What is coronavirus (COVID-19)?
The Coronavirus Disease 2019 (also called COVID-19) is a serious respiratory illness. It is caused by SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), one of the most recently discovered types of coronaviruses. It was first identified in Wuhan, China, at the end of 2019 and has spread globally, becoming a worldwide pandemic. Those who have this disease may or may not experience symptoms, which range from mild to severe.
What are the symptoms?
Individuals with COVID-19 typically develop fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing) but the full clinical spectrum of disease is not yet known. Signs and symptoms may appear any time from 2 to 14 days after exposure to the virus. Based on preliminary data, the median incubation period is approximately 5 days, but may range 2-14 days. Please see the CDC website for a complete list of symptoms and to access their symptom checker tool: https://www.cdc.gov/coronavirus/2019-ncov/index.html.
Am I at-risk for COVID-19?
COVID-19 is extremely contagious. It spreads from person-to-person when an infected person coughs, sneezes, or exhales air. The droplets containing the virus go into the air and onto the surfaces and objects around them. Breathing in these droplets (or then touching your mouth, eyes, or nose) or touching infected surfaces exposes you to the virus. The risk of getting COVID-19 is increased if you have close contact with people who have symptoms of COVID. Additionally, where you live and work may also increase your risk to contract the virus. Some recent studies have suggested that COVID-19 may be spread by people who are not showing symptoms. To protect yourself from exposure, it is important to follow the guidelines and recommendations issued by the federal, state, and local governments.
Who is considered high-risk for the disease?
Most people have mild symptoms. 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 disease (such as stroke) can also occur in younger, healthy adults.
Should I get testing for COVID-19?
- This test may also be helpful for anyone who has symptoms of COVID-19 and wants to check to see if they have the virus and can pass it on to others.
- If you are a healthcare professional, first responder, frontline worker, critical infrastructure worker, or live or work in a place where people reside, meet, or gather in close proximity (such as assisted living facilities, group homes, schools, homeless shelters, prisons) and believe you have been directly exposed to someone with COVID.
- If exposure is suspected, then you should consult your place of work for specific occupational health guidance about testing and whether to stay home or continue working while waiting for your results. You should adhere to recommendations set forth by your employer or the department of health, as they may differ from the CDC’s guidelines for testing https://www.cdc.gov/coronavirus/2019-ncov/downloads/priority-testing-patients.pdf.
- Individuals with the highest risk of infection should also consider testing.
How can I protect myself and prevent the spread of COVID-19?
- There are currently no vaccines for COVID-19. The best way to protect yourself is to avoid being exposed to the virus.
- Everyday actions can help protect you and prevent the spread of respiratory diseases such as COVID-19. These include:
- Avoid close contact with people who are sick (within 6 feet of one another), even within your home.
- Stay home when you are sick, unless you are seeking medical care.
- Put distance between yourself and other people outside of your home.
- Restrict any activities outside your home and maintain a safe distance (around 6 feet) between yourself and other people. Stay out of crowded places (such as public transportation, religious gatherings, shopping plazas) and avoid mass gatherings.
- Wear simple cloth face coverings in public settings (like grocery stores and pharmacies) where social distancing is difficult. The cloth face cover is meant to protect other people in case you are infected. Remember individuals without symptoms can still have and spread COVID.
- Wash your hands often with soap and water for at least 20 seconds.
- Clean and disinfect frequently touched objects and surfaces (including tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks).
- 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.
- Please see https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html for additional information.
When should I seek medical care?
- If you think you have been exposed, it is important to closely monitor for symptoms. Most mild cases of COVID-19 resolve within 2 weeks without treatment. Seek medical attention immediately if you develop severe symptoms, especially if you experience any of the following:
- Severe trouble breathing and shortness of breath
- Continuous pain or pressure in your chest
- Feeling confused or having difficulty waking up
- Blue-colored lips or face
- 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 an EUA and what does it mean?
