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Overview of Testing for SARS-CoV-2

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Note:  This document is intended to provide guidance on the appropriate use of testing and does not dictate the determination of payment decisions or insurance coverage of such testing, except as may be otherwise referenced (or prescribed) by another entity or federal or state agency.

Revisions were made on June 13, 2020, to reflect the following:

Changes noted were made in a retired document, “Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19),” which has been replaced by this Overview of Testing for SARS-CoV-2. See more changes.

This document provides a summary of considerations and current Centers for Disease Control and Prevention (CDC) recommendations regarding SARS-CoV-2 testing. The CDC recommendations for SARS-CoV-2 testing have been developed based on what is currently known about COVID-19 and are subject to change as additional information becomes available.

Recommendations for Viral Testing, Specimen Collection, and Reporting

Authorized assays for viral testing include those that detect SARS-CoV-2 nucleic acid or antigen. Viral (nucleic acid or antigen) tests check samples from the respiratory system (such as nasal swabs) and identify if an infection with SARS-CoV-2, the virus that causes COVID-19, is present. Viral tests are recommended to diagnose acute infection. Some tests are point-of-care tests, meaning results may be available at the testing site in less than an hour. Other tests must be sent to a laboratory to analyze, a process that may take 1-2 days once received by the lab. Testing the same individual more than once in a 24-hour period is not recommended.

For more information on diagnostic testing for COVID-19 see the Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens and Biosafety FAQs for handling and processing specimens from possible cases.

Recommendations for Antibody Testing

CDC does not currently recommend using antibody testing as the sole basis for diagnosis of acute infection, and antibody tests are not authorized by FDA for such diagnostic purposes. In certain situations, serologic assays may be used to support clinical assessment of persons who present late in their illnesses when used in conjunction with viral detection tests.  In addition, if a person is suspected to have post-infectious syndrome (e.g., Multisystem Inflammatory Syndrome in Children) caused by SARS-CoV-2 infection, serologic assays may be used.

Serologic assays for SARS-CoV-2, now broadly available, can play an important role in understanding the transmission dynamic of the virus in the general population and identifying groups at higher risk for infection. Unlike viral direct detection methods, such as nucleic acid amplification or antigen detection tests that can detect acutely infected persons, antibody tests help determine whether the individual being tested was previously infected—even if that person never showed symptoms.

It is currently not clear whether a positive serologic test indicates immunity against SARS-CoV-2; serologic tests should not be used at this time to determine if an individual is immune. As additional data are collected to understand the significance of the presence or level of antibodies and their correlation with immunity, serologic tests may have utility in infection control decisions, but for now this evidence is not available.

These tests can help determine the proportion of a population previously infected with SARS-CoV-2. Thus, demographic and geographic patterns of serologic test results can help determine which communities may have experienced a higher infection rate.

Categories for SARS-CoV-2 Testing

This document describes five categories of people for SARS-CoV-2 testing with viral tests (i.e., nucleic acid or antigen tests):

Generally, viral testing for SARS-CoV-2 is considered to be diagnostic when conducted among individuals with symptoms consistent with COVID-19 or among asymptomatic individuals with known or suspected recent exposure to SARS-CoV-2 to control transmission, or to determine resolution of infection. Testing is considered to be surveillance when conducted among asymptomatic individuals without known or suspected exposure to SARS-CoV-2 for early identification, or to detect transmission hot spots or characterize disease trends.

Recommended testing for individuals with signs or symptoms consistent with COVID-19

CDC recommends using authorized nucleic acid or antigen detection assaysexternal icon that have received an FDA EUA to test persons with symptoms when there is a concern of potential COVID-19. Tests should be used in accordance with the authorized labeling; providers should be familiar with the tests’ performance characteristics and limitations.

Clinicians should use their judgment to determine if a patient has signs or symptoms compatible with COVID-19 and whether the patient should be tested. Most patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough) but some infected patients may present with other symptoms as well. Clinicians are encouraged to consider testing for other causes of respiratory illness, for example influenza, in addition to testing for SARS-CoV-2 depending on patient age, season, or clinical setting; detection of one respiratory pathogen (e.g., influenza) does not exclude the potential for co-infection with SARS-CoV-2. Because symptoms and presentations may be different in children, consider referencing the CDC guidelines for COVID in neonates and for multisystem inflammatory syndrome in children (MIS-C).

The severity of symptomatic illness due to infection with SARS-CoV-2 may vary. Among persons with extensive and close contact to vulnerable populations (e.g., healthcare personnel [HCP]), even mild signs and symptoms (e.g., sore throat) of possible COVID-19 should prompt consideration for testing. Additional information is available in CDC’s Interim U.S. Guidance for Risk Assessment and Public Health Management of Healthcare Personnel with Potential Exposure in a Healthcare Setting to Patients with Coronavirus Disease 2019 (COVID-19).

