Home 5 Articles 5 Agency Green Lights First SARS-CoV-2 Tests for Sample Pooling

Agency Green Lights First SARS-CoV-2 Tests for Sample Pooling

by | Aug 20, 2020 | Articles, Essential, FDA-lir, Laboratory Industry Report

Revising an Emergency Use Authorization (EUA) to permit a new clinical use is usually pretty routine stuff. But the expanded EUA the FDA announced on July 18 was both unprecedented and significant because it was the first time the agency has given the green light for use of a previously cleared test on pooled samples. The Quest SARS-CoV-2 Test The Sir Edmund Hillary of the sample poolers is Quest Diagnostics’ SARS-CoV-2 RNA test, which initially received EUA back in March. The reissued EUA allow for use of the test with pooled upper respiratory specimens in sample pools comprised of four individuals. “The new update allows Quest to test 3,600 more tests per day,” noted Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health at FDA’s Center for Devices and Radiological Health during a recent agency “town hall” briefing, “and if you add pooling on top of that. . . they can substantially increase the throughput.” Use of pooling enables testing labs to get the most out of testing resources and overcome supply shortages. But there’s a tradeoff: Because pooling dilutes the nucleic acids produced by the SARS-CoV-2 virus, it creates the risk of false negatives. To […]

Revising an Emergency Use Authorization (EUA) to permit a new clinical use is usually pretty routine stuff. But the expanded EUA the FDA announced on July 18 was both unprecedented and significant because it was the first time the agency has given the green light for use of a previously cleared test on pooled samples.

The Quest SARS-CoV-2 Test

The Sir Edmund Hillary of the sample poolers is Quest Diagnostics’ SARS-CoV-2 RNA test, which initially received EUA back in March. The reissued EUA allow for use of the test with pooled upper respiratory specimens in sample pools comprised of four individuals. “The new update allows Quest to test 3,600 more tests per day,” noted Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health at FDA’s Center for Devices and Radiological Health during a recent agency “town hall” briefing, “and if you add pooling on top of that. . . they can substantially increase the throughput.”

Use of pooling enables testing labs to get the most out of testing resources and overcome supply shortages. But there’s a tradeoff: Because pooling dilutes the nucleic acids produced by the SARS-CoV-2 virus, it creates the risk of false negatives. To secure the EUA expansion for the SARS-CoV-2 RNA test, Quest provided the FDA clinical data showing that none of a total 3,091 specimens from a population with a prevalence rate of 1 to 10 percent would have come back falsely negative had the specimens been pooled. Quest began immediately to perform pooled sampling testing with the assay starting with its laboratories in Marlborough, MA, and Chantilly, VA.

LabCorp Gets OK for Pooling & Asymptomatic Screening

 Less than a week later, the FDA announced that LabCorp’s COVID-19 RT-PCR Test had received the second expanded EUA for pooled SARS-CoV-2 testing. The LabCorp test is authorized for human specimen collection at home using the Pixel by LabCorp or other home sample collection kits authorized for use with LabCorp’s test, or by a healthcare provider. However, only samples collected by healthcare providers may be pooled using the test, the FDA noted. The expanded EUA also allows the test to be used for testing the broad population under the FDA’s new asymptomatic screening guidance, making it the first SARS-CoV-2 test to gain that distinction.


