The Benefits of Concierge Medicine in the age of COVID-19

Concierge medicine allows patients to build strong relationships with their doctor through extended visits and more personalized care. Having a doctor who truly knows you, and who you can call on when you need them may have seemed like a luxury in the past. With the COVID-19 pandemic having become a ‘normal’ part of our lives, it has never been more important for patients to have easy access to trusted care when they need it the most. 

Across the country, medical facilities and doctors offices are playing catch-up in order to bring patients back up to date on routine checkups and preventive screening.  During the peak of the pandemic, healthcare providers were spread thin with regard to time and resources. In addition, patients were less likely to go for routine medical services due to social distancing, quarantine and isolation requirements. As a result, there is still a backlog of patients that are behind on basic medical care including sick visits, regular annual checkups, and preventive screenings. Healthcare practices are continuously making adjustments in order to ensure that these patient’s needs are being met.  Implementation of new technologies in the healthcare systems such as telemedicine have helped but that’s not enough. Clearly the pandemic has demonstrated that concierge medical practices, as early adopters of telemedicine technology and as providers that eliminate barriers to communication, are able to meet patients’ needs in a more efficient manner. The COVID-19 pandemic highlighted the benefits of having a personalized relationship with your physician.  During a crisis such as the pandemic, research has shown that concierge medicine reduces hospitalization rates and produces better clinical outcomes.

 

Benefits of Concierge Medicine during the age of COVID-19

 Fewer Patients, Longer Appointment Times

According to the American Academy of Private Physicians (AAPP), estimates have shown that a traditional primary care physician in the United States maintains between 2,000 – 4,000 patients. On a daily basis a GP sees 25 patients or more, giving approximately 15 minutes per patient. Practically speaking, this isn’t feasible with the given time constraints, patients queries are left unanswered, resulting in an unsatisfied patient experience. This is why concierge practices are different.

 In comparison, AAPP notes that since concierge practitioners have a smaller group of patients (around 600 patients) it allows them to dedicate more time to individual patients. This helps in establishing a rapport between the doctor and patients which goes much deeper than the normal screening or even a checkup routine.

 Avoid Crowded Areas

Nobody wants to spend time in a crowded wait room with the looming thought of contracting the COVID-19 virus. Even before the pandemic, concierge medical practices focused on keeping practice sizes small, eliminating the concept of a busy waiting room. 

 24/7 Access to your Physician

The data is clear that patients with multiple comorbid conditions such as diabetes, cardiovascular disease or respiratory illness are at higher risk for complications associated with COVID-19 infections.  Having 24-7 access to your concierge provider will certainly be beneficial and likely improve overall clinical outcomes in these patients, as acute illness or worsening chronic conditions will be addressed more quickly and efficiently. In many cases clinical concerns can be answered by cell phone or telemedicine encounters, from the comfort of your own home.

Looking to Concierge Practices for a Solution

Based on the current interest and demand for concierge physicians, particularly during the pandemic and as we move out of the pandemic, we now know that concierge medical practices will continue to thrive long after the pandemic comes to an end.  It is clear that patients now see the value and benefits of this type of doctor-patient relationship and see concierge medicine as a solution to the limitations of the current state of medical care. To become part of our concierge practice and take full advantage of the benefits of concierge medicine in Atlanta, Georgia, book an online appointment for a consultation with our doctors at Buckhead Medicine. Follow us on Instagram and Facebook for more insightful updates and posts. 

Coronavirus Update 13: Annual Exams, Chronic Disease Management, Addressing High Demands, COVID-19 Testing, Flu Season

Dear Patient,

I hope this letter finds you healthy and safe. Much has occurred since our last update, so I wanted to try to catch everyone up on where things are for us as a practice. The priority of Buckhead Medicine continues to be the health and well-being of our existing patients. We know that many of you have been dealing with COVID-19 infection with yourself or your family members. We continue to strive to ensure that we are able to provide appropriate and timely medical care for you during the current pandemic. We continue to urge everyone to frequently wash your hands, follow social distancing recommendations, wear masks, and avoid groups of greater than 8 to 10 people.

ADDRESSING THE HIGH DEMAND
As a practice, over the last 2 months, we have experienced unprecedented demands from our patients, particularly those who have been affected by this virus. We have been working continuously to improve our processes and protocols and have hired additional staff to support our established patients. We appreciate your patience through this transition. We have added a new automated receptionist system for high call volumes and have added an overflow support system with a live on-call answering service to assist us. To ensure your call is handled expeditiously, when calling our office, please identify yourself as a concierge patient, as we are currently receiving excessive calls from new or non-established patients and have hired new staff to support our practice and they may not be familiar with all the names of our concierge patients.

