Emerging Technologies to Increase Ligand Binding Assay Sensitivity

Overview

Journal AAPS J

Specialty Pharmacology

Date 2014 Oct 22

PMID 25331105

Citations 21

Authors

Saloumeh K Fischer

Alison Joyce

Mark Spengler

Tong-Yuan Yang

Yao Zhuang

Marianne Scheel Fjording

Alvydas Mikulskis

Affiliations

Soon will be listed here.

Abstract

Ligand binding assays (LBAs) have been the method of choice for protein analyte measurements for more than four decades. Over the years, LBA methods have improved in sensitivity and achieved larger dynamic ranges by using alternative detection systems and new technologies. As a consequence, the landscape and application of immunoassay platforms has changed dramatically. The introduction of bead-based methods, coupled with single molecule detection standardization and the ability to amplify assay signals, has improved the sensitivity of many immunoassays, in some cases by several logs of magnitude. Three promising immunoassay platforms are described in this article: Single Molecule Counting (SMC™) from Singulex Inc, Single Molecule Arrays (Simoa™) from Quanterix Corporation, and Immuno-PCR (Imperacer®) from Chimera Biotec GmbH. These platforms have the potential to significantly improve immunoassay sensitivity and thereby address the bioanalytical needs and challenges faced during biopharmaceutical drug development.

Citing Articles

Detection and Digital Resolution Counting of Nanoparticles with Optical Resonators and Applications in Biosensing.

Aguirre M, Long K, Li N, Manoto S, Cunningham B Chemosensors (Basel). 2024; 6(2).

PMID: 39559408 PMC: 11573240. DOI: 10.3390/chemosensors6020013.

Immunocapture LC-MS methods for pharmacokinetics of large molecule drugs.

Werth E, Roos D, Philip E Bioanalysis. 2024; 16(7):165-177.

PMID: 38348660 PMC: 11845110. DOI: 10.4155/bio-2023-0261.

Shifting the paradigm in RNA virus detection: integrating nucleic acid testing and immunoassays through single-molecule digital ELISA.

Wang Z, Wei P Front Immunol. 2024; 14:1331981.

PMID: 38235132 PMC: 10791976. DOI: 10.3389/fimmu.2023.1331981.

Non-invasive Biomarkers for Early Detection of Alzheimer's Disease: a New-Age Perspective.

Chimthanawala N, Haria A, Sathaye S Mol Neurobiol. 2023; 61(1):212-223.

PMID: 37596437 DOI: 10.1007/s12035-023-03578-3.

Diagnostic performance of Glial Fibrillary Acidic Protein and Prehospital Stroke Scale for identification of stroke and stroke subtypes in an unselected patient cohort with symptom onset < 4.5 h.

Jaeger H, Tranberg D, Larsen K, Valentin J, Blauenfeldt R, Luger S Scand J Trauma Resusc Emerg Med. 2023; 31(1):1.

PMID: 36604741 PMC: 9814331. DOI: 10.1186/s13049-022-01065-7.

References

Kuo H, Yeh J, Wu P, Jiang C, Wu M . Application of immunomagnetic particles to enzyme-linked immunosorbent assay (ELISA) for improvement of detection sensitivity of HCG. J Immunoassay Immunochem. 2012; 33(4):377-87. DOI: 10.1080/15321819.2012.655820. View

Shukla R, Santoro J, Bender F, Laterza O . Quantitative determination of human interleukin 22 (IL-22) in serum using Singulex-Erenna® technology. J Immunol Methods. 2013; 390(1-2):30-4. DOI: 10.1016/j.jim.2013.01.002. View

Shahim P, Tegner Y, Wilson D, Randall J, Skillback T, Pazooki D . Blood biomarkers for brain injury in concussed professional ice hockey players. JAMA Neurol. 2014; 71(6):684-92. DOI: 10.1001/jamaneurol.2014.367. View

Chang L, Rissin D, Fournier D, Piech T, Patel P, Wilson D . Single molecule enzyme-linked immunosorbent assays: theoretical considerations. J Immunol Methods. 2012; 378(1-2):102-15. PMC: 3327511. DOI: 10.1016/j.jim.2012.02.011. View

