Updated January 2021
The proliferation of COVID-19 has affected the world in many shapes and forms. In our industry, we have received reports that many reference labs are backlogged on routine testing. At Southwest Labs, we have taken all the necessary steps to ensure your practice keeps running smoothly through these uncertain times. Watch this quick 30-second video for our response to COVID-19.
Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China. The virus that causes COVID-19 probably emerged from an animal source, but is now spreading from person to person. The virus is thought to spread mainly between people who are in close contact with one another (within about 6 feet) through respiratory droplets produced when an infected person coughs or sneezes. It also may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes, but this is not thought to be the main way the virus spreads. (4)(5)
Official names have been announced for the virus responsible for COVID-19 (previously known as “2019 novel coronavirus”) and the disease it causes. The official disease name is Coronavirus Disease or COVID-19. The official virus name is severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). WHO announced “COVID-19” as the name of this new disease on 11 February 2020, following guidelines previously developed with the World Organisation for Animal Health (OIE) and the Food and Agriculture Organization of the United Nations (FAO). (7)
Many patients with COVID-19 have had mild to severe respiratory illness with symptoms of fever, cough, and shortness of breath. There are also many suspected and some proven cases of COVID-19 that are aymptomatic. If concerned, Southwest Labs recommends use of the CDC’s “Self Checker” and/or the NM DOH “Self Screener” which can be found at the links below. These are online interactive quizzes that can help to guide your decision about seeking medical care or lab testing.
CDC Self-Checker: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/index.html
NM DOH Self Screener: https://cv.nmhealth.org/should-i-get-tested/
According to the CDC: Not everyone needs to be tested for COVID-19. Most people have mild illness and are able to recover at home without medical care. They may not need to be tested. There is no treatment specifically approved for people who have COVID-19. CDC has guidance for who should be tested, but decisions about testing are at the discretion of state and local health departments and/or individual clinicians. Clinicians should work with their state and local health departments to coordinate testing through public health laboratories, or work with clinical or commercial laboratories. Clinicians considering testing of persons with possible COVID-19 should continue to work with their local and state health departments to coordinate testing through public health laboratories, or use COVID-19 diagnostic testing, authorized by the Food and Drug Administration under an Emergency Use Authorization (EUA) through clinical laboratories. Increasing testing capacity will allow clinicians to consider COVID-19 testing for a wider group of symptomatic patients. Clinicians should use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested. Most patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). Other considerations that may guide testing are epidemiologic factors such as the occurrence of local community transmission of COVID-19 infections in a jurisdiction. Clinicians are strongly encouraged to test for other causes of respiratory illness. Currently, it is a non-priority to test individuals with no symptoms. (1)(2)
According to the NM Department of Health (NM DOH): New Mexico has identified cases of COVID-19. We are currently working to identify cases as early as possible and implement isolation procedures to prevent further spread of the virus. Due to increased statewide test capacity, all New Mexico residents can receive testing through their provider or the 50 screening and testing sites that are available throughout the state. Testing is prioritized for 1) symptomatic people displaying cough, fever or shortness of breath, 2) asymptomatic people who are close contacts or household members of New Mexico residents who have already tested positive for COVID-19, 3) asymptomatic residents in nursing homes, and 4) asymptomatic people in congregant settings such as homeless shelters, group homes, and detention centers. (3)(5)
Generally, there are two main categories of tests that are currently being used by labs to test for COVID-19. The first is a test for antibodies and the second is a test for viral material:
1) COVID-19 Antibody test:
- Antibody testing, also known as serologic testing, is used to detect antibodies in a patient’s blood specimen (serum). Antibodies are produced by the immune system in response to an infection. The presence of antibodies indicates that an individual has been exposed to (infected with) that particular infectious agent. These antibodies can be detected in some cases for years after the individual has recovered from the infection and will also be present if the patient was never even symptomatic. Serologic tests detect antibodies against infectious agents in serum and are a marker of an immune response to infection. IgG antibodies to SARS-CoV-2 develop approximately 8 to 11 days post-symptom onset (seroconversion) for the majority of patients. Some individuals may develop antibodies after this time frame, while others, particularly those who are immunosuppressed, may never develop a detectable immune response. We are offering serology testing only as a means to detect antibodies to the virus, not to diagnose recent or active infection. Symptomatic patients should be tested using PCR viral testing (#2 below), not antibody serology testing. (9)
- A positive COVID-19 antibody result does not necessarily mean that you are immune to the virus. There simply is not enough laboratory and medical information available at this time for anyone to make statements regarding any immunity that may or may not be gained from SARS-CoV-2 IgG antibodies as currently tested for.