- EUA stands for Emergency Use Authorization, which is a declaration allowing for the emergency use of an in vitro diagnostic (IVD) test for the detection and diagnosis of the coronavirus (COVID-19). An EUA is declared by the FDA and supported by the Secretary of Health and Human Services.
- This test has been authorized only for the detection of nucleic acid from SARS- CoV-2, and not for any other viruses or pathogens.
- This test has not been FDA cleared or approved.
- This test has been submitted to the FDA for authorization FDA under an EUA for use by authorized laboratories.
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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.
How can I order this test?
At this time the test is only available for ordering by healthcare providers based on guidance provided by the FDA. We are working with telehealth providers to make the test more accessible if/when FDA guidance allows for at-home testing.
Pricing of the test only covers our expenses, including shipping, cost of performing the test in the lab inclusive of all reagents consumables, staff and equipment at no profit to the company.
How do I get the report?
You will be notified by email once results are available. Reports can be accessed in your provider portal.
What technology do we use?
Real-time reverse transcription polymerase chain reaction (rRT-PCR) is utilized for the detection of nucleic acid from Sars-CoV-2 in the provided specimen. This test is not appropriate for the detection of other viruses or pathogens. The test is looking for the presence (positive result) or absence (negative result) of the virus SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) which causes the disease “Coronavirus Disease 2019” (COVID-19).
What type of sample is needed for testing?
The Veritas rRT-PCR test is authorized for use on respiratory specimens, specifically a nasopharyngeal swab, from individuals suspected of COVID-19 by their healthcare provider. Specimens should be collected with the appropriate infection control precautions and the appropriate personal protective equipment must be used when collecting and handling specimens from individuals suspected of having COVID-19, as outlined by the CDC.
When would I get a molecular (PCR) test vs. a serology (antibody) test?
- Molecular tests, also called PCR (polymerase chain reaction), check to see if the virus SARS-CoV-2 (COVID-19) is present or absent, which may be helpful for anyone who has symptoms of COVID-19 and wants to check to see if they have the virus and can pass it on to others.
- Serology tests, also called antibody (IgG, IgM) testing, check to see if you’ve developed antibodies against the virus SARS-CoV-2 (COVID-19), which occurs after being exposed to the virus. Serology tests do not show whether a person is currently infected. (COMING SOON)
What does a POSITIVE test result mean?
- A positive result indicates the detection of viral RNA in the provided sample, thus confirming a diagnosis of COVID-19 in an individual with signs and symptoms of the disease. The individual is considered affected and contagious. Medical management should follow current CDC guidelines.
- Public health officials may request that samples from individuals who tested positive be sent to them for additional testing.
- Asymptomatic individuals with a positive result have been reported. However, the interpretation of a positive result in these cases remains unclear given the incubation and transmission periods of the disease remains unknown. Although false positive (incorrect positive) results are rare, they have been reported and may lead to unnecessary isolation, management, and treatment.
- A false positive may also occur if there was a problem with your sample or the test itself. However, 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.
- The state of Massachusetts requires that laboratories performing COVID-19 testing report all patient results to the Department of Public Health for epidemiological purposes.
What does a NEGATIVE test result mean?
- A negative result indicates that the viral RNA has not been detected in the sample.
- Please note that the absence of viral RNA does not rule out a diagnosis of the disease in individuals with signs and symptoms of COVID-19. A false negative (an incorrect negative) result should be considered if the individual has signs and symptoms, has had a known exposure, and other diseases have been ruled out. Additional testing in these instances may be recommended and considered.
- False negative results may also occur for the following reasons:
- 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.
- Due to limited disease knowledge at this time and known test limitations, a negative result should not be the sole determinant for treatment and management decisions. Clinical correlation and epidemiological information must also be considered when making these decisions.
- The state of Massachusetts requires that laboratories performing COVID-19 testing report all patient results to the Department of Public Health for epidemiological purposes.
What does an inconclusive result mean?
An inconclusive result indicates that not all testing targets were detected in the sample. An additional sample may be requested to complete testing.
What is an INVALID result?
An invalid result occurs when a sample fails testing. There may be sample and/or technical reasons for this to happen. Recollection of a new sample is needed to complete testing.
