FDA Publish Performance Evaluation EUA COVID-19 Ab Tests

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9th June 2020 Editorial by: rapidmicrobiology staff writer

FDA Publish Performance Evaluation of EUA COVID-19 Antibody Tests

Commercially manufactured antibody tests check for SARS-CoV-2 antibodies in individuals and are available through healthcare providers and commercial laboratories. CDC is evaluating the performance of these tests in collaboration with the following federal organizations:

Biomedical Advanced Research and Development Authority
U.S. Food and Drug Administration (FDA)
National Institutes of Health
Department of Defense
White House Office of Science and Technology Policy

Concerning performance results, please note: These estimates of sensitivity and specificity are just that: estimates. They include 95% confidence intervals, which are the range of estimates we are about 95% sure a test's sensitivity and specificity will fall within given how many samples were used in the performance validation.

The more samples used to validate a test, the smaller the confidence interval becomes, meaning that we can be more confident in the estimates of sensitivity and specificity provided.

Tests are also described by their Positive and Negative Predictive Values (PPV and NPV). These measures are calculated using a test's sensitivity, its specificity, and using an assumption about the percentage of individuals in the population who have antibodies to SARS-CoV-2 (which is called "prevalence" in these calculations).

Every test returns some false positive and false-negative results. The PPV and NPV help those who are interpreting these tests understand, given how prevalent individuals with antibodies are in a population, how likely it is that a person who receives a positive result from a test truly does have antibodies to SARS-CoV-2 and how likely it is that a person who receives a negative result from a test truly does not have antibodies to SARS-CoV-2.

The PPV and NPV of a test depend heavily on the prevalence of what that test is intended to detect. Because all tests will return some false positive and some false-negative results, including tests that detect antibodies to SARS-CoV-2, broad use of the tests, when not appropriately informed by other relevant information, such as clinical history or diagnostic test results, could identify too many false-positive individuals.

How performance measures were calculated: In some cases, there may be minor differences between the numbers on this page and those in the instructions for use. Confidence intervals for sensitivity and specificity that appear on this page were calculated per a score method described in CLSI EP12-A2 (2008). See Recognized Consensus Standards. Confidence intervals for PPV and NPV were calculated using the values from the 95% confidence intervals for sensitivity and specificity. (FDA)

Test Performance

Abbott Alinity i SARS-CoV-2 IgG

Developer: Abbott
Test: Alinity i SARS-CoV-2 IgG
Technology: High Throughput CMIA
Target: Nucleocapsid

Test Facts:

FDA Publish Performance Evaluation of EUA COVID-19 Antibody Tests

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