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SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an acute respiratory virus. This virus causes a respiratory disease called COVID-19 and was the genesis of a global pandemic that lasted from March 11, 2020, to mid-2022.
COVID-19 typically produces minor symptoms in most people, particularly people who have received a vaccination or are in good health. In a small percentage of individuals, however, COVID-19 causes severe symptoms that include respiratory failure, sepsis, and multiple organ dysfunction syndrome, making it potentially deadly. SARS-CoV-2 infection does not always cause COVID-19 and is asymptomatic in some individuals.
SARS-CoV-2 spreads from person to person through droplets released when an infected person coughs, sneezes, or talks. It may also be spread by touching a surface with the virus on it and then touching one’s mouth, nose, or eyes, although this method of transmission is rarer. During the COVID-19 pandemic, attempts to slow or stop the spread of SARS-CoV-2 resulted in lockdowns, masking, social distancing, and several other infection prevention measures.
Clinical discussions aside, the emergence of SARS-CoV-2 introduced sweeping social and business changes in the U.S. and elsewhere:
- Many students in the U.S. attended school remotely from home for months or longer during the height of the pandemic.
- City and state governments temporarily banned large-scale, in-person events.
- Business and leisure travel ground to a near halt for a time.
- A historically significant unemployment spike in occurred in 2020.
- The “Great Resignation” saw many workers leave their jobs to retire early or seek more rewarding occupations.
The origins of SARS-CoV-2 continues to be debated. One theory holds that the virus originated from a biological laboratory in Wuhan, China. There is evidence that NIH-funded, gain-of-function research was being performed on coronaviruses in this laboratory, and some evidence suggests that a laboratory accident may have released SARS-CoV-2 into the public. The other major theory holds that SARS-CoV-2 jumped to humans from an infected animal sold at a wet market in Wuhan, China.
Since its original entry into human circulation, SARS-CoV-2 has undergone several mutations. This led to multiple variants of SARS-CoV-2 that were prevalent at different points in the COVID-19 pandemic. The main SARS-CoV-2 variants include:
- Alpha (B.1.1.7), which appeared in November 2020 and was eventually displaced by the Delta variant.
- Beta (B.1.351), which was identified in late 2020 in South Africa. Beta spread to many countries but was never common in the U.S.
- Delta (B.1.617.2), which emerged in late 2020 and became the dominant strain worldwide until displaced by the Omicron variant.
- Omicron (BA.1), which was first identified in November 2021 and, as of August 2022, is the dominant strain of SARS-CoV-2.
While technically SARS-CoV-2 refers to a virus and COVID-19 refers to the disease the virus causes, these terms have become interchangeable. This has led to terms like “asymptomatic COVID-19” and “COVID-19 testing” gaining widespread use despite being technically incorrect.
The COVID-19 pandemic had a profound impact on clinical laboratories, generating a huge demand for SARS-CoV-2 testing throughout the world.
SARS-CoV-2 testing primarily includes:
- Molecular testing, which detects the presence of the genetic material of SARS-CoV-2. Polymerase chain reaction (PCR) tests are an example of molecular diagnostics.
- Antigen testing, which looks for components of SARS-CoV-2 that elicit an immune response. Antigen tests became popular at-home testing options during the pandemic.
The increased demand for SARS-CoV-2 testing led to many new clinical laboratories coming into operations, many of which focused exclusively on such testing. As the demand for SARS-CoV-2 testing declines, these labs are having to pivot to new business models or close their doors.
February 13, 2023, Intelligence: Late-Breaking Lab News
By Scott Wallask | From the Volume XXX No. 3 – February 13, 2023 Issue
Laboratory leaders should prepare now for the end of the federal public health emergency (PHE) for SARS-CoV-2. The White House announced the PHE would cease on May 11. One big change is that patients covered by Medicare, Medicaid, or private insurance may pay higher costs for COVID-19 t…
CAP, Joint Commission Under Pressure to Add More Inspectors
By Scott Wallask | From the Volume XXX No. 3 – February 13, 2023 Issue
CEO SUMMARY: Like the clinical laboratories they accredit to the requirements of CLIA, The Joint Commission and College of American Pathologist (CAP) face recruitment and hiring pressures when it comes to their surveyors and inspectors. Labs involved with CAP’s peer inspections ma…
Fujifilm Buys Inspirata’s Digital Pathology Assets
By Robert Michel | From the Volume XXX No. 3 – February 13, 2023 Issue
CEO SUMMARY: Fujifilm’s acquisition of the digital pathology technologies and clients of Inspirata marks the departure of one early entrant into the digital pathology market. At the same time, executives from Fujifilm Healthcare Americas Corporation discuss why the company is incr…
CLIA on Path to Recognize Lab Data As a Specimen
By Scott Wallask | From the Volume XXX No. 2 – January 23, 2023 Issue
CEO SUMMARY: Discussions within the federal Clinical Laboratory Improvement Advisory Committee (CLIAC) are focusing on digital diagnostic data and clinical laboratory testing conducted remotely. CLIAC recommendations about these important topics may eventually be part of updates to …
Eight Macro Trends for Clinical Labs in 2023
By Robert Michel | From the Volume XXX, No. 1 – January 3, 2023 Issue
CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…
Two Positive Messages to Focus on at Year’s End
By R. Lewis Dark | From the Volume XXIX, No. 17 – December 12, 2022 Issue
Clinical laboratory managers and anatomic pathologists are winding down another tumultuous year for the healthcare industry. It was a year marked by unexpected twists and turns. It was also a year marked by two positive developments for labs. First, the…
2022’s Top 10 Lab Stories Confirm Challenging Times
By Scott Wallask | From the Volume XXIX, No. 17 – December 12, 2022 Issue
CEO SUMMARY: There are valuable insights to be gleaned from The Dark Report’s “Top 10 Lab Industry Stories for 2022.” Several of this year’s story picks involve external forces reshaping healthcare in the United States in profound ways. Other story picks for 2022 illustrate …
October 31, 2022, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 15 – October 31, 2022 Issue
Clinical laboratories may soon face increasing pressure to test for respiratory syncytial virus (RSV) now that the public has become aware of the pathogen. Over the past month, there has been an onslaught of media attention on RSV. The coverage has often focused on how this common virus could tag…
How Genomic Testing Labs Can Improve Their Relationships with Payers
By Robert Michel | From the Volume XXIX, No. 14 – October 10, 2022 Issue
CEO SUMMARY: For payers and health plans, it may be a matter of trust that initially curtails speedy reimbursement of new and novel genomic test claims. A panel …
Thermo Fisher Expands Menu to Offset COVID-19 Decreases
By Scott Wallask | From the Volume XXIX, No. 14 – October 10, 2022 Issue
IT’S NOT JUST CLINICAL LABORATORIES seeking ways to repurpose the analyzers and automation they used to perform SARS-CoV-2 testing. As the pandemic continues to ease, some in vitro diagnostics (IVD) companies want to help their lab customers by expanding the types of diagnostic tests than can …
CURRENT ISSUE
Volume XXXI, No. 14 – October 14, 2024
For the second time in the past 16 months, respected health systems have taken steps to collaborate specifically to advance value-based care. Also, several statewide pilot programs—each involving tens of thousands of newborns—are publishing studies that demonstrate how exome, whole genome sequencing, and rapid whole genome sequencing can deliver both improved patient outcomes and a return on investment.
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