mteb/FeedbackQARetrieval huggingface dataset:
Frequently Asked Questions about Laboratory Testing and COVID-19
For Public Health Laboratories: Ordering Supplies
What Is CDC's International Reagent Resource (IRR)?
The International Reagent Resourceexternal
icon (IRR) was established by
CDC more than 10 years ago. It provides registered users with reagents, tools,
and information for studying and detecting influenza virus and other
pathogens, including SARS-CoV-2. IRR is primarily a resource used for
procuring pathogen test components and assembling, qualifying, and
distributing these kits for use in CDC-directed public health activities. This
resource supports detection and characterization of pathogens, which will aid
in informing interventions. By centralizing these functions within IRR, access
to and use of these materials in the scientific and public health community is
monitored and quality control of the reagents is assured.
To support health departments during the COVID-19 pandemic, IRR has expanded
to provide more products needed for viral testing, including numerous
commercially produced Emergency Use Authorization (EUA) assays. IRR is managed
under a CDC contract by American Type Culture Collection (ATCC).
Frequently Asked Questions about Laboratory Testing and COVID-19
For Clinical Laboratories: Ordering Supplies
Can I register my lab or hospital with IRR?
CDC limits IRR registration and SARS-CoV-2 diagnostic reagent distribution to
U.S. state and local public health laboratories validated to perform SARS-
CoV-2 viral testing. During the SARS-CoV-2 pandemic, CDC will defer the
decision to authorize new laboratories to the corresponding state public
health laboratory.
Frequently Asked Questions about Laboratory Testing and COVID-19
For All Laboratories: Accessing Laboratory Testing
How do clinicians get access to SARS-CoV-2 viral testing?

