COVID-19 TEST UPDATES
Company Name
Genetron Health Website
https://www.fda.gov/media/138685/download
GenMark Diagnostics
https://www.genmarkdx.com/solutions/panels/eplex-panels/ eplex-sars-cov-2-test/
GenoSensor Gnomegen Gnomegen Hologic Hologic Illumina InBios International
https://www.genosensorcorp.com/
COVID19%20Kit.html
https://gnomegendx.com/
https://gnomegendx.com/
http://hologic.com/hologic-products/diagnostic-solutions/ hologic-sars-cov-2-assays
https://www.hologic.com/coronavirus-test
https://www.illumina.com/products/by-type/ivd-products/
covidseq.html
https://inbios.com/smart-detecttm-sars-cov-2-rrt-pcr-kit/ Name of Test Type of Test
Genetron SARS-CoV-2 RNA Test
ePlex SARS-CoV-2 Test
GS COVID-19 RT-PCR Kit
Gnomegen COVID-19 RT-qPCR Detection Kit
Gnomegen COVID-19 RT-Digital PCR Detection Kit
Aptima SARS-CoV-2 Assay
Panther Fusion SARS-CoV-2
Illumina COVIDSeq Test
Smart Detect SARS- CoV-2 rRT-PCR Kit
Ipsum Diagnostics
Jiangsu Bioperfectus Technologies
LabCorp LabGenomics Luminex
Luminex Molecular Diagnostics
Maccura
Biotechnology Mesa Biotech
MicroGenDx Laboratories
https://www.ipsumdiagnostics.com/for-physicians/ supply-order-form-covid-19/
http://en.s-sbio.com/product/
420.html
https://www.labcorp.com/coronavirus-disease-covid-19
http://www.labgenomics.co.kr/eng/invest/news.php?act=view &encData=aWR4PTI3MA==
https://www.luminexcorp.com/aries/
https://investor.luminexcorp.com/news-releases/news- release-details/luminex-receives-fda-emergency-use- authorization-nxtagr-cov
COV-19 IDx assay
COVID-19 Coronavirus Real Time PCR Kit
Real-time RT-PCR Test
Nucleic Acid Multiplex assay
RT-PCR Test
RT-qPCR Detection Kit
RT-Digital PCR Detection Kit
In vitro Assay
Real-time RT-PCR test
NGS In Vitro Test Platform/Application Applied Biosystems 7500 Real-Time PCR System GenMark ePlex System
Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument
QuantStudio 3D Digital PCR System
Time to Results
Less than 2.5 hours
Less than 2 hours
Less than 90 minutes
3 hours Applied Biosystems QuantStudio 3D Digital PCR system N/A Panther and Panther Fusion Systems Panther Fusion NovaSeq 6000 Sequencing System
Real-time RT-PCR kit 7500 Fast Dx Real-Time PCR Instrument by Applied Biosystems CFX96 Touch Real-Time PCR Detection System (Bio- Rad) and CFX Maestro Software (Bio-Rad)
Real-Time RT-PCR test
RT-PCR Kit
COVID-19 RT-PCR Test Real-time RT-PCR test
LabGun COVID-19 RT-PCR Kit
ARIES SARS-CoV-2 Assay
NxTAG CoV Extended Panel Assay
https://www.maccura.com/en/product/
vAMA7UmFXAE-.html SARS-CoV-2 Fluorescent PCR Kit
https://www.mesabiotech.com/coronavirus
https://microgendx.com/covid19/ NeuMoDx Molecular
https://www.neumodx.com Novacyt/ Primerdesign
OPTI Medical Systems
https://www.optimedical.com/en/products-and-services/kits/ opti-sars-cov-2-rt-pcr-test-kit/
OSANG Healthcare
http://www.osanghc.com/en/products_en/ molecular-diagnosis/#
PerkinElmer QIAGEN Quest Diagnostics Quidel
https://perkinelmer-appliedgenomics.com/home/products/ new-coronavirus-2019-ncov-nucleic-acid-detection-kit/
https://www.qiagen.com/us/products/diagnostics-and-clini- cal-research/infectious-disease/qiastat-dx-syndromic-testing/ qiastat-dx-eua-us/#orderinginformation
https://testdirectory.questdiagnostics.com/test/ test-detail/39433/sars-cov-2-rna-qualitative-real-time-rt- pcr?q=39433&cc=MASTER
https://www.quidel.com/molecular-diagnostics/ lyra-direct-sars-cov-2-assay
Quidel Rheonix
Roche Molecular Systems
https://www.quidel.com/molecular-diagnostics/ lyra-sars-cov-2-assay
https://rheonix.com/covid-19/
https://diagnostics.roche.com/us/en/products/params/cobas-
sars-cov-2-test.html
http://www.primerdesign.co.uk/home
Accula SARS-CoV-2 test
SARS-CoV-2
Molecular Diagnostic Assay
NeuMoDx SARS- CoV-2 Assay
Primerdesign COVID- 19 genesig Real-Time PCR assay
OPTI SARS-CoV-2 RT PCR Test
GeneFinder COVID-19 Plus RealAmp Kit
PerkinElmer New Coronavirus Nucleic Acid Detection Kit
QIAstat-Dx Respiratory SARS-CoV-2 Panel
Quest SARS-CoV-2 rRT-PCR
Lyra Direct SARS- CoV-2 Assay
Lyra SARS-CoV-2 Assay
Rheonix COVID-19 MDx Assay
cobas SARS-CoV-2 rRT-PCR Test Qualitative Assay
Applied Biosystems QuantStudio12 Flex (QS12) instrument with software version 1.2.2
N/A N/A CFX96 DX System, ABI 7500 RT-PCR ARIES Systems Multiplex PCR test MAGPIX system
NA Fluorescent PCR Test
Real-time PCR test
Real-Time RT-PCR test
Real-Time RT-PCR test
Real-time PCR test
Multiplex RT-PCR Diagnostic Kit
Reverse Transcrip- tion Real-Time PCR Kit
Real-Time RT-PCR test
Multiplexed nucleic acid test
Real-time RT-PCR test
Real-time RT-PCT Assay
Real-time RT-PCR test
MDx Assay
Real-Time RT-PCR test
N/A Accula Dock and Silaris Dock N/A
NeuMoDx 288 Molecular and NeuMoDx 96 Molecular Systems
Applied Biosystem 7500 Real-Time PCR System Bio-Rad CFX96
Roche LightCycler 480 II N/A
Applied Biosystems 7500/7500FAST (Thermo Fisher) and CFX96 (Bio-Rad)
Applied Biosystems 7500 Real-Time PCR System QIAstat-Dx instrument N/A
Applied Biosystems 7500 Fast Dx, Applied Biosystems 7500 Standard, Roche LightCycler 480 Instrument II, Roche cobas z 480, Qiagen Rotor-Gene Q, Bio-Rad CFX96 Touch, Thermo Fisher QuantStudio 7 Pro.
Applied Biosystems 7500 Fast Dx, Applied Biosystems 7500 Standard, Roche LightCycler 480, Qiagen Rotor-Gene Q.
Rheonix Encompass MDx workstation cobas 6800/8800 Systems
3.5 hours or less
3 hours N/A 4 hours
24 hours 72 minutes Up to 4 days 1 hour 2 hours 96
samples/4 hours
2 hours 30 minutes 24 hours 1 hour 1 hour 2-3.5 hours 2 hours 96
samples/4 hours
1 hour 4-5 days
Less than 70 minutes
Less than 75 minutes
Same-day results
96 results/3 hours
COVID-19 Test Updates continued on page 32 CLR 2020-2021 • MLO •
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