I do want to remind you that if you are having any difficulty in reaching me or our staff, please know that for urgent medical matters, that need to be handled immediately, you can always reach me by cell phone or text message at 404-XXX-XXXX. If I am not able to respond to the call or text immediately, I will forward the message to our nurse practitioner or our nursing staff. You can also reach me by email at XX@buckheadmedicine.com. In order to appropriately manage call volumes, however, please always initially reach out to our office main number at 404-257-5585 or use the OHMD application.

ROUTINE LABS PROCESSING AND REPORTING
We are experiencing issues with the reliability of processing and reporting from our long standing commercial lab providers. We believe this is due to high volumes which they are currently experiencing. We are working closely with our lab partners to reduce these occurrences. In certain situations however, we may have to repeat blood draws, as some labs are not being processed as ordered. We apologize for this inconvenient and expect this to improve as our lab partners adjust to the high volume demands.

CHRONIC DISEASE MANAGEMENT AND ANNUAL EXAMS
We are continuing to actively reach out to each one of you to ensure that from a preventive medicine, as well as chronic disease management status, we are addressing your needs and keeping up with appropriate monitoring and treatment. We also are keenly aware that for our elderly or frail patients, annual exams may not be indicated given the current pandemic. For those at greatest risk for contraction of COVID-19, we are deferring a face to face visit unless absolutely necessary. If you have not received a call from us yet, and feel you require more expedited evaluation for an annual exam or for chronic disease management, please reach out to our office.

For annual exams we have successfully implemented a protocol where we initially set up a ZOOM call to go over prior medical history, family history, upcoming screening requirements and any medical concerns or medical complaints you may have. This is followed, usually within a week’s time, by a face-to-face encounter in the clinic, for the physical exam, vital sign measurement, and EKG if needed. During this portion of the encounter we perform blood work and urine collection. We will subsequently set up a phone call to review these labs once resulted. I know these are additional steps for the annual exam, but we believe that by following this protocol, we are able to spend more time in reviewing pertinent history and requiring less face-to-face time in the clinic, thereby decreasing unnecessary exposure.

COVID-19 Testing
As far as COVID-19 testing goes, we are working to enhance our testing capacity and increase available options for testing within the practice. We currently have the following COVID-19 testing available:

• COVID-19 Nasal PCR by Quest Diagnostic laboratories, billed to insurance when appropriate, insurance does not always cover this test, turnaround time 10-14 days
• COVID-19 Nasal PCR by Life hope labs, not billed to insurance, expedited turnaround time 2-3 days.
• COVID-19 Serum IgG antibody testing by Quest diagnostic laboratories, billed to insurance when appropriate, turnaround time 2-3 days.

Beginning September 1st, 2020 we will be adding an in-house COVID-19 rapid test:

• COVID 19 in-house rapid testing (ID Now), billed to insurance when appropriate, insurance does not always cover this test, turnaround time 15-20 minutes. This test is not as sensitive as the above Nasal PCR tests, but this test does offer the benefit of rapid results.

INFLUENZA SEASON AND VACCINATION
The Flu season is fast approaching. We believe the presence of both the influenza virus and COVID-19 during this upcoming fall and winter season will likely complicate the clinic presentation and response to treatment for both infections. We continue to strongly encourage that everyone receive the influenza vaccine to protect themselves from Influenza. My recommendation is for vaccination sometime between Mid-September to late October. We will have the Flu vaccine available for administration in our office during this period.

We will get through this together,

Dr. Edward Espinosa
Buckhead Medicine
91 W. Wieuca Road NE
Atlanta, GA 30342
404-257-5585

Why all the buzz about the accuracy and reliability of COVID 19 tests on the market?

Edward Espinosa, DO, MPH – Medical Director, Buckhead Medicine

As the country begins to emerge from the total shutdown imposed to control the exponential spread of the COVID 19 virus, widespread testing becomes key to controlling the community spread of the Coronavirus. In the past 8 weeks there has been widespread coverage in the media on the variety of COVID-19(Coronavirus) tests being introduced into the market and their accuracy and reliability. As highlighted in a previous blog, with the prevalence of coronavirus infection running at about 5% in the general population, test manufacturers and regulators alike will have to guard against a high rate of false positives from these tests.

