SLE-key® rule-out serologic test for excluding the diagnosis of systemic lupus erythematosus: Developing the ImmunArray iCHIP®

Chaim Putterman; Alan Wu; Anat Reiner-Benaim; D. Scott Batty; Ignacio Sanz; Jim Oates; Keren Jakobi; Michelle Petri; Pennina Safer; Robert Gerwien; Rachel Sorek; Yakov Blumenstein; Irun R. Cohen

doi:10.1016/j.jim.2015.12.003

SLE-key^® rule-out serologic test for excluding the diagnosis of systemic lupus erythematosus: Developing the ImmunArray iCHIP^®

Chaim Putterman, Alan Wu, Anat Reiner-Benaim, D. Scott Batty, Ignacio Sanz, Jim Oates, Keren Jakobi, Michelle Petri, Pennina Safer, Robert Gerwien, Rachel Sorek, Yakov Blumenstein, Irun R. Cohen

Research output: Contribution to journal › Article › peer-review

20 Scopus citations

Abstract

We describe here the development, verification and validation of the SLE-key^® rule-out test for a definitive rule-out of a diagnosis of systemic lupus erythematosus (SLE). The test uses the proprietary iCHIP^® micro-array technology platform (Fattal et al., 2010) to identify discriminating patterns of circulating autoantibodies among SLE patients compared with self-declared healthy individuals. Given the challenges associated with the diagnosis of SLE and the healthcare costs of delayed diagnosis and misdiagnosis, a definitive rule-out test can provide significant clinical benefits to patients and potentially major cost savings to healthcare systems.

Original language	English
Pages (from-to)	1-6
Number of pages	6
Journal	Journal of Immunological Methods
Volume	429
DOIs	https://doi.org/10.1016/j.jim.2015.12.003
State	Published - 1 Feb 2016
Externally published	Yes

Bibliographical note

Publisher Copyright:
© 2015 Elsevier B.V.

Funding

The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no. 115308 BIOVACSAFE, resources of which are composed of financial contributions from the European Union's Seventh Framework Programme ( FP7/2007-2013 ) and EFPIA companies in kind contribution. The Hopkins Lupus Cohort is supported by NIH RO-1 AR43727 . The authors wish to acknowledge the invaluable contributions of Ornit Cohen-Gindi, Miriam Lerner, Naama Shefer, Ilana Gilkaite, Angela Turner, Tim Van Meter, Justin Pitts, Joseph Green and Nazanin Mirshahi. The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no. 115308 BIOVACSAFE, resources of which are composed of financial contributions from the European Union''s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies in kind contribution. The Hopkins Lupus Cohort is supported by NIH RO-1 AR43727.

Funders	Funder number
National Institutes of Health	RO-1 AR43727, P60AR062755
National Center for Advancing Translational Sciences	UL1TR000062
European Federation of Pharmaceutical Industries and Associations
Seventh Framework Programme
Innovative Medicines Initiative	115308

Keywords

Autoantibodies
Diagnosis
ICHIP
Microarray
Multivariate classifier
Systemic lupus erythematosus

Access to Document

10.1016/j.jim.2015.12.003

Cite this

Putterman, C., Wu, A., Reiner-Benaim, A., Batty, D. S., Sanz, I., Oates, J., Jakobi, K., Petri, M., Safer, P., Gerwien, R., Sorek, R., Blumenstein, Y., & Cohen, I. R. (2016). SLE-key^® rule-out serologic test for excluding the diagnosis of systemic lupus erythematosus: Developing the ImmunArray iCHIP^®. Journal of Immunological Methods, 429, 1-6. https://doi.org/10.1016/j.jim.2015.12.003

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abstract = "We describe here the development, verification and validation of the SLE-key{\textregistered} rule-out test for a definitive rule-out of a diagnosis of systemic lupus erythematosus (SLE). The test uses the proprietary iCHIP{\textregistered} micro-array technology platform (Fattal et al., 2010) to identify discriminating patterns of circulating autoantibodies among SLE patients compared with self-declared healthy individuals. Given the challenges associated with the diagnosis of SLE and the healthcare costs of delayed diagnosis and misdiagnosis, a definitive rule-out test can provide significant clinical benefits to patients and potentially major cost savings to healthcare systems.",

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Putterman, C, Wu, A, Reiner-Benaim, A, Batty, DS, Sanz, I, Oates, J, Jakobi, K, Petri, M, Safer, P, Gerwien, R, Sorek, R, Blumenstein, Y & Cohen, IR 2016, 'SLE-key^® rule-out serologic test for excluding the diagnosis of systemic lupus erythematosus: Developing the ImmunArray iCHIP^®', Journal of Immunological Methods, vol. 429, pp. 1-6. https://doi.org/10.1016/j.jim.2015.12.003

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AU - Reiner-Benaim, Anat

AU - Batty, D. Scott

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AU - Oates, Jim

AU - Jakobi, Keren

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AU - Safer, Pennina

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AU - Sorek, Rachel

AU - Blumenstein, Yakov

AU - Cohen, Irun R.

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