COVID 19

What is COVID-19?

• COVID-19 is a severe respiratory illness caused by the SARS-CoV-2 virus, a type of coronavirus. It was first discovered in Wuhan, China, in 2019. Since then, it has become a global pandemic, leading to nearly 7 million reported deaths in the three years since its discovery. Vaccines have been developed and distributed, and new variants of the SARS- CoV-2 virus have emerged.
• SARS-CoV-2 is a spherical virus with four significant proteins: nucleocapsid protein (NP), spike protein (SP), membrane protein (MP), and envelope protein (EP). The spike protein (SP) plays a crucial role in infecting host cells by binding to the ACE2 receptor.
• People with COVID-19 may have varying symptoms, ranging from mild to severe, or they may not experience any symptoms at all.

PATIENT-CENTERED

When can I be tested?

• Testing is by appointment only and is subject to availability.

Am I required to show ID?

• Yes. Bring a form of personal identification to your test. This helps ensure that your test results are matched to the right person. Your identity and your test results are protected by federal law and will not be shared with any other agencies for purposes of law enforcement or immigration.

Can I schedule an appointment if I am not a resident of the area?

• Yes. Testing is available for anyone.

How do I cancel my appointment?

• You may cancel your appointment by clicking on the ‘Cancel’ button on your home page.

When do I need to arrive for my appointment?

• Please arrive at the scheduled time listed on your confirmation email.

Can I bring other people with me?

• If you’re signing up for yourself and someone else, simply complete the signup process for yourself and then click the ‘Add another person to my appointment’ button.
• Each patient must have their own appointment. If you are ill and experiencing symptoms consistent with the FLU or COVID-19 then you should not take a COVID-19 Antibody test and instead re-schedule for a COVID-19 test with our Pharmacy.

Can I have other people in my car when I arrive for testing?

• Yes, because you are only testing for Antibodies to COVID-19 and not for a diagnosis of illness you can have others arrive with you. If you are ill and experiencing symptoms consistent with the FLU or COVID-19 then you should not take a COVID-19 Antibody test and instead re-schedule for a COVID-19 test with our Pharmacy.
• If someone else in your car, who is also not experiencing symptoms consistent with the FLU or COVID-19, and they would like to be tested for Antibodies they must be added to your appointment.
• You can add other people to an appointment by clicking on the ‘Add another person to my appointment’ button. Only those with appointments will be tested.

How long will the test take?

• The testing process should not take more than 10 minutes. Results will be available within 3-5 days of receipt at the lab. You should have your result in about 1 week from the date of the test.

Why would I want an antibody test? What is the potential benefit?

• An antibody test can provide important information about your COVID-19 history. It can confirm if you've been infected with the virus, even if you had mild symptoms or were asymptomatic.
• Knowing this information can be valuable as we navigate the pandemic.

When should I get the antibody test?

• It's essential to time your COVID-19 antibody test correctly:
• Wait at least 21 days after your symptoms start or after testing positive for COVID-19 before taking the test.
• Avoid getting the antibody test within 14 days of receiving a COVID-19 vaccine.
• Ensure that your symptoms have improved and you have been fever-free (without fever- reducing medication) for 24 hours before taking the test.
• Current research suggests that the best timing for antibody testing is 3 to 4 weeks after symptom onset or known exposure to COVID-19 to minimize the risk of false-positive or false-negative results. Consult your healthcare provider for guidance.

What does semi-quantitative mean to me or my provider?

• A semi-quantitative test provides a numerical result. Still, it's essential to understand that this number doesn't indicate whether any level of antibodies will protect you from getting infected again or reduce the severity of future COVID-19 symptoms.
• The exact relationship between antibody levels and protection is still being studied.
• However, the numerical result can help establish a baseline for your current antibody levels, which your healthcare provider can use for future comparisons.
• Your healthcare provider will use the test results with your medical history, symptoms, possible exposures, and other factors to determine your best care plan.
• The Mobility Health COVID-19 Antibody Response Test is a multiplexed immunoassay test for IgG antibodies to the COVID-19 Spike glycoprotein S1 domain (SP), which is semi-quantitative, and the Nucleocapsid protein (NP), which is qualitative, in saliva samples.

