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

Coronavirus Update 12: Transitioning to routine annual exams and office visits

As we move forward cautiously to safely reopen the practice for annual exams and routine office visits, we wanted to update you on processes and protocols that we are implementing within the Buckhead Medicine office.

We are committed to providing you with a safe and clean office visit and have therefore implemented changes to reduce the risk of COVID-19 virus transmission, based on Centers for Disease Control and Prevention recommendations.

When appropriate, patients will continue to have an option for a tele-medicine encounter in place of or to augment the face to face encounter.

Transmission risk reduction strategies include providing and requiring the use of masks, gloves, hand sanitizer, and hand washing areas for all persons entering our office. Our waiting room has been removed. Patients now wait in their car. Our staff orchestrates social distancing during your encounter. Our staff performs thorough cleaning of all surfaces that have been in contact with patients and staff.

All staff and providers wear appropriate personal protective equipment and are continuously performing hand hygiene. All staff have daily temperatures measured and are routinely tested for the COVID-19 virus via nasal PCR and serum IgG. Any staff member with signs or symptoms of COVID-19 infection are immediately sent home.

All patients are required to inform Buckhead Medicine staff or providers of any active or recent COVID-19 symptoms, potential exposure or contact with person felt to be infected with the COVID-19 virus, or pertinent recent travel history.

Patients who are demonstrating signs of COVID-19 illness that need to be evaluated in the office will be asked to enter the office via the rear entrance and will be evaluated in our isolation room.

During the office encounter, we require all patients to wear face masks to reduce the risk of exposure to you and others. We require all patients wash hands or use hand sanitizer before and after treatment and any other appropriate situation, such as touching their face, coughing, sneezing, or using the restroom.

Transmission is thought to occur mostly from person-to- person via respiratory droplets among close contact. Our efforts in the office are focused on reducing the risk of transmission. Because of the mode of transmission, the risk of COVID19 infection cannot be eliminated. There is no way of assuring via testing that none of our employees have been exposed. We have little control, regarding the health status of any patients (other than those obviously manifesting signs or symptoms). Complete social distancing and quarantine are the only reliable protections. By coming to our office, you are assuming the same risks as the general population in other similar environments or situations.

As we move forward with annual exams, we believe the best way to handle this type of visit is by having an initial 20-minute tele-medicine visit to go over history and any active issues. The tele-medicine visit will be followed within the next 7 days by a 20 to 30-minute face to face visit in the office for physical exam, vital sign measurement, blood and urine studies and if needed EKG.

We will begin scheduling annual exams and routine office visits beginning Monday, June 8th, 2020. Please call the office or send a message via OHMD to schedule a visit.

We look forward to seeing you again,

Dr. Edward Espinosa
Buckhead Medicine