Clinicians can access laboratory tests for SARS-CoV-2, the virus that causes COVID-19, through clinical laboratories performing tests authorized or intended to be authorized by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA). Clinicians should consult with the laboratories that routinely perform their diagnostic services to see how best to access SARS-CoV-2 testing.
Clinicians also can access viral testing through their state public health departments. The Association of Public Health Laboratories (APHL)external icon provides a list of available public health laboratory testing locations.
For a list of COVID-19 EUAs, see FDA’s COVID-19 Emergency Use Authorizations for Medical Devicesexternal icon.
Frequently Asked Questions about Laboratory Testing and COVID-19
For All Laboratories: Accessing Laboratory Testing
When FDA authorizes emergency use for a SARS-CoV-2 point-of-care test, can that test be used in CLIA certificate-of-waiver facilities?
When the FDA grants an EUA for a point-of-care test, that test is deemed to be
CLIA-waived. For the duration of the national emergency declaration for
COVID-19, such tests can be performed in any CLIA-certified patient care
setting with a certificate of waiver.
Frequently Asked Questions about Laboratory Testing and COVID-19
For All Laboratories: Accessing Laboratory Testing
Can a pooling strategy be used to expand nucleic acid testing for SARS-CoV-2?
In areas with low COVID-19 prevalence, a two-stage specimen pooling approach
can help preserve testing reagents and resources. In the first stage, several
patients’ specimens are combined before extraction, and then tested all at
once. If the test comes back negative, then all of those patients can be
cleared with one test. If the test comes back positive, then all of those
specimens need to be extracted and re-tested individually.
The lower the prevalence of the disease, the larger the optimal pool size can
be. A recent studyexternal
icon from the
Nebraska Public Health Laboratory found that polymerase chain reaction (PCR)
tests for SARS-CoV-2 reliably return a positive result when one positive
sample is mixed with four negatives. Researchers in Germany and Israel have
had similar results.
A pooling strategy is not efficient when the prevalence of COVID-19 is
high. People with symptoms and people who have been exposed to someone with a
confirmed SARS-CoV-2 infection should still be tested individually.
Before using a pooling strategy, the laboratory must have the proper
regulatory approvals. If the manufacturer’s guidelines and the emergency use
authorization (EUA) for that SARS-CoV-2 test do not stipulate pooling,
laboratories that use authorized nucleic acid devices can still bridge to
alternative components, including extraction methods, PCR instruments,
software versions, etc., under Section IV. A. 4. of FDA’s Policy for COVID-19
Tests During the Public Health Emergencyexternal
icon. These component changes can be achieved through evaluation
and verification of the performance of the component with the test, without a
new EUA or an amendment to the original EUA. Additional detail and suggested
studies are discussed in FDA’s policy. The process used for such changes must
also comply with Clinical Laboratory Improvement Amendments
(CLIA) guidelines.
Frequently Asked Questions about Laboratory Testing and COVID-19
For All Laboratories: Accessing Laboratory Testing
What is the CLIA test complexity categorization of SARS-CoV-2 tests that do not have an EUA?
Tests for SARS-CoV-2 that are offered prior to or without an EUA have not been
reviewed by FDA, are not FDA-authorized, and have not received a CLIA
categorizationexternal icon. Thus, those tests are
considered high complexity by default until they receive an EUA or other FDA
review that indicates they may be performed as moderate complexity or waived
tests. For more information, visit FDA COVID-19 Resourcesexternal
icon, and navigate to the section titled “General
FAQs.”
Frequently Asked Questions about Laboratory Testing and COVID-19
For All Laboratories: Accessing Laboratory Testing
Under what circumstances should laboratories use either a SARS-CoV-2 viral or serology (antibody) test that has received EUA from FDA?
FDA has authorized EUAs for both viral and antibody tests for COVID-19. Viral
(nucleic acid and antigen) tests are used to diagnose the presence of SARS-
CoV-2 infections. In contrast, antibody tests can detect IgG, IgA, and IgM
antibodies from an immune response to SARS-CoV-2.
Whenever possible, laboratories should rely on viral tests to diagnose the
presence of SARS-CoV-2 infections. However, a negative result from viral
testing does not rule out COVID-19.
Most of the PCR-based tests that use two or more targets are likely to have
high specificity (few false positives). However, there is some variation in
the stated sensitivity of the different assays, and sensitivity is highly
dependent on the stage of the disease. For this reason, negative results
should always be interpreted in the context of the exposure history and
symptoms of the patient.
Results from antibody testing should not be used to diagnose or exclude SARS-
CoV-2 infections or to inform infection status. Negative results from antibody
testing do not rule out SARS-CoV-2 infections, particularly for those
individuals who have been exposed to the virus and are still within the
estimated incubation period. Until the performance characteristics of antibody
tests have been evaluated, it is possible that positive results from such
testing may be due to past or present infections with a coronavirus other than
SARS-CoV-2.
If a laboratory initially uses antibody testing for diagnostic purposes,
follow-up testing using a viral test should be performed.
Read: Important Information on the Use of Serological (Antibody) Tests for
COVID-19: FDA Letter to Healthcare Providersexternal
icon
More: FDA EUA Authorized Serology Test Performanceexternal
icon
Frequently Asked Questions about Laboratory Testing and COVID-19
For All Laboratories: Test Developers
Where do test developers get the genomic RNA needed to validate test performance for FDA?

