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SARS-CoV-2 Serology (COVID-19) Antibody (IgG), Immunoassay

The detection of SARS-CoV-2 (COVID-19) IgG antibodies that indicate exposure.

WE ARE NOT ABLE TO DISCOUNT THIS TEST. APPOINTMENTS ARE REQUIRED FOR THIS TEST. PLEASE SCHEDULE YOUR APPOINTMENT HERE.

Sample Report

Test Code: 39504

Also Known As: COVID19; Novel Coronavirus; nCOV; Wuhan; Coronavirus

Methodology: Immunoassay (IA)

Preparation: No special preparation required. It usually takes around 10 to 18 days after being infected with SARS-CoV-2 for your body to produce enough antibodies for detection in the blood.

Test Results: 1-3 days. May take longer based on weather, holiday or lab delays.


Details:

If you feel like you are having a medical emergency, please call 9-1-1.

If you are experiencing severe trouble breathing, continuous pain or pressure in your chest, feeling confused or having difficulty waking up, blue-colored lips or face, or any other emergency signs or symptoms, please seek immediate medical care.

What is a COVID-19 antibody test?

This test checks for a type of antibody called immunoglobulin G (IgG). If you’ve been exposed to COVID-19, your body produces IgG antibodies as part of the immune response to the virus. This test cannot tell you if you have an active infection. If you suspect you have COVID-19, follow up with your healthcare provider about getting a PCR test.

Who should get a COVID-19 antibody test?
This test may be right for you if you:

  • Have been diagnosed with COVID-19, it has been at least 10 days since your diagnosis, and you want to know if you have IgG antibodies.
  • Have not had symptoms and have not had a known exposure to COVID-19 within the last 10 days but want to see if you have IgG antibodies.
  • Have had or suspect you’ve had COVID-19 but have not experienced any new symptoms in the past 10 days (these symptoms include cough, difficulty breathing, chills, repeated shaking with chills, muscle pain, headache, sore throat, or new loss of taste or smell).
  • Have had or suspect you’ve had COVID-19 but have not experienced a fever in the past 3 days.

Who should not get a COVID-19 antibody test?
This test may NOT be right for you if you:

  • Are feeling sick or have had a fever within the last 3 days.
  • Are trying to diagnose COVID-19.
  • Have been diagnosed with COVID-19 less than 10 days ago.
  • Were directly exposed to COVID-19 in the past 14 days.
  • Have a condition that weakens your immune system.

What will a COVID-19 antibody test results tell me?
This test may help identify if you were exposed to the virus and, if so, whether or not your body has IgG antibodies against COVID-19. Although having antibodies usually gives immunity from further infection, there is not enough evidence at this time to suggest that people who have IgG antibodies are protected against future COVID-19 infection. Results from this test also will not provide any information on whether you can spread the virus to others.

If you have questions about returning to work, contact your employer for guidance. Be sure to continue to follow federal, state, and local government guidance regarding social distancing and isolation.

Are there any limitations to COVID-19 antibody tests?
Getting an antibody test too soon after being infected may cause a false negative result. Additionally, some individuals who are infected with COVID-19 may not develop detectable levels of IgG antibodies, such as those with weakened immune systems due to a medical condition or certain medications.

This test may detect IgG antibodies from previous exposure to coronaviruses other than COVID-19, which can cause a false positive result.

What guidance does the FDA provide regarding COVID-19 antibody testing?
Antibody testing can play a critical role in the fight against COVID-19. It can help identify individuals who may have been exposed to COVID-19 and have developed an immune response. Using antibody tests and clinical follow-up can also provide more information on immunity against COVID-19 for research and medical developments for the virus.

Having antibodies usually gives immunity from further infection. However, there is not enough evidence at this time to suggest that people who have these antibodies are protected against future COVID-19 infection. Experience with other viruses suggests that individuals who have antibodies may be able to resume work and other daily activities in society, as long as they are recovered and not currently infected with the virus.

How is a COVID-19 antibody test performed?
This test is conducted by collecting a blood sample (such as from a finger prick or needle draw).