Leroux-Roels G, Maes C, Clement F, van Engelenburg F, van den Dobbelsteen M, Adler M . Randomized Phase I: Safety, Immunogenicity and Mucosal Antiviral Activity in Young Healthy Women Vaccinated with HIV-1 Gp41 P1 Peptide on Virosomes. PLoS One. 2013; 8(2):e55438. PMC: 3577797. DOI: 10.1371/journal.pone.0055438. View

Lequin R . Enzyme immunoassay (EIA)/enzyme-linked immunosorbent assay (ELISA). Clin Chem. 2005; 51(12):2415-8. DOI: 10.1373/clinchem.2005.051532. View

Spengler M, Adler M, Jonas A, Niemeyer C . Immuno-PCR assays for immunogenicity testing. Biochem Biophys Res Commun. 2009; 387(2):278-82. DOI: 10.1016/j.bbrc.2009.07.001. View

Rissin D, Fournier D, Piech T, Kan C, Campbell T, Song L . Simultaneous detection of single molecules and singulated ensembles of molecules enables immunoassays with broad dynamic range. Anal Chem. 2011; 83(6):2279-85. PMC: 3056883. DOI: 10.1021/ac103161b. View

St Ledger K, Agee S, Kasaian M, Forlow S, Durn B, Minyard J . Analytical validation of a highly sensitive microparticle-based immunoassay for the quantitation of IL-13 in human serum using the Erenna immunoassay system. J Immunol Methods. 2009; 350(1-2):161-70. DOI: 10.1016/j.jim.2009.08.012. View

10.

Yohrling J . Ligand-binding assays: risk of using a platform supported by a single vendor. Bioanalysis. 2010; 1(3):629-36. DOI: 10.4155/bio.09.46. View

11.

Janssen K, Knez K, Spasic D, Lammertyn J . Nucleic acids for ultra-sensitive protein detection. Sensors (Basel). 2013; 13(1):1353-84. PMC: 3574740. DOI: 10.3390/s130101353. View

12.

Nong R, Gu J, Darmanis S, Kamali-Moghaddam M, Landegren U . DNA-assisted protein detection technologies. Expert Rev Proteomics. 2012; 9(1):21-32. DOI: 10.1586/epr.11.78. View

13.

Niemeyer C, Adler M, Wacker R . Immuno-PCR: high sensitivity detection of proteins by nucleic acid amplification. Trends Biotechnol. 2005; 23(4):208-16. DOI: 10.1016/j.tibtech.2005.02.006. View

14.

Diel P, Schiffer T, Geisler S, Hertrampf T, Mosler S, Schulz S . Analysis of the effects of androgens and training on myostatin propeptide and follistatin concentrations in blood and skeletal muscle using highly sensitive immuno PCR. Mol Cell Endocrinol. 2010; 330(1-2):1-9. DOI: 10.1016/j.mce.2010.08.015. View

15.

Rissin D, Kan C, Song L, Rivnak A, Fishburn M, Shao Q . Multiplexed single molecule immunoassays. Lab Chip. 2013; 13(15):2902-11. PMC: 10540087. DOI: 10.1039/c3lc50416f. View

16.

Walt D . Optical methods for single molecule detection and analysis. Anal Chem. 2012; 85(3):1258-63. PMC: 3565068. DOI: 10.1021/ac3027178. View

17.

Sano T, Smith C, Cantor C . Immuno-PCR: very sensitive antigen detection by means of specific antibody-DNA conjugates. Science. 1992; 258(5079):120-2. DOI: 10.1126/science.1439758. View

18.

Tarcha E, Chi V, Munoz-Elias E, Bailey D, Londono L, Upadhyay S . Durable pharmacological responses from the peptide ShK-186, a specific Kv1.3 channel inhibitor that suppresses T cell mediators of autoimmune disease. J Pharmacol Exp Ther. 2012; 342(3):642-53. PMC: 3422530. DOI: 10.1124/jpet.112.191890. View

19.

Zhang H, Zhao Q, Li X, Le X . Ultrasensitive assays for proteins. Analyst. 2007; 132(8):724-37. DOI: 10.1039/b704256f. View

20.

Schoffski P, Riggert S, Fumoleau P, Campone M, Bolte O, Marreaud S . Phase I trial of intravenous aviscumine (rViscumin) in patients with solid tumors: a study of the European Organization for Research and Treatment of Cancer New Drug Development Group. Ann Oncol. 2004; 15(12):1816-24. DOI: 10.1093/annonc/mdh469. View