Recommended testing for asymptomatic individuals with known or suspected exposure to SARS-CoV-2 to control transmission

Testing is recommended for all close contactspdf icon of persons with SARS-CoV-2 infection, especially initial testing during an outbreak or pandemic due to the high likelihood of exposure. Because of the potential for asymptomatic and pre-symptomatic transmission, it is important that contacts of individuals with SARS-CoV-2 infection be quickly identified and tested.

In some settings, broader testing, beyond close contacts, is recommended as a part of a strategy to control transmission of SARS-CoV-2.  This includes high-risk settings that have potential for rapid and widespread dissemination of SARS-CoV-2 (e.g., meat processing plant) or in which populations at risk for severe disease (e.g., long-term care facilities, including nursing homes, intermediate care facilities for individuals with intellectual disabilities, and psychiatric residential treatment facilities) could become exposed.  Expanded testing might include testing of all contacts in proximity to someone with SARS-CoV-2 infection, or even testing all individuals within a shared setting (e.g., facility-wide testing). Currently CDC recommends expanded contact testing in the following guidance documents:

Recommended testing for asymptomatic individuals without known or suspected SARS-CoV-2 exposure for early identification in special settings

Certain settings can experience rapid spread of SARS-CoV-2, resulting in substantial adverse effects. This is particularly true for settings that house vulnerable populations in close quarters for extended periods of time (e.g., long-term care facilities, correctional and detention facilities) and/or settings where critical infrastructure workers (e.g., healthcare personnel, first responders) may be disproportionately affected.

A strategy aimed at reducing introduction of SARS-CoV-2 into the setting through early identification could reduce the risk of widespread transmission in these situations.

Facilities are encouraged to work with local, territorial, and state health departments to help inform decision-making about broad-based testing. Before testing large numbers of asymptomatic individuals without known or suspected exposure, the facility should have a plan in place for how it will modify operations based on test results.

Approaches for early identification of asymptomatic individuals include:

  • Initial testing of everyone residing and/or working in the setting,
  • Regular (e.g., weekly) testing of everyone residing and/or working in the setting, and
  • Testing of new entrants into the setting and/or those re-entering after a prolonged absence (e.g., one or more days)

Settings for which these approaches could be considered include:

  • Long-term care facilities
  • Correctional and detention facilities
  • Homeless shelters
  • Other congregate work or living settings including mass care, temporary shelters, assisted living facilities, and group homes for individuals with intellectual disabilities and developmental disabilities
  • High-density critical infrastructure workplaces where continuity of operations is a high priority

CDC guidance currently addressing such testing includes:

  • Pre-admission or pre-procedure testing as part of the evaluation of patients could be considered to inform decisions about deferring elective care (e.g., certain dental procedures) or procedures and the use of personal protective equipment.
  • Testing guidance for nursing homes

Recommended testing to determine resolution of infection with SARS-CoV-2

A test-based strategy, which requires serial tests, can be used as an alternative to a symptom-based or time-based strategy, to determine when a person with SARS-CoV-2 infection no longer requires isolation or work exclusion.  This strategy could be considered in three situations:

Public health surveillance for SARS-CoV-2

Testing is a fundamental part of the United States SARS-CoV-2 Surveillance Plan, which uses multiple surveillance systems and epidemiology networks, in collaboration with state, local, and academic partners, to monitor the progression and impact of SARS-CoV-2 spread in the United States.

Viral tests are used in community, outpatient, and hospital-based surveillance systems to identify cases of SARS-CoV-2 infection. These data help identify areas of ongoing circulation (hot spots), determine trends in disease by location, provide insight into the impact of the disease over time and by location, and inform disease forecasts.

Antibody tests are increasingly used to monitor disease burden by location and over time. Use of serologic assays in populations can help determine the proportion of a population previously infected with SARS-CoV-2. Thus, demographic and geographic patterns of serologic test results provide data that can be used in forecasts of disease spread that can support resource allocation decisions and planning by local, territorial and state officials.

Additional Resources:

Summary of Changes to Retired Document, “Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19)”

Revisions were made on May 3, 2020 to reflect the following:

  • Updated recommendations for testing, specimen collection, and reporting patients and reporting positive test results
  • Specification of testing priorities

Revisions were made on April 27, 2020 to reflect the following:

  • Updated priorities for testing patients with suspected COVID-19 infection

Revisions were made on March 24, 2020 to reflect the following:

  • Updated priorities for testing patients with suspected COVID-19 infection

Revisions were made on March 9, 2020, to reflect the following:

  • Reorganized the Criteria to Guide Evaluation and Laboratory Testing for COVID-19 section

Revisions were made on March 4, 2020, to reflect the following:

  • Criteria for evaluation of persons for testing for COVID-19 were expanded to include a wider group of symptomatic patients.

