Antibody tests are among the tests used for Covid-19. Get detailed information on antibody testing guidelines for an employer’s workplace and employees.
Since the first case of Covid-19 was reported in December 2019, there has been a turn of events in different aspects of life. Business has not been, as usual, millions have lost their jobs and sources of income, students have had to defer schools among many other changes.
While things have been on a standstill for some time, governments have found ways for their countries to live with the virus. In a bid to save the economy, they have strategies to provide cushion for the economy. Companies have also been allowed to resume operations provided they follow CDC guidelines for the prevention of the spread of Covid-19.
Among the back to work safety practices include Covid-19 testing at the workplace. Here is all the information regarding EEOC antibody testing guidelines and requirements at the workplace.
Employees being tested have the right to get detailed information regarding the tests. The employer is expected to provide employees with clear information on:
1. The manufacturer and the name of the test, for instance.
2. There are different types of tests. The employee should get clear information on the kind of test they are taking. For instance, an antibody test.
3. The employee needs to know the reliability of the test. That is the accuracy in terms of sensitivity and specificity.
4. Information on how the test will be done and who will be paying for the test. Is it the employee or the insurance company?
5. The employee should also get information on how the results of the test are interpreted.
6. How will the results of the test be used and the action taken if the results turn negative or positive?
7. What happens if an employee refuses to take the tests.
The employees should also be given patient fact sheets as part of the test’s emergency use authorization external icon.
Employers Responsibilities for COVID-19 Reporting
The employer is expected to report for Covid-19. The Occupational Safety and Health Administration has issued interim guidance external icon for enforcing the requirements of 29 CFR Part 1904 external icon.
This is regarding the recording and reporting of occupational illnesses in respect to Covid-19.
OSHA states that since Covid-19 is a recordable illness and employers have the responsibility of recording Covid-19 cases at the workplace under the provided requirements.
Employers are also expected to check OSHA’s webpage at www.osha.gov/coronavirus external icon for updates on reporting requirements.
Here are the situations under which the employers are expected to record:
1. When the case is a confirmed case of COVID-19, as defined by the Centers for Disease Control and Prevention (CDC).
2. When the case is work-related as defined by 29 CFR § 1904.5;
3. When the case involves one or more of the general recording criteria outlined in 29 CFR § 1904.7.
EEOC Updates Guidance on Employers Testing Workers for COVID-19
The most recent update released by EEOC was on the 17th of June. The developments in the updates include CDC’s guidelines, which state that the antibody test results must not be used to drive decisions regarding the return of employees at the workplace.
Antibody testing is included in the ADA medical examinations and cannot bar the employees from returning to work.
Antibody testing and the diagnosis of acute infection
Can antibody testing be used to diagnose acute Covid-19 infection? CDC does not recommend using antibody testing as the basis for diagnosing acute infection. The FDA also is yet to approve antibody testing for the diagnosis of acute infection.
Diagnosis for Covid-19 infection for healthcare workers and residents of a nursing home should be done using both viral and antibody Covid-19 tests.
In some cases, serologic assays may be used to support the clinical assessment of persons who present late in their illnesses when used in conjunction with viral detection tests. In addition, if a person is suspected of having a post-infectious syndrome, for instance, Multisystem Inflammatory Syndrome in Children caused by SARS-CoV-2 infection, serologic assays may be used.
POC Antibody Tests
Point-of-care (POC) tests are also being used for Covid-19 testing. They are substantially lateral flow devices that can detect IgG or both IgM and IgG in plasma, whole blood, serum, and saliva. Some POS antibody tests can be performed on blood samples obtained by fingerstick as opposed to venipuncture. The other advantage that these tests carry is their simplicity and speed.
Governments across the globe are considering “Immunity Passports” as a strategy to help them resume normalcy. While the World Health Organization has published guidance on adjusting public health and social measures for the next phase of the COVID-19 response, some governments suggest using antibody tests to create “Immunity Passports,” which are also known as “ risk-free certificates.”