Currently, genomic RNA material can be used for validation purposes in biosafety level 2 laboratories (BSL-2). Genomic RNA material is available through BEI Resourcesexternal icon. Registrationexternal icon with BEI Resources is required to request SARS-CoV-2 materials. BEI Resources is prioritizing and fast-tracking all SARS-CoV-2 registrations with a 12- to 72-hour turnaround time for all SARS-CoV-2-related registrations. Please contact BEI Resources at contact@beiresources.org or 1-800 359-7370 for questions.
Developers are required to sign a material transfer agreement prior to the release of materials.
All BEI Resources reagents are provided worldwide. There is no cost for the reagents themselves. However, shipping and handling charges may apply.
Commercial sources also may have this material.
For Public Health Laboratories: If a kit to detect the virus (SAR-CoV-2) is needed, contact the International Reagent Resource external icon
Frequently Asked Questions about Laboratory Testing and COVID-19
For All Laboratories: Accessing Laboratory Testing
Can laboratories use specimen collection devices other than those listed in the manufacturer’s instructions or EUA (e.g., swabs) for SARS-CoV-2 testing?
According to FDA, when one entity establishes equivalent performance between
parallel testing of the same specimens with the new and original components
(including viral transport media [VTM]), and FDA’s review of the validation
data indicates that it could be applicable to modifications of other tests
with an authorized EUA, FDA will post this information on its website so that
other laboratories can refer to the validation for their testing. Then, other
laboratories do not need to conduct their own bridging study for the same
modification. For additional information regarding FDA’s policy for
modification, see FDA’s frequently asked questionsexternal
icon website.
Frequently Asked Questions about Laboratory Testing and COVID-19
For All Laboratories: Accessing Laboratory Testing
My facility would like to begin SARS-CoV-2 testing. Do we need a Clinical Laboratory Improvement Amendments (CLIA) certificate? Can my facility be granted a waiver from the CLIA certification requirements so that I can begin testing immediately?
Before conducting SARS-CoV-2 viral testing, a laboratory must be CLIA-
certified and meet applicable regulatory requirements. The Centers for
Medicare and Medicaid Services (CMS) does not have the authority to grant
waivers of exceptions that are not established in a statute or regulation. For
additional information, please refer to the FAQs on the CMS website: CMS
Coronavirus Informationexternal icon.
Frequently Asked Questions about Laboratory Testing and COVID-19
For All Laboratories: Accessing Laboratory Testing
Where do laboratories get access to reagents and materials to perform viral testing for SARS-CoV-2?
Public health laboratories can access collection materials for SARS-CoV-2
testing, including swabs and transport media, through the International
Reagent Resource (IRR)external
icon. The IRR
supports state and local public health laboratories, as well as other
qualified laboratories participating in public health surveillance and
studies, by providing reagents, tools, and information for studying SARS-CoV-2
and other pathogens.
Through IRR, CDC also provides the reagents that public health laboratories
use to detect SARS-CoV-2 virus in respiratory specimens. One test for SARS-
CoV-2 detection is a CDC-developed real-time reverse transcription polymerase
chain reaction (RT-PCR) test that received an EUA from FDA on February 4,
2020, to detect the virus in upper and lower respiratory specimens. IRR also
provides several additional commercially produced assays that have received an
EUA from FDA to detect SARS-CoV-2 viral RNA in respiratory samples.
Clinical and commercial laboratories conducting SARS-CoV-2 viral testing
can acquire test reagents from commercial reagent manufacturers that have
received EUA from FDA. Genomic RNA material for validation purposes can be
obtained from BEI Resources as indicated below.
Frequently Asked Questions about Laboratory Testing and COVID-19
For All Laboratories: Accessing Laboratory Testing
How do I apply for a CLIA certificate so that my testing facility can perform SARS-CoV-2 testing?
The federal CLIA program contracts with states to carry out certain oversight
and recording functions of the CLIA program. The state in which the laboratory
is located processes applications for CLIA certificates. After the laboratory
has identified a qualified and certified laboratory directorexternal
icon and has
provided all required information on the CMS-116 application, a CLIA number
will be assigned and the laboratory can begin testing if applicable CLIA
requirements have been met. For additional information, please refer to the
FAQs on the CMS website: CMS Coronavirus Informationexternal
icon.
Frequently Asked Questions about Laboratory Testing and COVID-19
For All Laboratories: Test Developers
What is NIH's BEI Resources Repository?
BEI Resources Repositoryexternal
icon was established by the National
Institute of Allergy and Infectious Diseasesexternal
icon at the National Institutes of Health to
provide reagents, tools, and information for studying Category A, B, and
Cexternal icon priority pathogens, emerging infectious diseaseexternal
icon agents, non-pathogenic microbes, and other microbiological
materials of relevance to the research community including diagnostic
developers. Centralizing these functions within BEI Resources facilitates
access to these materials by the scientific community and ensures quality
control of the reagents.
Frequently Asked Questions about Laboratory Testing and COVID-19
For All Laboratories: Serology
Will CDC submit its antibody test for an EUA?
Not at this time. CDC is using its antibody test as part of a multi-agency
study to evaluate current commercially marketed antibody tests for specificity
and sensitivity and to help determine how results from antibody tests could
support policymaking. CDC will share information publicly on the recommended
use of antibody testing as soon as enough data becomes available.
Frequently Asked Questions about Laboratory Testing and COVID-19
For All Laboratories: Accessing Laboratory Testing
I can’t find viral transport media (VTM) for SARS-CoV-2 testing. What are my options?
Public health laboratories can order VTM through IRR, as noted above.
Clinical testing laboratories should acquire VTM from commercial
sources.
Public health and clinical laboratories can also create their own VTM if they
are unable to order it. In response to VTM shortages, CDC has posted a 
standard operating procedurepdf icon to create VTM for laboratories. Saline is also an
acceptable transport media for some COVID-19 viral assays, including the CDC
EUA. Check the Instructions for Use with the EUA Assayexternal
icon to see which transport
media is acceptable.
Frequently Asked Questions about Laboratory Testing and COVID-19
For All Laboratories: Test Developers
My facility created a laboratory-developed test (LDT) to detect SARS-CoV-2. We need to have the first five positive and negative specimens confirmed. Can we send these specimens to CDC?
Laboratories using an LDT to detect SARS-CoV-2 should confer with their state
public health laboratory for assistance. If the state public health laboratory
cannot assist, contact respvirus@cdc.gov.
Frequently Asked Questions about Laboratory Testing and COVID-19
For Public Health Laboratories: Ordering Supplies
What is the new process for swab ordering?
Starting April 30, 2020, FEMA is assuming responsibility for the production
and distribution of LR-1, Flock Swabs. States can reach out to their federal
testing contact. The federal government will work with states who are on pace
to exceed their testing goals for the month to meet increased testing demand.
Learn more hereexternal
icon.
Frequently Asked Questions: Funeral and Burial Services for American Indians and Alaska Natives
COVID-19 and Funerals
What resources are available for burial of American Indian/Alaska Native veterans?
Spouses and families of American Indian/Alaska Native Veterans may be eligible
for burial assistance. Burial benefits can include opening and closing of the
grave, perpetual care, a government headstone or marker, a burial flag, and a
Presidential Certificate—at no cost to the family. Some veterans may also be
eligible to receive money to help cover the cost (burial allowances).
The National Cemetery Administration oversees burial benefits. This office is
under the Department of Veterans Affairs (VA), Veterans Benefits
Administration. The VA can be contacted at the following phone numbers:

