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Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers | FDA
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Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers

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Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers

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Antibodies are developed by the body in response to an infection or after vaccination. SARS-CoV-2 is the virus that causes COVID-19. SARS-CoV-2 antibody tests detect antibodies to the SARS-CoV-2 virus. SARS-CoV-2 antibody tests can help identify people who may have been infected with the SARS-CoV-2 virus or have recovered from COVID-19. Antibody tests should not be used to tell you if you have an active COVID-19 infection.
Scientists continue to learn more about COVID-19 and COVID-19 immunity. At this time, SARS-CoV-2 antibody tests do not tell you if:
You currently have COVID-19, the disease caused by the SARS-CoV-2 virus,
You have immunity that will prevent COVID-19,
You need a COVID-19 vaccine, or
Your COVID-19 vaccine worked.
On this page:
Antibodies and Antibody Tests: The Basics
Antibody Tests: Not for Use to Check Immunity 
Antibody Tests: Results and Terms
Additional Resources
Antibodies and Antibody Tests: The Basics
Post-COVID Conditions: Information for Healthcare Providers
2022 ACC Expert Consensus Decision Pathway on Cardiovascular Sequelae of COVID-19 in Adults: Myocarditis and Other Myocardial Involvement, Post-Acute Sequelae of SARS-CoV-2 Infection, and Return to Play
Post-COVID-19 Conditions in Children and Adolescents
Long COVID: A Primer for Family Physicians
European Respiratory Society Statement on Long COVID-19 Follow-Up
COVID-19 rapid guideline: managing the long-term effects of COVID-19

Support Groups

Body Politic 
Survivor Corps 
Long COVID Alliance 
Long COVID Kids 

Symptom and Condition Assessments

Measuring Orthostatic vital signs [1 page, 554 KB]
Health Measures Toolbox 
AAPM&R Functional Assessments 

Long COVID, Other Fatiguing Illnesses, and Disability

Guidance on “Long COVID” as a Disability Under the ADA, Section
Supporting Employees with Long COVID: A Guide for Employers
What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Disability and ME/CFS
Providing Medical Evidence for Individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
PolicyNet/Instructions Updates/EM-21032 REV : Evaluating Cases with Coronavirus Disease 2019 (COVID-19)

Educational Programs for Healthcare Providers

ECHO Program

iECHO Program on Long COVID Treatments and Fatiguing Illness Recovery
LC & FIRP was launched in August 2021 and is funded for three years. Investigators from partner organizations evaluate the use of a distance-learning platform to support primary health care providers (HCP) who care for patients at increased risk of Long COVID. The program has attracted >100 nationally recognized faculty/mentors representing multiple medical specialties.The Long COVID and Fatiguing Illness Recovery Program fills a critical community need for health information and clinical support.
Long COVID ECHO – ASU
A free, biweekly healthcare provider education session sharing best practices and consultation for providers treating or interested in best practices for Long COVID.
Foundations in Post-COVID Conditions – CANVAS
Post-COVID Conditions: Information for Healthcare Providers
Many adults with disabilities already experience challenges in accessing health services, and they may need different clinical management of their symptoms after SARS-CoV-2 infection, especially if their long-term symptoms are difficult to distinguish from their underlying chronic conditions.

People experiencing homelessness and people in correctional facilities

People experiencing homelessness or housing instability as well as people in correctional facilities may also experience challenges accessing healthcare and other support services. People with pre-existing substance use disorder may be at risk for relapse.

People with barriers to accessing health care

People with barriers to accessing health care due to lack of health insurance, access to healthcare professionals who accept their health insurance, or lack of transportation, childcare, or paid sick leave may face additional challenges accessing healthcare. Telehealth visits may be helpful for such patients with access to broadband.

Patient advocacy groups have raised concerns that some Post-COVID Conditions have been either misdiagnosed as or misattributed to psychiatric causes or deconditioning, particularly among persons who belong to groups that have been marginalized or disproportionately impacted. Sensitivity to and awareness of stigma, completing a full clinical evaluation, and maintaining an attitude of empathy and understanding can help address these concerns.
Top of PageDocumentation of Post-COVID Conditions
Documentation of SARS-CoV-2 infection and Post-COVID Conditions is critical for accurate public health surveillance. The World Health Organization (WHO) provided an ICD-10 code for Post-COVID Condition that was incorporated into the International Classification of Diseases, Tenth Edition Clinical Modification (ICD-10-CM) as of October 1, 2021:

U09.9 Post COVID-19 Condition, unspecified– to allow the establishment of a link with COVID-19; not to be used in cases that still are presenting with acute COVID-19.