Source: https://tools.cdc.gov/api/embed/downloader/download.asp?m=404952&c=408011

Covid19

Trump Announces Partnership With CVS, Walgreens For Nursing Home COVID Vaccination

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President Trump announced a partnership with two national pharmacy chains to administer coronavirus vaccines to nursing homes at an event in Fort Myers, Fla. Brendan Smialowski/AFP via Getty Images hide caption

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Brendan Smialowski/AFP via Getty Images

The Trump administration announced a new partnership with two major national pharmacy chains to facilitate the distribution of a future coronavirus vaccine to nursing homes on Friday.

“Today, I’m thrilled to announce that we have just finalized a partnership with CVS and Walgreens,” President Trump told a group in Fort Myers, Fla., at an event centered on seniors. He said the plan was for the pharmacies to “deliver the vaccine directly to nursing homes at no cost to our seniors.”

The Pharmacy Partnership for Long Term Care Program is part of the Trump administration’s Operation Warp Speed effort. No coronavirus vaccines have yet been authorized by the government, though several vaccine candidates are in the final stages of clinical trials.

“Early in the COVID-19 vaccination program, there may be a limited supply of vaccine and our planning efforts need to focus on those at highest risk for developing severe illness from COVID-19,” Dr. Jay Butler, deputy director for infectious diseases at the Centers for Disease Control and Prevention told reporters on a press call.

That includes people older than 65, who are much more likely to get severely ill and die from the coronavirus than other age groups. The details of which would be the first groups to get a vaccine once one is authorized is still in flux, but seniors would likely be among the first to be eligible.

The pharmacy program “provides end-to-end management of the COVID-19 vaccination process,” Butler explained. That includes scheduling on site clinic dates with each facility, ordering supplies like syringes, and ensuring cold-chain management of the vaccine. Once the vaccine is on site, pharmacy staff will administer it to residents and staff and report it to the required public health department.

The program will be free for facilities, but optional. “This is voluntary. They have to opt-in,” Paul Mango, deputy chief of staff for policy at the Department of Health and Human Services told reporters. “This will be something that will be available to every nursing home and senior living facility in the country.”

“This is really significant,” Claire Hannan, Executive Director of the Association of Immunization Managers wrote to NPR. “We’ve never really had coordinated partnership between pharmacies and public health across all states.”

Friday was the deadline for states to deliver a vaccine distribution plan to CDC, which will be evaluating the plans and providing feedback over the next two weeks, according to federal health officials.

One of the leading vaccine candidates, made by Pfizer, requires ultra-cold storage, which “could pose a major challenge to getting nursing home and long term care residents vaccinated,” explains Hannan, “so the value of this partnership can’t be understated.”

That aspect of the program stood out to Stacie Dusetzina, professor of health policy at Vanderbilt as well.

“Cold storage and the cold chain management has been a huge sticking point — how do you get [vaccine] to everyone who needs it and maintain these super cold temperatures?” she says. If CVS and Walgreens are going to be managing that challenge, she says, “that seems like a really big, positive thing.”

A federal government partnership early in the pandemic with retail pharmacies to provide COVID-19 testing ended up yielding much less testing than promised.

Source: https://www.npr.org/sections/coronavirus-live-updates/2020/10/16/924662542/trump-announces-partnership-with-cvs-walgreens-for-nursing-home-covid-vaccinatio?utm_medium=RSS&utm_campaign=coronavirusliveupdates

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$3.1 Trillion: Pandemic Spending Drives The Federal Budget Deficit To A Record

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The government shortfall for the fiscal year that just ended is far greater than was seen during the height of the Great Recession. The national debt now exceeds the size of the U.S. economy. Patrick Semansky/AP hide caption

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Patrick Semansky/AP

Updated at 3:16 p.m. ET

The U.S. budget deficit soared to a record $3.1 trillion, following a massive surge in government spending aimed at containing the economic damage from the coronavirus pandemic.

The deficit for the fiscal year that ended Sept. 30 was more than triple that of fiscal 2019 and easily eclipsed the previous record of $1.4 trillion recorded in 2009.

The Treasury Department said the surge was partly due to a drop in corporate and personal tax revenue, which fell by 1%.

But the overwhelming factor driving the deficit higher was a huge increase in federal spending to prop up businesses and keep people employed after the economy nearly ground to a halt in March.

