METADATA last updated: 2026-03-04 by BA file_name: FDA SARS-CoV-2 Reference Panel Comparative Data - Complied by Matt McFarlane.md file_date: 2021-01-11 title: FDA SARS-CoV-2 Reference Panel Comparative Data category: regulatory subcategory: fda-policy tags: source_file_type: xlsx xfile_type: xlsx gfile_url: https://docs.google.com/spreadsheets/d/1TgmptVRgCZa3yxD5hQcRTQGxrIKOeA-WnMH7JzkzJ6k xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/regulatory/fda-policy/FDA%20SARS-CoV-2%20Reference%20Panel%20Comparative%20Data%20-%20Complied%20by%20Matt%20McFarlane.xlsx pdf_gdrive_url: NA pdf_github_url: NA conversion_input_file_type: xlsx conversion: pandas license: 3rd Party tokens: 6657 words: 3124 notes: Missing date, unsure about license summary_short: The FDA SARS-CoV-2 Reference Panel Comparative Data spreadsheet compiles EUA-reported LoDs and FDA reference panel LoDs for many authorized molecular tests, enabling side-by-side comparison of relative analytical sensitivity across developers and platforms. It includes test names, developers, notes on data-release wave and versioning caveats, and a calculated FDA/EUA LoD ratio to highlight discrepancies between EUA-submitted LoD claims and reference-panel results. CONTENT ***INTERNAL TITLE*** FDA SARS-CoV-2 Reference Panel Comparative Data *Compiled by Matt McFarlane* ## Data | Test | EUA LOD (/3ml swab) | FDA Panel LOD (/3ml swab) | FDA/EUA LOD | DataNote | Developer | Full Test | | |--------------------------------------|-----------------------|-----------------------------|---------------|------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | PerkinElmer | 28 | 540 | 19.28571429 | 1st data release | PerkinElmer, Inc. | PerkinElmer New Coronavirus Nucleic Acid Detection Kit | | | ScienCell | 9600 | 1620 | 0.16875 | 1st data release | ScienCell Research Laboratories | ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit | | | BioCore | 1500 | 1800 | 1.2 | 1st data release | BioCore Co., Ltd. | BioCore 2019-nCoV Real Time PCR Kit | | | DiaCarta (4 1plex wells) | 600 | 1800 | 3.0 | 1st data release | DiaCarta, Inc | QuantiVirus SARS-CoV-2 Test kit | Results were obtained with the version of the test authorized on 4/08/2020 | | DiaCarta (duplex) | 300 | 1800 | 6.0 | 1st data release | DiaCarta, Inc | QuantiVirus SARS-CoV-2 Multiplex Test Kit | | | Hologic (Panther RTqPCR) | 600 | 1800 | 3.0 | 1st data release | Hologic, Inc. | Panther Fusion SARS-CoV-2 Assay | | | Hologic (TMA) | 638 | 1800 | 2.821316614 | 1st data release | Hologic, Inc. | Aptima SARS-CoV-2 assay | | | Seasun (PCR) | 3000 | 1800 | 0.6 | 1st data release | SEASUN BIOMATERIALS | U-TOP COVID-19 Detection Kit | | | PrivaPath (letsgetchecked) | 600 | 2160 | 3.6 | 1st data release | PrivaPath Diagnostics, Inc.2 | LetsGetChecked Coronavirus (COVID-19) Test | | | BD Max (2 duplex) | 120 | 5400 | 45.0 | 1st data release | Becton, Dickinson & Company (BD) | BioGX SARS-CoV-2 Reagents for BD MAX System | | | CirrusDx | 1170 | 5400 | 4.615384615 | 1st data release | CirrusDx Laboratories | CirrusDx SARS-CoV-2 Assay | | | EuroImmun | 450 | 5400 | 12.0 | 1st data release | Euroimmun US, Inc. | EURORealTime SARS-Cov-2 | | | Helix (PCR) | 3000 | 5400 | 1.8 | 1st data release | Helix OpCo LLC (dba Helix) | Helix COVID-19 Test | | | LabGenomics | 60000 | 5400 | 0.09 | 1st data release | LabGenomics Co., Ltd. | LabGun COVID-19 RT-PCR Kit | | | Quest Diagnostics | 408 | 5400 | 13.23529412 | 1st data release | Quest