Are there any risks involved in taking this test?

• The risk associated with this test is minimal as it involves collecting a saliva sample. However, if you are allergic to plastic, be cautious because the collection device is designed to contact your lips.
• If you have a plastic allergy, consult your provider for guidance on collecting the saliva sample.

What if I have had known exposure or currently have symptoms of COVID-19? Should I get an Antibody test?

• No, if you have symptoms of COVID-19 or known exposure to someone with COVID-19, you should not get an Antibody Test. Instead, you should undergo a Diagnostic test to check for current SARS-CoV-2 infection.
• Suppose you've had symptoms of COVID-19 within the last 21 days. In that case, your antibody test results may be negative due to the kinetics of seroconversion, meaning that measurable antibodies may not be present until more than 21 days after symptom onset.
• Mobility Health can provide a RT-PCR diagnostic test to identify if you are currently infected with COVID-19.

How do I order the test?

• To order the test, your healthcare provider will give you access to the Patient Portal or use the provider portal to requisition the test on your behalf.

How do I prepare for the test?

• To prepare for the test:
• Refrain from eating, drinking, smoking, using tobacco products, or chewing gum for 30 minutes before using the saliva collection kit.
• Wait 30 minutes to elapse after any of the above activities before collecting your saliva sample.
• Collecting up to 2ml of saliva may take 1-2 minutes or longer, depending on your saliva production. It may take longer for individuals over 65 or those taking medications that cause dry mouth. If you have a dry mouth due to medications, consult your pharmacist or doctor for assistance.
• There are no other specific preparations required for this test except meeting the criteria for testing (asymptomatic for at least 21 days, no COVID-19 vaccination within the last 14 days).

Do I need to provide my insurance information?

• Yes, unless you opt to pay cash for the test, you must provide your insurance information in the patient or provider portal during the requisition process.
• If you have Medicare as your insurance, you must process the test through your insurance and cannot pay cash for it.

How much will this COVID-19 antibody test cost me?

• The cost of the test depends on your insurance coverage:
• If you request the test through your doctor, there is no upfront cost.
• If you are not a Medicare patient and do not want to bill your insurance plan, you can pay cash for the test for $119.99.
• If you have Medicare as your insurance, you must process the test through your insurance, and you cannot pay cash for a test covered by Medicare.

Do I have to pay for the shipment of the test?

• No, the courier service for shipping the test is provided at no charge by Mobility Health.

When can I receive my results? Where are they reported?

• Your results will typically be available within 3-5 days after receiving the sample in the Mobility Health Laboratory.
• You can access and print your results by signing into your Mobility Health Patient account in the patient portal. Your healthcare provider can also access and provide your results through their Mobility Health provider portal.
• Additionally, your results will be reported to public health authorities as required by law.

What will my results tell me?

• Your test results will provide information about your COVID-19 antibody status:
• If you've received a COVID-19 vaccine, you should show antibodies.
• If you test positive for SARS-CoV-2 antibodies and haven't been vaccinated, it likely means you've had the virus. However, a "false positive" is possible if you have antibodies from a different coronavirus.
• A positive result may suggest some level of immunity to the coronavirus, but the strength and duration of this immunity are still being studied.
• A negative result means you haven't encountered the virus or had it long enough to develop antibodies. It's also possible to be exposed and not develop antibodies, resulting in a false negative.
• It's important to note that having antibodies doesn't guarantee immunity against future SARS-CoV-2 infections.

ANTIBODY TESTS

What are antibodies?

• Antibodies are proteins created by your immune system to fight infections, including those caused by viruses. Some of these antibodies can protect against specific infections. Your immune system can also learn to make antibodies through vaccination, and their protection can vary for each disease and person.

Can this test diagnose COVID-19?

