/A (Manual)
Ribospin vRD (Viral RNA/DNA Extraction Kit)
50 extractions (302-150 SG1701)
QIAGEN
N/A (Manual)
QIAmp DSP Viral RNA Mini Kit
50 extractions (61904)
Roche
Roche MagNA Pure 96 (MP96)
DNA and Viral NA Small Volume Kit
576 extractions (06 543 588 001)
Thermo Fisher Scientific
KingFisher Flex automated extraction
MagMAX Viral/Pathogen Nucleic Acid Isolation Kit
200 extractions (A42352) 2,000 extractions (A48310)

Amplification and Detection

Manufacturer
Instrument
Bio-Rad
CFX96™ Real-time PCR System
Bio-Rad
CFX96™ Dx System

The Seegene, Hamilton, LG Chem, and GeneAll extraction reagents / instrumentation can be purchased through Seegene Technologies (CA, US).

Publications

Note

Allplex™ 2019-nCoV Assay has not been FDA cleared or approved. This test has been authorized by FDA under an emergency use authorization for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.