Here are some of the other key FDA EUAs and clearances announced in July:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s) Product
Eli Lilly and Company EUA for Lilly SARS-CoV-2 Assay
Sandia National Laboratories EUA for SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay
Xiamen Biotime Biotechnology EUA for Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test, serology assay detecting and IgG and IgM antibodies
LabCorp Reissued EUA for COVID-19 RT-PCR Test for testing asymptomatic patients and pooled sample testing
CoWin Biotech EUA for Novel Coronavirus Fast Nucleic Acid Detection Kit run on Thermo Fisher’s Applied Biosystems 7500 RT-PCR system
Helix OpCo EUA for Helix COVID-19 Test detecting SARS-CoV-2 nucleocapsid, ORF1ab and spike protein genes
Thermo Fisher Scientific Clearance for ImmunoCAP Specific IgE alpha-Gal Allergen Component blood test detecting sensitization to alpha-gal carbohydrate in red meat and assessing risk for an anaphylactic reaction
DiaCarta EUA for QuantiVirus SARS-CoV-2 Multiplex Test Kit
Becton Dickinson Premarket approval supplement for expanded BD Onclarity HPV Assay
Becton Dickinson EUA for SARS-CoV-2 antigen test
Paige 510(k) clearance for use of FullFocus digital pathology image viewer with Philips Ultra Fast scanner for primary diagnosis
Access Genetics EUA for OraRisk COVID-19 RT-PCR test
Megna Health EUA for Rapid COVID-19 IgM/IgG Combo Test Kit (serology)
Luminex EUA for xMap SARS-CoV-2 Multi-Antigen IgG Assay
Boston Heart Diagnostics EUA for Boston Heart COVID-19 RT-PCR Test
Quest Diagnostics EUA for 3 coronavirus assays:
*PF SARS-CoV-2 Assay performed with Hologic’s Panther Fusion SARS-CoV-2 RT-PCR-based test
*RC SARS-CoV-2 Assay performed with Roche automated Cobas SARS-CoV-2 RT-PCR test
*HA SARS-CoV-2 Assay
KogeneBiotech EUA for PowerChek 2019-nCoV Real-time PCR Kit
Trax Management EUA for PhoenixDx SARS-CoV-2 Multiplex
Beijing Wantai Biological Pharmacy EUA for SARS-CoV-2 Ab Rapid Test lateral flow serology assay
Diazyme Laboratories EUA for Diazyme DZ-Lite SARS-CoV-2 IgG antibody test
BioSewoom EUA for Real-Q 2019-nCoV Detection Kit
Enzo Life Sciences EUA for Ampiprobe SARS-CoV-2 Test System
Access Bio EUA for CareStart COVID-19 MDx RT-PCR test
Gene By Gene EUA for RT PCR-based SARS-CoV-2 Detection Test
Saladax Biomedical De novo clearance for MyCare Psychiatry Clozapine Assay rapid blood test for clozapine levels in psychiatric patients
Assure Tech EUA for Assure COVID-19 IgG/IgM Rapid Test Device
US Centers for Disease Control and Prevention EUA for Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay real-time RT-PCR test for simultaneous detection and differentiation of SARS-CoV-2, influenza A and influenza B
Centogene EUA for PCR-based SARS-CoV-2 test
InBios International EUA for SCoV-2 Detect IgM ELISA kit (serological)

 

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

NEW CE MARKINGS IN EUROPE

Manufacturer(s) Product(s)
NowDiagnostics AdexusDx COVID-19 serology antibody test for SARS-CoV-2
Bruker FluoroType SARS-CoV-2 plus assay detecting two genes of SARS-CoV-2 genome
Devyser Next-generation sequencing-based hereditary breast and ovarian cancer assay
PerkinElmer Dry blood spot-based test for detecting SARS-CoV-2 IgG antibodies run on firm’s GSP/Delfia platform
NeuMoDx Molecular NeuMoDx HPV Assay molecular test for high-risk human papillomavirus types
BioMérieux BioFire Respiratory Panel 2.1 plus for SARS-CoV-2 and other respiratory infections
Dante Labs Immensa software for interpretating whole-genome sequencing data
Vela Diagnostics Automated version of ViroKey SARS-CoV-2 RT-PCR Test
Advanced Biological Laboratories UltraGene Combo2Screen SARS-CoV-2 qPCR assay
DiaSorin Molecular Simplexa Flu A/B & RSV Direct Gen II assay for influenza and respiratory syncytial virus (RSV) run on firm’s Liaison MDX real-time PCR instrument
Asuragen AmplideX SMA Plus Kit test for spinal muscular atrophy
KDx Diagnostics URO17 Bladder Cancer Recurrence urine test for bladder cancer
ContextVision Inify Prostate Screening digital pathology product
Roche uPath PD-L1 (SP263) automated digital pathology algorithm for non-small cell lung cancer
PathoFinder RealAccurate Quadruplex SARS-CoV-2 PCR kit

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
DiaCarta Mexico Mexico Ministry of Health approval for QuantiVirus SARS-CoV-2 test
Sysmex Japan Ministry of Health, Labour, and Welfare approval for Automated Hematology Analyzer XN-31

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