Frequently Asked Questions

Testing & Medical

Which tests are offered through our partner labs?

Covid-19  Laboratory Developed PCR Test

Covid-19 virus is known scientifically as SARS-CoV-2. Primex, Roche, Thermo Fisher, 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.

Sensitivity -     The Primex LDT assay reads the viral copies to 250 copies/mL.

Specificity -    The Primex LDT assay reported “Not Detected” on samples with known positives for associated viral pathogens, but reported “Detected” on known positive samples for SARS-CoV-2.  

SARS-CoV-2 (COVID-19) Antibody, IgG and IgM Tests

Primex is 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 medical device manufacturer for the SARS-CoV-2 IgM and IgG CLIA Kits that Primex is evaluating provides the following information:

"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)".

Sensitivity with the SARS-CoV-2 IgM and IgG CLIA Kits

  • IgM - When ordered with the IgG test, sensitivity was 89.9%.
  • IgG  - When ordered with the IgM test, sensitivity was 95.6%.

Specificity with the SARS-CoV-2 IgM and IgG CLIA Kits

  • IgM - When ordered with the IgG test,  specificity was 96.5%.
  • IgG - When ordered with the IgM test,  specificity was 96.0%.

The kit manufacturers are also listed on the FDA’s EUA website under FAQs on Diagnostic Testing for SARS-CoV-2.  

Incubation Period for Covid-19 virus

  • Median Incubation period:  5.1 days (95% confidence interval, 4.5 to 5.8 days)
  • 97.5 % of those who develop symptoms do so within 11.5 days (CI 8.2 to 15.6 days)

Ortho Clinical Antibody Test

“Ortho is proud that both of our COVID-19 total and IgG tests are achieving 100% specificity,” said Chris Smith, Ortho Clinical Diagnostics’ Chief Executive Officer. “During this health crisis, good is simply not good enough. This high level of specificity is a testament to Ortho’s strong belief that every test is a life.”

Ortho’s COVID-19 IgG antibody test detects the IgG antibody. It closely follows the introduction of Ortho’s COVID-19 Total test and the two tests offer greater choice in tracking and surveillance, patient management, and screening convalescent plasma. Both of Ortho’s tests help health care professionals understand if a patient has been exposed to and has developed antibodies to the SARS-CoV-2 virus.

Ortho’s COVID-19 IgG antibody test received Emergency Use Authorization from the U.S. Food and Drug FDA administration on April 24, 2020. Ortho’s total antibody test received CE Mark on May 8, 2020 and FDA Emergency Use Authorization on April 14, 2020.

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.

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:

  1. Drink plenty of water before your appointment. When you are hydrated your blood volume goes up, and your veins are plumper and easier to access.
  2. Eat a healthy meal before hand. This test does not require fasting, and taking the test on a full stomach may help prevent you from feeling lightheaded or dizzy after the test.
  3. Wear a short-sleeved shirt so that your healthcare professional can access your veins.

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).

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, Diazyme, Roche, 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:

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2#testkit

How accurate is the test?

A high-complexity CLIA certified lab, has independently validated the antibody tests being offered and will be providing your results. When the IgG and the IgM antibody tests are performed together the results 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 will be instructed on how to properly swab each nostril correctly, and then the sample will be placed into a specimen container for testing.

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:

  1. Ask you to expose one arm, and then use tight elastic band known as a tourniquet around to make your veins easier to identify.
  2. Identify a vein that appears easy to access.
  3. Clean the targeted vein with an alcohol pad or other cleansing method.
  4. 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.
  5. 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 a standard blood draw. You should find a comfortable place to sit for the appointment. All supplies will be provided by the clinician. Upon completion, the specimen will be prepared for lab drop off and testing. You will receive your test results one business day after your appointment.

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 uses a deep swab of the upper nose 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.

Can you get COVID-19 more than once?

The CDC has issued guidance on this and many other COVID-19 topics.

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 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.

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. We will also share the results with the prescribing physician (as required by law). As with any other medical test, you should discuss your results with your primary care physician. Directcare follows all HIPAA compliance measures.

Is my personal health information secure?

Directcare follows all HIPAA compliance guidelines when storing and accessing your personal information

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Regulatory 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.