Diagnostics Infectious Disease, Inc. | Quest SARS-CoV-2 rRT-PCR | | | Rheonix | 1875 | 5400 | 2.88 | 1st data release | Rheonix, Inc. | Rheonix COVID-19 MDx Assay | | | Roche | 138 | 5400 | 39.13043478 | 1st data release | Roche Molecular Systems, Inc. (RMS) | cobas SARS-CoV-2 | | | Applied DNA | 3750 | 7500 | 2.0 | 1st data release | Applied DNA Sciences, Inc. | Linea COVID-19 Assay Kit | | | Abbott (m2000) | 120 | 8100 | 67.5 | 1st data release | Abbott Molecular | Abbott RealTime SARS-CoV-2 assay | | | Fulgent | 15000 | 10800 | 0.72 | 1st data release | Fulgent Therapeutics, LLC | Fulgent COVID-19 by RT-PCR Test | | | Enzo | 840 | 10800 | 12.85714286 | 1st data release | Enzo Life Sciences, Inc. | AMPIPROBE SARS-CoV-2 Test System | | | Access Bio | 1286 | 16200 | 12.59720062 | 1st data release | Access Bio, Inc. | CareStart COVID-19 MDx RT-PCR | | | Applied BioCode | 0.017 TCID50/ml | 16200 | | 1st data release | Applied BioCode, Inc. | BioCode SARS-CoV-2 Assay | | | Assurance Sci. | 15000 | 16200 | 1.08 | 1st data release | Assurance Scientific Laboratories | Assurance SARS-CoV-2 Panel | | | BD Max (triplex) | 120 | 16200 | 135.0 | 1st data release | Becton, Dickinson & Company | BD SARS-CoV-2 Reagents for BD MAX System | Results were obtained with the version of the test authorized on 9/23/2020 | | BioFire Defense | 990 | 16200 | 16.36363636 | 1st data release | BioFire Defense, LLC | BioFire COVID-19 Test | | | Boston Heart | 750 | 16200 | 21.6 | 1st data release | Boston Heart Diagnostics | Boston Heart COVID-19 RT-PCR Test | | | Cepheid | 750 | 16200 | 21.6 | 1st data release | Cepheid | Xpert Xpress SARS-CoV-2 test | | | ChromaCode | 3000 | 16200 | 5.4 | 1st data release | ChromaCode Inc. | HDPCR SARS-CoV-2 Assay | | | Ethos | 60000 | 16200 | 0.27 | 1st data release | Ethos Laboratories | Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay | | | GeneMatrix | 7500 | 16200 | 2.16 | 1st data release | GeneMatrix, Inc | NeoPlex COVID-19 Detection Kit | | | Hackensack Uni MC | 12000 | 16200 | 1.35 | 1st data release | Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory | CDI Enhanced COVID-19 Test | | | Kogene | 12000 | 16200 | 1.35 | 1st data release | KogeneBiotech Co., Ltd. | PowerChek 2019-nCoV Real-time PCR Kit | | | Luminex (NxTAG) | 15000 | 16200 | 1.08 | 1st data release | Luminex Molecular Diagnostics, Inc. | NxTAG CoV Extended Panel Assay | | | Patients Choice | 300000 | 16200 | 0.054 | 1st data release | Patients Choice Laboratories, LLC | PCL SARS-CoV-2 Real-Time RT-PCR Assay | | | CDC (inf+CoV2) | ? | 17100 | | 1st data release | Centers for Disease Control and Prevention (CDC) | Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay | | | DiaSorin | 1500 | 18000 | 12.0 | 1st data release | DiaSorin Molecular LLC | Simplexa COVID-19 Direct assay | | | Quidel | 2400 | 18000 | 7.5 | 1st data release | Quidel Corporation | Lyra SARS-CoV-2 Assay | | | Seasun (LAMP, 1 duplex) | 21000 | 18000 | 0.8571428571 | 1st data release | Seasun Biomaterials, Inc | AQ-TOP COVID-19 Rapid Detection Kit | | | Sherlock BioSci | 20250 | 18000 | 0.8888888889 | 1st data release | Sherlock BioSciences, Inc. | Sherlock CRISPR SARS-CoV-2 Kit | | | UNC | 2640 | 18000 | 6.818181818 | 1st data release | University of North Carolina Medical Center | UNC Health SARS-CoV-2 real-time RT-PCR test | | | Exact Sciences | 7800 | 18075 | 2.317307692 | 1st data release | Exact Sciences Laboratories | SARS-CoV-2 (N gene detection) Test | | | CDC | 9500 | 54000 | 5.684210526 | 1st data release | Centers for Disease Control and Prevention (CDC) | CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) | | | Acupath | 75000 | 54000 | 0.72 | 1st data release | Acupath Laboratories, Inc | Acupath COVID-19 Real-Time (RT-PCR) Assay | | | Avellino Lab USA | 165000 | 54000 | 0.3272727273 | 1st data release | Avellino Lab USA, Inc. | AvellinoCoV2 test | | | Color | 2250 | 54000 | 24.0 | 1st data release | Color Genomics, Inc.2 | Color Genomics SARS-CoV-2 RT-LAMP Diagnostic Assay | Results were obtained with the version of the test authorized on 8/28/2020 | | Eli Lilly | 3000 | 54000 | 18.0 | 1st data release | Eli Lilly and Company | Lilly SARS-CoV-2 Assay | | | Gravity (CDC Primers) | 7200 | 54000 | 7.5 | 1st data release | Gravity Diagnostics, LLC | Gravity Diagnostics COVID-19 Assay | | | HealthQuest | 60000 | 54000 | 0.9 | 1st data release | HealthQuest Esoterics | HealthQuest Esoterics TaqPath SARS-CoV-2 Assay | | | Boston CH | 6900 | 54000 | 7.826086957 | 1st data release | Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's Hospital | Childrens-Altona-SARS-CoV-2 Assay | | | Psomagen | 3000 | 54000 | 18.0 | 1st data release | Psomagen, Inc. | Psoma COVID-19 RT Test | | | Yale | 6000 | 540000 | 90.0 | 1st data release | Diatherix Eurofins Laboratory | SARS-CoV-2 PCR Test | | | Luminex (Aries) | 999 | 540000 | 540.5405405 | 1st data release | Luminex Corporation | ARIES SARS-CoV-2 Assay | | | Qiagen | 1500 | 540000 | 360.0 | 1st data release | QIAGEN GmbH | QIAstat-Dx Respiratory SARS-CoV-2 Panel | | | Abbott (ID Now) | 313 | 15000 | 47.92332268 | 1st data release | Abbott Diagnostics Scarborough, Inc. | ID NOW COVID-19 | | | Quidel (LyraDirect) | 5120 | 27000 | 5.2734375 | 1st data release | Quidel Corporation | Lyra Direct SARS-CoV-2 Assay | | | Bio-Rad | 450 | 1800 | 4.0 | 2nd data release | Bio-Rad Laboratories, Inc | Bio-Rad SARS-CoV-2 ddPCR Test | | | Altru | 1875 | 5400 | 2.88 | 2nd data release | Altru Diagnostics, Inc. | Altru Dx SARS-CoV-2 RT-PCR assay | | | OPTI | 2700 | 5400 | 2.0 | 2nd data release | OPTI Medical Systems, Inc. | OPTI SARS-COV-2 RT PCR Test | | | Roche (infA/B+CoV2, Cobas) | 182 | 5400 | 29.67032967 | 2nd data release | Roche Molecular Systems, Inc. | cobas SARS-CoV-2 & Influenza A/B | | | Illumina | 3000 | 16200 | 5.4 | 2nd data release | Illumina, Inc. | Illumina COVIDSeq Test | | | NeuMoDx | 450 | 16200 | 36.0 | 2nd data release | NeuMoDx Molecular, Inc. | NeuMoDx SARS-CoV-2 Assay | | | ZhuHai Sinochips | 7500 | 16200 | 2.16 | 2nd data release | ZhuHai Sinochips Bioscience Co., Ltd | COVID-19 Nucleic Acid RT-PCR Test Kit | | | Columbia Uni. | 840 | 18000 | 21.42857143 | 2nd data release | Columbia University Laboratory of Personalized Genomic Medicine | TRIPLEX CII-SARS-CoV-2 rRT-PCR TEST | | | 1drop | 600 | 54000 | 90.0 | 2nd data release | 1drop Inc. | 1copy COVID-19 qPCR Multi Kit | | | BioMérieux | 1140 | 54000 | 47.36842105 | 2nd data release | BioMérieux SA | SARS-COV-2 R-GENE | | | Cedars-Sinai | 30000 | 54000 | 1.8 | 2nd data release | Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine | SARS-CoV-2-Assay | | | Curative | 600 | 54000 | 90.0 | 2nd data release | KorvaLabs Inc. | Curative-Korva SARS-Cov-2 Assay | | | Phosphorus Dx | 15000 | 54000 | 3.6 | 2nd data release | Phosphorus Diagnostics LLC | Phosphorus COVID-19 RT-qPCR Test | 4 | | Ultimate Dx | 300 | 54000 | 180.0 | 2nd data release | Ultimate Dx Laboratory | UDX SARS-CoV-2 Molecular Assay | | | Ipsum | 25500 | 540000 | 21.17647059 | 2nd data release | Ipsum Diagnostics, LLC | COV-19 IDx assay | Results were obtained with the version of the test authorized on 4/01/2020 | | Thermo Fisher | 750 | 540000 | 720.0 | 2nd data release | Thermo Fisher Scientific, Inc. | TaqPath COVID-19 Combo Kit | | | PreciGenome | 1714 | 540000 | 315.0525088 | 2nd data release | PreciGenome LLC3 | FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR) | | | MicroGen DX | 300 | 540000 | 1800.0 | 2nd data release | Southwest Regional PCR Laboratory LLC. dba MicroGen DX | COVID-19 Key | | | SDI | 1500 | 540000 | 360.0 | 2nd data release | Specialty Diagnostic (SDI) Laboratories | SDI SARS-CoV-2 Assay | | | Boston Medical | 3000 | 1800000 | 600.0 | 2nd data release | Boston Medical Center | BMC-CReM COVID-19 Test | | | Viracor Eurofins | 219 | 540 | 2.465753425 | 3rd data release | Viracor Eurofins Clinical Diagnostics | Viracor SARS-CoV-2 assay | | | Zymo | 750 | 1350 | 1.8 | 3rd data release | Zymo Research Corporation1 | Quick SARS-CoV-2rRT-PCR Kit | | | Fast Track | 0.0069 TCID50/ml | 1620 | | 3rd data release | Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company) | FTD SARS-COV-2 | | | UMass | 12000 | 5400 | 0.45 | 3rd data release | UMass Memorial Medical Center | UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel | | | Texas DSHS | 60 | 5400 | 90.0 | 3rd data release | Texas Department of State Health Services, Laboratory Services Section | Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay | | | Nationwide CH | 94 | 5400 | 57.44680851 | 3rd data release | Nationwide Children's Hospital | SARS-CoV-2 Assay (CH) | | | Maccura | 3000 | 5400 | 1.8 | 3rd data release | Maccura Biotechnology (USA) LLC | SARS-CoV-2 Fluorescent PCR Kit | | | Cormeum | 6000 | 5400 | 0.9 | 3rd data release | Cormeum Laboratory Services | Cormeum SARS-CoV-2 Assay | | | CSI Labs | 18750 | 5400 | 0.288 | 3rd data release | CSI Laboratories | CSI SARS-CoV-2 RT PCR Test | | | Biocollections | 3000 | 5400 | 1.8 | 3rd data release | Biocollections Worldwide, Inc. | Biocollections Worldwide SARS-Co-V-2 Assay | | | BayCare | 138 | 5400 | 39.13043478 | 3rd data release | BayCare SARS-CoV-2 RT PCR Assay | BayCare SARS-CoV-2 RT PCR Assay | | | Tempus | 750 | 7200 | 9.6 | 3rd data release | Tempus Lab, Inc. | iC SARS-CoV2 Test | | | Gencurix | 18000 | 8100 | 0.45 | 3rd data release | Gencurix, Inc. | GenePro SARS-CoV-2 Test | | | BGI genomics | 450 | 9000 | 20.0 | 3rd data release | BGI Genomics Co. Ltd | Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 | | | Guardant Health | 375 | 16200 | 43.2 | 3rd data release | Guardant Health, Inc.2 | Guardant-19 | | | ClearDx | 6000 | 16200 | 2.7 | 3rd data release | Clear Labs, Inc. | Clear Dx SARS-CoV-2 Test | | | Sandia | 18750 | 16200 | 0.864 | 3rd data release | Sandia National Laboratories | SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay | | | Roche (infA/B+CoV2, Liat) | 36 | 16200 | 450.0 | 3rd data release | Roche Molecular Systems, Inc. | cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System | | | Optolane | 15000 | 16200 | 1.08 | 3rd data release | OPTOLANE Technologies, Inc. | Kaira 2019-nCoV Detection Kit | | | LumiraDx | 1500 | 16200 | 10.8 | 3rd data release | LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 RNA STAR | | | BioSewoom | 18750 | 16200 | 0.864 | 3rd data release | BioSewoom, Inc. | Real-Q 2019-nCoV Detection Kit | | | InBios | 3300 | 18000 | 5.454545455 | 3rd data release | InBios International, Inc. | Smart Detect SARS-CoV-2 rRT-PCR Kit | | | BioFire (RP) | 480 | 18000 | 37.5 | 3rd data release | BioFire Diagnostics, LLC | BioFire Respiratory Panel 2.1 (RP2.1) | | | Diagnostic Solutions | 10 | 54000 | 5400.0 | 3rd data release | Diagnostic Solutions Laboratory, LLC | DSL COVID-19 Assay | | | SolGent | 600 | 54000 | 90.0 | 3rd data release | SolGent Co., Ltd | DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit | | | Miami Baptist | 6000 | 54000 | 9.0 | 3rd data release | Pathology/Laboratory Medicine Lab of Baptist Hospital Miami | COVID-19 RT-PCR Test (Miami) | | | Vela (v1, 2 duplex wells per sample) | 1680 | 54000 | 32.14285714 | 3rd data release | Vela Operations Singapore Pte Ltd | ViroKey SARS-CoV-2 RT-PCR Test | | | MD Anderson | 15000 | 54000 | 3.6 | 3rd data release | University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory | MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay | | | Stanford | 3000 | 54000 | 18.0 | 3rd data release | Stanford Health Care Clinical Virology Laboratory | Stanford SARS-CoV-2 assay | | | T2 Biosystems | 6000 | 54000 | 9.0 | 3rd data release | T2 Biosystems, Inc. | T2SARS-CoV-2 Panel | | | Gene By Gene | 18750 | 54000 | 2.88 | 3rd data release | Gene By Gene | Gene By Gene SARS-CoV-2 Detection Test | | | AIT Labs | 3000 | 54000 | 18.0 | 3rd data release | AIT Laboratories | SARS-CoV-2 Assay (AIT) | | | Gravity (ThermoPrimers) | 3000 | 54000 | 18.0 | 3rd data release | Gravity Diagnostics, LLC | Gravity Diagnostics SARS-CoV-2 RT-PCR Assay | | | Solaris | 30000 | 54000 | 1.8 | 3rd data release | Solaris Diagnostics | Solaris Multiplex SARS-CoV-2 Assay | | | Biomeme | 5400 | 54000 | 10.0 | 3rd data release | Biomeme, Inc. | Biomeme SARS-CoV-2 Real-Time RT-PCR Test | | | Visby | 3336 | 162000 | 48.56115108 | 3rd data release | Visby Medical, Inc. | Visby Medical COVID-19 | | | Primerdesign | 990 | 162000 | 163.6363636 | 3rd data release | Primerdesign Ltd.3 | Primerdesign Ltd COVID-19 genesig Real-Time PCR assay | | | GenMark (Panel) | 750 | 540000 | 720.0 | 3rd data release | GenMark Diagnostics, Inc. | ePlex Respiratory Pathogen Panel 2 | | | UTMG | 100 PFU | 540000 | | 3rd data release | UTMG Pathology Laboratory2 | UTHSC/UCH SARS-CoV-2-RT-PCR Assay | | | Omnipathology | 3690 | 540000 | 146.3414634 | 3rd data release | Omnipathology Solutions Medical Corporation | Omni COVID-19 Assay by RT-PCR | | | LCT | 609 | 540000 | 886.6995074 | 3rd data release | Laboratorio Clinico Toledo | Laboratorio Clinico Toledo SARS-CoV-2 Assay | | | Express Gene | 2400 | 540000 | 225.0 | 3rd data release | Express Gene LLC, DBA: Express Gene Molecular Diagnostics Laboratory | Express Gene 2019-nCoV RT-PCR Diagnostic Panel | | | Alpha Genomix | 12000 | 540000 | 45.0 | 3rd data release | Alpha Genomix Laboratories3 | Alpha Genomix TaqPath SARS-CoV-2 Combo Assay | | | BioTNS | 11145 | 1620000 | 145.3566622 | 3rd data release | TNS Co., Ltd (Bio TNS) | COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit | | | Cue Health | 40 | 3000 | 75.0 | 3rd data release | Cue Health Inc.a | Cue COVID-19 Test | | | Atila BioSystems | 3500 | 9000 | 2.571428571 | 3rd data release | Atila BioSystems, Inc. | iAMP COVID-19 Detection Kit | | || ## Chart _Scatter Plot showing EUA tests with EUA LOD on y axis and FDA Panel LOD on x axis. Above the line = Developer obtained worse LOD in original EUA than with FDA panel_