COVID-19 Testing FAQs

Content on this page has been derived from a variety of resources including, but not limited to, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Centers for Medicare & Medicaid Services,  and the U.S. Department of Health and Human Services.  This content is subject to change as more information becomes available on the COVID-19 pandemic.  Due to the frequency of changes amidst the pandemic, this information should be compared to the latest recommendations from those agencies providing guidance on this topic.

Molecular (Diagnostic) Testing:

Can you provide specifics regarding the SARS-CoV-2 molecular diagnostic test provided by Aegis Sciences Corporation?

  • Testing Method: Real Time Reverse-Transcriptase Polymerase Chain Reaction (Real Time RT-PCR).  The FDA has been alerted of testing by Aegis’ validated method and is under FDA Emergency Use Authorization review.  During this review, Aegis is authorized to perform this assay.
  • Aegis' in-house validation completed in accordance with the FDA’s guidelines demonstrated
    • Limit of detection: 0.4 copies of virus/microliter (μl) of sample
    • 100% concordance with all negative samples
    • >99% accuracy with contrived samples
  • Specimen Collection: Nasopharyngeal, oropharyngeal, nasal specimens to be collected in accordance with the Centers for Disease Control and Prevention (CDC) and New York State-issued guidelines; viral transport media required for assurance of specimen stability for up 72 hours at room temperature during transit
  • Turnaround time for Results: Average 24 hours.  If repeat analysis needed, may be in the 36-48 hour range
  • Cost: $100 per test (same for all CPT codes)
  • Coding: U0003
  • Patient and Provider Fact Sheets are located on our website (aegislabs.com)

How is Aegis authorized to complete molecular testing for SARS- CoV-2?

  • The FDA has created guidance and policies that provides framework for laboratories certified under CLIA to perform high-complexity testing to begin molecular testing to diagnose SARS-CoV-2.
  • The FDA is actively working with test developers and issues Emergency Use Authorizations (EUAs) frequently for EUA requests with sufficient supporting data.

How do I decide if a patient needs to be tested for COVID-19?

  • Per the CDC's "Criteria to Guide Evaluation and Laboratory Testing for COVID-19”:
    • Clinicians should use their judgment to determine if a patient has signs and symptoms compatible with COVID-19, which may appear 2-14 days after exposure to the virus, and whether the patient should be tested. Asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19, has been reported. 
    • Many patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing) but some people may present with other symptoms as well (e.g., fever, chills, shaking, muscle pain, headache, sore throat, new loss of taste/smell). 
    • Other considerations that may guide testing are epidemiologic factors such as known exposure to an individual who has tested positive for SARS-CoV-2, and the occurrence of local community transmission or transmission within a specific setting/facility (e.g., nursing homes) of COVID-19.  Clinicians are encouraged to test for other causes of respiratory illness.

Which providers have the capability to order COVID-19 diagnostic testing?

  • The CDC recommends that all testing for SARS-CoV-2 be conducted in consultation with a healthcare provider.
  • The Centers for Medicare and Medicaid Services (CMS) has issued guidance on temporary flexibilities afforded to providers and facilities in fighting COVID-19.  Physician extenders may have increased ordering capabilities. Supervisory guidelines may be altered, including for resident trainees.  Telehealth opportunities are also increased.  Physicians and extenders should consult their local state boards to ensure that any COVID-19-related practice initiatives align with state law and the provider's scope of practice.

Should certain patients be prioritized for testing?

CDC Priorities for COVID-19 Diagnostic Testing (Nucleic Acid or Antigen) (Accessed on May 5, 2020)

High Priority

  • Hospitalized patients
  • Healthcare facility workers, workers in congregate living settings, and first responders with symptoms
  • Residents in long-term care facilities or other congregate living settings, including correctional and detention facilities and shelters, with symptoms

Persons identified by public health officials or clinicians as high priority

  • Persons with symptoms of a possible infection with COVID-19, including: fever, cough, shortness of breath, chills, muscle pain, new loss of taste or smell, vomiting or diarrhea, and/or sore throat.
  • Persons without symptoms who come from racial and ethnic minority groups disproportionately affected by adverse COVID-19 outcomes-currently African Americans, Hispanics and Latinos, some American Indian tribes (e.g., Navajo Nation).
  • Persons without symptoms who are prioritized by health departments or clinicians, including but not limited to: public health monitoring, sentinel surveillance, presence of underlying medical condition or disability, residency in a congregate housing setting such as a homeless shelter or long term care facility, or screening of other asymptomatic individuals according to state and local plans.