They believe that these will be instrumental in helping individuals travel and travel to work. The approach of using antibody tests for this is based on the assumption that people are protected against reinfection. However, the suggestion is currently under criticism. It is yet to be proven that people who have been infected with Covid-19 and recovered have antibodies that can protect them from subsequent infection.
Additionally, it is yet to be proven that there is a marked decrease in viral load in the respiratory tract of recovered persons. For people to be protected from reinfection of Covid-19, there needs to be a development of antibodies and a decrease in viral load, which have both not been proven in Covid-19 cases.
There lacks data surrounding protection from reinfection and information regarding the concentration of antibodies needed to protect people adequately.
Neutralization tests and Covid-19
Viral neutralization tests are used to gauge the functional ability of antibodies to prevent infection of viruses in vitro. The tests involve the incubation of serum or plasma with live virus, followed by the infection and incubation of cells. There are two types of laboratories that can be used for neutralization tests: BSL-3 or BSL-2, and the choice will depend on the Covid-19 virus used.
However, these tests are not yet in use as the FDA is yet to approve the use of neutralization tests for Covid-19.
Definition of high-prevalence & low-prevalence
In a high-prevalence setting, the positive predictive value increases. This means that it is more likely that persons who test positive are truly antibody-positive, unlike if the test is performed in a low-prevalence population. When a test is used in a population where prevalence is low, the positive predictive value drops because there are more false-positive results, since the pre-test probability is low. At the same time, the negative predictive value is also affected by prevalence. In a high-prevalence setting, the negative predictive value declines, whereas, in a low-prevalence setting, it increases.
Covid-19 viral tests performance
Currently, there is no substantive performance advantage of assays, whether they test for IgG, IgM, and IgG, or total antibody. Thus, the immunoglobulin class should not determine the assay chosen in most circumstances. The detection of IgM antibodies may indicate more recent infection, but the IgM antibody response dynamics are not well defined at present. Over time, it may be essential to characterize and evaluate the performance of assays in samples that are IgM negative and IgG positive to ensure that tests remain fit for purpose in population studies as the pandemic progresses. More individuals are expected to have lower IgM levels.
Covid-19 serology tests guideline
Serologic tests are generally blood tests done to look for antibodies in a blood sample. Here are the instructions for serology tests concerning Covid-19.
1. Serologic testing should not determine immune status in individuals until the presence, durability, and duration of immunity are established.
2. Serologic testing can be offered to support the diagnosis of acute COVID-19 illness for persons who present late. For persons who present 9-14 days after illness onset, serologic testing can be provided in addition to recommended direct detection methods such as polymerase chain reaction. This will maximize sensitivity as the sensitivity of nucleic acid detection decreases, and serologic testing is increasing during this period.
3.Serologic testing should be offered to help establish a diagnosis when patients present with late complications of COVID-19 illness, such as multisystem inflammatory syndrome in children.
4. Serologic test results should not be used to make decisions about grouping persons residing in or being admitted to congregate settings, such as schools, dormitories, or correctional facilities.
5. Serologic test results should not be used to make decisions about returning persons to the workplace.
6. Until more information is available about the dynamics of IgA detection in serum, testing for IgA antibodies is not recommended.
Health Care Providers
Health care providers also have a responsibility concerning antibody testing. The U.S. Food and Drug Administration (FDA) recommends that health care providers continue to use serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been exposed to the virus, or have recovered from Covid-19.
Health care providers are also expected to be well-versed with the tests’ limitations as the primary basis for diagnosing Covid-19. They should even understand the risks to patients and the community if they used the tests alone to diagnose Covid-19.
According to the FDA, they are yet to receive an approved antibody test for the diagnosis of Covid-19 and do not expect that there will be an antibody test designed to diagnose the virus.
