TAG:
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.
Executive War College to Show New Opportunities for Labs
By Robert Michel | From the Volume XXVIII, No. 13 – September 27, 2021 Issue
CEO SUMMARY: Yes, the pandemic continues and hospitals are running short of beds in many communities. At the same time, 225 million Americans are either vaccinated or have some immunity to COVID-19. Based on the early registrations to attend the 27th annual Executive War College, it…
New Class of IVD Firms Wants to Serve POCT in Near-Patient Settings
By Robert Michel | From the Volume XXVIII, No. 13 – September 27, 2021 Issue
CEO SUMMARY: Our second installment in this series describes an emerging new clas…
2020 Rankings of the World’s Largest IVD Corporations
By Robert Michel | From the Volume XXVIII, No. 12 – September 7, 2021 Issue
IN VITRO DIAGNOSTICS (IVD) MANUFACTURING continues to be dominated by a handful of companies, all of which sell their products worldwide. As the rankings below demonstrate, for 2020, just 11 companies accounted for 82.7% of international IVD sales. The …
September 7, 2021 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXVIII, No. 12 – September 7, 2021 Issue
New diagnoses of cancer in the United States fell by almost 30% in the early months of the SARS-CoV-2 pandemic. That’s one conclusion in a paper authored by Quest Diagnostics and published on Aug. 31, in JAMA Network Open. Quest looked at the new diagnoses of eight common types of can…
Insurers Get Aggressive with Years-Old Audits, Searching for Lab Overpayments
By Robert Michel | From the Volume XXVIII, No. 11 – August 16, 2021 Issue
This is an excerpt of a 1,971-word article in the July 26, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Not only are health insurers looking back to find lab overpayments and funds paid erroneously, but…
Insurers Get Aggressive with Years-Old Audits
By Robert Michel | From the Volume XXVIII, No. 11 – August 16, 2021 Issue
CEO SUMMARY: Not only are health insurers looking back to find overpayments and funds paid erroneously, but payers also are requiring documentation for overpayments. If clinical labs and anatomic pathology groups do not appeal such claims quickly, they may be liable for any amount i…
Genesis Lab Lawsuit Pursues UnitedHealth Over Unpaid Test Claims
By Robert Michel | From the Volume XXVIII, No. 9 – July 6, 2021 Issue
This is an excerpt of a 1,946-word article in the July 6, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: New case law in how health insurers should reimburse for COVID-19 lab test claims might be one outc…
NJ Lab Sues UnitedHealth Over Unpaid Test Claims
By Robert Michel | From the Volume XXVIII, No. 9 – July 6, 2021 Issue
CEO SUMMARY: New case law in how health insurers should reimburse for COVID-19 lab test claims might be one outcome if a New Jersey lab company were to prevail in a federal lawsuit it filed against UnitedHealthcare alleging non-payment of COVID-19 test claims. An interesting fact me…
Amazon Now Interested in Home Testing Services
By Robert Michel | From the Volume XXVIII, No. 9 – July 6, 2021 Issue
CEO SUMMARY: In the past year, internet retailing giant Amazon has built sizeable clinical laboratories in the United States and the United Kingdom. Now it has regulatory clearance to sell a molecular COVID-19 test to consumers for home collection. Comments made in the past month by…
July 6, 2021 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXVIII, No. 9 – July 6, 2021 Issue
Did the SARS-CoV-2 virus infect people in the United States earlier than the first case diagnosed on Jan. 19, 2020? A newly-published study in Clinical Infectious Diseases, says there is evidence of COVID-19 infections in December 2019. The research team included scientists from the Nationa…
CURRENT ISSUE

Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.
Topics
- Anatomic Pathology
- Clinical Chemistry
- Clinical Laboratory
- Clinical Laboratory Trends
- Digital Pathology
- Genetic Testing
- In Vitro Diagnostics
- IVD/Lab Informatics
- Lab Intelligence
- Lab Marketplace
- Lab Risk & Compliance
- Laboratory Automation
- Laboratory Billing
- Laboratory Compliance
- Laboratory Equipment
- Laboratory Information Systems
- Laboratory Management
- Lean Six Sigma
- Managed Care Contracts
- Molecular Diagnostics
- Pathology Trends
- People
- Uncategorized