FDA Watch

Agency Okays COVID-19 Blood Spot Self-Collection & Molecular Test Pooling

Pandemic pressures continue to produce unprecedented action from the FDA. The current imperative is to clear assays and collection kits for rapid and easy screening, including products that can be used in home settings. A new barrier was crossed on April 6 when the agency granted Emergency Use Authorization (EUA) for a SARS-CoV-2 antibody detection test used in dried blood spot samples collected at home.

The Symbiotica System

The groundbreaking EUA went to Symbiotica’s COVID-19 Self-Collected Antibody Test System, a prescription-only test designed to detect immunoglobulin G against SARS-CoV-2 in dried blood spots obtained via fingerstick. The kit includes lancets that individuals can use to collect the blood samples themselves and mail to Symbiotica’s California lab for analysis.

“The authorization of the first prescription use, home collection antibody test will play an important role in helping health care professionals identify individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection,” noted Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement.

Molecular Test Pooling Two weeks after clearing the Symbiotica system, the agency amended its guidelines to facilitate authorization for pooling by allowing molecular COVID-19 tests with EUA to be used with pooled samples performed to screen the asymptomatic as part of a “serial testing program,” such as in a school or workplace setting. In other words, specific clearance for the use isn’t required as long as the test developer self-certifies that it has validated the test for pooling and submits its validation data and pooling procedures.

Here are the other key new FDA EUAs and clearances announced in April:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s) Product
Enzo Biochem EUA for Ampicollect Sample Collection kit
Synergy Diagnostic Laboratory “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
Synergy Diagnostic Laboratory 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

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

NEW CE MARKINGS IN EUROPE

Manufacturer(s) Product(s)
GenomSys MPEG-G Codec Suite software tools for processing genomic data
DiaSorin Liaison IQ immunodiagnostic point-of-care reader
DiaSorin Liaison Quick Detect COVID TrimericS Ab test
DiaSorin + Qiagen Liaison LymeDetect early Lyme Disease detection assay
Qiagen Artus SARS-CoV-2 Prep&Amp UM Kit for high-throughput PCR-based COVID-19 testing
Scope Fluidics Methicillin-resistant Staphylococcus aureus (MRSA) assay for use on firm’s PCR One rapid molecular system
Snibe Diagnostic Maglumi HIV Ab/Ag Combi CLIA kit for detecting HIV-1 and HIV-2 antibodies and HIV-1 p24 antigen
Ortho Clinical Diagnostics Vitros SARS-CoV-2 Antigen test for use with additional samples and viral transport media
AnteoTech EuGeni COVID-19 Antigen Rapid Test
Siemens Healthineers Atellica VTLi Patient-Side Immunoassay Analyzer test for high-sensitivity cardiac troponin I (hs-cTnI)
Lucira Health Lucira Check It test kit for SARS-CoV-2
BioMérieux 3 immunoassays to detect dengue virus infections run on firm’s Vidas systems: i. Vidas Dengue NS1 Ag assay; ii. Anti-Dengue IgM assay; and iii. Anti-Dengue IgG assay
Roche Elecsys Anti-p53 immunoassay for quantitative detection of anti-p53 autoantibodies
Roche Elecsys Epstein-Barr Virus panel for use with blood samples
Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test
Diazyme Laboratories SARS-CoV-2 neutralizing antibody test
Euroimmun SARS-CoV-2 Neutralisa assay for detecting neutralizing antibodies against SARS-CoV-2
Altona Diagnostics AltoStar HIV RT-PCR Kit 1.5
Fluxergy COVID-19 RT-PCR test

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Yourgene Health said this week that its UK Yourgene Genomic Services COVID-19 testing services
Roche Canada Elecsys Anti-SARS-CoV-2-S test
Aurora Biomed Canada FaStep COVID-19 Rapid Antigen Test Device
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