“The increase in the deficit from FY 2019 reflects the effect of COVID-19 on the economy and legislation that created or enhanced programs to protect public health and support hard-hit industries, small businesses, and American individuals and families,” the Treasury statement said.

The higher deficit comes just as Congress and the White House are negotiating a new coronavirus relief package.

While lawmakers and the administration agree on the need for a bill, they remain far apart on the size. While Democrats have pushed for more than $2 trillion in aid, Senate Majority Leader Mitch McConnell has called that “outlandish.”

The federal debt — the total owed by the government — has grown to more than $21 trillion, larger than the size of the U.S. economy.

“This astronomical level of debt is only going to get bigger,” says Maya MacGuineas, president of the Committee for a Responsible Federal Budget.

“Borrowing to combat the pandemic and economic crisis makes sense. But that’s no excuse for the massive tax cuts and spending increases enacted before the pandemic, nor the failure to control the rising costs of our health and retirement programs once normalcy returns,” she added.

Source: https://www.npr.org/sections/coronavirus-live-updates/2020/10/16/924582156/-3-1-trillion-pandemic-spending-drives-the-federal-budget-deficit-to-a-record?utm_medium=RSS&utm_campaign=coronavirusliveupdates

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Israel To Relax Its 2nd Nationwide Coronavirus Lockdown On Sunday

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Ultra-Orthodox Jews watch a funeral for Rabbi Mordechai Leifer from their balconies in the port city of Ashdod, Israel, on Oct. 5. The rabbi, who had been the spiritual leader of a small ultra-Orthodox community founded a century ago in Pittsburgh, died after being infected with COVID-19. Tsafrir Abayov/AP hide caption

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Tsafrir Abayov/AP

Israel, which imposed the world’s strictest second nationwide lockdown, will be loosening some restrictions this weekend.

After a four-week lockdown, including a ban on movement beyond one-third of a mile from home, the country has dramatically brought down its number of infections.

On Sept. 30, Israel’s health ministry reported there were 9,013 new cases, among the world’s highest per capita daily infection rates. On Thursday, there were 1,608 new cases.

Israel’s cabinet voted Friday to partially relax the country’s lockdown beginning Sunday. Earlier this week, the country lifted a ban on travel abroad and a ban on Israelis protesting in groups larger than 20. Critics accused Prime Minister Benjamin Netanyahu of seeking to quash months of protests outside his residence. Demonstrators were calling for his resignation due to a corruption indictment.

Israeli police scuffle with protesters during a demonstration against Prime Minister Benjamin Netanyahu in Tel Aviv on Oct. 6. Protests continued despite a government ban on large public gatherings, including protests against Netanyahu. The sign reads: “Bibi you failed the wrong generation.” Ariel Schalit/AP hide caption

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Ariel Schalit/AP

The ban limiting public protests achieved the opposite result, spurring thousands to protest against Netanyahu and the protest ban, as demonstrations spread across the country.

Jerusalem’s three main holy sites — the Al-Aqsa Mosque compound, the Western Wall and the Church of the Holy Sepulcher — will reopen to the general public with distancing measures, the prime minster’s office said in a statement.

People will be allowed to move without restriction and visit each other’s homes, capping gatherings at 10 people indoors and 20 outdoors. Israel will also reopen beaches and national parks.

Shops can operate without in-store customers. Restaurants will not be able to offer dining inside, but can sell takeout meals. Public transportation will operate at 50% capacity.

Most schools will remain closed, but preschools and kindergartens will reopen for children up to age 6. A group of Hebrew University scientists concluded that children up to age 10 are less likely to spread the virus.

But Israel’s teachers union opposes the reopening, saying authorities have not offered assurances it will be done safely or provided support for preschool and kindergarten teachers who are at home with their own elementary school-age children.

“We believe it is a mistake and that lessons were not learned from the hasty exit of the first lockdown,” when infections spiked among schoolchildren, the union said in a statement.

In a public Facebook post, Israel’s ultra-Orthodox interior minister Aryeh Deri protested Friday against restrictions on large weddings, an important element of ultra-Orthodox Jewish life.

Several cities with mostly ultra-Orthodox populations will remain under restrictions as they continue to suffer high infection rates. Some Orthodox communities flouted the lockdown and held large Jewish holiday gatherings, driving up Israel’s virus rate.

Source: https://www.npr.org/sections/coronavirus-live-updates/2020/10/16/924436599/israel-to-relax-its-second-nationwide-coronavirus-lockdown-on-sunday?utm_medium=RSS&utm_campaign=coronavirusliveupdates

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