- This test can aid in the detection of the virus that causes COVID-19 using a technique known as polymerase chain reaction (PCR). This test requires an upper respiratory nasal swab which is then tested using PCR looking for COVID-19 causative viral material, specifically the SARS-CoV-2 coronavirus. (10)
- A positive COVID-19 PCR Viral test result indicates that RNA from SARS-CoV-2 was detected, and the patient is infected with the virus and presumed to be contagious. Patient management should follow current CDC guidelines. The cobas® SARS-CoV-2 test has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects. (10)
- A negative COVID-19 PCR Viral test result indicates that RNA from SARS-CoV-2 was not detected above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. A negative result does not exclude the possibility of COVID-19. When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. The possibility of a false negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that COVID- 19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative. If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing should be considered in consultation with public health authorities. Risks to a patient of a false negative include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events. (10)
3) COVID-19 Antigen test:
- It can be used to quickly determine who likely has an active infection.
- It can help identify people who may be contagious to others.
- May need PCR confirmation for Positive results.
Southwest Labs (SWL) is a locally owned and operated clinical laboratory located in Albuquerque, NM. Southwest Labs performs all levels of COVID-19 testing in its Albuquerque laboratory. Southwest Labs continues to add to testing capacity every week.
The United States (U.S.) FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19. An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in the detection of the virus that causes COVID-19. The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used). (8)
Southwest Labs follows applicable regulations regarding the reporting of COVID-19 test results. We believe that increased testing alongside accurate reporting and aggregate data gathering will greatly assist our public health and government leaders in making the best decisions possible as we all work against this pandemic. COVID-19 is considered a reportable disease and as an emerging disease we will report all findings (negative included). We are reporting to the CDC for FEMA/HHS in addition to each state in which the patient resides.
Southwest Labs offers COVID-19 testing directly to patients, regardless of referral from their medical provider, on a walk-in basis or by appointment, as part of our broad direct-to-consumer laboratory product line. We feel strongly that patients can and should be free to help direct their own healthcare. NM State laws permit direct patient access to laboratory testing within a direct-to-consumer private payment model.
It is likely that you can receive COVID-19 PCR nasal swab testing for free from a State resource if you meet their criteria regardless of your insurance status. It is not necessary that you come to Southwest Labs and pay for this testing unless you choose to. Please contact the New Mexico Department of Health if you have questions, or you may reach out to your insurance carrier. If you choose to be tested at Southwest Labs, you will be required to sign a brief form simply stating that you understand there may be no-cost testing options available to you but that you are choosing to use Southwest Labs. NM DOH website: https://cv.nmhealth.org/public/
Federal, State, and local mandates regarding the costs of care surrounding COVID-19 are changing rapidly, can be confusing, and are sometimes even contradictory. Regardless, we are pleased that there are developing financial support mechanisms for the community. Southwest Labs is making efforts to communicate with insurance carriers, other payers, and regulatory agencies to determine our procedures and protocols.
(1) https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html (04/23/20)
(2) https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html (04/23/20)
(3) https://cv.nmhealth.org/about-covid-19/ (04/23/20)
(4) https://cv.nmhealth.org/wp-content/uploads/2020/04/2019-ncov-factsheet-NMDOH.pdf (04/23/20)
(5) https://cv.nmhealth.org/about-covid-19/ (04/23/20)
(6) https://cv.nmhealth.org/2020/04/23/updated-new-mexico-covid-19-cases-now-at-2379/ (04/23/20)
(7) https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/naming-the-coronavirus-disease-(covid-2019)-and-the-virus-that-causes-it (04/23/20)
(9) https://news.mayocliniclabs.com/frequently-asked-questions-covid-19-serology-testing/ (04/26/20)
(10) https://news.mayocliniclabs.com/frequently-asked-questions-covid-19-pcr-testing/ (04/26/20)