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Expanded COVID-19 Resources for Labs



AACC has gathered essential information and resources to help laboratories implement and expand coronavirus disease 2019 (COVID-19) testing, including the latest research form its journals and free education programs for laboratory medicine professionals.

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COVID-19 Research

New item icon Out of the Darkness-Into the Light: Value of SARS-CoV-2 Antibody Testing in Populations to Benefit Public Health and in Individuals for Peace of Mind

The task now facing governments and national regulators is to balance urgency against the everyday sensitivity and specificity concerns that apply to any novel medical diagnostic tests.

Read the Journal of Applied Laboratory Medicine Article External Link

New item icon Screening the general population for SARS CoV-2 virus and COVID-19 antibodies: A counter-argument

The prevalence of disease is an important issue for mass screening. If it turns out that the prevalence is low, the clinical sensitivity of current virus tests will be inadequate for mass screening.

Read the Journal of Applied Laboratory Medicine Article External Link

New item icon Hydroxychloroquine interference in common biochemistry laboratory assays

A small positive interference was noted in the Cedia urine amphetamine-like substances immunoassay on the Beckman AU480. While analytically significant, this interference is unlikely to cause false positive test results.

Read the Journal of Applied Laboratory Medicine Article External Link

New item icon What to expect from antibody assays of SARS-CoV-2

Presence of SARS-CoV-2 IgG potentially correlates with virus-blocking effect, i.e., immunity, but further direct evidence needs to be collected.

Read the Journal of Applied Laboratory Medicine Article External Link

New item icon Laboratory tests and outcome for patients with COVID-19: A systematic review and meta-analysis

In this systematic review and meta-analysis, we examine which routine laboratory tests are associated with severe COVID-19 disease.

Read the Journal of Applied Laboratory Medicine Article External Link

Antibody Profiles in Mild and Severe Cases of COVID-19

Authors of an article in AACC's journal Clinical Chemistry found that patients with severe COVID-19 are more likely to mount robust antibody responses than those with mild cases.

Read the Clinical Chemistry Article External Link

Clinical Validation of a SARS-CoV-2 Real-Time Reverse Transcription PCR Assay Targeting the Nucleocapsid Gene

Authors of an article in AACC's Journal of Applied Laboratory Medicine found that endemic coronavirus controls were useful in optimizing the extraction procedure for this assay, and in the absence of live or attenuated virus, recombinant virus in a protein coat was an appropriate control specimen type for assay validation during a pandemic.

Read the Journal of Applied Laboratory Medicine Article External Link

Clinical Performance of the Roche SARS-CoV-2 Serologic Assay

Authors of an article in AACC's Clinical Chemistry journal found that the clinical performance between certain Roche, Abbott, and EI SARS-CoV-2 assays are similar and can detect antibodies to SARS-CoV-2 in a majority of patients 14 days after the onset of symptoms.

Read the Clinical Chemistry Article External Link

Clinical performance of the Elecsys electrochemiluminescent immunoassay for the detection of SARS-CoV-2 total antibodies

This study is the first to report the external validation of a new electrochemiluminescent immunoassay test, the Elecsys anti-SARS-CoV-2 from Roche Diagnostics. The test
allows the detection of total antibodies specifically directed against SARSCoV-2 nucleocapsid.

Read the Clinical Chemistry Article External Link

AACC Issues Recommendations on the Use of COVID-19 Antibody Tests

To ensure the proper use of antibody testing for the novel coronavirus, AACC issued a public statement detailing the role these tests should play in the management of COVID-19 patients and in the development of public health policy.

Read the Statement

Molecular and Serological Assays for SARS-CoV-2: Insights from Genome and Clinical Characteristics

Authors of a review article in AACC's Clinical Chemistry journal explain that SARS-CoV-2 has unique gene sequences and specific transmission and clinical features that can inform the conduct of molecular and serological assays.

Read the Clinical Chemistry Article External Link

Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19

Research published in AACC's Journal of Applied Laboratory Medicine for the first time reports longitudinal data showing the evolution of seroconversion for both IgG and IgM in a cohort of acutely ill patients with COVID-19 in the US.