To determine contraction risk, the antibody tests for short and long term immunity to Coronavirus become important. If an individual test is positive for short term antibodies (IgM) it implies that they are in a convalescence phase, recovering from an active infection from the virus. Testing positive for long term antibodies (IgG) indicates that the individual has had an infection in the distant past. This confers a degree of immunity for re-infection. The higher number of tested individuals within a group that have antibodies present, the increased likelihood of conferring immunity against re-infections or minimizing the degree of re-infection. Considering the utility of such tests in providing guidance with regards to contraction risk these tests become important for employers to assess and evaluate returning to work front-line workers.

In spite of the utility of antibody tests, a key question remains regarding their accuracy and reliability, since they have been released onto the market with very little regulatory oversight. This is however about to change, with the FDA, CDC and NIH saying last week that they will work together to validate the accuracy of the tests on sale in the US. The article referenced below provides an excellent overview of the accuracy of the current tests on the market.

https://www.evaluate.com/vantage/articles/analysis/spotlight/covid-19-antibody-tests-face-very-specific-problem

COVID-19: What employer can do legally to safeguard workplaces post-shutdown?

COVID-19: Workplace Safety Update

The COVID-19 (Coronavirus) disease pandemic and the resulting total shutdown of workplaces for the past 2 months has been emotionally challenging for employers, employees and people in general, changing day-to-day life as we knew it in unprecedented ways. Now with shelter at home restrictions being lifted, and the real danger of community spread of the Coronavirus still ever present, all sections of society – including employers and employees – need to play a role to protect themselves, each other, and the customers they serve to help prevent and limit further spread of the disease. Recognizing the direct threat at workplaces and to mitigate liability, a number of employers are instituting systematic COVID-19 screening programs in place. Provided below is a synopsis of the updates from the EEOC and the ADA with regards to the legal implications of such screening programs and what is applicable.

With regards to the Equal Employment Opportunity Organization’s (EEOC) laws, including the American Disabilities Act (ADA) and the Rehabilitation Act – these continue to apply during the time of the COVID-19 pandemic. However, recent updates with guidance from these organizations indicate that their existing laws are not to interfere with or prevent employers from following the guidelines and suggestions made by the CDC or state/local public health authorities with regards to steps employers need to take for COVID-19 to safeguard the health of coworkers, customers, and for participating in the control of the pandemic.

The EEOC recently issued an update regarding pandemic screening for COVID-19, which includes a temperature check, and COVID-19 testing. Further, the EEOC update indicated that “During a pandemic, ADA-covered employers may ask employees if they are experiencing symptoms of the pandemic virus, such as fever, chills, cough, shortness of breath, or sore throat.” The EEOC indicated that Employers are to maintain all such information about an employee’s illness or absence thereof as a confidential medical record in compliance with the ADA.” The EEOC’s most recent update provides an answer to the following question: “May an employer administer a COVID-19 test (a test to detect the presence of the COVID-19 virus) before permitting employees to enter the workplace?” In answering this question, the EEOC applies the ADA standard which requires medical testing of employees be “job related and consistent with business necessity.” Applying this standard to the current COVID-19 pandemic, the EEOC states employers may take steps to determine if employees entering the workplace have COVID-19 because an individual with the virus will pose a direct threat to the health of others. But, the EEOC notes that employers should ensure that the tests are “accurate and reliable.” The EEOC’s ADA regulations also require direct threat determinations be based “on a reasonable medical judgment that relies on the most current medical knowledge and/or on the best available objective evidence.” To satisfy these standards, employers should consider FDA and CDC guidance concerning standards for safe and accurate testing, including evaluating the incidence of false positives or negatives with the test. So like its earlier statements, allowing employers to conduct temperature checks on employees, this latest addition provides employers with additional support for conducting or requiring employees to be tested for COVID-19 before returning to the workplace.

Recognizing the challenges faced by employers and to aid the local businesses in and around Atlanta, Buckhead Medicine recently introduced a COVID-19 Surveillance System that employers can subscribe to and have instituted for their worksites. The program embodies a comprehensive set of data driven components to determine transmission and contraction risk: COVID-19 testing for active infection using the nasal RT PCR test from Quest Diagnostics, complete clinical evaluation at baseline of employees enrolled into the program (temperature checking, pulse oximeter readings if needed, paired with questions concerning potential COVID-19 symptoms or activities (e.g., attendance at mass gatherings, family member COVID status, etc.) that increase the risk of COVID-19 exposures. In addition all enrolled employees are also tested for antibodies (IgM & IgG). Though none of these tests are yet definitive or expressly recommended by the CDC, they provide additional data for computation of the different types of risk and the summary recommendations generated by the system for an employee.