The code should be used for patients with a history of probable or confirmed SARS CoV-2 infection who are identified with a Post-COVID Condition. In addition, assign codes for specific conditions and symptoms identified.
Post-COVID Conditions: Information for Healthcare Providers
Post-covid syndrome in individuals admitted to hospital with covid-19: retrospective cohort study. BMJ. 2021 Mar 31;372:n693. doi:10.1136/bmj.n693
Atalla E, Kalligeros M, Giampaolo G, et al. Readmissions among patients with COVID-19. Int J Clin Pract. 2020 Sep 7:e13700. doi:10.1111/ijcp.13700
Donnelly JP, Wang XQ, Iwashyna TJ, et al. Readmission and Death After Initial Hospital Discharge Among Patients With COVID-19 in a Large Multihospital System. JAMA. 2021 Jan 19;325(3):304-306. doi:10.1001/jama.2020.21465
Somani SS, Richter F, Fuster V, et al. Characterization of Patients Who Return to Hospital Following Discharge from Hospitalization for COVID-19. J Gen Intern Med. 2020 Oct;35(10):2838-2844. doi:10.1007/s11606-020-06120-6
Jeon WH, Seon JY, Park SY, et al. Analysis of Risk Factors on Readmission Cases of COVID-19 in the Republic of Korea: Using Nationwide Health Claims Data. Int J Environ Res Public Health. 2020 Aug 12;17(16). doi:10.3390/ijerph17165844
Akinbami LJ, Petersen LR, Sami S, et al. COVID-19 symptoms and SARS-CoV-2 antibody positivity in a large survey of first responders and healthcare personnel, May-July 2020. Clin Infect Dis. 2021 Jan 30. doi:10.1093/cid/ciab080
Petersen LR, Sami S, Vuong N, et al. Lack of antibodies to SARS-CoV-2 in a large cohort of previously infected persons.
Post-COVID Conditions: Information for Healthcare Providers
new-onset signs, symptoms, or conditions following asymptomatic disease or a period of acute symptom relief or remission
an evolution of symptoms and conditions that include some persistent symptoms (e.g., shortness of breath) with the addition of new symptoms or conditions over time (e.g., cognitive difficulties)
worsening of pre-existing symptoms or conditions

Factors that might make it more difficult to distinguish the presentation of Post-COVID Conditions include:

pre-COVID comorbidities (underlying medical conditions)
physical deconditioning at baseline or after a prolonged acute disease course that can be nonspecific to COVID-19
physical and mental health consequences of illness with a long or complicated disease course, including depression and anxiety
social, environmental, and economic stressors

Some presentations may share similarities with other post-infectious syndromes, such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), postural orthostatic tachycardia syndrome (POTS) and other forms of dysautonomia, or mast cell activation syndrome (MCAS). Some of these types of conditions were also reported in patients following severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), two other life-threatening illnesses resulting from coronavirus infections.
New or persistent symptoms
A wide range of other new or persistent symptoms and clinical findings can occur in people with varying degrees of illness from acute SARS-CoV-2 infection, including patients who have had mild or asymptomatic SARS-CoV-2 infection. These effects can overlap with multiorgan complications, or with effects of treatment or hospitalization. This category is heterogeneous, as it can include patients who have clinically important but poorly understood symptoms (e.g., difficulty thinking or concentrating, post-exertional malaise) that can be persistent or intermittent after initial acute infection with SARS-CoV-2.

Commonly reported symptoms include:

Dyspnea or increased respiratory effort
Fatigue
Post-exertional malaise* and/or poor endurance
Cognitive impairment or "brain fog"
Cough
Chest pain
Headache
Coronavirus FAQs: What Veterans Need To Know | Veterans Affairs
There is no cure for COVID-19 at this time. There are treatments for COVID-19, but the risk of severe illness and death are still high in certain groups of people. 
Talk to your health care provider before taking any medications to prevent or treat COVID-19. 
If you have questions about a treatment, call or send a secure message to your VA provider.
Learn more about COVID-19 treatments on the CDC website
Get answers to COVID-19 treatment questions on the FDA website

At VA, we've completed thousands of research studies with the goal of improving the health and well-being of Veterans. Because of this research history, we have the long-term data to best understand how illnesses, vaccines, and treatments affect Veterans.