For burial, survivors’ pension, or other benefits: 1-877-294-6380
For the status of VA headstones and markers: 1-800-697-6947
For obtaining bereavement counseling: 1-202-461-6530
For telecommunications devices for the Deaf and Hard of Hearing services, dial 711.
Additional informationexternal icon
VA Survivors and Burial Benefits kitpdf iconexternal icon
Frequently Asked Questions: Funeral and Burial Services for American Indians and Alaska Natives
Higher Risk
Who is most at risk for severe illness from COVID-19?
COVID-19 can cause mild to severe illness. This can result in someone being
admitted to the hospital and even an intensive care unit. It can even cause
death. People who are infected often have symptoms of illness. People 65 and
older and people of any age who have serious underlying medical
conditions might be at higher risk for severe illness from COVID-19. This
includes people with serious heart conditions, severe obesity, diabetes,
chronic kidney disease (or undergoing dialysis), liver disease, chronic lung
disease or moderate to severe asthma, or people who have a weakened immune
system (immunocompromised). Everyone can take actions, such as social
distancing, to help slow the spread.
Frequently Asked Questions: Funeral and Burial Services for American Indians and Alaska Natives
COVID-19 and Funerals
Am I at risk if I go to a family gathering, traditional event, ceremony, or funeral for someone who died of COVID-19?
There is currently no known risk associated with being in the same room at a
funeral or visitation service with the body of someone who died of COVID-19.
Anyone who is sick should stay home. These actions help prevent people from
getting sick and help stop the spread of the virus.
Also, tribal leaders can help. While each tribe has its own traditions
regarding death rituals and funerals (including family feeds, giveaways, and
commemorative gatherings), it is important for leaders to determine ways for
immediate family members to take part while making sure that

Vulnerable populations are protected.
Everyone practices frequent hand washing (hand hygiene) and social distancing (keep 6 feet of space or greater between people).
Gatherings are limited to 10 or fewer people.