The program is in compliance with the law in light of the pandemic environment that businesses are having to operate within that poses a direct threat to the safety and wellbeing of their employees and customers. It should be noted that the updates and guidance from the EEOC and ADA are in place to address a “Direct Threat,” and most likely will no longer apply once the pandemic is no longer deemed a threat. What remains consistent under ADA guidelines, however, is the illegality of firing an individual over a condition like COVID-19. Also note that the EEOC’s opinion only addresses concerns under the ADA. Employers also need to consider state and local laws, including privacy concerns that might apply when instituting any health screening program.

To view the EEOC update, click here for the latest update: What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws

Other useful links:

https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws

https://www.eeoc.gov/laws/guidance/pandemic-preparedness-workplace-and-americans-disabilities-act

Why a serology test for Coronavirus should not be used as the sole test when making staffing decisions?

The landscape for SARS-CoV-2 screening tests (COVID 19 testing) continues to evolve. When it comes to a serology test, shortcomings in the quality of testing, poor sensitivity, false negative rates, as well as variations in the interpretation of results can significantly impact decisions for employers wanting to screen their employees. Without a doubt, limitations exist in the current tools available for us to determine individual immunity, and the risk of COVID19 contraction and/or transmission within a community.

The Infectious Disease Society of America (IDSA) recently provided guidance as to the potential utility, as well as drawbacks of currently available Coronavirus (COVID-19) screening tests on the market. IDSA COVID-19 Antibody Testing Primer document, dated May 4 2020, is provided below for reference. Because of the current limitations of available tests, it is strongly recommended that employers not rely on one single variable (such as a temperature reading) or a single serology test within their employee population when making staffing decisions. Instead, we believe that employers should look at multiple factors and quantitative indicators within their employee population, such as presence and/or absence of specific symptoms, exposure risk (direct and indirect), vital sign measurements, nasal RT PCR, and serum antibody screening tests for COVID-19.

Employer’s decisions regarding staffing should be based on the results of analysis of data from multiple factors and indicators. This data driven approach will provide businesses with a more informed understanding of the overall risk of their employee population with regards to Coronavirus, and allow them to be better prepared to implement preventative strategies to reduce transmission and contraction risk within their workforce, and workplaces.


Access the IDSA Primer Document here:[pdf-embedder url=”https://buckheadmedicine.com/wp-content/uploads/2020/06/idsa-covid-19-antibody-testing-primer.pdf”]

Addressing Confidentiality with the COVID-19 Surveillance System

Ordinarily, the Americans with Disability Act (ADA) prohibits an employer from performing medical tests/clinical exams on its employees – but these are no longer ordinary times – we are now living in a new normal with unfolding waves of the COVID-19 pandemic, prompting the EEOC and the ADA to issue updates regarding what is permissible in these times. 

On April 23, 2020, the Equal Employment Opportunity Commission (EEOC) stated that “an employer may choose to administer COVID-19 testing / temperature checks to employees before they enter the workplace to determine if they have the virus.” Recent updates with guidance from these organizations indicate that their existing laws are not to interfere with or prevent employers from following the guidelines and suggestions made by the CDC or state/local public health authorities with regards to steps employers need to take for COVID-19 to safeguard the health of coworkers, customers, and for participating in the control of the pandemic. Further, the EEOC update indicated that “During a pandemic, ADA-covered employers may ask employees if they are experiencing symptoms of the pandemic virus, such as fever, chills, cough, shortness of breath, or sore throat.” The EEOC indicated that Employers are to maintain all such information about an employee’s illness or absence thereof as a confidential medical record in compliance with the ADA.” 

The EEOC’s most recent update specifically provides an answer to the following question: “May an employer administer a COVID-19 test (a test to detect the presence of the COVID-19 virus) before permitting employees to enter the workplace?” In answering this question, the EEOC applies the ADA standard which requires medical testing of employees be “job related and consistent with business necessity.” Applying this standard to the current COVID-19 pandemic, the EEOC states employers may take steps to determine if employees entering the workplace have COVID-19 because an individual with the virus will pose a direct threat to the health of others. But, the EEOC notes that employers should ensure that the tests are “accurate and reliable.” The EEOC’s ADA regulations also require direct threat determinations be based “on a reasonable medical judgment that relies on the most current medical knowledge and/or on the best available objective evidence.” To satisfy these standards, employers should consider FDA and CDC guidance concerning standards for safe and accurate testing, including evaluating the incidence of false positives or negatives with the test. So like its earlier statements, allowing employers to conduct temperature checks on employees, this latest addition provides employers with additional support for conducting or requiring employees to be tested for COVID-19 before returning to the workplace.