We're now working to find ways to prevent and treat COVID-19 for Veterans and others. We have a lot to learn. We can’t learn without doing research. And we can’t do research without people who volunteer to participate in research studies. 

As a research study participant, you can help us:

Better understand how COVID-19 affects different people
Find ways to prevent and treat COVID-19 for you, your family, and your community
Make sure vaccines and treatments are safe and effective in people of all ages, genders, races, and ethnicities

As a research participant, you may also:

Learn more about your own health
Receive more regular health check-ins as part of your study visits
Get early access to a new vaccine or treatment

Learn more about volunteering for coronavirus research at VA

Health care, appointments, and more

Appointments and health protection levels

 What are VA health facilities’ guidelines on masks? 
 

When you come to a VA health facility, your health and safety are our priorities.
All facilities require masks in high-risk areas like these: 

Chemotherapy units
Dialysis units
Emergency departments and urgent care 
Post-transplant units 

Masks are also required for people who are sick with COVID-19 or other viral respiratory illnesses. 
You can choose to wear a mask at any time.
Post-COVID Conditions: Information for Healthcare Providers
Patients who experienced multisystem inflammatory syndrome (MIS) during or after COVID-19 illness may be at higher risk for on-going multiorgan system effects and Post-COVID Conditions. It is unknown how long multiorgan system effects might last and whether the effects could lead to chronic health conditions.
Patients who experienced multisystem inflammatory syndrome (MIS) during or after COVID-19 illness may be at higher risk for on-going multiorgan system effects and Post-COVID Conditions. It is unknown how long multiorgan system effects might last and whether the effects could lead to chronic health conditions.
Effects of COVID-19 illness or hospitalization
Effects of COVID-19 illness or hospitalization can include severe weakness, muscle atrophy, and tracheal stenosis from prolonged intubation.
Some of these effects are similar to those from hospitalization for other respiratory infections or other conditions.

This category can also encompass post-intensive care syndrome (PICS), which includes a range of health effects that remain after a critical illness.
These effects can include severe weakness and post-traumatic stress disorder (PTSD).

Though the effects of hospitalization may not be unique to COVID-19 illness, they are considered Post-COVID Conditions if they occur after a SARS-CoV-2 infection and persist for 4 or more weeks.
Top of PageAssessment and Testing for Post-COVID Conditions
Some patients with Post-COVID Conditions will not have had positive test results for SARS-CoV-2 due to a lack of testing, inaccurate testing during the acute period, waning antibody levels, or false-negative antibody testing during follow up.
Many Post-COVID Conditions can be diagnosed clinically based on history and findings on physical examination. Others might require directed diagnostic testing with the understanding that such clinical assessments might be uninformative, and that potential harms could arise from excessive testing such as:

the increased risk for incidental findings,
anxiety about abnormal results that do not have clinical significance,
imaging-related radiation exposure,
cost, and
time spent for medical appointments.
COVID-19 Testing: What You Need to Know | CDC
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Post-COVID Conditions: Information for Healthcare Providers
CDC uses the term “Post-COVID Conditions” (PCC) as an umbrella term for the wide range of health consequences that can be present 4 or more weeks after infection with SARS-CoV-2, the virus that causes COVID-19.
Post-COVID Conditions are associated with a spectrum of physical, social, and psychological consequences, as well as functional limitations that can present substantial challenges to patient wellness and quality of life.
Although standardized case definitions are still being developed, in the broadest sense, Post-COVID Conditions can be considered a lack of return to a usual state of health following acute COVID-19 illness. Post-COVID Conditions can also include development of new or recurrent symptoms or new conditions after the symptoms of acute COVID-19 illness have resolved.
Time frame
Most patients appear to recover from acute COVID-19 illness within 4 weeks. However, some continue to have persistent, emergent, and re-emergent symptoms and conditions after this acute phase. CDC considers Post-COVID Conditions to be present if recovery does not occur after the 4-week acute phase even though many patients continue to recover between 4 and 12 weeks.
CDC considers Post-COVID Conditions to be present if recovery does not occur after the 4-week acute phase even though many patients continue to recover between 4 and 12 weeks.

