What is pooling?
What is pooling?
Pooling is a testing technique that allows the lab to mix a portion of several patient samples together (up to 4 in the Quest test) to create one “pooled” sample for testing. If the pooled sample is negative, that indicates all the patient samples are negative. If the pooled sample is positive (or invalid/inconclusive), then each patient sample is tested again individually to identify which is positive. Pooling helps labs get more testing done faster. It is useful for testing groups of people that are unlikely to have a high number of positive results. For example, pooling is used by blood banks to test blood donations for a variety of viruses. Pooling and other lab innovations have increased Quest’s ability to meet the demand for COVID-19 testing across the country.
COVID-19 testing statements
- The antibody tests and the molecular tests (together “All tests”) have not been FDA cleared or approved;
- All tests have been authorized by FDA under EUAs for use by authorized laboratories;
- The antibody tests have been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens;
- The molecular tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses, pathogens; and,
- All tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.