Read the Journal of Applied Laboratory Medicine Article External Link

Clinical Performance of Two SARS-CoV-2 Serologic Assays

A first-of-its-kind study published in AACC’s Clinical Chemistry journal compared the performance of two COVID-19 antibody tests and found that—even though both tests are FDA authorized—one produced more incorrect results than the other.

Read the Clinical Chemistry Article External Link

Rapid detection of SARS-CoV-2 by low volume real-time single tube reverse transcription recombinase polymerase amplification using an exo probe with an internally linked quencher

A newly developed assay is one of the fastest nucleic acid based method that has been reported for the detection of SARS-CoV-2, with results in as few as 20 minutes and potential for point of care use.

Read the Clinical Chemistry Article External Link 

Metagenomic analysis reveals clinical SARS-CoV-2 infection and bacterial or viral superinfection and colonization

Metagenomic sequencing offers the promise of unbiased detection of emerging pathogens, without requiring prior knowledge of the identity of the responsible agent or its genomic sequence.

Read the Clinical Chemistry Article External Link

Modeling SARS-CoV-2 positivity using laboratory data: timing is everything

As it pertains to the current Lab 2.0 movement, there has never been a more clear example of the value of the laboratory in not only diagnostics and treatment of COVID-19, but in real-time policy decisions, write the authors of this Clinical Chemistry journal article.

Read the Clinical Chemistry Article External Link

Unleashing the Power of Laboratory Developed Tests: Closing gaps in COVID diagnosis and beyond

Efforts to rapidly develop and implement COVID-19 LDTs were heroic. The devastating scope and consequences of COVID-related illness shone an unusually bright light on the experts in the clinical lab, notes the author of this article in AACC's Journal of Applied Laboratory Medicine.

Read the Journal of Applied Laboratory Medicine Article External Link

Selecting a SARS-CoV-2/COVID molecular testing method for your laboratory

This reflection in AACC's Journal of Applied Laboratory Medicine highlights some of the considerations when selecting the best method for COVID-19 testing, with specific examples highlighted from a medium volume clinical laboratory.

Read the Journal of Applied Laboratory Medicine Article External Link

Preparedness and Rapid Implementation of External Quality Assessment Helped Quickly Increase COVID-19 Testing Capacity in the Republic of Korea

The key factors in Korea's rapid expansion of testing were the establishment of an emergency use authorization system, an external quality assessment, and the collaboration between the public and private sectors, write authors in this Clinical Chemistry journal article.

Read the Clinical Chemistry Article External Link

Rapid Detection of COVID-19 Coronavirus Using a Reverse Transcriptional Loop-mediated Isothermal Amplification Diagnostic Platform

Scientists have developed a new, faster molecular method to detect SARS-CoV-2 that may allow greater access to testing around the globe, published in AACC's Clinical Chemistry journal.

Read the Clinical Chemistry Article External Link

Limits of Detection of Six Approved RT–PCR Kits for SARS-CoV-2

Research from AACC's Clinical Chemistry journal explores how the limit of detection, the lowest analyte concentration that a kit can detect, is an important performance parameter in evaluating the quality of coronavirus test kits.

Read the Clinical Chemistry Article External Link

COVID-19 in Pediatrics: A Laboratory Perspective

Biochemical findings in children, along with levels of cytokines and T-cell responses in this population, as well assessment of antibody titres, may offer insights into SARS-CoV-2 infection, according to authors of an article in AACC's Journal of Applied Laboratory Medicine.

Read the Journal of Applied Laboratory Medicine Article External Link

A Laboratory Risk Assessment during the COVID-19 Pandemic

The authors of an article in AACC's Journal of Applied Laboratory Medicine explain how performing a risk assessment of the laboratory, with a focus on staff safety and prevention of exposure, is key for every clinical laboratory.

Read the Journal of Applied Laboratory Medicine Article External Link

Heat Inactivation in Laboratories Might Contribute to False Results for SARS-CoV-2 Tests

Research in AACC's Clinical Chemistry journal shows that certain clinical laboratory procedures may lead to false-negative results for PCR-based coronavirus tests.