While patients may still recover after 12 weeks, persistent illness becomes more likely.

Presentation
Different onset patterns for Post-COVID Conditions have been identified that further exemplify their heterogeneity, including:

persistent symptoms and conditions that begin at the time of acute COVID-19 illness
new-onset signs, symptoms, or conditions following asymptomatic disease or a period of acute symptom relief or remission
an evolution of symptoms and conditions that include some persistent symptoms (e.g., shortness of breath) with the addition of new symptoms or conditions over time (e.g., cognitive difficulties)
worsening of pre-existing symptoms or conditions

Factors that might make it more difficult to distinguish the presentation of Post-COVID Conditions include:

pre-COVID comorbidities (underlying medical conditions)
Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers | FDA
Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers | FDA

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In this section:

 Coronavirus (COVID-19) and Medical Devices
 
 

 Coronavirus (COVID-19) and Medical Devices
 

At-Home OTC COVID-19 Diagnostic Tests
Counterfeit At-Home OTC COVID-19 Diagnostic Tests
At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19
Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA)
Contacts for Medical Devices Related to COVID-19
Post-COVID Conditions: Information for Healthcare Providers
Post-COVID Conditions: Information for Healthcare Providers
 
 

 

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Post-COVID Conditions: Information for Healthcare ProvidersPost-COVID Conditions: Information for Healthcare Providers 


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This page provides an overview for healthcare providers. For information on CDC research, see Science behind Long COVID.

 For the General Public: Long COVID (Post-COVID Conditions)

On This Page

Key PointsTools & ResourcesOverviewAssessment and Testing for Post-COVID ConditionsManagement of Post-COVID Conditions 

Documentation of Post-COVID ConditionsResearch on Post-COVID ConditionsTools and ResourcesReferences 

Key Points

The term “Post-COVID Conditions” is an umbrella term for the wide range of physical and mental health consequences experienced by some patients that are present 4 or more weeks after SARS-CoV-2 infection, including by patients who had initial mild or asymptomatic acute infection.
Based on current information, many Post-COVID Conditions can be managed by primary care providers, using patient-centered approaches to optimize the quality of life and function of affected patients.
Objective laboratory or imaging findings should not be used as the only measure or assessment of a patient’s well-being; normal laboratory or imaging findings do not invalidate the existence, severity, or importance of a patient’s Post-COVID Conditions.
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Post-COVID Conditions: Information for Healthcare Providers
Eur J Phys Rehabil Med. 2020 Jun;56(3):339-344. doi: 10.23736/S1973-9087.20.06298-X. PMID: 32672029. doi:10.23736/s1973-9087.20.06298-x
Daynes E, Gerlis C, Chaplin E, et al. Early experiences of rehabilitation for individuals Post-COVID to improve fatigue, breathlessness exercise capacity and cognition – A cohort study. Chron Respir Dis. 2021 Jan-Dec;18:14799731211015691. doi:10.1177%2F14799731211015691
Berger Z, Altiery DE Jesus V, Assoumou SA, et al. Long COVID and Health Inequities: The Role of Primary Care. Milbank Q. 2021 Mar 30. doi:10.1111/1468-0009.12505
Waltenburg MA, Victoroff T, Rose CE, et al. Update: COVID-19 Among Workers in Meat and Poultry Processing Facilities ― United States, April–May 2020. MMWR Morb Mortal Wkly Rep 2020;69:887-892. Accessed at: https://www.cdc.gov/mmwr/volumes/69/wr/mm6927e2.htm
DT Arnold, A Milne, E Samms, et al. Are vaccines safe in patients with Long COVID? A prospective observational study. medRxiv. 2021 March 11; 21253225. Accessed at: https://www.medrxiv.org/content/10.1101/2021.03.11.21253225v2
Santoli JM, Lindley MC, DeSilva MB, et al. Effects of the COVID-19 Pandemic on Routine Pediatric Vaccine Ordering and Administration – United States, 2020.