The COVID-19 Surveillance System embodies a comprehensive set of components to determine transmission and contraction risk (Click here to learn more): COVID-19 testing for active infection using the nasal RT PCR test from Quest Diagnostics, complete clinical evaluation at baseline of employees enrolled into the program (temperature checking, pulse oximeter readings if needed, paired with questions concerning potential COVID-19 symptoms or activities (e.g., attendance at mass gatherings, family member COVID status, etc.) that increase the risk of COVID-19 exposures. In addition all enrolled employees are also tested for antibodies (IgM & IgG). Though none of these tests are yet definitive or expressly recommended by the CDC, they provide additional data for computation of the different types of risk and the summary recommendations generated by the system for an employee. We have provided further information regarding serology tests from the FDA.

The other key issue to address here is the disclosure and confidentiality of an employee’s COVID-19 test results. According to the EEOC guidance, employers are to maintain confidentiality of employees’ medical information, including COVID-19 test results. After test results are received, the tester can share the results with a designated individual at the employer, who can then communicate the information to managers on a need-to-know basis only. And this is exactly the way the COVID-19 Surveillance System works – employee participation is decided upon by the employer and is voluntary and the results / recommendations from the data algorithms are accessed via a secure portal with restricted access to key designated users at the employer organization, and with employees having access to their own results. The information provided to the employer for a given employee is a summary based data driven recommendation – safe to return to work (green), work from home for XX days (yellow), and self-isolate to minimize transmission risk (red). An employee’s identity is only disclosed to their manager only if it is necessary to prevent a direct threat to safety to co-workers and or customers. 

Also, in accordance with the ADA / HIPAA, the system is compliant with requirements for an employer’s storage of medical information. As required by the ADA, the COVID-19 Surveillance System maintains the COVID-19 related medical information concerning an employee separately from the employee’s personnel file in a confidential and secure encrypted medical data repository. In addition, even after the end of their subscription, employers will have access to the data and information in the encrypted secure repository for the statutory period of 7 years.

We are expecting the EEOC and ADA guidelines to continue to evolve as testing becomes more widely available and state governments begin to loosen stay-at-home restrictions. These guidance are in place to address a “Direct Threat,” and most likely will no longer apply once the pandemic is no longer deemed a threat. What remains consistent under ADA guidelines, however, is the illegality of firing an individual over a condition like COVID-19. Also note that the EEOC’s opinion only addresses concerns under the ADA. Employers also need to consider state and local laws, including privacy concerns that might apply.

ADDITIONAL RESOURCES

1. To view the EEOC update, click here for the latest update: What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws.

2. To review the FDA’s device center’s webpage listing the serology tests that are administered under the EUA policy, some of which are directed toward a single antibody while others capture multiple antibodies, click on the link below. The list includes data on sensitivity and specificity along with positive and negative predictive values (PPV and NPV, respectively). The agency has advised that the PPV and NPV values are still based on an assumed prevalence of 5% in the area where a given serological test is administered.

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance

Other links with more detail on above topics:

https://www.eeoc.gov/laws/guidance/pandemic-preparedness-workplace-and-americans-disabilities-act

https://www.venable.com/insights/publications/2020/04/eeoc-says-ok-for-mandatory-employee-covid19

https://www.natlawreview.com/article/eeoc-opines-covid-19-testing-employers

FAQs- COVID 19 Surveillance System

Coronavirus Update 8 – Convalescent Plasma Donation

The Dogma of the Realities of the Accuracy of SARS-CoV-2 Tests!

SARS-CoV-2, the virus responsible for the COVID-19 pandemic, is a new/novel virus for the human race. One of the pillars of managing this virus and the pandemic is accurate testing. Testing for the SARS-CoV-2 virus remains a challenge with regards to the accuracy of tests on the market. Epidemiologically, any diagnostic or laboratory test is always evaluated on two key metrics: it’s specificity and sensitivity rate.

Specificity

Specificity is the likelihood that the COVID test results are truly positive. That is, could a similar Non-COVID-19 Coronavirus be responsible for the positive result? A COVID test with a high specificity (i.e., reliable) will have a LOW false positive rate. Generally speaking it is desirable to have a test with high specificity. However, high specificity is attained at the expense of sensitivity. It is desirable to have a test with high specificity and sensitivity, but almost impossible to create a perfect test.