How do I prepare for the test?
You do not need to do anything to prepare for the test. You do not need to fast or stop taking any medications before testing. Further instructions will be provided to you at the lab or in your test kit.

Where can I get more information?

Please note: The antibody tests and the molecular tests (together referred to as “tests”) have not been cleared or approved by the Food and Drug Administration (FDA).

General COVID-19 FAQs

What is coronavirus disease ( COVID-19)?
Coronavirus disease (also called COVID-19) is an infection caused by SARS-CoV-2 (severe acute respiratory syndrome coronavirus), one of the most recently discovered types of coronaviruses. Those who have this disease may or may not experience symptoms, which range from mild to severe.

How does COVID-19 spread?
COVID-19 spreads easily from person-to-person, even when an infected person is not showing symptoms. When an infected person coughs, sneezes, or talks, droplets containing the virus go into the air. These droplets can be inhaled or land in the mouths or noses of people who are nearby, exposing them to the virus.

People may also be exposed to COVID-19 by touching their eyes, nose, or mouth after touching a surface with the virus on it. Although this is not thought to be the main way the virus spreads, researchers are still learning more about COVID-19.

What are the symptoms of COVID-19?
Symptoms may appear 2 to 14 days after being exposed to the virus. The most common symptoms include:

  • Fever
  • Cough
  • Shortness of breath or difficulty breathing

Cases of COVID-19 range from mild to severe. Some people who are infected don’t have any symptoms and don’t feel sick. Most people have mild symptoms. Visit the CDC website for more information about symptoms.

Who is at high risk of getting very sick?
Severe cases are more likely to occur in older adults (65 years of age and older), as well as pregnant women, those with weakened immune systems, and those with underlying health issues (such as lung disease, diabetes, obesity, high blood pressure, heart conditions, stroke, kidney disease or on dialysis, liver disease, cancer, transplant, AIDS, lupus, and rheumatoid arthritis). However, serious illness can also occur in young, healthy adults.

Am I at risk of getting COVID-19?
COVID-19 is very contagious. The risk of getting COVID-19 depends on many factors, including close contact with people who have symptoms of COVID-19. It is important to follow your federal, state, and local government guidance to protect yourself from exposure.

How is COVID-19 treated?
There is currently no treatment for COVID-19. Not all patients with COVID-19 will require medical attention, and most people recover within 2 weeks without any specific treatment. For severe cases, hospitalization and respiratory support may be required. For mild cases, treatment focuses on managing symptoms.

How can I protect myself from getting COVID-19?
The best way to protect yourself is to avoid situations in which you may be exposed to the virus. Everyday actions can help protect you and prevent the spread of respiratory diseases such as COVID-19.

  • Avoid close contact with people who are sick.
  • Restrict any activities outside your home and maintain a safe distance (around 6 feet)

    between yourself and other people if COVID-19 is spreading in your community. This includes avoiding crowded areas, shopping malls, religious gatherings, public transportation, etc.

  • Wear simple cloth face coverings in public settings (like grocery stores and pharmacies) where social distancing is difficult, especially in areas where COVID-19 is spreading.
  • Stay home when you are sick, unless you are seeking medical care.
  • Clean and disinfect frequently touched objects and surfaces (including tables, doorknobs,

    light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and

    sinks).

  • Wash your hands often with soap and water for at least 20 seconds.
  • Use an alcohol-based hand sanitizer with at least 60% alcohol if soap and water aren’t

    available. Always wash hands with soap and water if your hands are visibly dirty.

  • Avoid touching your eyes, nose, and mouth with unwashed hands.

