The demand for antibody or serological testing may increase significantly with the COVID-19 vaccination rollout across the globe. Is your laboratory ready?
Antibody testing, though not currently recommended to assess immunity after COVID-19 vaccination, will help in the following ways:
Determine prior exposure to the COVID-19 virus.
Assess immunity after COVID-19 vaccination.
Determine the efficacy of vaccine candidates in clinical trials.
Perform epidemiological studies to ascertain the protection in the population.
Identify a population that is no longer at the risk of getting infected directly (herd immunity).
On a global scale, antibody testing is vital for the management and surveillance of the virus. It will help determine the full scope of the disease, the efficacy of the vaccination efforts, and this, in turn, will help to rebuild public confidence.
To this end, highly accurate antibody testing is needed to support both clinical and public health decision-making, even as the government and organizations strive to devise safe return-to-work strategies.
The FDA recently approved antibody testing for COVID-19 to facilitate the safe return to work for people who are immune to a certain level from the disease. The immunity conferred may not be long-lasting and is subject to several factors such as mutation of the virus which may compromise one’s acquired immunity. However, antibody testing can guide governments on the necessary steps to take to curb the spread of the virus.
How Does the COVID-19 Antibody Test Work?
After a person is infected by the coronavirus, the patient’s body initiates an antibody response against the virus. Two different kinds of antibodies are produced: IgM antibodies which are produced in the first few weeks post-infection and later IgG antibodies which confer long-term immunity. Detection of IgM antibodies denotes a recent infection while that of IgG antibodies denotes a distant infection. The antibody test is done on a blood sample and may take up to two hours to be completed.
Serological testing can be either qualitative or quantitative. A qualitative test detects the presence of antibodies against the virus. A quantitative test detects the exact amount of antibodies that are present in blood circulation.
Types of Antibody Testing for COVID-19 Virus
There are two broad types of antibody tests for the COVID-19 virus: binding antibody detection tests and neutralizing antibody detection tests.
Neutralizing antibodies can predict protection from future infection. High-throughput antibody tests can accurately quantify neutralizing antibodies in an individual and provide highly specific information to determine risk versus safety protocols. Assaying the amounts of neutralizing antibodies in exposed or vaccinated individuals will guide public health strategies to determine the possible trajectory of the pandemic. Consequently, neutralizing antibody detection tests are the gold standard in the industry.
The Emerging Demand for Antibody Testing
The economic pressure due to the stringent measures instituted to combat the COVID-19 pandemic is approaching a breaking point. Consequently, governments are being forced to devise measures to restore normalcy, even as they ensure that the spread of the virus is still controlled. This is an intricate balancing act, and hence, there is an increased demand for antibody testing. It is probable that in the coming months, antibody tests that can specifically detect the antibodies induced by COVID-19 vaccines will receive authorization.
Is your laboratory ready for COVID-19 vaccine antibody testing?
The Role of COVID-19 Testing Laboratories
In the wake of the COVID-19 vaccination roll-out across the globe, COVID-19 testing laboratories must be ready to meet the antibody testing demand that is likely to increase in the near future.
COVID-19 testing laboratories receive a large number of specimens and test requests on a regular basis. They are required to manage a large number of samples, protect personal information, and provide accurate, timely, and reliable data consistently. With the increasing demand for antibody testing, they will need to drastically improve their processes while remaining compliant and ensuring accuracy and confidentiality.
The Role of a LIMS
A cloud-based Laboratory Information Management System (LIMS) can help COVID-19 testing laboratories to meet the increasing demand for antibody testing throughout the cycle: collecting and managing specimens, ensuring privacy and compliance, reporting accurate and reliable test results. A LIMS helps COVID-19 testing laboratories manage data, automate workflows, and generate custom test reports to comply with the FDA and CDC reporting guidelines while limiting manual errors.
COVID-19 diagnostic testing laboratories need to respond to changes to assays and workflows with the advent of new tests that receive emergency use authorization. They also need to be equipped with quickly turning around antibody testing results for the local authorities to make decisions about the spread, immunity and administering boosters to ensure the safety of the population. A preconfigured, scalable, and in the cloud COVID-19 LIMS solution would help such laboratories quickly come up to speed with the testing and reporting requirement through automation and quick deployment.