Has there been any guidance regarding the "best" time for a molecular test to diagnose a patient with SARS-CoV-2?

  • At this time, guidance varies regarding the most appropriate time to test patients.  Although we are still awaiting larger clinical trials to gain greater understanding of the virus, some preliminary evidence is available.  An overview of this information has been provided by the Sanford Guide online.
    • Mean incubation time is estimated to be ~5 days after exposure (range 4.1 - 7.0 days, but as short as 36 hours or as long as 14 days).  Transmission can occur from an infected person who is asymptomatic (prior to onset of symptoms), although transmission is likely more efficient once symptoms develop.
    • Viral loads collected in patients with SARS-CoV-2 were highest in the early symptomatic period, declining slowly and remained detectable into the second or third week after onset of illness, despite resolution of symptoms.
    • Seroconversion, or detection of antibodies, was not followed by a rapid decline in viral RNA.  Thus, it would be possible for a patient with detectable antibodies present to still cause viral transmission.

Where can I seek out guidance in order to determine how to move forward with diagnostic testing for COVID-19?

  • Per the CDC's "Criteria to Guide Evaluation and Laboratory Testing for COVID-19”:
    • Clinicians considering diagnostic testing of people with possible COVID-19 should continue to work with their local and state health departments to coordinate testing through public health laboratories, or work with commercial or clinical laboratories using diagnostic tests authorized for emergency use by the U.S. Food and Drug Administration.

Do I need to wear personal protective equipment (PPE) while collecting a patient's specimen?

  • The CDC recommends that proper infection control be maintained and PPE be used while collecting specimens within 6 feet of patients suspected to be infected with SARS-CoV-2.
    • PPE includes an N95 or higher-level respirator (or facemask if a respirator is not available), eye protection, gloves, and a gown, when collecting specimens.
  • For providers who are handling specimens, but are not directly involved in collection (e.g. self-collection) and not working within 6 feet of the patient, follow Standard Precautions; gloves are recommended. Healthcare personnel are recommended to wear a form of source control (facemask or cloth face covering) at all times while in the healthcare facility.
    • PPE use can be minimized through patient self-collection while the healthcare provider maintains at least 6 feet of separation.

How will Aegis be reporting results?

Results will be reported as "positive", "negative", or "indeterminate." If a result is reported as indeterminate, then it has undergone two rounds of testing, and neither positive or negative results were reportable.  This can happen for a multitude of reasons, including, but not limited to insufficient collection of the specimen, identification of only 1 of 2 genetic targets during testing, or insufficient signal of the genetic targets that were detected.

I collected a sample for a symptomatic patient, and the results were negative. What does that mean?

  • According to the CDC, a negative result means that the virus that causes COVID-19 was not found in the person's sample. In the early stages of infection, it is possible the virus will not be detected.
  • For COVID-19, a negative test result for a sample collected while a person has symptoms likely means that the COVID-19 virus is not causing their current illness.
  • Proper collection of specimens is the most important step in the laboratory diagnosis of infectious diseases. A specimen that is not collected correctly may lead to false negative test results.  Additional information from the CDC regarding specimen collection is available here.

Are there diagnostic tests that have been approved by the FDA for use at the point-of-care?

Managing patients that are positive for SARS-Cov-2

* CDC guidance for COVID-19 may be adapted by state and local health departments to respond to rapidly changing local circumstances.*

When may a patient with COVID-19 who has symptoms that was directed to care for themselves at home discontinue isolation?

  • Symptom-Based Strategy
    • At least 3 days (72 hours) have passed since recovery defined as resolution of fever without the use of fever-reducing medications and improvement in respiratory symptoms (e.g., cough, shortness of breath); and,
    • At least 10 days have passed since symptoms first appeared.
  • Test-Based Strategy
    • Resolution of fever without the use of fever-reducing medications and
    • Improvement in respiratory symptoms (e.g., cough, shortness of breath), and
    • Negative results of an FDA Emergency Use Authorized COVID-19 molecular assay for detection of SARS-CoV-2 RNA from at least two consecutive respiratory specimens collected ≥24 hours apart (total of two negative specimens).