What can I do to prevent spreading COVID-19?
If you believe you may have COVID-19 or test positive for COVID-19 and have mild symptoms, the following steps can help prevent the disease from spreading to others:

  • Stay home
    • Stay in a specific room and away from other people in your home
    • Restrict any activities outside your home, except for getting medical care
    • Avoid public areas, including work and school
    • Avoid using public transportation, ride-sharing, or taxis
  • Cover your nose and mouth
    • If you are sick, wear a facemask when you are around other people or pets
    • Cover your mouth and nose with a tissue when you cough or sneeze, and throw away used tissues
  • Wash hands
    • Wash your hands often with soap and water for at least 20 seconds
    • Wash your hands especially after blowing your nose, coughing, sneezing, going to

      the bathroom, or before eating or preparing food

    • If soap and water are not available, use an alcohol-based hand sanitizer that

      contains at least 60% alcohol

    • Avoid touching your eyes, nose, mouth, and other people with unwashed hands
  • Do not share
    • Do not share dishes, cups, eating utensils, towels, or bedding with other people or

      pets

    • After using personal items, they should be washed thoroughly with soap and water
  • Clean and disinfect
    • Clean high touch surfaces such as counters, tabletops, doorknobs, bathroom

      fixtures, toilets, phones, keyboards, tablets, and bedside tables

    • Clean any surfaces that may come in contact with body fluids, blood, or stool
    • Use a household cleaning spray or wipes
    • Immediately remove and wash clothes or bedding that have body fluids, blood, or stool on them

When should I seek medical care?
If you think you have been exposed, it is important to closely monitor for symptoms. Seek medical attention immediately if you develop severe symptoms, especially if you experience:

  • Severe trouble breathing (such as being unable to talk without gasping for air)
  • Continuous pain or pressure in your chest
  • Feeling confused or having difficulty waking up
  • Blue-colored lips or face
  • Any other emergency signs or symptoms

If you seek medical attention, be sure to call ahead before visiting the facility. This will help the facility keep other people from possibly getting infected or exposed.

  • Tell any healthcare provider that you may have COVID-19.
  • Avoid using public transportation, ride-sharing, or taxis.
  • Put on a facemask before you enter any healthcare facility. 

What is social distancing?
Social distancing, also called “physical distancing,” means keeping space between yourself and other people outside of your home. It includes:

  • Staying at least 6 feet (2 meters) from other people
  • Not gathering in groups
  • Staying out of crowded places and avoiding mass gatherings

Social distancing is one of the best ways to avoid being exposed and to help slow the spread of the virus. It is especially important for people who are at higher risk of getting very sick.

Be sure to continue to follow federal, state, and local government guidance regarding social distancing.

Should I self-quarantine or self-isolate? How does it work?
If you think you may have been exposed to COVID-19, it is very important to stay home and limit your interaction with others in your household and in public.

  • If you have not been tested but may have been exposed to COVID-19, self-monitoring and self-quarantine is recommended to see if you get sick.
  • If you have tested positive for COVID-19, self-isolation is recommended so that you do not pass the virus to others.

For more information on self-isolation and self-quarantine, click here.

If you are a healthcare professional, first responder, frontline worker, or critical infrastructure worker and believe you have been directly exposed while at work, you should consult your place of work for specific occupational health guidance about whether to stay home or continue working. You should adhere to recommendations set forth by your employer or the department of health, as they may differ from the CDC’s guidelines.

What’s the difference between quarantine and isolation?
Isolation and quarantine are both ways to limit your interaction with others to prevent the spread of disease.

  • Isolation is separating individuals with COVID-19 from people who are not sick. Individuals are separated for a period of time until they are no longer infectious.
  • Quarantine is separating individuals who may have been exposed to COVID-19 but haven’t been tested. They are separated for a brief period of time (14 days after possible exposure) to see if they develop symptoms.

For more information on self-isolation and self-quarantine, click here.

If you are a healthcare professional, first responder, frontline worker, or critical infrastructure worker and believe you have been directly exposed while at work, you should consult your place of work for specific occupational health guidance about whether to stay home or continue working. You should adhere to recommendations set forth by your employer or the department of health, as they may differ from the CDC’s guidelines.

Is there a difference between stopping isolation vs. stopping quarantine?
The Centers for Disease Control and Prevention (CDC) guidelines about this may at first seem confusing. These guidelines are:

● Those who have been infected with COVID-19 should isolate. They may be able to stop isolating once symptoms have improved, and it has been at least 10 days since symptoms first appeared. Those who have never had symptoms may be able to stop isolating 10 days after testing.
● Those who have been possibly exposed to COVID-19 should quarantine. They may be able to stop quarantining if they don’t develop symptoms, and it has been at least 14 days after possible exposure.

