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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.
PerkinElmer Says California Terminated COVID-19 Contract
By Robert Michel | From the Volume XXIX, No. 5 – April 4, 2022 Issue
ACCORDING TO A NEW SECURITIES FILING FROM PERKINELMER, the State of California served notice of termination of the company’s contract to run the beleaguered Valencia Branch Laboratory (VBL). PerkinElmer, a diagnostics firm based in Waltham, Mass., made the surprising announcement a…
Federal Healthcare Fraud Enforcement Turns to Emerging Areas
By Robert Michel | From the Volume XXIX, No. 5 – April 4, 2022 Issue
CEO SUMMARY: Healthcare compliance attorneys say the Department of Justice (DOJ) is turning its focus to fraudulent activity related to COVID-19 testing. But that’s not the only area attracting greater scrutiny by the DOJ. Fraud stemming from opioid treatment has snared clinical l…
New Trends Reshaping Healthcare, Lab Testing
By Robert Michel | From the Volume XXIX, No. 4 – March 14, 2022 Issue
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March 14, 2022 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 4 – March 14, 2022 Issue
Telehealth proved to be popular with Medicare patients during the SARS-CoV-2 pandemic. The federal U.S. Department of Health and Human Services (HHS) reported telehealth visits for Medicare beneficiaries increased in 2020 by an incredible 63 times—from approximately 840,000 in 2019 to 52.7 m…
Quest and Walmart to Expand Consumer-Initiated Test Options
By Robert Michel | From the Volume XXIX, No. 3 – February 22, 2022 Issue
SERVING CONSUMERS INTERESTED IN ORDERING THEIR OWN CLINICAL LABORATORY TESTS is a goal in an expanded collaboration involving Quest Diagnostics and Walmart. This is also consistent with The Dark Report’s prediction that retail pharmacies are poised to expand the diagnostic testing ser…
Non-COVID Part B Lab Spend Declined by 15.9% in 2020
By Robert Michel | From the Volume XXIX, No. 2 – January 31, 2022 Issue
MEDICARE PART B CLINICAL LABORATORY FEE SCHEDULE CUTS mandated by PAMA continue to bite deeply. A new government report shows that during fiscal 2020, the Medicare program spent 15.9% less for lab tests, when COVID-19 test payments are excluded. The fed…
January 31, 2022 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 2 – January 31, 2022 Issue
DNA-based breast cancer testing is taking a step forward. Illumina in San Diego, which sells next-generation sequencing (NGS) technology, announced a partnership with Agendia in Irvine, Calif., to develop in vitro diagnostic tests for oncology. Agendia offers proprietary breast …
January 10, 2022 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 1 – January 10, 2022 Issue
Imagine a medical lab temporarily closing because of the demand for too many tests! That’s just what happened at one of Australia’s largest medical lab companies. Australian Clinical Labs had to temporarily discontinue offering COVID-19 testing because test volumes had gotten too large. Au…
2021’s Top 10 Lab Stories Highlight Important Trends
By Robert Michel | From the Volume XXVIII, No. 17 – December 20, 2021 Issue
This is an excerpt of a 3,075-word article in the December 20, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Much like 2020, the pandemic dominated our new list of the top 10 lab stories for 2021. Beyond…
Congress Votes: No PAMA Price Cuts for 2022
By R. Lewis Dark | From the Volume XXVIII, No. 17 – December 20, 2021 Issue
IT’S WELCOME NEWS THAT CONGRESS VOTED EARLIER THIS MONTH to defer the PAMA price cuts to the Clinical Laboratory Fee Schedule (CLFS) that were scheduled to take place in 2022. This is a positive development for the finances of the nation’s clinical labs, particularly the smaller, independent labs t…
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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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