CDC recommends wearing cloth face coverings in public settings where social
distancing is difficult to maintain (for example, at grocery stores and
pharmacies). This is especially important in communities where COVID-19 is
spreading. So, if you do go to a funeral or gathering, use a cloth face
covering. But also try to keep about 6 feet from others who are present. You
can find more information about using a cloth face
covering.
Do not place cloth face coverings on young children under age 2. Also, don’t
place a face covering on anyone who has trouble breathing or who is
unconscious or unable to remove the mask without assistance.
Frequently Asked Questions: Funeral and Burial Services for American Indians and Alaska Natives
COVID-19 and Funerals
How do you protect yourself after body preparation?
After the body has been prepared for viewing and burial, clean surfaces using
EPA-approved products in accordance with manufacturer’s instructions for all
cleaning and disinfection products (such as concentration, application method,
and contact time).

Products with EPA-approved emerging viral pathogens claimspdf iconexternal icon are expected to be effective against the virus that causes COVID-19 based on data for harder to kill viruses.
After removal of PPE, perform hand hygiene by washing your hands with soap and water for at least 20 seconds. If soap and water are not available, use an alcohol-based hand sanitizer that contains at least 60% alcohol.

Information on cleaning and sanitizing can be found on the CDC website:

For facilitites
For households
Frequently Asked Questions: Funeral and Burial Services for American Indians and Alaska Natives
COVID-19 and Funerals
Are there any special requirements for burying or cremating people who die from COVID-19?
People who died from COVID-19 can be buried or cremated. But check for any
additional tribal, state, local, or territorial requirements that may dictate
the handling and disposition of the body of individuals who have passed from
certain infectious diseases.
Frequently Asked Questions: Funeral and Burial Services for American Indians and Alaska Natives
COVID-19 and Funerals
How can communities plan for an increase in the number of deaths?
Tribes have asked for guidance to help them plan for increased death from
COVID-19. While an increase in deaths may be a very difficult topic to discuss
and plan for, tribal leaders have resources to help:

Resources for emergency preparedness.
CDC Interim Guidance for Administrators and Leaders of Community- and Faith-Based Organizations to Plan, Prepare, and Respond to Coronavirus Disease 2019 (COVID-19).

Tribal leaders can also do the following:

Postpone large events, including celebrations such as funerals, weddings, baptisms, and holiday gatherings.
Limit gatherings to a small number (less than 10) of family and friends and ensure social distancing and hand washing.
Frequently Asked Questions: Funeral and Burial Services for American Indians and Alaska Natives
Coronavirus Disease 2019 Basics
What is COVID-19?
Coronavirus Disease 2019 (COVID-19) is a new disease, and we are still
learning about how it spreads and the severity of illness it causes. The
virus that causes COVID-19 is believed to spread person-to-person between
people who are in close contact (being within about 6 feet) with one another.
Some people without symptoms may be able to spread the virus.
The virus likely spreads primarily through saliva or mucus droplets produced
when an infected person coughs, sneezes, or talks. This is somewhat like how
the flu (influenza) and other infections such as the common cold spread.
These droplets can land in the mouths or noses of people who are nearby or
possibly be breathed in. Droplets can remain on surfaces such as countertops
and doorknobs for hours to days.
Frequently Asked Questions: Funeral and Burial Services for American Indians and Alaska Natives
COVID-19 and Funerals
How do you transport the body of a person who has died from COVID-19?
Follow these steps if you are involved in transporting the body of someone who
died from COVID-19:

If the body of a tribal member needs to be moved, wear disposable gloves and contain the body in a body bag, an impermeable shroud, or another impermeable covering that does not allow body fluids to leak from the enclosure. The virus that causes COVID-19 is not thought to be carried by blood (bloodborne), but leaked fluids could cause exposure to pathogens.
If a body bag is used to contain the body, disinfect the outside of the bag with an EPA-approved disinfectant for emerging viral pathogensexternal icon. Be sure to follow the manufacturer’s instructions for cleaning and disinfection products including concentration, application method, and contact time.
Following transport of the body, carefully remove your gloves and immediately wash your hands with soap and water for 20 seconds. If soap and water are not available, use a hand sanitizer that contains at least 60% alcohol.