COVID 19 Special Collection
COVID-19 (SARS-CoV-2) Special Collection
Latest COVID-19 Articles
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Research Article
Comparison of Commercially Available and Laboratory Developed Assays for in vitro Detection of SARS-CoV-2 in Clinical Laboratories
Multiple laboratory developed tests and commercially available assays have emerged to meet diagnostic needs related to the SARS-CoV-2 pandemic. To date, there is limited comparison data for these different testing platforms. We compared the analytical performance of a laboratory developed test (LDT) developed in our clinical laboratory based on CDC primer sets and four commercially available, FDA emergency use authorized assays for SARS-CoV-2 (Cepheid, DiaSorin, Hologic Panther, and Roche Cobas) on a total of 169 nasopharyngeal swabs. The LDT and Cepheid Xpert Xpress SARS-CoV-2 assays were the most sensitive assays for SARS-CoV-2 with 100% agreement across specimens. The Hologic Panther Fusion, DiaSorin Simplexa, and Roche Cobas 6800 only failed to detect positive specimens near the limit of detection of our CDC-based LDT assay. All assays were 100% specific, using our CDC-based LDT as the gold standard. Our results provide initial test performance characteristics for SARS-CoV-2 RT-PCR and highlight the importance of having multiple viral detection testing platforms available in a public health emergency.
Accepted Manuscript Posted 29 April 2020, JCM
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Research Article
Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 Panel, the first rapid multiplex PCR commercial assay for SARS-CoV-2 detection
In the race to contain SARS-CoV-2, efficient detection and triage of infected patients must rely on rapid and reliable testing. In this work we performed the first evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAstat-SARS) for SARS-CoV-2 detection. This assay is the first rapid multiplex PCR (mPCR) assay including SARS-CoV-2 detection, and is fully compatible with a non-PCR trained laboratory or point-of-care (POC) testing.
Accepted Manuscript Posted 27 April 2020, JCM
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Research Article
Evaluation of Transport Media and Specimen Transport Conditions for the Detection of SARS-CoV-2 Using Real Time Reverse Transcription PCR
The global COVID-19 pandemic has resulted in a worldwide shortage of viral transport media and raised questions about specimen stability. The objective of this study was to determine the stability of SARS-CoV-2 virus RNA in specimen transport media under various storage conditions. Transport medium tested included: VCM, UTM®-RT, ESwab™, M4 and saline (0.9% NaCl). Specimen types tested included Nasopharyngeal/Oropharyngeal (NP/OP) swabs in the above transport media, bronchoalveolar lavage (BAL) and Sputum. A high-titer SARS-CoV-2 remnant patient specimen was spiked into pooled SARS-CoV-2 RNA-negative specimen remnants for the various media types. Aliquots of samples were stored at 18°C to 25°C, 2°C to 8°C and -10°C to -30°C and then tested at time points up to 14 days. Specimens consistently yielded amplifiable RNA with mean Ct differences of <3 over the various conditions assayed, thus supporting the use and transport of alternative collection media and specimen types under a variety of temperature storage conditions.
Accepted Manuscript Posted 27 April 2020, JCM
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Research Article
Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel human coronavirus that causes coronavirus disease 2019 (COVID-19), was first discovered in December 2019 as the cause of an outbreak of pneumonia in the city of Wuhan, Hubei province, China. The clinical presentation of COVID-19 is fairly non-specific, and symptoms overlap with other seasonal respiratory infections concurrently circulating in the population. Furthermore, it is estimated that up to 80% of infected individuals experience mild symptoms or are asymptomatic, confounding efforts to reliably diagnose COVID-19 empirically. To support infection control measures, there is an urgent need for rapid and accurate molecular diagnostics to identify COVID-19 positive patients. In the present study, we have evaluated the analytical sensitivity and clinical performance of four SARS-CoV-2 molecular diagnostic assays granted Emergency Use Authorization by the FDA using nasopharyngeal swabs from symptomatic patients: the New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel (Modified CDC), the Simplexa COVID-19 Direct (Diasorin Molecular), GenMark ePlex SARS-CoV-2 assay (GenMark) and the Hologic Panther Fusion® SARS-CoV-2 assay (Hologic). This information is crucial for both laboratories and clinical teams, as decisions on which testing platform to implement are made.
Accepted Manuscript Posted 27 April 2020, JCM
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Research Article
Clinical Evaluation of Three Sample-To-Answer Platforms for the Detection of SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has now spread across the globe. As part of the worldwide response, many molecular diagnostic platforms have been granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) to identify SARS-CoV-2 positive patients. Our objective was to evaluate three sample-to-answer molecular diagnostic platforms (Cepheid Xpert® Xpress SARS-CoV-2 [Xpert Xpress], Abbott ID NOW™ COVID-19 [ID NOW], GenMark ePlex® SARS-CoV-2 Test [ePlex]) to determine analytical sensitivity, clinical performance, and workflow for the detection of SARS-CoV-2 in nasopharyngeal swabs from 108 symptomatic patients. We found that the Xpert Xpress had the lowest limit of detection (100% detection at 100 copies/mL), followed by the ePlex (100% detection at 1,000 copies/mL), and the ID NOW (20,000 copies/mL). The Xpert Xpress also had highest positive percent agreement (PPA) when compared to our reference standard (98.3%) followed by the ePlex (91.4%) and ID now (87.7%). All three assays showed 100% negative percent agreement (NPA). In the workflow analysis, the ID NOW produced the most rapid time to result per specimen (~17 minutes) as compared to the Xpert Xpress (~46 minutes) and the ePlex (~1.5 hours), but what the ID NOW gained in rapid results, it lost in analytical and clinical performance. The ePlex had the longest time to results and showed a slight improvement in PPA over the ID NOW. Information about the clinical and analytical performance of these assays, as well as workflow, will be critical in making informed and timely decisions on testing platform.
