COVID-19 (formally known as 2019-nCoV) is the name for the respiratory syndrome caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The World Health Organization has declared COVID-19 a pandemic.
Symptoms of COVID-19 include fever or chills, new loss of taste or smell, cough, sore throat, shortness of breath or difficulty breathing, fatigue or lethargic, muscle or body ache, dizziness, headache, nausea or vomiting, diarrhea, slurred speech, and/or seizures.
If you experience symptoms of COVID-19 and want to get tested, call your healthcare provider first. Your healthcare provider can review your symptoms to determine if and what appropriate testing is needed.
Two types of tests are available for COVID-19 – a molecular test to detect active infection and an antibody test that might tell you if you had a past infection.
The molecular test for active infection involves collecting swab specimens from your nose or throat. The antibody test involves collecting a sample of blood. Your specimens will be sent to labs like TargetDx for advanced testing.
TargetDx Laboratory offers both molecular and antibody COVID-19 tests.
For post-infection antibody test, TargetDx utilizes an immunoassay for in vitro qualitative detection of antibodies (including IgG, IgA, and IgM) to SARS-CoV-2 in human serum and plasma. This test is intended as an aid in the determination of the immune reaction to SARS-CoV-2 virus. The test is FDA-approved for use under Emergency Use Authorization (EUA).
For the molecular test to detect active infection, TargetDx utilizes a real-time reverse transcription polymerase chain reaction (RT-PCR) intended for the qualitative detection of nucleic acid from SARS-CoV-2. This test is FDA-approved for use under Emergency Use Authorization (EUA).
Lab test accuracy is measured in two ways—specificity and sensitivity.
The molecular test (for active infection) currently offered and performed by TargetDx has been validated for FDA Emergency Use Authorization (EUA) for the current pandemic. Based on a validation study using 20 bronchoalveolar lavage (BAL) and 20 NP (Nasopharyngeal) swabs, the test was able to detect 100% of positive specimens accurately.
The antibody test currently offered by TargetDx Laboratory has specificity value of 99.5% which keeps false positive results to a minimum. The antibody test sensitivity value is approximately 99.5% to 100%. This test has met validation standards and been granted Emergency Use Authorizations (EUA) by the FDA for public health and clinical use.
An antibody test might not show if you have a current infection because it can take 1–3 weeks after infection for your body to make antibodies.
You are considered “recovered” from COVID-19 and no longer infectious if it has been at least 10 days from the start of your first symptoms, and at least 24 hours without a fever, and all other symptoms have improved.
An antibody test may also be able to detect if you previously had an infection and already recovered, even if you had never experienced symptoms.
Antibodies are proteins that help fight off infections and can provide protection against getting that disease again (immunity).
More research is needed on this because it is not yet known how long antibodies will last after infection and whether antibodies offer short- and/or long-term protection against getting infected again.
Knowing if you currently have COVID-19 gives you the information you need to self-isolate and protect everyone around you.
If you suspect you have COVID-19 or were recently in contact with someone who had it, a swab test can tell you whether you have an active infection.
If you suspect that you previously had COVID-19, even if you had never experienced the symptoms, you can take an antibody blood test to confirm prior infection. If the test detects antibodies, you may possibly have a lower risk of re-infection.
Understanding your antibody status also gives you and your healthcare provider the insight to make an informed decision about returning to activity. Other reasons why it’s beneficial to know if you are positive for COVID-19 antibodies include:
1- Encouraging those you were in contact with to talk to their doctor about getting tested
2- Reducing the need to be monitored and retested for COVID-19 infection
3- Donating plasma for those who are seriously ill from COVID-19
4- Doing your part to slow the spread of the virus by being counted in global pandemic statistics
The typical turnaround time is 2-5 business days. The quickest way to get your test result is through the secured online patient portal.
Testing for an active COVID-19 infection or antibody cannot be ordered online. If you suspect you have an active COVID-19 infection or have been exposed to the virus, contact your doctor or an authorized healthcare provider. If testing is right for you, your healthcare provider will direct you to where to get tested.
Yes, it is possible. You may test negative if the sample was collected early in your infection and test positive later during this illness. You could also be exposed to COVID-19 after the test and get infected then. Even if you test negative, you still should take steps to protect yourself and others.
This test is designed to detect antibodies to SARS-CoV-2, the virus that causes COVID-19. Antibodies are proteins that the body produces in response to infections. The antibodies can be produced even if a person has few or no symptoms during the infection.
It generally takes some time after infection for antibodies to be produced and become detectable in blood (sometimes up to 3 weeks).
It is important to remember that we do not yet know whether having antibodies to SARS-CoV-2 will prevent getting the infection again or if you are totally free of the virus.
Even if you have recovered and have antibodies, there is a chance that you still have the virus and you can infect others. It is still critical to keep taking measures to avoid getting infected again and/or spreading the infection.
For detecting active COVID-19 infection, the swab test (also known as a molecular, RNA or PCR test) should be used.
A negative antibody test result means that antibodies were not detected in your blood sample. This can have few possible implications:
1 – You have not been infected with SARS-CoV-2, or
2 – You have been infected with SARS-CoV-2, but your antibodies have not reached a sufficient level for the test to be able to detect them, or
3 – You have been infected with SARS-CoV-2, but there has not been enough time for antibodies to develop (it can take up to one to three weeks to develop antibodies after someone is infected, sometimes longer).
A positive antibody test result means that antibodies were detected in your blood sample. This can have several possible implications:
1 – You have potentially been exposed to SARS-CoV-2 in the past.
2 – A positive result does not preclude that you may still be contagious.
3 – It is unknown how long antibodies to SARS-CoV-2 will remain present in the body after infection and if they confer immunity to infection.
4 – False positive results may occur due to cross reactivity from pre-existing antibodies or other possible causes.
The antibody test and the molecular test (together “All tests”) have not been FDA cleared or approved.
1- All tests have been authorized by FDA under Emergency Use Authorization (EUA) for use by authorized laboratories.
2- The antibody test has been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
3- The molecular test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses, pathogens.
4- All tests are only authorized for the duration of the declaration that circumstances exist justifying 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.