By Diagnostics World News Staff
April 3, 2020 | The diagnostics community has come out in force to address testing issues for the novel coronavirus. As of April 3, 25 test kit manufacturers and commercial laboratories have been issued Emergency Use Authorization from FDA, and many commercial and healthcare system/academic laboratories have notified the FDA that they have validated their own COVID-19 test and have started patient testing.
Here are the test kits and commercial labs currently granted EUAs, listed in reverse chronological order based on their EUA date:
BD (Becton, Dickinson and Company) and BioGX Inc.
The BioGX SARS-CoV-2 Reagents test will be run on the BD MAX Molecular Diagnostic Platform, which is already in use in nearly every state across the U.S. at hundreds of laboratories, with each unit capable of analyzing hundreds of samples per day. The system is fully automated, reducing the opportunity for human error and increasing the speed to result. Samples are capable of being analyzed start to finish in two to three hours. Each BD MAX System can process 24 samples simultaneously.
Ipsum Diagnostics
- COV-19 IDx assay
- EUA granted on April 1, 2020
The COV-19 IDx assay is a real-time reverse transcription polymerase chain reaction (rRT -PCR) test. The test uses one primer and probe set to detect one region in the SARSCoV-2 nucleocapsid (N) gene and one primer and probe set to detect human RNase P (RP) in a clinical sample. RNA isolated from nasopharyngeal or oropharyngeal swabs is reverse transcribed to cDNA and subsequently amplified using Applied Biosystems QuantStudio12 Flex (QS12) instrument with software version 1.2.2.
Cellex Inc.
- qSARS-CoV-2 IgG/IgM Rapid Test
- EUA granted on April 1, 2020
The Cellex qSARS-CoV-2 IgG/IgM Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA, citrate) or venipuncture whole blood specimens from patients suspected of COVID-19 infection by a healthcare provider. The qSARS-CoV-2 IgG/IgM Rapid Test 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.
QIAGEN
- QIAstat-Dx Respiratory SARS-CoV-2 Panel
- EUA granted on March 30, 2020
The QIAstat-Dx test kit can differentiate the [COVID-19] virus from 21 other serious respiratory infections in patients who may have similar symptoms in a single testing run of about one hour. It is a multiplexed nucleic acid test that evaluates samples such as nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. The newly approved panel includes assays targeting two genes used to detect the pathogen behind Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2), and is intended for use in laboratories certified under CLIA to perform moderate and high complexity tests.
NeuMoDx Molecular
- NeuMoDx SARS-CoV-2 Assay
- EUA granted on March 30, 2020
The NeuMoDx SARS-CoV-2 Test Strip detects SARS-CoV-2 in nasal, nasopharyngeal, and oropharyngeal swab samples from patients suspected of having COVID-19, the disease caused by SARS-CoV-2 infection. The multiplexed test detects the Nsp2 gene and the N gene of the virus, and the time to first results on the instrument is approximately 80 minutes.
Luminex Molecular Diagnostics
- NxTAG CoV Extended Panel Assay
- EUA granted on March 27, 2020
The NxTAG Respiratory Pathogen Panel (RPP) is a next generation closed tube, molecular assay with an all-inclusive coverage created to enhance laboratory workflow. This will enable a laboratory to simultaneously detect 20 respiratory pathogens, accommodating the higher throughput necessary to respond to changes on demand. In fact, in order to get a thorough insight into a patient’s respiratory health, the NxTAG CoV Extended Panel can be run in parallel with the NxTAG RPP.
Abbott Diagnostics Scarborough
- ID NOW COVID-19
- EUA granted on March 27, 2020
The ID NOW platform is small, lightweight (6.6 pounds) and portable (the size of a small toaster), and uses molecular technology, which is valued by clinicians and the scientific community for its high degree of accuracy. Abbott will be making ID NOW COVID-19 tests available next week to healthcare providers in urgent care settings in the U.S.
BGI Genomics
- Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV
- EUA granted on March 26, 2020
BGI’s RT-PCR kit for detecting SARS-2019-nCoV test can return results within three hours. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in bronchoalveolar lavage fluid (BALF) and throat swabs.
Avellino Lab USA, Inc.
The AvellinoCoV2 test identifies two genetic factors that test the SARS-CoV-2 virus expression. Original CDC guidance specified that coronavirus testing required three specific genetic parts. Avellino has confirmed through its validation process that only two of these parts are necessary in identifying COVID-19. As a result, the company has the technology today to quickly identify the two genetic parts required to confirm the presence of COVID-19.
PerkinElmer
The PerkinElmer New Coronavirus Nucleic Acid Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in human oropharyngeal and nasopharyngeal swab samples. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.
Mesa Biotech Inc.
The Accula SARS-CoV-2 Test is a visually read test using polymerase chain reaction (PCR) technology to detect SARS-CoV-2 (the virus responsible for COVID-19) via throat and nasal swab samples. Similar to Mesa Biotech’s commercially available tests for influenza and RSV, the Accula SARS-CoV-2 Test is designed for the point-of-care use, including temporary screening facilities, physician office labs, urgent care, and long term nursing facilities. The system complements central laboratories where current testing is performed. Mesa Biotech’s compact coronavirus test yields laboratory-quality results in approximately 30 minutes.
BioFire Defense
The BioFire COVID-19 test detects SARS-CoV-2 in approximately 45 minutes from a nasopharyngeal swab in transport media. This test runs on the fully automated FILMARRAY 2.0 and FILMARRAY TORCH platforms and is extremely easy to use, therefore requiring minimal training and skills in molecular biology.