When may a patient with COVID-19 who has not had symptoms that was directed to care for themselves at home discontinue isolation?

  • Time-Based Strategy
    • At least 10 days have passed since the date of their first positive COVID-19 diagnostic test assuming they have not subsequently developed symptoms since their positive test.

    • If they develop symptoms, then the symptom-based or test-based strategy should be used. 
    • Note, because symptoms cannot be used to gauge where these individuals are in the course of their illness, it is possible that the duration of viral shedding could be longer or shorter than 10 days after their first positive test.
  • Test-Based Strategy
    • Negative results of an FDA Emergency Use Authorized COVID-19 molecular assay for detection of SARS-CoV-2 RNA from at least two consecutive respiratory specimens collected ≥24 hours apart (total of two negative specimens).

    • Note, because of the absence of symptoms, it is not possible to gauge where these individuals are in the course of their illness. There have been reports of prolonged detection of RNA without direct correlation to viral culture.

Are there certain patient populations that may be required to remain in isolation longer in order to minimize the chance of prolonged viral transmission?

I have a patient that is caring for someone in their home that tested positive for COVID-19. Has there been any guidance made available for caregivers?

  • The CDC has created recommendations for caring for others that are either showing signs or symptoms compatible with COVID-19, or have tested positive for SARS-CoV-2.

Access to Care

What telehealth services are available to my patients while face-to-face visits are restricted?

  • The Centers for Medicare & Medicaid Services is covering a broad range of telehealth services during the Public Health Emergency, including many services medical providers may perform in conjunction with ordering diagnostic testing for COVID-19. 
    • New patient visits – E/M 99201 – 99205 
    • Established patient visits – E/M 99211-99215 
  • Eligible practitioners include: physicians, nurse practitioners, physician assistants, and other authorized providers under applicable state laws 
  • Types of virtual services included/covered: 

    Type of Service

    What is the Service

    HCPCS/CPT Code

    Patient Relationship with Provider

    Medicare Telehealth Visits

    A visit with a provider that uses telecommunication systems between a provider and a patient

    Common telehealth services include: 

    • 99201-99215 (Office or other outpatient visits)
    • G0425-G0427 (Telehealth consultations, emergency department or initial inpatient)
    • G0406-G0408 (Follow-up inpatient telehealth consultations furnished to beneficiaries in hospitals or SNFs)
    • Complete list is located here.

    For new* or established patients


    *to the extent the 1135 waiver requires an established relationship, HHS will not conduct audits to ensure that such a prior relationship existed for claims submitted during this public health emergency

    Virtual Check-In

    A brief (5-10) minutes) check in with your practitioner via telephone or other telecommunications device to decide whether an office visit or other service is needed.  A remote evaluation of recorded video and/or images submitted by an established patient.

    HCPCS code G2012

    HCPCS code G2010

    For established patients.

    E-Visits

    A communication between a patient and their provider through an online patient portal.

    99421

    99422

    99423

    G2061

    G2062

    G2063

    For established patients

    I'm relatively new to telehealth and I'm concerned about a potential HIPAA violation. Is there guidance available on this topic?

    • The Office for Civil Rights (OCR) at the Department of Health and Human Services (HHS) is responsible for enforcing certain regulations issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act, to protect the privacy and security of protected health information, namely the HIPAA Privacy, Security and Breach Notification Rules (the HIPAA Rules).
    • OCR will exercise its enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the HIPAA Rules against covered health care providers in connection with the good faith provision of telehealth during the COVID-19 nationwide public health emergency.  This notification is effective immediately.

    Can you provide information about the services hospitals are able to provide in temporary expansion sites?

    • CMS has a new initiative referred to as "Hospital Without Walls” that allows for
      • Off-site patient screening permitted for hospitals, psychiatric hospitals, and critical access hospitals  
      • Temporary expansion sites permitted allowing hospitals and provider-based departments to establish and classify additional locations as part of the hospital

    Can a patient be seen by me or my office staff solely for the purpose of being assessed or tested for COVID-19?