This means that it’s possible for a person diagnosed with COVID-19 to stop isolation before someone possibly exposed can stop quarantining.

When can I stop in-home isolation?
If you’ve been diagnosed with COVID-19, please check with your primary healthcare provider or local health department to help determine when it’s right to stop isolation. Typically this is done when fever and symptoms improve and/or a specified amount of time has passed, or when you’ve had follow-up PCR testing done. Be sure to continue to follow federal, state, and local government guidance regarding social distancing and isolation. For more information, please visit the Centers for Disease Control and Prevention (CDC) website.

Can someone who has had COVID-19 become infected again?
At this time, it is not known whether someone who has been infected with COVID-19 can become infected again after recovering.

Antibody Test-Specific FAQs

What is the purpose of COVID-19 antibody testing?
On an individual level, an antibody test looks for antibodies in the blood. Your immune system makes antibody proteins to help fight infections. If you were exposed to COVID-19, an antibody test will show whether or not you’ve developed antibodies against SARS-CoV-2, the virus that causes COVID-19. An antibody test cannot tell you whether you have a current COVID-19 infection.

On a population level, antibody testing can give researchers a sense of how many people have been exposed to and infected by COVID-19. In the future, antibody testing may show whether someone has immunity against COVID-19, meaning that they cannot get infected again. If antibodies make people immune to COVID-19, it can help inform leaders and public health officials about whether the population has reached herd immunity. Herd immunity is when a large percentage of a population has become immune to COVID-19, which can protect those people who are not immune.

What are the different types of antibodies? Do they offer different types of immunity?
There are three different types of antibodies: IgM, IgG, and IgA.

  • Immunoglobulin M (IgM) is produced as the body’s first response to a COVID-19 infection. Generally, IgM may provide short-term protection and can help tell if an individual has been recently infected.
  • Immunoglobulin G (IgG) is the most common type of antibody. It’s made several days to weeks after being exposed to COVID-19. Generally, IgG remains in the body and may provide long-term protection against future exposure.
  • Immunoglobulin A (IgA) is found in the blood, sinuses, lungs, and stomach. Generally, IgA helps protect these areas from infection. However, the role of these antibodies in determining exposure or immunity is unknown.

There is not enough evidence at this time to suggest that people who have these antibodies are protected against future COVID-19 infections.

When do IgG antibodies develop?
Based on the most current research, IgG antibodies develop around 10 to 18 days after infection from COVID-19. However, this varies by individual, and some people may take a longer time to develop IgG antibodies.

Can antibody tests be used to diagnose a COVID-19 infection?
Antibody tests do not show whether a person is currently infected. A molecular (PCR) test is a more reliable indicator of current COVID-19 infection.

My COVID-19 antibody test was positive, but I’m still having symptoms. What should I do?
If you’re having symptoms of COVID-19, contact your healthcare provider or local health department to get tested for active infection. The antibody test can only tell you if you’ve been exposed and have developed an immune response, but it cannot say whether you have an active infection.

My COVID-19 antibody test was negative, but I previously tested positive for COVID-19 or was exposed. Is my result incorrect?
Getting an IgG antibody test too soon after being infected may cause a false negative result. It usually takes around 10 to 18 days after being infected with COVID-19 for your body to produce enough IgG antibodies to be detected in the blood. Some people may take even longer to develop antibodies or may not develop enough antibodies to be detected by the test. It is recommended that you contact your healthcare provider or local health department to see if retesting is needed.

If my COVID-19 antibody test is positive, can I get sick again with COVID-19?
At this time, there is not enough evidence to suggest that people who have IgG antibodies are protected against future COVID-19 infections.

What is the chance that my COVID-19 antibody test result was a false positive?
False positives occur when a person tests positive even though they DO NOT have the antibodies for COVID-19. There is a small chance that the result could be a false positive. Manufacturers must demonstrate a high specificity of approximately 99% to 100% to ensure validation of their test. If you have additional questions, please contact the lab directly for more information.

