Agency Streamlines Authorization of COVID-19 Molecular Test Pooling for Screening Programs

Last July, in an effort to meet the desperate need for high throughput COVID-19 testing, the U.S. Food and Drug Administration (FDA) issued the first clearance for use of a previously authorized test on pooled samples to Quest Diagnostics’ SARS-CoV-2 RNA test (See DTET, Sept. 8, 2020). More than two dozen other COVID-19 tests have received Emergency Use Authorization (EUA) since then. Now the agency has doubled down by promulgating new rules making it easier for makers of previously authorized molecular tests to get expanded EUA for pooling. COVID-19 Test Pooling Pooling is a technique that enables laboratories to expand throughput by testing a batch of combined specimens at once. If the pool tests negative, it becomes unnecessary to test the constituent samples. The tradeoff is that the pooled samples must be diluted, which makes the nucleic acids produced by the SARS-CoV-2 virus more difficult to detect thus increasing the risk of false negatives. The other downside is that pooling can backfire and consume more testing time and resources when the sample comes back positive because the samples then need to be tested individually to detect the source(s) of the positive result. For these reasons, the FDA has been historically reluctant to allow pooling. But with COVID-19 testing resources stretched so thin, the agency issued its first ever guidelines to help molecular test makers secure EUA for pooling. On April 20, the agency issued an amended version of those guidelines to facilitate authorization for pooling. The punchline: Molecular COVID-19 tests that have received EUA can be used with pooled samples performed to screen asymptomatic people as part of a “serial testing program,” such as in a school or workplace setting as long as the test developer self-certifies that it has validated the test for pooling. “If a test developer has self-certified it has validated its test for pooling, FDA will add that test to a list of tests that can be used for pooling nasal specimens as part of a serial testing program,” noted the FDA’s device center director, Jeffrey Shuren, in a statement, describing the policy as a way to help schools, workplaces and others establish routine testing programs. The New Pooling Protocols The amendment applies only to pooling of anterior nasal respiratory specimens and tests being used at least once per week as part of a serial testing program. To qualify for use of a test on a pool of more than three specimens without first going through agency review, test makers must provide the FDA notification along with their validation data and the pooling procedures to be used, after which the test will be listed on the FDA website as allowed for pooling and updated labeling will be posted with the test’s EUA. They can place up to three samples in the same transport vial, the amended guidelines explain, including self-performed swabs and swabs collected by a healthcare professional, without additional validation, as long as the analysis is performed in certified CLIA laboratories. Here are some of the key new FDA EUAs and clearances announced in April: tableheader

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Enzo Biochem	EUA for Ampicollect Sample Collection kit
Enzo Biochem	"EUA for SynergyDx SARS-CoV-2 RNA Test + SynergyDx SARS-CoV-2 RNA Test DTC, an over-the-counter version of test "
Celltrion	EUA for DiaTrust COVID-19 Ag Rapid Test
LGC Biosearch Technologies	EUA for Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test
Yale School of Public Health	EUA for SalivaDirect At-Home Collection Kit
Clinical Enterprise	EUA for Clinical Enterprise SARS-CoV-2 RT-PCR Assay
Qorvo Biotechnologies	EUA for Omnia SARS-CoV-2 Antigen Test
Thermo Fisher Scientific	EUA for use of its Amplitude Solution with TaqPath COVID-19 High-Throughput Combo Kit
Lucira Health	EUA for Lucira Check It test kit for SARS-CoV-2 for over-the-counter use at home
Symbiotica	EUA for COVID-19 Self-Collected Antibody Test System, first antibody test authorized for use with home collected dried blood spot samples
Gold Standard Diagnostics	Clearance for B. burgdorferi IgG/IgM VlsE-OspC EIA test
DiaSorin	EUA for Liaison SARS-CoV-2 Ag SARS-CoV-2 antigen test
Bluestar Genomics	Breakthrough Device Designation for pancreatic cancer liquid biopsy assay in patients with new-onset diabetes
Quidel	EUA for QuickVue At-Home OTC COVID-19 Test
Abbott	EUA for BinaxNOW COVID-19 Ag Self Test for over-the-counter use by children as young as 2
Becton Dickinson	EUA for BD Veritor Plus System for Rapid Detection of SARS-CoV-2
Becton Dickinson	EUA for BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B
Binx Health	CLIA waiver for Binx Health io CT/NG Assay rapid point-of-care assay for detection of chlamydia and gonorrhea
NeuMoDx Molecular	EUA for NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay
Twist Bioscience	EUA for SARS-CoV-2 Next-Generation Sequencing assay
Beckman Coulter	EUA for Access SARS-CoV-2 IgG II rapid antibody test
Color Health	EUA for Color SARS-CoV-2 RT-LAMP Diagnostic Assay
Color Health	EUA for DTC version of Color COVID-19 Self-Swab Collection Kit