Cepheid
The Xpert Xpress SARS-CoV-2 test is a molecular in vitro diagnostic test that aids in the detection and diagnosis SARS-CoV-2 and is based on widely used nucleic acid amplification technology. The Xpert Xpress SARS-CoV-2 test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in nasopharyngeal swab specimens and/or nasal wash/aspirate specimens.
Primerdesign Ltd.
The Primerdesign Ltd COVID-19 genesig Real-Time PCR assay is a molecular in vitro diagnostic test for the detection of the SARS-CoV-2 RNA in oropharyngeal swab specimens from patients suspected of COVID-19 by their healthcare provider and aids the diagnosis of coronavirus COVID19 disease. The assay is based on widely used nucleic acid amplification technology. The product contains oligonucleotide primers and dual-labeled hydrolysis probes, as well as control material, for the use in reverse transcriptase Real-Time-PCR for the in vitro qualitative detection of SARSCoV-2 RNA in oropharyngeal swab specimens.
GenMark Diagnostics, Inc.
GenMark’s ePlex SARS-CoV-2 Test was developed for the qualitative detection of SARS-CoV-2 virus in nasopharyngeal swab samples for patients suspected of COVID-19 by their health care provider. Rapid and easy detection of SARS-CoV-2 is becoming increasingly critical and customers are adopting the ePlex test based on the workflow and ease-of use to address this urgent need. The test is exclusively for use on the company’s ePlex system, which had a global installed base of more than 500 analyzers as of December 31, 2019. The ePlex sample-to-answer system provides an automated solution to the diagnostic process and provides results in under two hours with the capacity to process up to 96 tests per 8-hour shift. The ePlex system’s modular and expandable design enables near-patient COVID-19 testing to be widely accessible to meet the needs of various types of laboratories, from small decentralized sites, to large central hospitals and laboratories.
DiaSorin Molecular LLC
The Simplexa COVID-19 Direct kit is designed for use on the LIAISON MDX. It can be utilized by hospital laboratories without the need to send the sample out, allowing for timely testing and results. The kit contains an all-in-one reagent mix which is ready to use. Only one instrument and one reagent are required to perform the test. It bypasses the need for traditional extraction procedures, enabling rapid detection in a little over an hour which is significantly faster than the up to seven hours currently required by traditional extraction followed by amplification technologies, ultimately allowing prompt decision making regarding isolation of infected patients.
Abbott Molecular
The Abbott RealTime SARS-CoV-2 EUA test can be used on Abbott's molecular instrument, the m2000 RealTime system, by authorized laboratories in the U.S. These lab instruments, which test for a broad array of infectious diseases and are found in health systems across the U.S., can now have access to a SARS-CoV-2 assay to help healthcare providers deal with the high demand for testing.
Quest Diagnostics Infectious Disease, Inc.
The Quest SARS-CoV-2 rRT-PCR test is a qualitative test for the detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, tracheal aspirates, and bronchoalveolar lavage) collected from individuals suspected of COVID-19 by their healthcare provider.
Quidel Corporation
The Lyra SARS-CoV-2 Assay is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19 by their healthcare provider. The Lyra product line offers PCR reagent kits for use by molecular diagnostic laboratories with existing molecular testing infrastructure such as the Applied Biosystems 7500 Fast DX instruments. These reagents include unique features that provide for simple transport and storage, improved workflow, shorter time to result, and other benefits that favorably affect diagnostic test outcome.
Laboratory Corporation of America (LabCorp)
LabCorp’s COVID-19 RT-PCR Test is a qualitative test for the detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) collected from individuals suspected of COVID19 by their healthcare provider. The SARS-CoV-2 nucleic acid is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; 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.
Hologic, Inc.
Using the Panther Fusion system, healthcare providers can test for SARS-CoV-2 from the same patient sample and collection vial that they currently use to diagnose other common respiratory viruses whose symptoms overlap with COVID-19, boosting efficiency and increasing clinical insight. With a small physical footprint and a broad menu that includes 16 FDA-cleared tests for various infectious diseases, the Panther Fusion system is already widely used in low-, medium- and high-throughput laboratories.
Thermo Fisher Scientific, Inc.
The TaqPath COVID-19 Combo Kit contains the assays and controls for a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider. TaqPath COVID-19 Combo Kit is for use only under Emergency Use Authorization (EUA). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
Roche Molecular Systems, Inc. (RMS)
The cobas SARS-CoV-2 Test is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing. Hospitals and reference laboratories can run the test on Roche’s fully automated cobas 6800 and cobas 8800 Systems, which are widely available in the U.S. and around the world.
Wadsworth Center, New York State Department of Public Health's (CDC)
The New York SARS-CoV-2 Real-time RT-PCR Diagnostic Panel is for the presumptive qualitative detection of SARS-CoV-2 RNA in nasopharyngeal/oropharyngeal swabs and sputa, and other specimens as authorized by FDA, collected from individuals who meet COVID-19 clinical and/or epidemiological criteria for testing. The testing procedure consists of nucleic acid extraction and purification from the human specimen using authorized extraction methods/instruments followed by real time RT-PCR, where the RNA is reverse transcribed into cDNA and then amplified using the primer sets and detected using specific probes. The real time reverse transcriptase (RT)-PCR is performed on the FDA cleared Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument with SDS 1.4 software, or other authorized instruments or software.
Centers for Disease Control and Prevention's (CDC)
The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel is for the qualitative detection of SARS-CoV-2 RNA in upper and lower respiratory specimens, and other authorized specimens collected from individuals who meet COVID-19 clinical and/or epidemiological criteria. The testing procedure consists of nucleic acid extraction and purification from the human specimen using authorized extraction methods/instruments followed by real time RTPCR, where the RNA is reverse transcribed into cDNA and then amplified using the primer sets and detected using specific probes.