FDA message to healthcare providers:
The FDA states that it has not approved all the serological tests available in different markets. To find information regarding the serological tests that have been approved, healthcare providers are advised to visit the Emergency Use Authorization (EUA) page. Tests being offered under a policy outlined in the FDA’s COVID-19 Diagnostic Policy Guidance are also listed on the FDA FAQ page. The FDA has not reviewed such tests unless a EUA has also been submitted and evaluated by the FDA.
How reporting of COVID-19 should be handled
Laboratory data elements should be reported in the following ways.
1. Submit laboratory testing data directly to state or local public health departments according to state/or local law or policy. Data must be sent using existing reporting channels to ensure rapid initiation of case investigations, and concurrent reporting of results must be shared with the ordering provider or patient, as applicable.
2. Submit laboratory testing data to state and local public health departments through a centralized platform (such as the Association of Public Health Laboratories’ AIMS platform external icon). The data will then be routed to the appropriate state and local authorities and routed to CDC after the removal of personally identifiable information according to applicable rules and regulations.
3. Submit laboratory testing data through a state or regional Health Information Exchange (HIE) to the appropriate state or local public health department and then to CDC as directed by the state.
4. Public health departments should submit de-identified data to CDC daily, using either Health Level 7 (HL7) messaging or the CDC-provided CSV format.
What should be reported
Complete laboratory data must include the following data elements for state and jurisdictional health departments.
1. The test ordered, using harmonized LOINC codes provided by CDC
2. Device Identifier
3. Test result using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC
4. Test Result date (date format)
5. Accession # / Specimen ID
6. Patient age
7. Patient race
8. Patient ethnicity
9. Patient sex
10. Patient residence zip code
11. Patient residence county
12. Ordering provider name and NPI (as applicable)
13. Ordering provider zip
14. Performing facility name and CLIA number
15. Performing facility zip code
16. Specimen Source – use appropriate LOINC, SNOMED-CT, or SPM4 codes, or equivalently detailed alternative codes
17. Date test ordered (date format)
18. Date specimen collected (date format)
The following additional demographic data should also be collected and reported to state or local public health departments.
1. Patient name (Last name, First name, Middle Initial)
2. Patient street address
3. Patient phone number with area code
4. Patient date of birth
5. Ordering provider address
6. Ordering provider phone number
To protect patient privacy, any data that state and jurisdictional health departments send to CDC will be de-identified and will not include some patient-level information. The deidentified data shared with CDC will help understand COVID-19’s impact, positivity trends, testing coverage, and help identify supply chain issues for reagents and other materials.
What should be included in laboratory test orders
Anyone who orders a COVID-19 test collects a specimen or performs a laboratory test must make every reasonable effort to collect complete demographic information and responses to the following “ask on order entry” (AOE) questions. These data elements are critical for the COVID-19 public health response. Including them with test orders will help the laboratories that perform the test to report the information to state and jurisdictional health departments, as required. These elements should be collected under the HL7 Version 2.5.1 Lab Order Interface Implementation Guide external icon and associated standards.
When information is not available, the healthcare providers, or their designees, who ordered the COVID-19 test and laboratories performing those tests should consider leveraging other information sources to obtain these data. For instance, health information exchanges, employee records, school records.
Healthcare providers can answer the following questions on behalf of the individual being tested for COVID-19:
1. Do you currently work in a healthcare setting with direct patient contact?
This is determined if the individual, at the time of this COVID-19 test order, works with patients in a high-risk role, such as, but not limited to
- first responders,
- front-line clinicians,
- nursing home staff,
- environmental staff, or
- therapists in direct contact with patients.
Users include (but are not limited to):
- Clinical laboratory personnel
- Federal, state, and local public health agencies
- IVD test developers or manufacturers
- Laboratory Information System (LIS) and Electronic Health Records (EHR) vendor
Paul Singh, MHA, BA
Office: 855-Plant-Rx (Toll Free 1-855-752-6879)
Covid Antibody Diagnostics™
A Natures Body Wellness Corporation
255 Primera Blvd
Lake Mary FL 32746