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 authorized​ ​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 if you’ve been previously exposed or believe you’ve been exposed to COVID-19 and want to see if you have developed antibodies.

You should get a PCR test if you think you have an active COVID-19 infection

Visit the ​CDC website​ for more information.

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?

Antibody tests do not show whether a person is currently infected. Therefore, they 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?

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 COVID-19 safety precautions.

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.

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