    • CMS has finalized an interim policy to compensate physicians for COVID-19 assessments and specimen collection performed by their clinical staff, even when the patient receives no other services. The Interim Final Rule states: 
      • For the duration of the COVID-19 [Public Health Emergency (PHE)], we are therefore finalizing on an interim basis that when the services described by CPT code 99211 for a level 1 E/M visit are furnished for the purpose of a COVID-19 assessment and specimen collection, the code can be billed for both new and established patients. We believe this policy will support expanded access to COVID-19 testing, and provide appropriate payment for COVID-19 testing-related services furnished by physician and other practitioners. This policy will allow physicians and practitioners to bill for services provided by clinical staff to assess symptoms and take specimens for COVID-19 laboratory testing for all patients, not just established patients. We note that a physician or practitioner cannot bill for services provided by auxiliary clinical staff unless those staff meet all the requirements to furnish services "incident to” services, as described in 42 CFR 410.26 and further described in section 60 of Chapter 15 Covered Medical and other Health Services in the Medicare Benefit Policy Manual 100-02. We further note that we adopted an interim final policy to permit the direct supervision requirement to be met through virtual presence of the supervising physician or practitioner using interactive audio and video technology for the duration of the PHE (85 FR 19245). CMS-5531-IFC, 188 

    I'm interested in offsite assessment of patients that are concerned about COVID-19. Am I able to set up a Drive-Thru testing site?

    • In addition to the telehealth options discussed above, COVID-19 screening can also take place through a designated external triage station at a physician's practice or other designated locations within the community. Billing and coding for these face-to-face outpatient services is based on existing standards for new and established outpatient services. 
    • While the intent of telephone, virtual check-in and online digital E/M is to limit potential transmission of COVID-19 to patients and healthcare workers alike, there may be circumstances where face-to-face physician services occur in a temporary outside assessment center. 
    • Specimen collection via throat swabbing can be performed within a medical practice, at community or medical practice drive-thru sites, or other designated locations.  
    • Licensed staff trained in triage protocol can determine which patients can be managed safely at home vs. those that need to be seen at a healthcare facility. 
    • Patients must have an authorized medical provider's order to receive COVID-19 testing. 
    • Criteria for patients that should go to drive-thru testing may vary from state-to-state. 

    If I set up a Drive-Thru testing center, how should I direct my patients to utilize this testing process?

    • Patients will be guided by road signs/cones directing them to keep their windows up and follow a series of cones 
    • Patients will be directed to a tent where a healthcare lab worker will use a microphone to remind them to keep their window up 
    • Lab worker will ask how many people in the car will be getting tested 
    • Patient(s) will be asked to hold up their photo ID and insurance card to the window for a picture 
    • A label will be generated for their sample 
    • A nurse or provider will advise the patient to roll their window down just a crack, tilt their head back and the back of their throat will be swabbed 
    • Patients roll up their window and depart 

    Serologic (Antibody) Testing

    What is the CDC referring to when mentioning a test for "past infection?"

    • Antibody blood tests, also called antibody tests or serology tests, check the blood by looking for antibodies, which show if someone had a previous infection with the virus. Depending on when someone was infected and the timing of the test, the test may not find antibodies in someone with a current COVID-19 infection. Antibodies are proteins that help fight off infections. Antibody tests should not be used as the only way to diagnose someone as being currently sick with COVID-19.
    • We do not know yet if the antibodies that result from infection with SARS-CoV-2 can protect someone from reinfection with this virus (immunity) or how long antibodies to the virus will protect someone. Scientists are conducting research to answer those questions.

    What directives are being provided on use of serologic testing in clinical practice at this time?

    • According to the Infectious Disease Society of America, serology testing for SARS-CoV-2 can be used for: 
      • Detection of PCR-negative cases, especially for patients who present late with a very low viral load below the detection limit of RT-PCR assays, or when lower respiratory tract sampling is not possible
      • Identification of convalescent plasma donors
      • Epidemiologic studies of disease prevalence in the community
      • Verification of vaccine response once antibody correlate(s) of protection identified (a vaccine for SARS-CoV-2 is not currently available.
    • Please continue to check this page for more updates regarding the role of serologic testing in clinical practice as more research becomes available.