• No, antibody tests cannot diagnose COVID-19.

What's the difference between a coronavirus test and an antibody test?

• A coronavirus test, also known as a diagnostic test, checks for active virus presence faster than an antibody test. It only tells you if you currently have the virus.
• An antibody test reveals whether you had the virus in the past but doesn't indicate whether you're currently contagious. It looks for two types of antibodies: IgG, which appears later after infection, and IgM, which is present closer to the time of infection.
• Our test focuses on IgG, offering insight into your longer-term response to COVID-19.

Why do we need antibody testing?

• For clinically vulnerable individuals, antibody testing and medical records can guide their COVID-19 care plan. Some people may have had the virus without symptoms, and antibody tests help health officials gauge the virus's prevalence.

How does an antibody test work?

• You'll receive a saliva collection kit from a technician. The test checks for IgG antibodies, which usually appear about 14 days after symptoms start. These antibodies can remain in your blood even after the infection has been resolved.

What types of samples are used for antibody tests?

• Antibody tests can use serum, plasma, or saliva samples. Saliva- based tests are non-invasive and accessible to a broader range of patients. IgG levels in saliva correlate with levels in serum/plasma, allowing for effective monitoring of antibody changes over time.
• The Mobility Health COVID-19 Antibody Response Test detects IgG levels in saliva for NP (Nucleocapsid Protein) and SP
  (Spike Protein).

What is the difference between spike and nucleocapsid proteins?

• Spike and nucleocapsid proteins are both viral structural proteins. Spike facilitates the virus's entry into human cells, while nucleocapsid organizes viral RNA.
• Antibodies to the SP (spike protein) have neutralizing effects. Current vaccines target them.
• Antibodies to the NP (nucleocapsid protein) indicate prior infection but don't help detect vaccine-induced antibodies.
• The Mobility Health COVID-19 Antibody Response Test detects both SP and NP IgG levels from saliva.

What are neutralizing antibodies, and why are they important?

• Neutralizing antibodies prevent virus replication and offer protection against infection. They play a crucial role in reducing the severity of illness.
• The Mobility Health COVID-19 Antibody Response Test detects these neutralizing antibodies, which have been shown to predict immune protection. Neutralizing antibodies interfere with the virus's ability to bind to the ACE2 receptor and enter host cells, making them vital for immunity.
• The Mobility Health COVID-19 Antibody Response Test provides a semi-quantitative score for the SP, which plays a role in determining the neutralizing antibody levels.

Are COVID-19 antibody tests accurate?

• The Mobility Health COVID-19 Antibody Response test measures antibodies to the spike and nucleocapsid proteins. It can distinguish between antibodies from natural infection and vaccination.
• The test's accuracy demonstrates 96% Sensitivity and 100% Specificity (0% False Negatives), making it highly reliable in detecting antibodies 21 days or more after symptom onset. This ensures that the antibodies detected are specific to the COVID-19 virus and not another virus you may have been exposed to.
• In its internal validation studies, the Mobility Health COVID-19 Antibody Response Test demonstrated an overall accuracy of 95%, an overall Intra-Assay Precision of 96%, and an overall Inter-Assay Reproducibility of 97%, confirming and documenting its strong performance characteristics.

MOBILITY HEALTH’S COVID-19 ANTIBODY RESPONSE TEST

Who is the test for?

• This test may be suitable for you if:
  • You've previously tested positive for COVID-19 and want to check for detectable antibodies.
  • You've never been diagnosed with COVID-19 and want to see if you've been exposed to the virus.
  • You've received a COVID-19 vaccine and want to check for detectable antibodies.
  • You haven't had any COVID-19 symptoms in the last 21 days.
  • You haven't received a COVID-19 vaccine in the last 14 days.
• This test may NOT be proper for you if:
  • You want to determine if you currently have COVID-19.
  • You were diagnosed with COVID-19 less than 21 days ago.
  • You were directly exposed to the virus in the past 21 days.
  • You received a COVID-19 vaccine in the last 14 days.

