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 […]
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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