Author Interviews, BMJ, COVID -19 Coronavirus / 03.09.2020
False Negative COVID-19 Tests Relatively Common During Recovery
MedicalResearch.com Interview with:
Dr. Francesco Venturelli
Servizio di Epidemiologia
Direzione Sanitaria - Azienda USL-IRCCS di Reggio Emilia
Padiglione Ziccardi, Via Amendola
MedicalResearch.com: What is the background for this study?
Response: Contact tracing and isolation for people testing positive for SARS-CoV-2 are two of the main strategies to limit the viral spread and contain the current pandemic. Long persistence of viral RNA detected by RT-PCR on nasopharyngeal swabs is commonly reported, while its correlation to virus viability is still debated.
MedicalResearch.com: What are the main findings?
Response: The study showed that in people with COVID-19, the median time between symptoms onset and viral clearance at RT-PCR was 36 days. Moreover, an overall 20% risk of “false negative” results at RT-PCR was observed, decreasing with time from diagnosis.
Dr. Francesco Venturelli
Servizio di Epidemiologia
Direzione Sanitaria - Azienda USL-IRCCS di Reggio Emilia
Padiglione Ziccardi, Via Amendola
MedicalResearch.com: What is the background for this study?
Response: Contact tracing and isolation for people testing positive for SARS-CoV-2 are two of the main strategies to limit the viral spread and contain the current pandemic. Long persistence of viral RNA detected by RT-PCR on nasopharyngeal swabs is commonly reported, while its correlation to virus viability is still debated.
MedicalResearch.com: What are the main findings?
Response: The study showed that in people with COVID-19, the median time between symptoms onset and viral clearance at RT-PCR was 36 days. Moreover, an overall 20% risk of “false negative” results at RT-PCR was observed, decreasing with time from diagnosis. 
Ruth Fernandez-Ruiz, MD
Post-Doctoral Fellow
Department of Rheumatology
NYU Langone Heath
MedicalResearch.com: What is the background for this study?
Response: Patients with systemic lupus erythematosus (SLE) represent a unique population in considering risk for COVID-19 with biologic, genetic, demographic, clinical and treatment issues at play. By the nature of their chronic inflammatory autoimmune condition, the presence of comorbidities, and regular use of immunosuppressants, these individuals would traditionally be considered at high risk of contracting SARS-CoV-2 and possibly having worse outcomes from the viral infection.
However, it might be speculated that inherently elevated type I Interferon, characteristic of the majority of patients with SLE, confers a protective effect as a first line anti-viral defense. Additionally, hydroxychloroquine, which was suggested as a potential therapeutic agent for COVID-19 early on, is used in most patients with SLE. Accordingly, we initiated this study to provide critical data needed to address the frequency and severity of COVID-19 in patients with SLE.
Dr. Yonker[/caption]
Lael Yonker, MD
Pediatric Pulmonology
Director, MGH Cystic Fibrosis Center
Principal Investigator, Pediatric COVID biorepository
Mucosal Immunology and Biology Research Center
Massachusetts General Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Children were initially felt to be spared from the COVID-19 pandemic. Here, we show that children can become sick from SARS-CoV-2 infection, and even if the initial illness is mild, some go on to develop a severe inflammatory illness after the initial illness. We also show that children can carry very high levels of virus early in the course of infection, suggesting they may play a larger role in spreading the virus than previously thought.
Dr. Jimenez[/caption]
Monik Carmen Jimenez, Sc.D
Assistant Professor of Medicine
Brigham and Women's Hospital
MedicalResearch.com: What is the background for this study?
Response: We wanted to get a comprehensive picture of the epidemiology of COVID-19 in carceral facilities that included jails and was not restricted solely to prisons. We utilized publicly available data collected in Massachusetts, pursuant to a court order. These data included prison and jail systems and were used to calculate rates of confirmed cases of COVID-19 and testing rates among incarcerated individuals. We were also able to compare those to changes in the population size within each system.
