COVID-19 serology point-of-care tests | Therapeutic Goods ...

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COVID-19 serology point-of-care tests
Serology point-of-care tests are not the same as rapid antigen point-of-care tests. To find out more information on rapid antigen point-of-care tests see COVID-19 point-of-care tests.
COVID-19 serology point-of-care tests can detect human antibodies that are produced in the days or weeks after a person is infected with the SARS-CoV-2 virus or received a vaccination. These tests are usually presented in a small plastic cassette, similar to pregnancy tests, and require a blood specimen for testing.
Note: Some states and territories have prohibited or restricted use of serology point-of-care tests. Please visit the relevant government website for further information.
A number of COVID-19 serology point-of-care tests have been approved by the Therapeutic Goods Administration (TGA) subject to conditions, including restrictions on who can obtain them. The TGA is conducting a post-market review of all approved COVID-19 serology point-of-care tests to verify their performance and inform their best use. The Department of Health has engaged the Peter Doherty Institute to assist in the post-market validation of these tests.
A significant risk in serology point-of-care testing relates to misinterpretation of the result. Accurate identification of a COVID-19 infection based on serology results requires an understanding of how the antibody response develops with time, and how there is a significant lag time between infection and the development of antibodies. All point-of-care serology tests currently available in Australia detect IgM and/or IgG antibodies that develop in response to an infection with the SARS-CoV-2 virus. These tests do not detect the SARS-CoV-2 virus itself. This is important because, while these tests can detect if a person has been exposed to the SARS-CoV-2 virus, they cannot determine whether a person is currently infectious or has recently been infected with the virus.
Positive serology point-of-care result
A positive IgM, IgG and/or IgA serology result indicates that a person has been exposed to the SARS-CoV-2 virus. It is possible that the person has a current COVID-19 infection and is potentially infectious. In a symptomatic person, a positive result may be sufficient to presume infection with COVID-19 but this should be confirmed by laboratory testing. Current Communicable Diseases Network Australia guidelines for further testing and self-isolation should be followed.
Negative serology point-of-care result
It can take up to two weeks, or even longer, for a serology point-of-care test to detect antibodies that are produced in response to a viral infection or following vaccination. It is recommended that COVID-19 serology point-of-care tests should not be used until at least two weeks post onset of symptoms. A negative IgM, IgG and/or IgA serology result cannot rule out a current COVID-19 infection. This is particularly true if a patient has no symptoms or has had symptoms for less than two weeks.
Note: The ability of serology tests to accurately detect exposure to the SARS-CoV-2 relies on their sensitivity and specificity, which can vary significantly between different assays. Serology tests can be cross-reactive and detect antibodies produced in other infections. For example, less severe seasonal coronaviruses circulating in the community can induce antibodies that cross-react in a COVID-19 test to produce false-positive results. Serology tests can also fail to detect COVID-19 if testing is performed in the acute phase of the infection prior to the development of detectable antibodies.
Serology testing is generally used in epidemics to aid in the investigation of the outbreak to better understand the rate and pattern of infection. This relies on the serology point-of-care test results being captured by public health reporting networks. Serology testing may also be useful if SARS-CoV-2 nucleic acid tests are repeatedly negative, but the patient's symptoms and epidemiology are strongly suggestive of infection with COVID-19. However, such complex cases should be referred to a specialist infectious disease physician for further investigation.
Testing to confirm immunity status
The TGA has not approved any serology point-of-care tests for inclusion in the ARTG that can definitively provide information on an individual's immune status against COVID-19. Currently, there is insufficient evidence that serological tests can effectively assess an individual's immunity to COVID-19 following vaccination.
The existing scientific evidence does not support the claim that a positive antibody test indicates an individual is immune to SARS-CoV-2. Absence of antibodies following vaccination does not necessarily mean that the person will not mount a response to a SARS-CoV-2 infection in the future, nor does the presence of antibodies guarantee that the patient will be protected from symptomatic disease, or onward transmission of the virus. This position is consistent with the broader evidence base, and the policy position of multiple agencies in Australia and overseas.
The Public Health Laboratory Network (PHLN) does not currently recommend routine diagnostic serological testing pre- or post-vaccination, except in specific cases where this kind of testing may be requested as part of the assessment by a treating medical practitioner to inform a patient's clinical pathway e.g. immunocompromised patients.
The TGA continues to monitor and consider the evolving COVID-19 pandemic, as well as the scientific and clinical evidence to support new technologies and claims for COVID-19 testing.
Point-of-care testing considerations
There are a number of issues that require particular consideration for any point-of-care testing services. These include:
potential for misidentification of the patient and/or test specimen
infection risk for the patient and the operator.
Blood specimens collected for point-of-care testing, as for other forms of testing, should be regarded as potentially infectious not just for SARS-CoV-2, but also for other blood-borne infectious diseases. Staff must be trained in appropriate specimen collection and infection control.
If you are intending to offer COVID-19 serology point-of-care testing, staff in your facility should have the knowledge, experience and capabilities to safely and accurately carry out the specimen collection and testing, correctly interpret the results and be able to provide current and correct health advice based on these results. The National Pathology Accreditation Advisory Council has published guidance on key considerations for COVID-19 point-of-care testing used in health care settings.
COVID-19 serology point-of-care post market evaluation
As part of a post market review the TGA is now reviewing all approved serology-based COVID-19 POC tests to verify their ability to detect antibodies to SARS-COV-2 (the virus that causes COVID-19), taking into consideration the timeframes for an individual to develop detectable levels of antibody. The Peter Doherty Institute for Infection and Immunity (the Doherty Institute), has been engaged by the Department of Health to assist with the post-market verification process of these tests, to inform their best use. However, reports by other Australian laboratories or comparable international regulators may also be taken into consideration.
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The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.