COVID-19 Testing FAQs:

What is a COVID-19 PCR test?
PCR (polymerase chain reaction) tests check for genetic material (viral RNA) produced by the virus. This determines if an individual is actively infected with COVID-19 and can spread it to others.
Who should get a COVID-19 PCR test?

You should get tested 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 public health department or contact investigator has identified you as someone who should get tested.

This test may also be helpful if:

  • You have symptoms of COVID-19 and want to check to see if you have the virus and can
    pass it on to others.
  • You do not have symptoms but the health department or your clinician identified you as someone who should get tested.

If you believe you have symptoms of COVID-19 or that you have been exposed to the virus, you should consult your place of work for specific 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.

If you have any other questions, we recommend that you speak with your primary healthcare provider about testing recommendations to see if testing is right for you at this time.

What will my COVID-19 PCR test results tell me?
Your test results will confirm whether or not you are currently infected with COVID-19. If your results are positive, it is important to limit your exposure to other people and continue to monitor your symptoms. If your results are negative, the virus was not present in the sample you provided.

After receiving your results, you will have an opportunity to speak with a licensed physician, who can answer any questions you may have about your test results and help determine next steps in care.

Are there any limitations to COVID-19 PCR tests?
This test may not detect the virus in early stages of infection. Furthermore, the virus may not be detected if the sample is not collected as directed. ​Although the possibility is low, a false negative result should be considered if you have had recent exposure to the virus along with symptoms consistent with COVID-19.
How is a COVID-19 PCR test performed?
This test is conducted by saliva collection. The test requires providing a sample of your spit into a collection tube.
How do I prepare for the test?
You should not eat, drink, smoke or chew gum for 30 minutes before collecting the sample. You do not need to fast or stop taking any medications before testing. Further instructions will be provided to you once you activate your test kit
Where can I get more information?

Centers for Disease Control and Prevention: About Coronavirus Disease 2019 (COVID-19)

World Health Organization: Coronavirus disease (COVID-19) outbreak

PWNHealth: COVID-19 FAQs

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).

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 steps can I take to protect myself at work?
What steps can I take to protect myself at work?

Follow your employer’s guidance regarding ways to protect yourself and others from becoming infected with COVID-19. In general, some protective measures include, but are not limited to, the following:

  • Wearing a face mask or cloth face covering
  • Avoiding touching your face
  • Using gloves
  • Washing your hands frequently
  • Cleaning and disinfecting frequently touched objects and surfaces
  • Staying more than 6 feet away from others
  • Your employer may also have procedures in place to check your temperature regularly.

[DS1]What is the TAT from order receipt to fulfillment?
[CH2]It depends on when the sku and when they take/drop the test in mail – Once the kits are received by the lab, it’s 48 hours or less, but if we re-run samples due to inconclusive readings, it could take longer (ie 72 hours).

For this document, we should insert into the contract the below:

FLAT FEE PRODUCT
SKU’s and products listed below: Spectrum Solutions LLC SDNA-1000 Saliva[DS1] [CH2] Collection Device authorized under the Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay EUA (the “Zero Contact COVID-19 Test Kit“)

SKU | Item Number

Refer to proposal for contents

Unit Cost 

2 Day Return Mailer SKU

SKU – 1H-COV-U2DR-0407

$109

$6 revenue share per kit

FedEx Overnight Return Mailer SKU

SKU – 1H-COV-FONR-0708

$129

$6 revenue share per kit

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 previously tested positive for COVID-19, you do not need to quarantine or get tested again for up to 3 months, as long as you do not develop symptoms.

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.

What should I do if someone in my household is exposed to COVID-19 or develops symptoms?

You should also follow the precautions recommended by the Centers for Disease Control and Prevention (CDC):

  • Watch for symptoms.
    • Talk to your healthcare provider if you develop symptoms of COVID-19 (such as fever, cough, or shortness of breath).
    • Stay at home if you have any symptoms.
    • Seek emergency medical care if you experience severe trouble breathing, continuous pain or pressure in your chest, feeling confusion, difficulty waking up, blue-colored lips or face, or any other emergency signs or symptoms.
  •  Create a separate space or room for the person who is ill or has been exposed.
    • The person who is sick or has been exposed should stay in their own room or area away from others, use a separate bathroom, and eat (or be fed) in their separate area, if possible.
    • The person who is sick should limit close contact with others as much as possible (staying at least 6 feet apart) and avoid having any unnecessary visitors, especially visits by people who are at higher risk.
    • Make sure shared spaces have good airflow by opening a window and turning on a fan to increase air circulation.
  •  Keep surfaces disinfected and avoid sharing personal items.
    • Wash dishes and utensils with soap and hot water while using gloves.
    • Do not share dishes, cups/glasses, silverware, towels, bedding, or electronics (like a cell phone) with the person who is sick.
    • Clean and disinfect “high-touch” surfaces and items every day (such as tables, doorknobs, light switches, handles, desks, toilets, faucets, sinks, and electronics).