    What does it mean if a patient has positive antibody test results?

    • A positive test result shows that a patient has antibodies that likely resulted from an infection with SARS-CoV-2, or possibly a related coronavirus.
    • It's unclear if those antibodies can provide protection (immunity) against getting infected again. This means that we do not know at this time if antibodies make patients immune to the virus.
    • If the patient has no symptoms, it is unlikely that he/she has an active infection and no additional follow-up is needed.
    • If a patient has symptoms and meets other guidelines for testing, he/she would need another type of test called a nucleic acid test, or viral test. An antibody test alone cannot tell if a patient has an active case of COVID-19.
    • It's possible you might test positive for antibodies and you might not have or have ever had symptoms of COVID-19. This is known as having an asymptomatic infection, or an infection without symptoms.

    What does it mean if a patient has negative antibody test results?

    • If a patient tests negative for COVID-19 antibodies, he/she probably did not have a previous infection that has gotten better. However, he/she could have a current infection. It's possible that the patient could still get sick if exposed to the virus recently, since antibodies don't show up for 1 to 3 weeks after infection.
    • Some patients may take even longer to develop antibodies, and some patients may not develop antibodies.
    • If a patient has symptoms and meets other guidelines for testing, he/she would need another type of test called a nucleic acid test, or viral test. An antibody test alone cannot tell if a patient has an active case of COVID-19.

    Sample Logistics

    Will Aegis provide instructions on how to collect and ship specimens?

    • A comprehensive set of instructions have been developed for specimen collection and shipment. Contact Aegis with any questions on this process at 1-800-533-7052.

    Are there any additional resources available on specimen collection?

    • The CDC has provided an overview of appropriate specimens that should be collected for SARS-CoV-2 testing as well as the collection process.
    • Additionally, the New England Journal of Medicine has provided an instructional video on collection of nasopharyngeal specimens.

    Are Aegis personnel capable of collecting SARS-CoV-2 specimens?

    • Aegis personnel are not able to collect specimens for SARS-CoV-2 diagnostic testing.  At this time, the CDC recommends that specimens be collected either by a healthcare professional or under the supervision of a healthcare professional.

    Additional Links and Resources

    Has guidance been issues on how testing should be utilized prior to elective procedures?

    • CMS has provided guidance on re-opening facilities that provide elective procedures.
      • All patients must be screened for potential symptoms of COVID-19 prior to entering the NCC facility, and staff must be routinely screened for potential symptoms as noted above.
      • When adequate testing capability is established, patients should be screened by laboratory testing before care, and staff working in these facilities should be regularly screened by laboratory test as well.

    Has guidance been published regarding billing for services rendered as it related to telehealth and COVID-19 testing?

    • Downstream effects of COVID-19 on your patients

      Downstream effects of COVID-19 on your patients

      Date and Time:

      Length: 30 minutes

    Resources

    1. COVID-19 Testing FAQs

       

      Aegis’ COVID-19 testing FAQ provides information specific to our lab’s testing capabilities.  Additionally, the FAQ document summarizes pertinent information from various resources leading the fight against the COVID-19 pandemic.

      Clinical FAQ for COVID-19 

    2. Specimen Collection Instructions

      Specimen Collection Instructions

       

      DOWNLOAD SPECIMEN COLLECTION INSTRUCTIONS

    3. Patient Fact Sheet

      Patient Fact Sheet

      This Fact Sheet contains information to help you understand the risks and benefits of using this test for the diagnosis of COVID-19. After reading this Fact Sheet, if you have questions or would like to discuss the information provided, please talk to your healthcare provider. 

      DOWNLOAD PATIENT FACT SHEET - ENGLISH

      DOWNLOAD PATIENT FACT SHEET - SPANISH

       

    4. Provider Fact Sheet

      Provider Fact Sheet

      This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of a Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Test (Molecular LDT COVID-19 Authorized Test) that has been issued an Emergency Use Authorization (EUA) by FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider. 

      DOWNLOAD PROVIDER FACT SHEET