Ethos Laboratories Tru Immune

GTR Test IDHelpEach Test is a specific, orderable test from a particular laboratory, and is assigned a unique GTR accession number. The format is GTR00000001.1, with a leading prefix 'GTR' followed by 8 digits, a period, then 1 or more digits representing the version. When a laboratory updates a registered test, a new version number is assigned.: GTR000592449.3
Last updated: 2021-07-14
Annual Review past due read more
Test version history
- 592449.3, last updated: 2021-07-14
- 592449.2, last updated: 2021-05-21
- 592449.1, last updated: 2021-02-26

Clinical microbial testHelpIn the U.S., clinical tests must be performed under CLIA certification. When a lab uses the same methods for a test in both clinical and research settings, the test appears as two separate GTR records. for COVID-19
Offered by Ethos Laboratories

Interpretation

Not provided

Comments about the test interpretation (e.g. clinical implication of test results)

POSITIVE RESULT A positive test result with the Tru-Immune SARS-CoV-2 Neutralizing Antibody ELISA test indicates that functional antibodies capable of neutralizing or inhibiting the SARS-CoV-2 virus were detected in the specimen. This result indicates that the individual has potentially been exposed to COVID-19 and has produced antibodies that are now capable of blocking the interaction between the virus and its target receptor (ACE2). The Tru-Immune SARS-CoV-2 Neutralizing Antibody ELISA test is isotype independent meaning that it can detect the inhibition capacity of all neutralizing antibodies (e.g., IgG, IgM) present in the sample. Positive test results indicate that neutralizing antibodies were detected in the specimen. Semi-quantitative results will be provided which describe the capacity of detected antibodies to block the SARS-CoV-2/ACE2 interaction. Blocking capacity of detected antibodies will be reported as a percentage (%) where the higher the result, the greater the inhibition capacity of the neutralizing antibodies. Neutralizing antibodies to SARS-CoV-2 generally do not begin to appear until 2-10 days after infection. When neutralizing antibodies are present, it often indicates a past infection but does not exclude recently infected individuals who are still contagious. It is unknown how long neutralizing antibodies to SARS-CoV-2 will remain present in the body after infection. Neutralizing antibodies are the best way to evaluate protective immunity to infection, however the duration of this protection is currently unknown. A positive result for neutralizing antibodies may not mean that an individual’s current symptoms are due to COVID-19 infection. Laboratory test results should always be considered in the context of clinical observations and epidemiological data to guide patient management decisions. The Tru-Immune SARS-CoV-2 Neutralizing Antibody ELISA test has been designed to minimize the likelihood of false positive results. However, in the event of a false positive result, immediate measures to consider could include the following: a recommendation for isolation of the individual, monitoring of household or other close contacts for symptoms, isolation that might limit contact with family, friends, or other potentially COVID-19 infected individuals, limits in the ability to work, or other unintended adverse effects. All laboratories using this test must follow standard confirmatory testing and reporting guidelines according to their appropriate public health authorities. NEGATIVE RESULT A negative test result with this test means that SARS-CoV-2 neutralizing antibodies were not present in the specimen above the limit of detection. However, a negative result does not preclude COVID-19 infection and should not be used as the sole basis for treatment, patient management decisions, or to rule out active infection. Individuals tested early after infection may not have detectable neutralizing antibody despite active infection; in addition, not all individuals will develop a detectable neutralizing response SARS-CoV-2 infection. The absolute sensitivity of the Tru-Immune SARS-CoV-2 Neutralizing Antibody ELISA test is unknown. When diagnostic testing is negative, the possibility of a false negative should be considered in the context of an individual’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. This is especially important if the individual has had recent exposure to COVID-19, or clinical presentation suggestive of COVID-19, and diagnostic tests for other causes of illness (e.g., other respirator illness) are negative. Direct testing for virus (e.g., RT-PCR testing) should always be performed in any individual suspected of COVID-19, regardless of the Tru-Immune SARS-CoV-2 Neutralizing Antibody ELISA test result. Risks to an individual of a false negative result include: restriction of activities deemed appropriate for individuals with evidence of a neutralizing antibody response to SARS-CoV-2, or other unintended adverse events.

Research

Is research allowed on the sample after clinical testing is complete?HelpAfter clinical testing is complete, does the laboratory perform any research testing using the submitted specimen? (Quality control is not considered as research for this question.): Not provided

Reviews

Clinical resources

Practice guidelines

NICE, 2024
UK NICE Guideline NG191, COVID-19 rapid guideline: managing COVID-19, 2024

Consumer resources

MedlinePlus

IMPORTANT NOTE: NIH does not independently verify information submitted to the GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in the GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.