How can I get this antibody test?

• It’s not a Rapid or Point of Care (P.O.C.) test, so you can't perform this test at home.
• It's a Lab-Based test, meaning it is performed in a laboratory.
• It’s a Laboratory Developed Test (LDT) and has not been reviewed or cleared by the FDA.
• Unlike tests with Emergency Use (EU) authorization, which pharmacists can order under the PREP-ACT until December 31, 2024, this LDT requires a doctor's order. This may vary by state regulations for Pharmacy and may change over time, but it should be assumed that a doctor’s order is required for a COVID-19-related LDT.
• You can inquire with your doctor, pharmacist, or local hospital about how to access the test. Your physician can order the test if deemed clinically appropriate.

Do I need to be a certain age to order this test?

• This antibody test is available for patients 18 or older; a physician must order it.

What does this test evaluate?

• Mobility Health's COVID-19 Antibody Response Test checks for IgG antibodies, explicitly targeting the immunoglobulin G (IgG) type.
• If you've been exposed to the SARS-CoV-2 virus or have received a COVID-19 vaccine, your body produces IgG antibodies as part of the immune response.
• This test measures your neutralizing antibodies, which play a crucial role in preventing virus replication and have been linked to immune protection.
• It provides a numerical value indicating the level of antibodies present that may afford you protection from COVID-19.

Are there any limitations to IgG antibody tests?

• It typically takes at least 21 days after being infected with SARS-CoV-2 for your body to produce enough antibodies for detection in saliva.
• Testing too soon after infection may result in a false-negative result.
• Additionally, IgG antibody tests may detect antibodies from previous exposure to other coronaviruses, potentially causing a false-positive result.
• The presence of IgG antibodies does not guarantee immunity to future SARS-CoV-2 infections.

Why does this test provide results for NP IgG related to natural infection and SP IgG related to vaccination antibodies, and how does this help with COVID-19 care planning?

• Combining natural infection and vaccination often offers better protection against severe disease than vaccination alone. This approach increases the durability of antibodies.
• The Mobility Health COVID-19 Antibody Response Test reports on both types of antibodies to provide a comprehensive view of your immune response.
• Understanding your antibody response can aid in discussing your COVID-19 protection plan with your healthcare provider.

What is the Mobility Health SARS-CoV-2 Antibody Response - Semi-Quantitative Multiplexed Immunoassay Test methodology?

• The Mobility Health COVID-19 Antibody Response Test is a semi-quantitative multiplexed immunoassay test for IgG antibodies to the COVID-19 Spike glycoprotein S1 domain (SP), which is semi-quantitative, and the Nucleocapsid protein (NP), which is qualitative, in saliva samples.
• It uses an enzyme-linked immunosorbent assay (ELISA) format and calculates results as a signal-to-cutoff (S/Co) score, indicating positive, equivocal, or negative results.
• The test is designed to help identify individuals with an adaptive immune response to COVID-19 from prior infection or vaccination.

What is a Laboratory Developed Test (LDT)?

• A Laboratory Developed Test (LDT) is an in vitro diagnostic test developed, manufactured, and used within a single laboratory.
• LDTs are used to measure or detect various analytes (substances like proteins, chemicals, or DNA) in samples taken from the human body. These tests can be used for a wide range of purposes.
• It's important to note that the FDA does not consider diagnostic devices to be LDTs if they are designed or manufactured entirely or partly outside the laboratory offering and using them.
• The Mobility Health COVID-19 Antibody Response Test is an LDT.

What does an FDA Emergency Use (EU) authorization mean?

• The FDA has not authorized the Mobility Health COVID-19 Antibody Response Test under an Emergency Use (EU) authorization.
• Tests with EU authorization are authorized solely to detect antibodies against SARS-CoV-2, specifically for COVID-19, not other viruses or pathogens. The
  authorization is valid only during the declaration of circumstances that justify emergency use. It may be terminated or revoked earlier if necessary.