April 27, 2020 | Forty-one molecular diagnostics tests and eight serology tests for SARS-CoV-2 virus infection have been granted Emergency Use Authorization from the Food and Drug Administration. Many more commercial and healthcare system/academic laboratories have notified the FDA that they have validated their own COVID-19 test and have started patient testing.
Among this month’s Emergency Use Authorizations is one from Seegene, a molecular diagnostics company based in Seoul, South Korea. Seegene’s Allplex 2019-nCoV real-time PCR Assay identifies 3 different target genes (E, RdRP and N genes) in a single reaction tube, which allows for highly accurate results and maximizes the throughput for high volume testing.
Korea’s FDA approved the Allplex 2019-nCoV real-time PCR Assay in February. Since then, more than 10 million kits have been exported to more than 60 countries. Using its AI-based assay design platform, Seegene was able to rapidly develop the assay shortly after the COVID-19 outbreak started in China. Seegene's proprietary high multiplex chemistry technology combined with its unique automated solution, has played a pivotal role in South Korea's rapid response to the COVID 19 outbreak, said Dr. Jong-Yoon Chun, CEO.
Here’s the full list of EUAs since our last round up on April 3.
Abbott Laboratories Inc.
The SARS-CoV-2 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma on Abbott’s ARCHITECT i System.
DiaSorin Inc.
The LIAISON SARS-CoV-2 S1/S2 IgG uses chemiluminescence immunoassay (CLIA) technology for the quantitative determination of anti-S1 and anti-S2 specific IgG antibodies to SARS-CoV-2 in human serum or plasma samples. The assay is intended as an aid in the diagnosis of CoVID-19 and to support the study of the immune status of infected patient by providing an indication of presence of neutralizing IgG antibodies against SARS-CoV-2.
Ortho-Clinical Diagnostics, Inc.
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. It helps identify the immune response in individuals that are currently or recently infected with the COVID-19 virus.
Autobio Diagnostics Co. Ltd.
The Autobio Anti-SARS-CoV-2 Rapid Test is designed to detect SARS-CoV-2 IgG/IgM in one cassette at the same time and report SARS-CoV-2 IgG positive and SARS-CoV-2 IgM positive separately.
SD Biosensor, Inc.
STANDARD M nCoV Real-Time Detection kit is used for rapid identification and detection of novel coronavirus (2019-nCoV) nucleic acids in human nasopharyngeal swabs and throat swab samples.
altona Diagnostics GmbH
The RealStar SARS-CoV-2 RT-PCR Kit U.S. is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test. It is designed to detect RNA from the SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes and nasal aspirates. The RealStar SARS-CoV-2 RT-PCR Kit U.S. includes two different amplification and detection systems. One primer and probe set enables the detection of an E gene sequence, which is specific for lineage B-betacoronavirus (B-βCoV; including SARS-CoV-2), whereas a second primer and probe set specifically amplifies and detects a SARS-CoV-2 specific sequence of the S gene. In addition to the amplification and detection systems for lineage B-betacoronavirus and SARS-CoV-2 specific RNA the assay also includes a probe and primer set for the detection of an Internal Control to identify possible rRT-PCR inhibition and to confirm the integrity of the reagents of the kit.
Seegene, Inc.
Seegene’s Allplex 2019-nCoV real-time PCR Assay identifies 3 different target genes (E, RdRP and N genes) in a single reaction tube, which allows for highly accurate results and maximizes the throughput for high volume testing.
Trax Management Services Inc.
The PhoenixDx test is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in nasal, nasopharyngeal and oropharyngeal swabs and BAL specimens. SARS-CoV-2 nucleic acid is first extracted, isolated and purified from nasal, nasopharyngeal and oropharyngeal swabs and BAL specimens. The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection using an authorized real-time (RT) PCR instrument.
OSANG Healthcare
Seattle-based ELITechGroup MDx (ELITech) has brought a proven COVID-19 test kit, the GeneFinder COVID-19 Plus RealAmpKit, to the U.S. through their Korean partner, OSANG Healthcare. The GeneFinderTM COVID-19 Plus RealAmp Kit delivers qualitative results within 4.5 hours and was validated using ABI 7500 thermocycler and Bio-Rad CFX96 cycler PCR platforms. The kit has been used in Europe since the beginning of March. Over 700,000 tests have been distributed worldwide. It requires one sample and one reaction.
Fosun Pharma USA Inc.
Shanghai-based Fosun Pharmaceuticals has developed a kit that can realize qualitative detection of novel coronavirus RNA targeting for its specific ORF1ab, N and E gene, and can complete the detection of 96 samples within two hours by supporting fast automatic nucleic acid extraction instrument and extraction reagents. In addition, automated testing will lower the risk of operator infection, reduce the probability of cross contamination in the clinical laboratory, and improve detection efficiency.
KorvaLabs Inc.
SARS-CoV-2 nucleic acid is first extracted, isolated and purified from oropharyngeal (throat) swab, nasopharyngeal swab, nasal swab, and oral fluid specimens. The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection using an authorized real-time (RT) PCR instrument. The Curative-Korva SARS-Cov-2 Assay uses all commercially sourced materials or other authorized materials and authorized ancillary reagents commonly used in clinical laboratories as described in the authorized procedures submitted as part of the EUA request.
GenoSensor, LLC
The GS COVID-19 RT-PCR KIT is a real-time reverse transcription polymerase chain reaction (RT-PCR) test which detects three genes from the SARS-CoV-2 virus from clinical nasopharyngeal swab specimens.
