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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.
2021’s Top 10 Lab Stories Confirm Important Trends
CEO SUMMARY: Much like 2020, the pandemic dominated our new list of the top 10 lab industry stories for 2021. Beyond COVID-19 testing, the virus crept its way into long-term trends, such as pathology jobs and technology innovation. New ways of delivering healthcare will need respons…
IVD Companies Report Record Sales as 2021 Draws to Close
JUDGING BY THE THIRD QUARTER FINANCIAL PERFORMANCE of the major in vitro diagnostics (IVD) manufacturers, the demand for COVID-19 testing continues to generate a substantial stream of revenue. During their respective conference calls with investo…
Congress May Soon Act on LDT, IVCT Regulation
CEO SUMMARY: Congress is gearing up for a debate on how to regulate laboratory-developed tests (LDTs) and other in vitro clinical tests (IVCTs). The VALID Act sets the stage for the FDA to take a greater role in pre-market review of LDTs, and the VITAL Act proposes to keep those tes…
Congress May Soon Act on IVCT, LDT Regulation
This is an excerpt of a 2,017-word article in the November 29, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Congress is gearing up for a debate on …
It’s Flu Season and COVID-19 Cases Continue
SUBSTANTIAL NUMBERS OF NEW COVID-19 CASES CONTINUE to be reported weekly. No one yet understands whether SARS-CoV-2 may disappear at some future date (as did the 1918 influenza pandemic and SARS outbreak in 2003) or whether SARS-CoV-2 will become endemic and stay with us for years….
New Lab, Pathology Trends at Executive War College 2021
CEO SUMMARY: Hundreds of lab leaders traveled to San Antonio last week for the 27th annual Executive War College on Laboratory and Pathology Management. After almost two years of virtual conference and meetings using Zoom, attendees were ready to gather for a live event, complete with speakers,…
Post-COVID: Repurposing Excess PCR Instruments
CEO SUMMARY: Currently, there are hospital, health system, and independent clinical laboratories that have between two and five different PCR testing platforms. These analyzers were acquired during the pandemic as one way to increase the daily number of SARS-CoV-2 their labs could p…
November 8, 2021 Intelligence: Late-Breaking Lab News
Last week, the state of California auto-renewed its controversial COVID-19 testing contract with PerkinElmer to run the Valencia Branch Laboratory. Designed, built, and operated by PerkinElmer, the lab began SARS-CoV-2 testing in the fall of 2020 and immediately was in the news for a range of …
SUNY Hospital Uses Drones to Move COVID Test Kits
CEO SUMMARY: One healthcare trend accelerated by the SARS-CoV-2 pandemic is the use of drones to move COVID-19 test kits, specimens, and medical supplies. Earlier this year, the SUNY Upstate Medical University Hospital in Syracuse tested the reliability of drones to move unused COVI…
October 18, 2021 Intelligence: Late-Breaking Lab News
One interesting development from the SARS-CoV-2 outbreak is a new ability to collect genetic data on the virus and its variants from a growing number of countries across the globe. The World reported that “In March, the one millionth genomic sequence for the new coronavirus came from Chile; …
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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.
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