Read the Clinical Chemistry Article External Link

What Diagnostic Tests Are Available to Help Combat COVID-19?

In this Scientific Short from the AACC Academy, Sheng Feng, PhD, and Ping Wang, PhD, DABCC, FAACC, briefly review the available molecular and serological assays for SARS-CoV-2.

View the Scientific Short Article External Link

The SARS-CoV-2 Outbreak: Diagnosis, Infection Prevention, and Public Perception

Experts across the globe from clinical laboratories, public health laboratories, infection control, and the diagnostic industry share their views on the diagnosis and control of SARS-CoV-2.

Read the Clinical Chemistry Q&A External Link

Emergence of Novel Coronavirus Disease and the Importance of Diagnostic Testing

Dr. Matthew Binnicker, a virology expert from the Mayo Clinic, discusses why partnership between clinical laboratories, public health agencies, and industry is essential to controlling this outbreak.

Read the Clinical Chemistry Opinion External Link

Two New Rapid Coronavirus Tests Could Play a Key Role in Efforts to Contain Growing Epidemic

Research in AACC’s Clinical Chemistry journal shows that two new tests accurately diagnose coronavirus infection in about 1 hour. These tests could play a critical role in halting this deadly outbreak by enabling healthcare workers to isolate and treat patients much faster than is currently possible.

Read the Clinical Chemistry Study External Link

Racing Towards the Development of 2019 Novel Coronavirus Diagnostics

The sensitive and specific detection of this virus is an important part of the global healthcare response to this outbreak.

Read the Clinical Chemistry Editorial External Link


COVID-19 Education

SARS CoV-2: Rising to the testing challenge in the United States

In this webinar, Dr. Steven Cagas and Dr. M. Laura Parnas explain the CoV family of viruses, the unique features of SARS-CoV-2 and COVID-19, the current outbreak epidemiology, as well as current biomarkers, serological assays, and potential therapies for COVID-19.

View the Webinar

The Role of Laboratory Diagnostics in SARS-CoV-2 Infection and Related Comorbidities: Experiences and Population Management Strategies from Highly Affected Regions of China and Italy

Professor Mario Plebani and Professor Shu Kui Wang give perspectives from Italy and China on how laboratory medicine can efficiently contribute patient care during the COVID-19 pandemic.

View the Webinar

Free Course on COVID-19 from AACC Learning Lab

AACC developed this content with leading scientists as part of AACC Learning Lab on NEJM Knowledge+. The free course covers COVID-19 transmission, complications, diagnosis, and more.

View the Course External Link

Pearls of Laboratory Medicine: Coronavirus Disease 2019 (COVID-2019)

In this video, Giuseppe Lippi of the University Hospital of Verona, Italy, provides an overview of Coronavirus Disease 2019 (COVID-19).

Watch the English Video External Link

Watch the Chinese Video External Link

Clinical Chemistry Podcast: Why Clinical Labs Are Essential to Containing COVID-19

Dr. Matthew Binnicker gives an update on the coronavirus outbreak and discusses what is needed to bring this global epidemic under control. This podcast is in English and Chinese.

Listen to the Podcast

Clinical Chemistry Podcast: Molecular Diagnosis of a Novel Coronavirus

Dr. Leo Poon of the University of Hong Kong gives expert insight into the 2019 novel coronavirus, and discusses the new molecular diagnostic assays his team has developed to detect and quantify this virus. This podcast is in English and Chinese.

Listen to the Podcast


Key Resources

Food and Drug Administration

Contact FDA: If you are trying to obtain an EUA for a COVID-19 test, send all comments and questions to CDRH-EUA-Templates@fda.hhs.gov.

You can also report issues with FDA-authorized COVID-19 tests or related materials by calling 1-888-INFO-FDA.

Other FDA resources:

Centers for Disease Control and Prevention

National Institutes of Health

In response to questions about turnaround time for laboratories to acquire positive control RNA, AACC has confirmed that the NIH Biodefense and Emerging Infections Research Resources Repository is prioritizing SARS-CoV-2 and anticipates a 12-72 hour turnaround.

Centers for Medicare and Medicaid Services




 

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