Maccura Biotechnology (USA) LLC
Simultaneous detection of the three genes of ORF1ab / E / N in 2019-nCoV, meeting the requirements of relevant documents of the World Health Organization (WHO). The assay has a full-process negative control, positive control and internal control.
Mount Sinai Laboratory
This test detects the presence or absence of antibodies to SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) and importantly, may also be used to identify positive specimens with an antibody titer (level) up to a dilution of 1:2880 for the identification of individuals with higher antibody titers.
Chembio Diagnostic System, Inc
The DPP COVID-19 System is a serological test and analyzer that provides numerical readings for both IgM and IgG levels within 15 minutes from a simple finger stick drop of blood. Both Chembio’s Micro Reader 1 and Micro Reader 2 analyzers are compatible with the test.
Ortho Clinical Diagnostics, Inc.
VITROS Immunodiagnostic Products Anti-SARS-COV-2 Total Reagent Pack and Calibrators is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. It helps identify the immune response in individuals that are currently or recently infected with the COVID-19 virus.
Atila BioSystems, Inc.
The iAMP COVID-19 Detection Kit is a real-time reverse transcription isothermal amplification test. The test is based on a proprietary isothermal amplification technology termed OMEGA amplification. OMEGA primer sets are designed to specifically detect RNA and later cDNA from the N and ORF-1ab genes of the SARS-CoV-2 virus in nasal, nasopharyngeal and/or oropharyngeal swabs. The iAMP COVID-19 assay’s key differentiator from current rRT-PCR COVID-19 assays is its ability to detect SARS-CoV-2 RNA directly from samples without prior RNA extraction process. Swab specimens are inserted directly into our 1X iAMP COVID-19 Sample Buffer Mix with a 15 min incubation at room temperature and can be directly used for OMEGA isothermal amplification and signal detection. Sample to result takes about 1 hour.
DiaCarta, Inc
The QuantiVirus SARS-CoV-2 Test Kit is based on Real-Time PCR technology, developed for specific detection of SARS-CoV-2 (COVID-19) viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum. The sensitivity is 100 copies per mL of SARS-CoV-2 viral with a 95% confidence. The assay is highly specific without cross-reaction with different types of non-SARS-CoV-2 species tested. The clinical validation shows 96.7% sensitivity and 100% specificity.
Becton, Dickinson & Company
The BioGX SARS-CoV-2 Reagents for BD MAX System utilizes multiplexed primers and probes targeting RNA from the nucleocapsid phosphoprotein gene (N1 and N2 regions) of the SARS-CoV-2 coronavirus, and the human RNase P gene. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal and oropharyngeal swab samples during infection.
InBios International, Inc
Smart Detect SARS-CoV-2 rRT-PCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in human nasopharyngeal swab, anterior nasal swab and mid-turbinate nasal swab specimens. Clinical laboratories that are certified to perform high complexity tests in the U.S. can immediately begin using this kit, which offers results in about 4 hours.
Gnomegen LLC
Compared to current qPCR methods, the Gnomegen COVID-19 RT-Digital-PCR Detection Kit is 4X more sensitive with a limit of detection of 2.5 copies per reaction in comparison to qPCR platforms at 10 copies per reaction using the same kit. At this limit of detection, qPCR identifies 62.5% positive while digital PCR identifies 95% of positive sample replicates. This improvement in the limit of detection would better protect the population from potential false negative results. The Gnomegen COVID-19 RT-Digital-PCR Detection Kit for use on the high throughput QuantStudio 3D Digital PCR System is capable of running up to 24 samples per run allowing up to 48 samples to be tested per day on a single device further increasing the speed of COVID-19 diagnosis.
Co-Diagnostics, Inc.
Co-Diagnostics presented its Logix Smart rapid diagnostic test to the audience at TriCon in early March, and spoke with editor Allison Proffitt at the event. The Co-Diagnostics Logix Smart Coronavirus COVID-19 Test uses the Company’s patented CoPrimer technology to target the RdRp gene of the SARS-CoV-2 virus. The advanced nature of CoPrimers has allowed Co-Diagnostics to design a highly-specific, single-well PCR test, allowing higher throughput over tests that require multiple wells. Since granting the EUA, the company announced that OralDNA Labs, a CLIA-certified laboratory, has recently validated a COVID-19 PCR test based on the Company’s patented CoPrimer technology for use with saline oral rinse samples.
ScienCell Research Laboratories
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ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit
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Molecular diagnostic
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EUA granted on April 3, 2020
The ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR Detection Kit is a qualitative test detecting the virus from nasal, nasopharyngeal, and oropharyngeal swabs, as well as bronchoalveolar lavage. Based in Carlsbad, California, ScienCell provides cell-based products – including human and animal cells, cell culture media and reagents, and gene analysis tools – to the research community.
Luminex Corporation
For more targeted coronavirus testing in moderate-complexity labs, the ARIES SARS-CoV-2 Assay is a sample-to-answer test that detects SARS-CoV-2 in nasopharyngeal swabs, and now has received an EUA from the FDA. The ARIES SARS-CoV-2 Assay offers a moderate-complexity, sample-to-answer test that enables targeted SARS-CoV-2 detection, minimal hands-on time and an automated workflow delivers results in about 2 hours, and exonuclease-sensitive probes for the ORF1ab and N viral genes provide superior specificity.