Accepted Manuscript Posted 24 April 2020, JCM
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Letter to the Editor
Comparison of Abbott ID Now and Abbott m2000 methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from symptomatic patients
The ID NOW COVID-19 (IDNCOV) assay performed on the ID Now Instrument (Abbott Diagnostics, Scarborough, Inc. Scarborough, ME) is a rapid diagnostic test that can be performed in a point of care setting equivalent to CLIA waived testing...
Accepted Manuscript Posted 23 April 2020, JCM
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Perspective
COVID-19: an Immunopathological View
Since its emergence in December 2019, it took only a couple of months for an outbreak of the novel coronavirus disease 2019 (COVID-19) to be declared a pandemic by the World Health Organization (WHO). This along with the highly infectious nature of the disease and the associated mortality call for particular attention to the underlying (immuno)pathomechanism(s). The latter will inform case management and vaccine design. Unravelling these mechanisms can assist basic scientists, laboratory medicine practitioners, clinicians, public health practitioners, funding agencies, and health care policymakers in responding to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic.
22 April 2020, mSphere
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Letter to the Editor
Validation of the Hologic's Aptima Unisex and Multitest Specimen collection kits used for Endocervical and Male Urethral Swab Specimen (Aptima Swab) for sample collection of SARS-CoV-2
Recent events have seen the rise of SARS-CoV-2 all across the world affecting the lives and economies of every nation...
Accepted Manuscript Posted 21 April 2020, JCM
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Letter to the Editor
Saliva as a non-invasive specimen for detection of SARS-CoV-2
Diagnostic testing for COVID-19 is central to controlling the global pandemic...
Accepted Manuscript Posted 21 April 2020, JCM
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Letter to the Editor
Nafamostat mesylate blocks activation of SARS-CoV-2: New treatment option for COVID-19
The currently unfolding coronavirus pandemic threatens health systems and economies worldwide...
Accepted Manuscript Posted Online 20 April 2020, Final Article Posted 21 May 2020, AAC
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Letter to the Editor
Comparison of Abbott ID Now, Diasorin Simplexa, and CDC FDA EUA methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from individuals diagnosed with COVID-19
Dozens of in vitro diagnostics (IVDs) have received emergency use authorization (EUA) from the U.S. Food & Drug Administration (FDA) for the detection of SARS-CoV-2, but little has been studied to determine how well these assays perform using clinical specimens...
Accepted Manuscript Posted 17 April 2020, JCM
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Letter to the Editor
The Detection of SARS-CoV-2 using the Cepheid Xpert Xpress SARS-CoV-2 and Roche cobas SARS-CoV-2 Assays
SARS-CoV-2, a novel coronavirus responsible for a December 2019 outbreak in Wuhan, China, causes a syndrome characterized by fever, cough, and dyspnea progressing to acute respiratory distress syndrome (1)...
Accepted Manuscript Posted 17 April 2020, JCM
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Research Article
Human leukocyte antigen susceptibility map for SARS-CoV-2
Individual genetic variation may help to explain different immune responses to a virus across a population. In particular, understanding how variation in HLA may affect the course of COVID-19 could help identify individuals at higher risk from the disease. HLA typing can be fast and inexpensive. Pairing HLA typing with COVID-19 testing where feasible could improve assessment of viral severity in the population. Following the development of a vaccine against SARS-CoV-2, the virus that causes COVID-19, individuals with high-risk HLA types could be prioritized for vaccination.
Accepted Manuscript Posted 17 April 2020, JVI
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Editorial
Coping with COVID: How a Research Team Learned To Stay Engaged in This Time of Physical Distancing
Physical distancing imposed by the COVID-19 pandemic has led to alterations in routines and new responsibilities for much of the research community. We provide some tips for how research teams can cope with physical distancing, some of which require a change in how we define productivity. Importantly, we need to maintain and strengthen social connections in this time when we can’t be physically together.
17 April 2020, mBio
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Letter to the Editor
Nasal swab sampling for SARS-CoV-2: A convenient alternative in time of nasopharyngeal swab shortage
Nasopharyngeal swab is the reference sampling method to detect SARS CoV2, as recommended by world Health Organization (WHO) (1)...
Accepted Manuscript Posted 15 April 2020, Final Article Posted 26 May, 2020, JCM