Frequently Asked Questions
Testing & Medical
Which tests are offered through our partner labs?
Covid-19 Laboratory Developed PCR Test
Thermo Fisher and Ortho Clinical are listed on the FDA Emergency Use Authorization at the FDA website, under FAQs on Diagnostic Testing for SARS-CoV-2.
All swab tests have high sensitivity and high specificity.
SARS-CoV-2 (COVID-19) Antibody, IgG and IgM Tests
Roche and BD are performing the SARS-CoV-2 Antibody, IgG and IgM Tests in combination. Below is some background information on this testing.
After infection with SARS-CoV-2, viral antigens stimulate the body’s immune system to produce antibodies. The virus incubation period and the days/weeks when the antibodies appear in the blood are defined below.
SARS-CoV-2 virus Antibodies, IgM and IgG
- IgM appears early in the blood circulation after an infection (as early as 3-5 days).
- IgG appears later in the blood circulation after an infection (within 3-4 weeks).
"The IgM and IgG tests are able to detect the antibodies to the SARS-CoV-2 virus and the kits have high specificity, sensitivity and clinical agreement with samples confirmed with PCR methods (RT-qPCR)".
How should I prepare for my test?
Please have a government issued picture ID to show to the clinician.
The COVID-19 PCR Swab test uses a nasal swab inserted into the upper part of each nostril to obtain a sample. Directcare has throat swabs available upon request and saliva tests available upon request for an additional fee.
The COVID-19 Antibody test is administered as a standard blood draw. To prepare for the blood draw, you should be sure to do the following:
- Please drink water and eat a meal before your appointment.
- Wear a short-sleeved shirt so that your healthcare professional can access your veins.
- Provide a safe, well lit area for testing including a sturdy table and chair.
Is the swab test and the antibody test approved by the FDA?
Our lab partners are performing both the swab testing and the antibody testing under a FDA Emergency Use Authorization (EUA). All tests offered by Directcare are FDA Authorized.
The two antibody tests being offered are serological (blood draw) tests which are considered to be more accurate than a pirck test.
The manufacturers of each test offered Roche, BD, Thermo Fisher, Ortho Clinical, have followed the FDA’s Emergency Use Notification process as provided in the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (March 16, 2020) and serological tests are listed on FDA’s website under “FAQs on Diagnostic Testing for SARS-CoV-2”. Further detailed information can be found here:
How accurate is the test?
The PCR test being offered are over 99% accurate when there are detectable levels of the virus in your body.
A high-complexity CLIA certified lab, has independently validated the antibody tests being offered. The antibody tests performed are over 95% accurate.
What's the procedure for the test?
The COVID-19 PCR Swab test uses a nasal swab inserted into the upper part of each nostril to obtain a sample. You can either be guided on how to administer the test yourself or our clinician can administer the test for you.
The COVID-19 Antibody test is administered as a standard blood draw, and is administered by a certified Phlebotomist. While the process may vary a bit depending on your environment and needs, your Phlebotomist will generally do the following:
- Ask you to expose one arm, and then use tight elastic band known as a tourniquet around to make your veins easier to identify.
- Identify a vein that appears easy to access.
- Clean the targeted vein with an alcohol pad or other cleansing method.
- Insert a needle into the skin to access the vein, allowing them to collect a small sample. This usually takes just a minute or two.
- Release the tourniquet and remove the needle, then wrap your arm with a bandage to apply pressure and prevent bleeding.
What should I expect during my appointment?
The certified healthcare provider will arrive at your home and administer the PCR swab test and/or a standard blood draw.
All supplies will be provided by the clinician. Upon completion, the specimen will be prepared for lab drop off and testing. You will receive an email alerting you to your test results one to two business day after your appointment.
If you do see an email from Directcare for your questionnaire or results please check your "promotions" or "spam" folder in you email client.
What certifications does your lab have?
The labs we use are CLIA certified and meet all required standards and guidelines.
What is the difference between the COVID-19 Antibody Test and the COVID-19 PCR Swab Test?
The COVID-19 PCR swab test swabs the mid-nasal turbinate area of the upper nose. The test is looking for viral particles and will tell you if you currently have the virus and could potentially pass it on.
