| Electrochemical Reader based | FDA Cleared | Tests being developed | |
| Metrohm Palmsense Zimmer Peacock Tech | no no no | multiple | |
| AUREUM Diagnostics | NO | Covid antigen, sepsis biomarkers, cardiac biomarkers | |
| Emitech proprietary potentiostat | NO | OpiTest saliva, urine, pill, and sweat fentanyl immuno-electrochemical sensing | |
| EnLiSense proprietary potentiostat | NO | Real-Time Health Monitoring and Saliva fentanyl sensor | |
| Zio Health proprietary potentiostat | NO | ||
| Identify Sensors proprietary potentiostat | NO | ||
| VERV Technologies proprietary potentiostat | NO | ||
| Informed Data Systems Inc. dba One Drop proprietary potentiostat | NO | ||
| One Health (onehealthbiosensing.com) | NO | ||
| innotech Precision Medicine proprietary potentiostat | NO | ||
| Bioware proprietary potentiostat | NO | ||
| Academic based electrochemical methadone sensors. | NO | ||
| Spectrometer Based | |||
| In Diagnostics | NO | BUN, Creatinine, AST, ALT | |
| Waveguide and CMOS Readers | FDA Cleared | Tests being developed | |
| Genalyte -MRR | Silicon Chip Based Blood Test – TSH | hs CRP | |
| SiPhox -MRR | NO | Telemedicine system for at home diagnostic testing using Silicon optical chip with MRR. ( initially providing sample transfer services ) | |
| Evergreen Health – Proactive Dx – Linear Waveguide Matrix – utilizes effervescence | NO | Inflammation markers IL10, Interferon gamma, IL6, TNF-alpha, Interleukin 1 Beta | |
Optical LFA readers,LFAs, Magnetic readers, and SERS Readers
Optical LFA Readers
- iPeak lateral flow reader – IUL
- dg technologies – Lateral Flow Reader
- C2Sense – Halo – color or fluorometric reader
- Axxim- AX-2X-S-N or W – color or fluoro reader
- DCNdx – Using Abingdon’s AppDX and their own reader
- Cube Reader from Biosynex
- QAssay Reader
- Finecare fluorescent reader
- Roche : Lumira Dx Reader
- Sofia 2 Reader
- ID Now
- Veritor
| Lateral Flow ImmunoAssay Product Providers | FDA or CE IVDR cleared | Manufacturing Location | Tests in development , sold for food safety monitoring, environmental monitoring, or veterinary use cases. |
| Abingdon Seralite FLC Serum and Urine Assays | yes Quantitative tests for free light chains (kappa/lambda) in serum and urine, used in monitoring multiple myeloma. paired with the FDA-registered ADxLR5 reader | US, UK | Vitamin D STD Panel (In Development): self-tests detecting HIV, hepatitis B/C, and syphilis by 2025? Find out from Home Inc. color or fluorometric reader Abingdon is part owner |
| NOWDx – Now Diagnostics blood tests for syphilis, hcg, and covid antibody | yes Syphilis antibodies – fingerstick blood hCG – fingerstick blood | US | Covid Antibody from fingerstick blood |
| Prometheus Bio Drugs of Abuse | yes | China | urine and saliva based tests |
| BTNX Drugs of Abuse | yes | Canada | urine and saliva based test |
| DoChek Drugs of Abuse possible deal with QASSAY Reader | yes | China | |
| Premier Biotech– LZI Saliva methadone currently no reader | yes | US | |
| Instanosis Inc. Validation of a Sensitive Lateral Flow Assay for Rapid Urine Fentanyl Screening in the ER | yes | US | fentanyl instant test strip |
| Biosynex- Chembio- Cube reader – color reader | Yes with Clia waiver HIV -Syphilis antibodies | US, France, Germany | Exacto triplex test Hepatitis C antibodiesHepatitis B antibodies |
| Roche Diagnostics – Lumira Dx Reader | Yes SARS-Covid 19 antigenSARS/RSV/Influenza digital health | US | |
| Abbot Diagnostics IDNOW reader – color and fluorometriciStat System | Yes Hepatitis CHIVHepatitis BID/Binax Now – Covid 19Influenza | US | |
| Nano-Ditech Corporation color or fluorometric TRF proprietary readers | Yes Nano-CheckTMCardiac MarkersInflammation/ Sepsis TestDrug TestRespiratory TestFLUORO-CHECKTMCardiac MarkersOther Markers | US | Coming Soon Products |
| BD Becton Dickinson BD Veritor Reader | Yes infectious diseases hospital acquired infections | US | |
| Quidel Ortho Sofia 2 Reader – Color based | Yes influenzastrep throatcovid | US | |
| QIAGEN ESEQuantitative LFR dg technologies – Lateral Flow Reader | Yes SARS-Covid 19 | Germany | |
| Wondfo FinecareTM fluorescent reader | Yes | China | 2019-nCoV S-RBD lateral flow assay |
| Intelligent Bio Solutions Fingertip Sweat based testing for Drugs of AbuseProprietary LFA Reader | pending | Australia, UK | Fingerprint sweat based LFIA for Opioids, Drugs of Abuse |
| Sapphire bio – AXIM Biotech iPeak Reader – Color based | FDA clearance not required Lactoferrin-tear fluidIgE -tear fluid | Spain for iPeak | |
| Validation of a lateral flow chromatographic immunoassay for the detection of fentanyl in drug samples | no | n/a | |
| Carfentanil Forensic ELISA Kit | Diagnostics | Neogen | no | US | |
| Cessation Therapeutics Investigation of monoclonal antibody CSX-1004 for fentanyl overdose | no | US | |
| Affimedix Cube Reader from Biosynex | No Quantitative Vitamin D TestNOW® – Ferritin Quantitative | US | |
| Magnetic Readers | |||
| Quantum Design International MagnaBioSciences, Magnetic LFA Reader Higher SNR from full thickness reading of test line versus just surface reading for most optical methods. Leads to better LOD and range of detection. Magnetic signals provide better stability compared to Colorimetric Gold NP Signals. | NO | US | Listeria Monocytogenes food safety – 3-amino-2-oxazolidinone (AOZ) |
| Siemens Healthineers | infectious disease and cardiac markers | ||
| Thermo Fisher Scientific | |||
| Bio-Rad Laboratories | infectious disease food safety | ||
| Meridian Bioscience | respiratory pathogens gi pathogens | ||
| Fluxergy (Fluxergy multimodal reader) | No | Respiratory Panel RSVInfluenzaSARS-Covid19 Veterinary panel Equine Herpes Virus 1Equine SalmonellaEquine Streptococcus | |
| Truvian – proprietary colorimetric, fluorometric sensors. Immunoassays both heterogenous and homogenous. Uses beads for some of the assays and centrifugal force for microfluidic flow control and blood cell – plasma separation. | No | US | Complete blood count with differentialComprehensive metabolic panel including glucoseLipid panel including cholesterolHemoglobin A1cTSH |
| G-FET | FDA Cleared | Tests being developed | |
| GinerLabshttps://pubs.acs.org/doi/10.1021/acsnano.1c07094 | NO | waste water EDDP | |
| SERS Readers | FDA Cleared | Tests being developed | |
| Spectraplasmonics | NO | Drugs of Abuse | |
| SERS LFIA | NO | SARS Spike protein | |
| Multiplexed SERS Detection of Serum Cardiac Markers Using Plasmonic Metasurfaces – Zheng – 2024 | NO | Cardiac Markers | |
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