Dr. Reyes Gil[/caption]
Dr. Heald-Sargent[/caption]
Taylor Heald-Sargent, M.D., Ph.D.
Ann & Robert H. Lurie Children’s Hospital
Chicago
MedicalResearch.com: What is the background for this study?
Response: Given the ongoing debate around the ability of children to transmit SARS-CoV-2, we noticed that our clinical data could address one of the prevalent assumptions. Some people postulated that the reason children have less severe infections with SARS-CoV-2 is because they are not able to replicate virus as much as adults and therefore may not transmit as readily. 
Dr. Sinha[/caption]
Pranay Sinha, MD
Research Fellow
Section of Infectious Diseases
Boston University School of Medicine
MedicalResearch.com: What is the background for this study?
Response: In the early days of the COVID-19 pandemic there were no evidence-based treatments for severely ill patients infected with this virus. We formed an interdisciplinary group of physicians from departments of adult and pediatric infectious diseases, rheumatology, and pulmonary/critical care as well as clinical pharmacy specialists. Given some promising data from China, we instituted treatment with off-label IL-6 receptor inhibitors (tocilizumab and sarilumab). The rationale was to mitigate the exuberant immune response observed in some patients infected with SARS-CoV-2 (also called cytokine storm or cytokine release syndrome).
Quite quickly, we started noticing that giving the drug to our sickest patients wasn’t eliciting dramatic improvement. We reasoned that by the time patients were severely ill and requiring ventilators, the damage to their lungs from the cytokine storm had already taken place. It was like closing the barn door after the horse had already bolted.
Dr. Hervé Perron[/caption]
Hervé Perron PhD
Chief Scientific Officer at GeNeuro
MedicalResearch.com: What is the background for this study?
Response: Human endogenous retroviruses (HERVs), remnants of ancestral viral genomic insertions, are known to represent 8% of the human genome and are associated with several pathologies. Certain proteins produced by HERVs have previously been found to be involved in pathogenic mechanisms linked to, e.g., multiple sclerosis (MS) or amyotrophic lateral sclerosis. However, despite previous results having shown an abnormal expression of HERV-W in patients with schizophrenia or bipolar disorder, the mechanisms involved in these psychiatric disorders are poorly understood.
Prof. Garnier[/caption]
Gil Garnier PhD
Director and Professor
Bioresource Processing Research Institute of Australia (BioPRIA)
PALS ARC Industry Transformation Research Hub
Department of Chemical Engineering
Monash University
MedicalResearch.com: What is the background for this study?
Response: We wanted to develop a test that would be:
1) Reliable and fast to perform,
2) Easy and fast to manufacture,
3) Easy and fast to distribute and be adopted by the Health care community.
We also wanted to capitalize on our vast expertise and experience from developing novel blood typing tests. Our strategy was to develop a serology COVID test using the current Gel card technology available in most hospital and blood laboratories throughout the world. Equipment and expertise are already available from point of care setting to high throughput/automated systems measuring 100-200 test/ h. Also, these cards are currently produced by many companies all over and these can be shipped all international.
Dr. Ghaffari[/caption]
Abdi Ghaffari, Ph.D.
Associate Professor (adjunct)
Dept. of Pathology and Molecular Medicine
Queen’s University
MedicalResearch.com: What is the background for this study?
Response: SARS-CoV-2 virus has infected millions and changed our way of life by placing nearly 3 billion people under lockdown or some form of physical isolation. In the absence of a vaccine or reliable treatment, diagnostic testing must be a pillar of public health policy to control further spread of the virus and to guide gradual removal of lockdown measures.
COVID-19 antibody diagnostic tests are being increasingly used to assess the protective immunity status in the population. There are over 100 different COVID-19 antibody tests developed by companies worldwide in an effort to address this need. However, companies’ reported performance data are not always in line with the actual performance of these diagnostic tests in the real-world. In this work, we conducted a systemic review of independent studies (sponsored by academic or government institutions) that aimed to validate the performance of currently available COVID-19 antibody tests on the market. 