Am I immune if I tested positive for antibodies?
If your test results show that you’re positive for COVID-19 antibodies in the blood, it means you’ve likely been exposed to COVID-19. Although having antibodies usually gives immunity from further infection, there is not enough evidence at this time to suggest that people who have these antibodies are protected against future COVID-19 infections.

If I had more severe symptoms of COVID-19, does that mean I have a higher antibody level?
Some studies have shown that individuals with more severe symptoms develop higher antibody levels. However, although having antibodies usually gives immunity from further infection, there is not enough evidence at this time to suggest that people who have these antibodies—in any amount—are protected against future COVID-19 infections.

If I had high antibody levels, does that mean I’m better protected against COVID-19?
Some studies have shown that individuals with more severe illness develop higher antibody levels. However, although having antibodies usually gives immunity from further infection, there is not enough evidence at this time to suggest that people who have these antibodies—in any amount—are protected against future COVID-19 infections.

Can I have antibodies if I did not have any symptoms of COVID-19?
Yes. You can have IgG antibodies from an asymptomatic COVID-19 infection. An asymptomatic infection is when you are infected but do not show any symptoms.

Can my antibody value change over time?
It usually takes 10 to 18 days for IgG antibodies to be detected in your blood. Because antibodies develop over time, it’s possible that your antibody levels can change depending on when you tested.

My antibody value is low. Should I get retested to see if my result will change?
It usually takes 10 to 18 days for IgG antibodies to be detected in your blood. Because antibodies develop over time, it’s possible that your antibody levels can change depending on when you tested. However, this varies by individual. Talk with your healthcare provider or local health department about your results to see if retesting is advised.

What does an equivocal COVID-19 antibody result mean?
If your test results show that you’re equivocal for COVID-19 antibodies in the blood, this means that the results were neither positive nor negative. You will likely need to be retested in order to confirm whether or not you have antibodies in the blood. An equivocal result can happen if you do not have enough antibodies in your blood for the test to detect, such as if you test too soon after becoming infected. This result can also happen if there was a problem with your sample or the test itself.

Based on the results of my antibody test, do I need to continue social distancing and/or wearing a mask? Can I visit someone who is at risk for severe symptoms of the virus?
Although having antibodies usually gives immunity from further infection, there is not enough evidence at this time to suggest that people who have these antibodies will no longer transmit the virus. There is no test that can tell you when to stop social distancing or isolating. Check with your primary healthcare provider or local health department to help determine when it’s right to stop isolation. Be sure to continue to follow federal, state, and local government guidance regarding social distancing, wearing a mask, and hand washing. You should also use caution or avoid visiting at-risk individuals like those above the age of 65 or with pre-existing medical conditions.

If I have antibodies, am I a good candidate for donating plasma?
People who have fully recovered from COVID-19 and have antibodies are encouraged to consider donating plasma. You must be completely recovered from symptoms for at least 14 days prior to donation. If you have additional questions, please contact the donation center directly for more information.

General Test FAQs

How do I know if the COVID-19 test is accurate and reliable?
PWNHealth only uses COVID-19 tests that have received Emergency Use Authorization (EUA). These approved tests minimize the chance of inaccurate, false positive, or false negative results. The FDA has found that tests that meet certain standards are of superior quality and have high sensitivity and specificity* (measurements of accuracy).

PWNHealth will not use tests that have been shown to have low sensitivity and specificity. For additional information, please reach out to the lab directly.

*Actual sensitivity and specificity may vary between test manufacturers. A sample that is not properly collected may also result in an inaccurate result.

What is the difference between an antibody test and a PCR test?
An antibody test checks to see if you’ve developed antibodies against COVID-19, which occurs after being exposed to the virus. Antibody tests do not show whether a person is currently infected.

PCR tests check for genetic material (viral RNA) produced by the virus. It determines if you’re currently infected and can spread COVID-19 to others.

When would I get an antibody test vs. a PCR test?
You should get an antibody test to check if you’ve been previously exposed to COVID-19.