What is a serology (antibody) test?
A serology test looks for antibodies in the blood. Your immune system makes antibody proteins to help fight infections. If you were exposed to SARS-CoV-2, a serology test will show whether or not you have developed antibodies against SARS-CoV-2. These antibodies usually reach detectable levels in the blood about 10 to 18 days after symptoms start.
What is the accuracy of your antibody (serology) test?
Based on a clinical validation study of 30 confirmed positive serum samples and 80 negative serum/plasma samples performed at a federally funded NCI lab, the accuracy of this assay is 97.2% (95% C. I. 92.24% to 99.43%). You can find the Serology Test Evaluation Report from NCI here.
How are serology (antibody) test performed?
Serology tests are collected through a blood sample (such as from a blood spot, finger prick, or needle draw).
Which antibodies can a serology test detect?
A serology test can measure two antibodies called Immunoglobulin M (IgM) and Immunoglobulin G (IgG). IgM is produced as the body’s first response to a SARS-CoV-2 infection. Generally, IgM may provide short-term protection and can help tell if an individual has been recently infected. However, there is not enough evidence at this time to suggest that people who have IgM antibodies are protected against future SARS-CoV-2 infections. IgG is the most common type of antibody. It’s made several days to weeks after being exposed to SARS-CoV-2. Generally, IgG remains in the body and may provide long-term protection against future exposure. However, there is not enough evidence at this time to suggest that people who have IgG antibodies are protected against future SARS-CoV-2 infections.
When do IgG antibodies develop?
Based on the most current research, IgG antibodies develop around 15-21 days after infection from SARS-CoV-2.
What will a serology (antibody) test tell me?
An antibody test can tell you whether or not you have been exposed to SARS-CoV-2 (COVID-19), and if your your immune system has responded by making IgG antibodies. In the future, IgG antibody tests may be able to tell us whether an individual has immunity against SARS-CoV-2 (COVID-19).
What will a serology (antibody) test NOT tell me?
An antibody test cannot be used to diagnose COVID-19 nor does it show if a person is currently infected. If you are having symptoms of COVID-19 or have recently been exposed, you should get a molecular PCR test to see if you are currently infected with the virus.
What are there limitations to IgG antibody tests?
It usually takes around 15 to 21 days after being infected with SARS-CoV-2 (COVID-19) for the body to produce enough antibodies for detection in the blood. Getting an IgG antibody test too soon after being infected may cause a negative result that is false (false negative). Additionally, IgG antibody tests may detect IgG antibodies from previous exposure to coronaviruses other than SARS-CoV-2 (COVID-19) . This can cause a positive result that is false (false positive). There is not enough evidence at this time to suggest that people who have IgG antibodies are protected against future SARS-CoV-2 (COVID-19) infections.
What does a positive result mean?
A positive test result with the SARS-CoV-2 antibody test indicates that IgG antibodies to SARS-CoV-2 (COVID-19) were detected, and the individual has potentially been exposed to COVID-19.
Antibodies typically suggest protective immunity from further infection. However, evidence is still being collected to determine if IgG antibodies provide protective immunity against future SARS-CoV-2 infections.
There is also the small chance that this test can give a positive result that is wrong (a false positive result). It is not known how long antibodies to SARS-CoV-2 will remain present in the body after infection. and it is not known if they confer immunity to infection. If you have been previously diagnosed with or exposed to other types of coronaviruses, there is a possibility of a false positive. There is also a possibility of a false positive if it’s unlikely you had SARS-CoV-2 based on your exposure history or symptoms.
Your healthcare provider will work with you to determine how best to care for you based on the test results along with other factors of your medical history, and your symptoms, possible exposures, and geographic location of places you have recently traveled.
Your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in making a final diagnosis and deciding how to care for you. It is important that you work with your healthcare provider to help you understand the next steps you should take.
What does a negative result mean?
- A negative result means IgG antibodies were not detected in the provided blood sample.