SARS-CoV-2 in its worldwide prevalence in the general population is still low. Even with the current pandemic raging, the prevalence and incidence is still low based on identified active cases (Some 5 million active cases identified worldwide out of a population of about 7.7 billion as of May 21, 2020). Aside from the diagnosed positive cases, it is estimated that the prevalence of coronavirus infection is more around 5% in the general population. We commonly associate a low prevalence of disease with increased false positive rates when testing. The current low prevalence of COVID infection affects the accuracy of SARS-CoV-2 tests coming into the market for use, with the risk of false positives becoming a major problem. Test manufacturers and regulators alike will have to be diligent and guard against a high number of false positives when developing and approving tests.

Sensitivity

Sensitivity of a SARS-CoV-2 molecular test or antibody test is the likelihood of how accurately the test will detect the virus or presence of the different types of antibodies. That is if you are infected with the virus, will the test correctly identify that you are infected, or will it not identify the virus in your respiratory system, resulting in a false negative. A highly sensitive test (i.e., accurate) will have a LOW false negative rate.

Most of the tests granted emergency use approval by the FDA during this pandemic have limited data with regards to their reliability and accuracy. Scientists at the Cleveland Clinic found that one popular rapid genetic test (the widely promoted Abbot test) told users they didn’t have the virus when they actually did (false negatives) about 15 percent of the time (1). Meanwhile, researchers at UCSF California studied 14 antibody tests on the market, some that were granted emergency use authorizations by the Food and Drug Administration (FDA), and found that only three of these tests delivered consistent results (1). Given the 5% prevalence rate, if a serological test has about 90% specificity, its positive predictive value (PPV) will be 32.1% – meaning nearly 70% of positive results will most likely be false. At this same disease prevalence, a test with 95% specificity will lead to a 50% chance that a positive result is wrong. Only at 99% specificity does the false positive rate become anywhere near acceptable, and even here the chances are that 16% of positive results would be wrong.

We know that a number of individuals with COVID infection are asymptomatic, sometimes for weeks, increasing the transmissibility of the disease in the population. For such cases it is important to have tests that can look for active infections with a high degree of sensitivity and specificity (low number of false negatives and false positives). If we can quickly identify such cases and isolate them, then we can prevent the rapid spread of this contagion.

The table below summarises test accuracy data, as of May 06, 2020, from selected manufacturers for their serological Covid-19 tests. However, when reviewing this data it has to be stressed that the validation tests these companies have performed have varied widely in size; Abbott’s antibody assay was tested on 1,200 specimens, whereas Epitope’s tests were run on only 54 samples from healthy people, and just 20 and 30 cases of PCR-confirmed Covid-19 cases for the IgM and IgG tests respectively.

Accuracy & Reliability of Selected COVID 19 Tests in the US & EU Markets:

[table id=3 /]

Note: All accuracy claims made by the companies. *Tests with FDA emergency use authorisation. Source: EvaluateMedTech & company websites.

Similar to most processes associated with COVID 19, since the emergence of the infection, tests for active infection and/or for antibodies are evolving daily by different clinical research laboratories, academic health organizations, and biomedical companies worldwide. However, in the US we are still facing a challenge with regards to ready and widespread availability of accurate and reliable COVID tests for both the molecular PCR test and the serological tests for the different antibodies. The situation is both dire and murky to say the least.

At this point, it is well recognized that both the molecular tests for Covid-19 (the nasal PCR that look for active infections) and the serological antibody tests (IgM for more recent and IgG for past infections) have had significant issues with respect to their accuracy. Shortage of good tests in turn means that we will not know how many active cases are out there in the public, or how many have recovered with a degree of short or long term immunity conferred on them to decrease the risk of contraction and/or rate of reinfection.

REFERENCES
1. https://www.vox.com/2020/5/1/21240123/coronavirus-quest-diagnostics-antibody-test-covid
2. Data compiled by EvaluateMedTech.
3. Loeffelholz MJ, Tang YW. Laboratory diagnosis of emerging human coronavirus infections – the state of the art. Emerg Microbes Infect. 2020;9(1):747–756. doi:10.1080/22221751.2020.1745095
4. Sheridan C. Fast, portable tests come online to curb coronavirus pandemic. Nat Biotechnol2020. [Epub ahead of print] doi:10.1038/d41587-020-00010-2 pmid:32203294