Special COVID-19 Section: New & Noteworthy

May 2020 - Vol.9 No. 5 - Page #16

As health systems across the United States continue to adapt and apply strenuous effort in managing the effects of COVID-19, the US Food and Drug Administration has granted Emergency Use Authorization (EUA) for a growing number of tests and related products.* Comprising this special section are a sampling of the diagnostic testing systems that have been granted an EUA as of this issue’s press date.

Per the FDA, these tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of 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.


PerkinElmer’s Nucleic Acid Detection kit is a real-time Reverse Transcriptase (RT)-PCR test intended for the qualitative detection of SARS-CoV-2 RNA isolated in human oropharyngeal and nasopharyngeal swab samples. The kit enables high-throughput, qualitative detection of SARS-CoV-2 RNA from 94 patient samples in approximately 2.5 hours. Full process QC with built-in controls helps ensure testing accuracy. The kit has a limit of detection of 20 copies/mL for the SARS-CoV-2 ORF1ab and N genes. It does not show cross reactivity with common respiratory tract pathogens and blood stream pathogens.


The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test from Ortho Clinical Diagnostics was recently granted EUA by the FDA. The company previously received EUA for its total antibody test (both tests have 100% specificity). Ortho’s newest test detects only the IgG antibody, which appears in a patient’s blood in the later phase of the infection, while the total test detects all COVID-19 related antibodies. The tests run on Ortho’s high-throughput, fully automated analyzers, including its flagship VITROS XT 7600 Integrated System, the VITROS 3600 Immunodiagnostic System, the VITROS 5600 Integrated System, and will soon be available on VITROS ECi/ECiQ Immunodiagnostic Systems.

 Ortho Clinical Diagnostics


BD and BioGX Inc announce a new diagnostic test that will enable hospitals to screen for COVID-19 on site and obtain results in under 3 hours. BioGX developed the assay for the BD MAX System (capable of processing 24 samples simultaneously) in their “Sample-Ready” ready-to-use format to detect the presence of the SARS-CoV-2 virus. Because most BD MAX systems are installed in hospital laboratories, a quicker time to results is accommodated. The assay is based on the same viral RNA targeting sequences and real-time PCR detection method as the test developed by the US Centers for Disease Control and Prevention (CDC). As an easy-to-use, rapid diagnostic test, it can be used to screen patient and health care worker specimens for COVID-19 on BD’s molecular diagnostic platform, the BD MAX System. Each unit is capable of analyzing hundreds of samples per day and can help detect current and past exposure to COVID-19. Laboratories already utilizing the BD MAX System can quickly on-board the test and as the system is fully automated, opportunities for human error are decreased, and speed to result is accelerated.


The ePlex SARS-CoV-2 test from GenMark Diagnostics was developed for the qualitative detection of SARS-CoV-2 virus in nasopharyngeal swab samples for potential COVID-19 patients. Offering rapid and easy detection, the test is exclusively used on the GenMark ePlex system, a sample-to-answer system that can provide an automated solution to the diagnostic process. Results can be obtained in under two hours with the capacity to process up to 96 tests per 8-hour shift. The system’s modular and expandable design enables testing to be widely accessible to meet the needs of various types of laboratories, from small decentralized sites, to large central hospitals and laboratories.

GenMark Diagnostics, Inc


BioFire Defense, a subsidiary of bioMérieux, announces the BIOFIRE COVID-19 test for use in CLIA moderate- and high-complexity clinical laboratories to detect SARS-CoV-2. The test can detect SARS-CoV-2 in approximately 45 minutes from a nasopharyngeal swab in transport media. Offering ease of use, the test runs on the fully automated Filmarray 2.0 and Filmarray Torch platforms and requires minimal training and skills.


DiaCarta’s QuantiVirus PCR diagnostic (Dx) test specifically detects three different genes of SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs, and sputum samples. The three viral RNA-encoded genes are the N, ORF1ab, and E genes detected by real-time quantitative RT-PCR assay, enabling high sensitivity and specificity with a limit of detection of 100 copies/mL without any detectable cross-reactivity to other human respiratory pathogens. Hospitals with high-complexity molecular diagnostic laboratories can now use QuantiVirus kits to detect SARS-CoV-2 within 2 hours following RNA extraction. The Dx reagent kit can be used with commonly available PCR instruments, such as Applied Biosystems Inc’s 7500 and QuantStudio 5.

DiaCarta, Inc

DiaSorin Molecular presents the Simplexa COVID-19 Direct Kit, which provides a sample-to-answer test for the detection of SARS-CoV-2. The kit is designed for use on the LIAISON MDX and works with nasopharyngeal swab specimens. Hospital laboratories can utilize it without the need to send out the sample, allowing for timely testing and results. The kit contains an all-in-one reagent mix that is ready to use, and just one instrument and one reagent are required to perform the test. Detection can occur in a little over an hour, allowing prompt decision making regarding isolation of infected patients. The test is highly specific to COVID-19 and targets several regions of the viral genome to minimize the impact on performance should there be possible
future mutations.

DiaSorin Molecular LLC

The QIAstat-Dx Respiratory SARS-CoV-2 Panel test kit from QIAGEN is a syndromic solution integrating the detection of SARS-CoV-2 coronavirus. It can differentiate novel coronavirus from 20 other serious respiratory infections, delivering results in approximately 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 the disease and is intended for use in laboratories certified under CLIA to perform moderate- and high-complexity tests. The automation system aims to provide fast, cost-effective, and easy-to-use syndromic testing with Sample-to-Insight workflows. A technician simply loads a clinical sample (such as a swab) into a single-use QIAstat-Dx cartridge and places it in the analyzer.


The NeuMoDx SARS-CoV-2 Assay from NeuMoDx Molecular is a rapid, automated, in vitro, real-time RT-PCR diagnostic test for the direct detection of SARS-CoV-2 coronavirus RNA from nasopharyngeal and oropharyngeal swab specimens in transport medium. The multiplexed assay detects highly conserved regions of two SARS-Cov-2 genes, the Nsp2 gene and N gene, and uses different fluorophores for reporting each target. The assay is available to CLIA-certified hospitals and reference laboratories with experience performing high complexity tests. The NeuMoDx 288 and 96 Molecular Systems can provide the first test results in as few as 80 minutes. Reagents and consumables do not require refrigeration and are provided in a ready-to-use format for immediate processing.

NeuMoDx Molecular

The cobas SARS-CoV-2 test from Roche is intended for the qualitative detection of SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing. The test can be run on Roche’s fully automated cobas 6800/8800 Systems, which provide test results and offer operating efficiency, flexibility, and fast time to results. Users can expect a throughput of up to 96 results in approximately 3.5 hours, for a total of 384 results for the 6800 System and 960 results for the 8800 System in 8 hours. The test can be run simultaneously with other assays provided by Roche for use on these systems.

Roche Molecular Solutions

The NxTAG CoV Extended Panel from Luminex is a multiplex test intended for the detection of the SARS-CoV-2 virus. High-complexity molecular laboratories can use the test on the MAGPIX System to rapidly detect the virus that causes COVID-19 for up to 96 patients in approximately 4 hours. This combination provides a cost-effective testing solution for the rapid delivery of test results. The NxTAG CoV Extended Panel was created by Luminex as a high-throughput, scalable, cost-effective option for detecting SARS-CoV-2. To provide a more complete picture of a patient’s respiratory health, the NxTAG CoV Extended Panel can also be run in parallel with the NxTAG Respiratory Pathogen Panel (RPP). The test can detect and differentiate between SARS-CoV-2 and other common respiratory infections.

Luminex Corporation



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