- This may suggest no exposure to SARS-CoV-2 (COVID-19) or it may indicate that IgG antibodies have not yet developed. It takes approximately 15-21 days for the body to generate an immune response to COVID. If you test too soon, your body may not have produced enough IgG antibodies to be detected by the test yet. If that is the case, retesting may be needed.
- If you were recently diagnosed with COVID-19, were exposed to someone with COVID-19, or previously had symptoms of COVID-19, there is a possibility of a negative result that is wrong (false negative). In this situation, a molecular test for COVID should be considered as you may still have COVID.
- The risks of a false negative result may include unnecessary self-isolation and quarantine, activity restrictions, and other unintended adverse events.
- Your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you. It is important that you work with your healthcare provider to help you understand the next steps you should take.
- A negative result may not provide enough evidence to determine an individual’s risk and thus should not be used to rule out infection.
What does an inconclusive result mean?
An inconclusive result means the test was unable to confirm the presence or absence of IgG antibodies in the provided sample. This means that the results were neither positive nor negative. Testing will need to be repeated in order to confirm whether or not IgG antibodies are in the blood. This type of result may occur when there is not enough antibodies for the test to detect, such as performing the test too soon after becoming infected. This result can also happen if there was a problem with the blood sample or the test itself.
What does an invalid result mean?
An invalid result means the test could not be performed. Another sample will be needed to confirm the presence or absence of IgG antibodies. This type of result can happen if there was a problem with how the sample was collected or transported, or issues with the sample or test itself.
My serology (antibody) test was positive, but I’m still having symptoms. What should I do?
If you are having symptoms of COVID-19, contact your healthcare provider or local health department to get tested for active infection. The serology (antibody) test can only tell you if you have been exposed and have developed an immune response to COVID-19, but it cannot say whether you have an active infection. For that, you’ll need a molecular (PCR) test. Please click here to learn more about our Molecular test.
My serology (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 15 to 21 days after being infected with SARS-CoV-2 (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 re-testing is needed.
Can I take a serology (antibody) test to see when I can go back to work?
No. There is no test that can tell you when it’s right to go back to work. The decision to return to work should be determined by you, your healthcare provider (if applicable), and your employer based on a number of factors. Contact your employer for guidance about returning to work.
Can I take a serology (antibody) test to see if I can stop isolating?
No. There is no test that can tell you when to stop 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 and Isolation.
Can I take a serology (antibody) test to determine when I can visit someone who is at risk for more severe symptoms of COVID-19 (i.e., those 65 years of age or older or someone with an underlying medical condition)?
No. 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.
When will I get my myGenome report?
- Your myGenome report will take 16 weeks starting from the date our lab receives a viable sample and validates the order
- Your account portal allows you and your physician to check in on your report status to see where your sample is in the process
- Reports can be and normally are distributed to both the customer and the customer’s authorizing physician or healthcare provider
- It is our normal practice to release a patient’s report to their physician 72 hours before they get a copy as this time lag allows the doctor to discuss any sensitive findings with you before you see them, if they/you wish
What is the turnaround time for each test?
- The duration is 16 weeks for myGenome tests
- The duration is 16 weeks for myGenome with Diagnostic Interpretation (myGenomeDx)
Can I get my raw data file?
- Yes, Veritas offers raw data in the form of a Variant Call File (VCF, a specific format of a text file used in bioinformatics for storing gene sequence variations) for certain tests
- To receive this file you can place an order after your report is released by emailing Customer Support at email@example.com
- The VCF costs $99 and is available to be delivered 5 to 7 days after your order is placed. Pricing is subject to change.
Why do I need a doctor to authorize the myGenome test?
- It is our policy that all tests require a physician to authorize the test, because:
- A physician can help guide you to better understand and review your test results.
- our physician can assist you in making medical and lifestyle decisions based on your myGenome report.
- It is important for your doctor to be aware so he/she can help you make informed medical decisions for your future.
- If you don’t have a physician, prefer not to involve your physician/healthcare provider, or if your provider is not responsive/ willing to sign off, we offer access to third party physicians to streamline ordering and increase privacy, for an additional fee.