The antibody test is a blood test that will tell you if you have been previously exposed to the virus at some time in the past, and now have detectable levels of antibodies to the virus.
This article is a good resource for understanding the difference between the two tests.
Does having COVID-19 antibodies make me immune?
Based on data from other viruses and coronavirus strains, we know that people make antibodies 7-10 days after infection and that, depending on the type of virus, these antibodies can fend off reinfection for months to years after recovery (antibodies provide immunity only to the specific strain of virus that a person was infected with) . Since COVID-19 is a new virus, we still don’t know how long antibodies will stay in our system after this specific viral infection or if they will be effective in preventing reinfection.
Long-term studies in humans will be necessary in order to determine whether people who recover from COVID-19 are immune, and to learn how long potential immunity may last.
Can I be tested for antibodies more than once?
Yes, you can. It's possible that you may test negative now and test positive a few weeks later depending on when you were exposed to the virus.
What does a positive antibody test result mean?
If your test result states that antibodies are detected (reactive) in your blood, then you have a positive result. This suggests that you have been previously exposed to COVID-19.
If your antibody test is positive, you may have immunity. You should discuss this result with your physician and consult the CDC website for more information.
What does a negative antibody test result mean?
If your test result states that antibodies are not detected (non-reactive) in sufficient quantity or are undetected, then you have a negative result.
A negative test result for this test means that the amount of antibodies to coronavirus in the specimen was not above the limit of detection.
What is the difference between COVID-19 and SARS-COV-2?
SARS-COV-2 is the scientific name for the virus that causes the disease COVID-19.
Scheduling & Support
What if my clinician doesn’t show up?
A no show without prior notification is rare and could be the result of an emergency or an unforeseen occurrence. Please contact us immediately if this should occur.
What if my clinician is late?
We make every effort to arrive on time. Occasionally there are delays, and in such an event, we will typically notify you in advance via either email or text message.
How do I give feedback about my experience?
We appreciate your feedback. If selected, you will receive a brief survey to rate your experience. You can also email us at hello@directcare.us.
What if I need to reschedule my appointment?
If the request is more than 24-hours in advance, we can reschedule once at no charge. You can request a change here. Within 24-hours hours of your appointment, we're unable to reschedule your appointment.
Billing & Insurance
Do you accept insurance?
We do not accept insurance. However, you can submit your Directcare receipt to your insurance provider for reimbursement. Reimbursement is subject to your insurance provider’s determination.
Directcare does not submit claims directly to insurance companies. We do not know and make no representation about whether particular services provided through Directcare will be covered or reimbursed by any particular health plan.
As a courtesy, we are providing for informational purposes only certain codes and information that we understand are used for relevant services, but we make no representations or warranties that these are appropriate or will be accepted. All information provided should be independently verified with the insurer in connection with any request for insurance reimbursement.
We offer concierge services with lab processing.
Physician lab requisition CPT code: 87635 (U0003)
COVID PCR Swab test CPT code- U0002
Diagnosis code: Contact with and (suspected) exposure to other viral communicable diseases Z20.828
Will my insurance reimburse me?
You can contact your insurance provider for further information and submit your receipt for reimbursement to your insurance provider subject to their approval and determination of benefits.
Privacy & Security
Who will have access to my results?
You will receive access to your results via our secure client portal one business day after your appointment. As with any other medical test, you should discuss your results with your primary care physician. Directcare follows all HIPAA compliance measures.
Varying by state our lab partners may be required by law to share results with government agencies.
Is my personal health information secure?
Directcare follows all HIPAA compliance guidelines when storing and accessing your personal information
STILL HAVE QUESTIONS?
Contact UsRegulatory Statements
The CLIA lab validated diagnostic tests being offered by this site are in accordance with the FDA’s Emergency Use Notification and Authorization process as provided in the FDA’s “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency” (March 16, 2020) for laboratories certified under CLIA and FDA standards to perform high-complexity testing. Our test’s manufacturing lab has notified the FDA as required and has been listed on the FDA’s website accordingly and is pending FDA authorization.