The coronavirus continues to affect a significant number of people from the Northwest to the Southeast, and although the numbers may be plateauing, there is still a significant burden on the healthcare system. Hopefully with continued effort, the curve will bend down and allow us to carefully begin treating our patients in person in the near future.
In the meantime, all members of our staff have been busy changing protocols for the office and treatment rooms with your safety in mind. We are minimizing patient traffic, continuously disinfecting all contact surfaces between patient visits, and requiring everyone in the office to wear personal protective equipment (PPE). Our goal is to keep everyone safe while continuing to give the best care possible and keep us all healthy.
We are now offering COVID-19 antibody testing to detect for immunity to SARS-CoV-2. It is not a diagnostic test to determine if a person is infected with coronavirus and hence, contagious. Please note, no one antibody test has yet been approved by the FDA to confirm full immunity to COVID-19 and hence, cannot guarantee a person is no longer susceptible for reinfection by the virus. The reason is dozens of laboratories have applied for Emergency Use Authorization of their antibody test kits. They have been able to speedline production and necessary testing of the test itself in order to avoid the tedious, thorough process typically required for U.S. Food and Drug Administration (FDA) approval. This translates to the antibody test may have errors in its ability to accurately identify who has antibodies and who doesn’t have antibodies.
In order to understand the validity of diagnostic tests, let’s define two important terms (Parikh et al., 2008).
Sensitivity: the ability of a test to correctly classify an individual as “diseased”. It is the probability that a positive test result truly means “disease” is present.
Specificity: the ability of a test to correctly classify an individual as "disease-free". it is the probability that a negative test result truly means "disease" is absent.
Having antibodies basically means you have what the test is looking for. It does not translate to being diseased. In the of COVID-19 antibody testing, most of the early tests historically available have low sensitivity. This means that they are not great at identifying the specific COVID-19 antibody the test is designed to screen for. This translates to high false-positive results where a positive test result does not actually mean there are antibodies present. Scaled up, this can be a total failure when trying to determine large groups of people who are immune and who are not immune to COVID-19.
Thus, someone who does not have antibodies to COVID-19 and gets a test with low sensitivity would be more likely to test positive for antibodies and to go back to work (when they don’t have antibodies and could spread the virus further, intensifying the continued spread of the virus.
The good news is that this month Roche (a Swiss multinational healthcare company that operates worldwide) announced that the FDA has issued another EUA for its new Elecsys® Anti-SARS-CoV-2 antibody test. Roche invested a lot of time to develop the test, and their efforts resulted in an assay that has a specificity of 99.8% and a sensitivity of 100% (Roche Diagnostics (2020). The test, like others before it, is designed to determine if one has been exposed to the virus and if the patient has developed antibodies against COVID-19.
Roche has already started shipping the new antibody test to leading laboratories globally and will ramp up production capacity to high double-digit millions per month.
Although we would all like antibody tests at the moment, we have been waiting until labs had sufficient time to perform the necessary research to produce an accurate test. Distributed by Quest Diagnostics, the high specificity of the test is crucial to determine reliably if a person has been exposed to the virus and if the patient has developed antibodies.
“Thanks to the enormous efforts of our dedicated colleagues we are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to better manage the COVID-19 health crisis,” said Severin Schwan, CEO Roche Group. ”I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis.”
“Our best scientists have worked 24/7 over the last few weeks and months to develop a highly reliable antibody test to help fight this pandemic,” said Thomas Schinecker, CEO Roche Diagnostics. “Roche is committed to helping laboratories deliver fast, accurate, and reliable results to healthcare professionals and their patients.”
While there is a lot of concern, discussion, and confusion at the moment regarding how best to support your immune system and stay safe going forward, we are here to support you during this healthcare crisis and beyond through videoconference, telephone, and in-person appointments. Read more about our services here!
We are now offering SARS-CoV-2 antibody testing for our patients through Quest Diagnostics. If you would like to order a COVID-19 antibody test, please contact Dr. Bhandari at 1-415-506-9393 to learn more.
Dr. Bhandari and the Advanced Health Team Are Here to Support Your Health.
Our expert team of integrative holistic practitioners work with patients suffering from chronic health concerns. We take the extra step to understand the root cause and how to optimize every organ’s functioning. By better understanding how your environment directly fits into your overall well-being, we create personalized treatment plans which drive away sickness. To learn more and book an appointment, contact Advanced Health or call 1-415-506-9393.
Parikh, R., Mathai, A., Parikh, S., Chandra Sekhar, G., & Thomas, R. (2008). Understanding and using sensitivity, specificity and predictive values. Indian journal of ophthalmology, 56(1), 45–50.
Roche Diagnostics (2020). Full specifications of Roche’s Elecsys® Anti-SARS-CoV-2 antibody test and immunoassay systems, including throughput, can be found on their website at https://diagnostics.roche.com/#selectProfile
World Health Organization (WHO). "Immunity passports" in the context of COVID-19: Scientific Brief. 24 April 2020 Retrieved from: https://www.who.int/news-room/commentaries/detail/immunity-passports-in-the-context-of-covid-19