- For anyone who wants to be proactive about their health
- Insights on 59 highly actionable conditions and 24 carrier conditions
- Genetic results informing drug sensitivities
- Information on 50+ traits and ancestry
- NEW Veritas Risk Section on lower-impact genetic findings that contribute to 15 common diseases whose risk can be minimized proactively by lifestyle changes
- Review of actionable medical findings with a genetic counselor
Can I change my doctor?
- Yes, please call Customer Support to receive the proper form.
Am I eligible for genetic counseling?
- If you have a finding located in the red, “Very Important”, section of your report, you are eligible for a complementary 15-20 minute Genetic Counseling session
- If you have no red, “Very Important” findings, but would still like to receive genetic counseling, a 60 minute session is available for $299.
- The genetic counselors will NOT review your raw data
What is myGenome with Diagnostic Interpretation (myGenomeDx)?
- myGenome with Diagnostic Interpretation (myGenomeDx) is a genetic test that utilizes whole genome sequencing (WGS) with diagnostic interpretation to help identify a condition suspected to have a genetic cause.
- Additionally, if requested, the test can include genetic results informing drug sensitivities and, for adults, a full myGenome report.
Who is myGenomeDx for?
- myGenome with Diagnostic Interpretation is for patients with a complex medical history or symptoms suggestive of a genetic condition, even if other genetic tests have shown a negative result.
How do I order myGenomeDx?
- myGenome Diagnostic orders must be initiated by a physician.
- Please contact Customer Support for further information for you and your doctor
- If you don’t have a physician, prefer not to involve your physician/healthcare provider, or if your provider is not responsive/willing to sign off, we offer access to third party physicians to streamline ordering and increase privacy, for an additional fee.
How do I upgrade from myGenome to myGenomeDx?
- Please call Customer Support for assistance
Does myGenome test for specific genes?
- We do not test for specific variants
- We test for the most actionable genes put forth by the ACMG59. ACMG refers to a list of 59 genes deemed medically actionable by the American College of Medical Genetics and Genomics (Kalia, 2017 PMID 27854360).
- If you have a common variant in your genome, we will find it
- If you are searching for a specific gene or variant, consult with a Genetic Counselor before you purchase the test
- Please reference our resources page for the specific list of genes tested for in myGenome: https://www.veritasgenetics.com/ mygenome/technical
Does my data get deleted or is it saved by Veritas Genetics?
- Your data is encrypted in our cloud once the DNA sample has been sequenced
- We do not sell this information to 3rd parties without your consent
How does Veritas ensure my data is safe?
- Veritas adheres to US law for the Health Insurance Portability and Accountability Act (HIPAA) to protect confidentiality
- Veritas also adheres to European General Data Protection Regulation (GDPR), and is in the process to applying this protection for consumers in the US. This means, for example, that you are able to update data and contact consents you have provided when placing your order or subsequently.
- If you are ordering through the website, your report is only given to you and your primary care physician
- If you decide you want us to remove this information from our encrypted cloud, we have a form that we will ask you to sign to authorize Veritas to remove this record.
- It is Veritas Genetics’ policy that genomic data, including VCF (variant call file) and BAM, be kept for 10 years for regulatory and legal archival purposes and no other use.
- If you request to have your data destroyed, it will NOT be used for research; however, it remains securely filed for 10 years as stated above.
- Be aware that you will not be eligible for any future updates in our services if you have requested to destroy your records.
- If you want to have your data removed from our system, please call Customer Support for assistance
I am a physician, may I authorize my own test?
- AMA discourages physician self orders however it is not disallowed. Thus Veritas may accept self ordered tests.
- Veritas also highly discourages customers from using relatives who are physicians for their test order
Where am I able to order a myGenome test from?
- We can fulfill orders from anywhere within the United States, but we are unable to ship to New York due to differences in regulations regarding genetic testing. Because of this, if the physician authorizing your test is based in New York, kindly ensure they are licensed to practice in an additional state.