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regulatory guidance

The guidance suggests validating a five-sample pooling strategy, but notes that this may need to be adjusted depending on assay sensitivity and local prevalence.

Recent guidance from HHS has improved data collection by clarifying which testing data all laboratories must report, including demographic data.

While new ways to carry out pool testing for SARS-CoV-2 abound, questions remain about sensitivity issues and the regulation of such tests.

The move is intended to increase testing for COVID-19 and may help conserve resources, which were a major problem during the height of the pandemic.

Some of the additional data required includes the patient's age, race, ethnicity, sex, and residence zip code, along with info about the ordering provider.

The template describes the data and information that should be submitted for EUA of collection kits or tests with a home self-collection component.

The assays, which were previously listed under the agency's Policy D, either voluntarily withdrew or failed to submit newly required validations.

With the US now awash in positive samples, assay developers seeking authorization will no longer be allowed to use contrived samples.

The agency will now require commercial antibody test manufacturers to meet certain sensitivity and specificity thresholds.

During a town hall on Wednesday, the agency addressed the thorny issue of how it will plan for and monitor serology tests for SARS-CoV-2.

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