If you or a member of your household has been infected with COVID-19, please follow up with your employer before returning to work.

If someone in my household has to quarantine, should I quarantine as well?

If someone in your household is told to quarantine because they’ve been exposed to COVID-19, you should quarantine as well. This is especially true if you’ve been in close contact with that person. It’s possible for you to have the virus even if you don’t have symptoms. Quarantine should last 14 days from your last close contact with this person in order to see whether you develop symptoms. Limit close contact with others as much as possible (stay at least 6 feet apart) and avoid having any unnecessary visitors, especially people who are at high risk of severe illness. If you have questions, contact your healthcare provider for additional information.

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. Some symptoms such as loss of taste or smell may last for weeks or months and should not delay ending isolation. Those who have never had symptoms may be able to stop isolating 10 days after testing. However, those who had severe illness from COVID-19, or people with a weakened immune system, may need to isolate longer than 10 days or may require testing to determine when they can be around others.
  • 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. However, those who’ve been possibly exposed to COVID-19 but have already had COVID-19 in the last 3 months, recovered, and do not have symptoms, do not need to quarantine.

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 10 days have passed. Some symptoms, such as loss of taste or smell, may last for weeks or months and should not delay ending isolation. If you do not have symptoms, you may be able to stop isolating 10 days after your test was performed. 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.

If I can stop isolating, does that mean I can go back to work?
The decision to return to work should be determined by you and your employer based on a number of factors. Contact your employer for guidance about returning to work. Be sure to continue to follow federal, state, and local government guidance regarding social distancing and isolation.
What are the risks of going back to work too soon?

If you go back to work too soon, you risk transmitting COVID-19 to others or becoming infected with COVID-19 yourself.

  • Transmitting to others: If you’ve been infected with COVID-19, you can transmit the infection to your coworkers or customers. Many people who are infected have no symptoms. Only a PCR test can determine if you have an active infection.
  • Becoming infected: Coworkers or customers who have COVID-19 can transmit the virus to you. There is a risk of becoming infected if you have had close contact with an infected person (being within six feet of them for more than a few minutes within the past 14 days).
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. A positive PCR test result during the 90 days after illness started is most likely from the initial infection rather than reinfection. Visit the CDC website for further information.
What is “prolonged viral shedding”?
Prolonged viral shedding is what happens when parts of a virus are detectable in a person for a period of time even after they’ve recovered from an illness. For some individuals who had or have COVID-19, the virus may be in their test samples for up to six weeks. It is not known whether individuals are able to spread the virus during this period. The best available evidence suggests that most individuals who have recovered are likely no longer infectious, but there is not enough evidence at this time to confirm this. If you have questions, contact your healthcare provider for additional information.
Are the rates for COVID-19 higher in the Black and Hispanic communities? Am I more likely to get COVID-19 if I’m Black and/or Hispanic?

Data from the Centers for Disease Control and Prevention (CDC) has shown that there is a higher burden of illness and death from COVID-19 among certain racial and ethnic minority groups. Based on ​data from New York City​, Black and Hispanic people have more cases of COVID-19, as well as higher rates of hospitalization and death due to COVID-19 than White and Asian people. More studies are underway to confirm this data and reduce the impact of COVID-19 on these communities.

Whether or not you get infected with COVID-19 depends on a number of factors.

The good news is that you can control many of these factors. Visit the ​CDC website​ for more information.

Why are certain racial and ethnic minority groups impacted more by COVID-19?

Recent data suggests that COVID-19 has a greater impact on certain racial and ethnic minority groups. Health differences are often due to social and economic conditions. In public health emergencies, these conditions can isolate people from the resources they need to prepare for and respond to outbreaks.