You should get a PCR test if you have symptoms of COVID-19, are a healthcare worker, or you live or work in a place where people reside, meet, or gather in close proximity. This can include homeless shelters, assisted living facilities, group homes, prisons, detention centers, schools, and workplaces.

A PCR test may also be helpful if you currently have symptoms of COVID-19 or want to check if you have the virus and can pass it on to others.

If I’m having symptoms of COVID-19 or believe I’ve been exposed to it, what type of test should I get?
If you’re currently having symptoms of COVID-19 or have recently been exposed, you should get a PCR test to see if you’re currently infected.

Can an antibody test be used instead of a PCR test to diagnose COVID-19?
IgG antibody tests do not show whether a person is currently infected. Therefore it should not be used in place of a PCR test to diagnose a current infection.

Can an antibody test be used together with a PCR test?
IgG antibody tests can complement PCR tests by providing information about exposure and how the immune system responds to COVID-19 infections.

Can a COVID-19 test tell me when I can visit someone who is at risk for severe symptoms of the virus?
There is no test that can tell you when you can visit someone who is at risk for more severe symptoms of COVID-19. Check with your primary healthcare provider or local health department to help determine when the time is right to make such visits. Be sure to continue to follow federal, state, and local government guidance regarding social distancing and isolation.

What is the difference between Emergency Use Authorization (EUA) and Food and Drug Administration (FDA) approval?
The FDA has the authority to grant Emergency Use Authorization (EUA) to diagnostic tests that have not yet received formal approval in times of a public health emergency. The FDA has granted EUA for certain tests during the COVID-19 pandemic to help detect or diagnose COVID-19.

Like full FDA approval, EUA relies on strict standards. However, EUA is completed more quickly based on the limited data that is available, unlike full FDA approval.

For more information, please visit the FDA website.

Have COVID-19 tests been approved by the Food and Drug Administration (FDA)?
The antibody tests and the molecular tests (together referred to as “tests”) have not been cleared or approved by the Food and Drug Administration (FDA);

The FDA has authorized the use of some tests by certain laboratories under Emergency Use Authorization (EUA);

The antibody tests have been authorized for the detection of antibodies against SARS-CoV-2 only, and not for the detection of any other viruses or pathogens;

The molecular (PCR) tests have been authorized for the detection of nucleic acid from SARS-CoV-2 only, and not for the detection of any other viruses or pathogens; and,

Tests are only authorized for as long as the circumstances exist to justify the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

What does “sensitivity” mean? What does “specificity” mean?
Sensitivity and specificity are different and complementary measures to inform doctors and patients about the accuracy of a test. A good test has both high sensitivity and high specificity.

Sensitivity is a measure of how well a test is able to detect people who are infected (positive cases). If a person has an infection, a test with 100% sensitivity can accurately detect it with a positive result.

Specificity is a measure of how well a test can detect people who are NOT infected (negative cases). If a person does not have an infection, a test with 100% specificity can accurately detect it with a negative result.

What are false positives and false negatives?
A positive result that is incorrect is called a false positive. False positives occur when a person tests positive even though they do not have the infection.

A negative result that is incorrect is called a false negative. False negatives occur when a person tests negative even though they do have the infection.

False negatives and positives can worsen the COVID-19 pandemic by providing false reassurance to those who have the infection or by causing those who do not have it to use critical resources.

This test request is reviewed and authorized by a physician.

Description

The detection of SARS-CoV-2 (COVID-19) IgG antibodies that indicate exposure. It normally takes IgG at least ten days to hit measurable levels after the onset of the symptoms. An IgG positive outcome may indicate an immune response to a primary SARS-CoV-2 infection, but the relationship between IgG positive and SARS-CoV-2 immunity has not yet been firmly defined. 

Antibody studies were not shown to reliably diagnose or exclude infection with SARS-CoV-2. Positive findings can also be due to past or current infection with non-SARS-CoV-2 coronavirus types, such as HKU1, NL63, OC43, or 229E coronavirus. COVID-19 diagnosis is made using molecular test methods to identify SARS-CoV-2 RNA, consistent with a patient's clinical findings.

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