Lab test accuracy is measured in two ways—specificity and sensitivity. The antibody tests currently offered by Quest Diagnostics have specificity values of 99.6% to 100% which keeps false positive results to a minimum. The antibody test sensitivity values are approximately 90% to 100%.
Quest’s antibody tests have met robust validation standards and have been granted Emergency Use Authorizations (EUA) by the FDA for public health and clinical use. It is not yet known how effective this test is at detecting antibodies in those that have been vaccinated. Additionally, how long antibodies remain detectable after infection or vaccination and how long protection, if any, may last is also not known. The results of this test should not be interpreted as an indication of degree of immunity or protection.
Additionally, Quest verifies the tests using strict criteria for precision, reproducibility, accuracy, method comparison, cross-reactivity, and clinical performance.
The active infection (molecular) tests currently performed by Quest have been validated for FDA Emergency Use Authorization (EUA) for the current pandemic. However, no COVID-19 active infection tests have clinical sensitivity and specificity data at this time. Learn more about the analytical validation studies to earn FDA EUA designation.
It is important to note that rapid antigen tests are less accurate than molecular tests, so your doctor may recommend a molecular test when your antigen test result does not make sense with your symptoms and exposure history. For example, when the antigen test says you are infected but you do not have symptoms (and have not been exposed recently). Another example is when your antigen test says you are not infected but you have symptoms. Rapid antigen tests have their best accuracy within 7 days of symptoms starting. Accuracy and the clinical significance of results beyond the 7 days is not known.