Some conditions contribute to a higher risk of getting sick with COVID-19 for certain racial and ethnic minority groups. These conditions include:

  • Some racial and ethnic minority groups are more likely to live in densely populated areas and have multi-generational households, making it difficult to practice prevention and social distancing.
  • Racially segregated and medically underserved neighborhoods are linked to more underlying health conditions. These groups have higher rates of chronic conditions — such as heart disease, diabetes, and lung disease — that increase the severity of COVID-19.
  • Some racial and ethnic minority groups are less likely to have health insurance and have distrust of the medical system, making them less likely to seek care when they are sick.
  • Some racial and ethnic minority groups are critical workers or work jobs where they do not receive paid sick leave, making it more likely they will continue to work even when they are sick.
  • Some racial and ethnic minority groups are overrepresented in jails, prisons, and detention centers, which have specific risks due to close living quarters, shared food services, etc.
  • Some racial and ethnic minority groups don’t speak English or speak English as a second language, sometimes creating a barrier when it comes to access to care.
What is being done to help lower illness and death rates in certain racial and ethnic minority groups?
Researchers as well as state and federal governments are currently monitoring the number of COVID-19 cases, complications, and deaths in minority groups, which will help improve the management of patients, distribution of resources, and public health information.

Additionally, there are many resources available within the community, such as free and low-cost health services, grocery delivery services, and educational materials. Please contact your healthcare provider or local health department for more information.

I am Black and/or Hispanic. What can I do to lower my chances of getting COVID-19?

The best way to protect yourself is to avoid situations in which you may be exposed to the virus. If you or someone you care for is at higher risk of getting sick with COVID-19, ​take steps​ to protect them, as well as yourself, from getting sick. These steps include:

  • Stay home and follow isolation practices
  • Wash your hands often
  • Stay away from people you know are sick
  • Wear simple cloth face coverings in public settings
What is a false negative COVID-19 PCR test result?

The test can show a negative result even if you are infected with COVID-19*. This can happen if:

  • It is too soon for the test to detect the virus.
  • There was a problem with your sample or the test itself.

No test is 100% accurate at all times.

  • If your results are negative and you’re having symptoms, continue to follow isolation precautions and ask your healthcare provider if you need further testing.
  • If your results are negative and you don’t have any symptoms, continue to monitor for any symptoms up to 14 days after your last possible exposure.

*Although the possibility is low, a false negative result should be considered if you have had recent exposure to the virus along with symptoms consistent with COVID-19.

What is a false positive COVID-19 PCR test result?
This test can show a positive result even if you are not infected with COVID-19. This can happen if there was a problem with your sample or the test itself. These tests have been designed to minimize false positive results. If you are concerned about the accuracy of your results, ask your healthcare provider if you need further testing.
What does an indeterminate COVID-19 PCR test result mean?

Indeterminate means that the test did not detect a clear positive or negative result. It was unable to accurately detect COVID-19.

Your result could be indeterminate if:

  • You are infected with COVID-19 but the test was done too early to detect the virus, OR
  • There was a problem with the sample you provided or the test itself.

It is recommended that you get retested or see a healthcare provider to discuss your result and confirm next steps. To get retested, contact support@vitagene.com or ask your healthcare provider about testing recommendations.

When can a COVID-19 PCR test detect the virus?
A PCR test shows if you’re currently infected and can spread COVID-19 to others. It may take several days for the virus to be detected, so the test may not identify the virus if you were recently infected.
If I have a positive PCR test result, can I pass the virus to others?

A PCR test shows if you’re currently infected and can spread COVID-19 to others. However, it is possible to have a positive PCR test result for up to 6 weeks after infection. How long someone remains infectious varies by individual and depends on the severity of illness. To prevent the spread of COVID-19 and protect people in your home and community, follow ​these guidelines​ provided by The Centers for Disease Control and Prevention (CDC).

What is contact tracing?
Contact tracing is a process done by local and state health departments to help prevent the spread of COVID-19. Public health officials work with patients diagnosed with COVID-19 to help them recall everyone they may have had close contact with when they were infectious. Public health officials then notify these contacts that they may have been exposed to COVID-19. Contacts are provided with education, information, and support to understand their risk, testing, next steps, and how to monitor themselves for illness.
How do I know if the COVID-19 PCR test is accurate and reliable?

Vitagene only uses COVID-19 tests that have received FDA Emergency Use Authorization (EUA) in order to 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).

Vitagene 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 molecular PCR test to see if you’re currently infected.

Can an antibody test be used instead of a PCR test to diagnose COVID-19?

A​ntibody tests do not show whether a person is currently infected. Therefore​, they​ ​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?

A​ntibody 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 Food and Drug Administration (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 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);

Vitagene’s COVID-19 test and partner lab have received FDA EUA authorization;

These 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.