Clinical diagnostics

Promonitor

The Promonitor family of tests measures both drug levels and anti-drug antibody levels with validated ELISA assays to complement biological therapies for drug monitoring.

Promonitor

Testing for drug bioavailability and immunogenicity includes IFX, Anti-IFX, ADL, Anti-ADL, RTX, Anti-RTX, ETN, Anti-ETN, GLM, Anti-GLM, VDZ, Anti-VDZ, UTK, and Anti-UTK. Personalize high-quality treatment of chronic inflammatory diseases with ease.

Main benefits

Optimized Therapy

Refine treatment of chronic inflammatory diseases with a individualized treatment for every patient enabling a personalized approach to therapy with biologics. Promonitor provides an early warning if the treatment regime may require modification.

Cost Effective

Reduce the use of ineffective treatment strategies, allowing a more efficient use of available resources. Effectively manage resources with the information provided by Promonitor.

Easy to use

Quickly generate easy to interpret results with ELISA-based tests and readily available equipment in 4 simple steps and 30 mins of hand-on time with precoated microplates and ready-to-use reagents.

Flexible

Expand lab operations and workflow with multiple tests and configurations and test both drug levels and anti-drug antibody levels in manual or automated modes.

High-quality

Results you can rely on with high specificity and sensitivity testing supported by a large number of peer-reviewed articles and referenced in over 100 publications.

Monitoring Biosimilars

Evaluation studies have demonstrated that Promonitor kits are able to quantify not only biological drug levels, but also biosimilar drugs.

Product specifications

Promonitor-IFX

Product Detail

Method

Specification: Quantitative capture ELISA

Microplate size

Specification: 96 wells

Kit storage conditions

Specification: Refrigerated at 2-8°C

Sample

Specification: Serum

Serum storage conditions

Specification: Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be
stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or
lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Biosimilars

Specification

Internal evaluation studies have demonstrated that Promonitor IFX is able to quantify levels for
the following biosimilars1,2:

CT-P13
SB2
GP1111

Standard

Specification: WHO 1° international standard for IFX (NIBSC: 16/170)

References/ISI

Ruiz-Argüello MB, Maguregui A, Ruiz Del Agua A, et al. Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilars. Ann Rheum Dis. 2016;75(9):1693-1696.
Fiorino G, Ruiz-Argüello MB, Maguregui A, et al. Full interchangeability in regard to immunogenicity between the infliximab reference biologic and biosimilars CT-P13 and SB2 in inflammatory bowel disease. Inflamm Bowel Dis. 2018;24(3):601-60

**References/ISI**

Ruiz-Argüello MB, Maguregui A, Ruiz Del Agua A, et al. Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilars. Ann Rheum Dis. 2016;75(9):1693-1696.

Fiorino G, Ruiz-Argüello MB, Maguregui A, et al. Full interchangeability in regard to immunogenicity between the infliximab reference biologic and biosimilars CT-P13 and SB2 in inflammatory bowel disease. Inflamm Bowel Dis. 2018;24(3):601-60
Product Detail	Specification
Method	Quantitative capture ELISA
Microplate size	96 wells
Kit storage conditions	Refrigerated at 2-8°C
Sample	Serum
Serum storage conditions	Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.
Biosimilars	Internal evaluation studies have demonstrated that Promonitor IFX is able to quantify levels for the following biosimilars1,2: CT-P13 SB2 GP1111
Standard	WHO 1° international standard for IFX (NIBSC: 16/170)

Promonitor-ANTI IFX

Product Detail

Method

Specification: Quantitative bridging ELISA

Microplate size

Specification: 96 wells

Kit storage conditions

Specification: Refrigerated at 2-8°C

Sample

Specification: Serum

Serum storage conditions

Specification: Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be
stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or
lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Biosimilars

Specification

Internal evaluation studies have demonstrated that Promonitor anti-IFX is able to quantify anti-drug antibodies levels for following biosimilars¹

CT-P13
SB2

References

Fiorino G, Ruiz-Argüello MB, Maguregui A, et al. Full interchangeability in regard to immunogenicity between the infliximab reference biologic and biosimilars CT-P13 and SB2 in inflammatory bowel disease. Inflamm Bowel Dis. 2018;24(3):601-606.

**References**

Fiorino G, Ruiz-Argüello MB, Maguregui A, et al. Full interchangeability in regard to immunogenicity between the infliximab reference biologic and biosimilars CT-P13 and SB2 in inflammatory bowel disease. Inflamm Bowel Dis. 2018;24(3):601-606.
Product Detail	Specification
Method	Quantitative bridging ELISA
Microplate size	96 wells
Kit storage conditions	Refrigerated at 2-8°C
Sample	Serum
Serum storage conditions	Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.
Biosimilars	Internal evaluation studies have demonstrated that Promonitor anti-IFX is able to quantify anti-drug antibodies levels for following biosimilars¹ CT-P13 SB2

Promonitor-ADL

Product Detail

Method

Specification: Quantitative sandwich ELISA

Microplate size

Specification: 96 wells

Kit storage conditions

Specification: Refrigerated at 2-8°C

Sample

Specification: Serum

Serum storage conditions

Specification: Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be
stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or
lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Biosimilars

Specification

Internal evaluation studies have demonstrated that Promonitor ADL and Promonitor Anti-ADL are able to quantify the drug levels anti-drug antibodies levels for the following biosimilars¹:

ABP501
SB5
GP 2017

Standard

Specification: WHO 1° international standard for ADL (NIBSC code: 17/236)

References

Ruiz-Argüello MB, Maguregui A, Martinez A, Nagore D. P329 Adalimumab therapeutic drug monitoring test validated for measuring ABP 501 biosimilar. J Crohns Colitis. 2019;13(S1):S265-S266.

**References**

Ruiz-Argüello MB, Maguregui A, Martinez A, Nagore D. P329 Adalimumab therapeutic drug monitoring test validated for measuring ABP 501 biosimilar. J Crohns Colitis. 2019;13(S1):S265-S266.
Product Detail	Specification
Method	Quantitative sandwich ELISA
Microplate size	96 wells
Kit storage conditions	Refrigerated at 2-8°C
Sample	Serum
Serum storage conditions	Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.
Biosimilars	Internal evaluation studies have demonstrated that Promonitor ADL and Promonitor Anti-ADL are able to quantify the drug levels anti-drug antibodies levels for the following biosimilars¹: ABP501 SB5 GP 2017
Standard	WHO 1° international standard for ADL (NIBSC code: 17/236)

Promonitor-ANTI ADL

Product Detail

Method

Specification: Quantitative bridging ELISA

Microplate size

Specification: 96 wells

Kit storage conditions

Specification: Refrigerated at 2-8°C

Sample

Specification: Serum

Serum storage conditions

Specification: Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be
stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or
lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Product Detail	Specification
Method	Quantitative bridging ELISA
Microplate size	96 wells
Kit storage conditions	Refrigerated at 2-8°C
Sample	Serum
Serum storage conditions	Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Promonitor-RTX

Product Detail

Method

Specification: Quantitative sandwich ELISA

Microplate size

Specification: 96 wells

Kit storage conditions

Specification: Refrigerated at 2-8°C

Sample

Specification: Serum

Serum storage conditions

Specification: Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be
stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or
lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Biosimilars

Specification

Internal evaluation studies have demonstrated that the Promonitor RTX kit is able to quantify drug levels for
the following biosimilars:

CT-P10 (Truxima/Blitzima/Ritemvia/Rituzema)

Product Detail	Specification
Method	Quantitative sandwich ELISA
Microplate size	96 wells
Kit storage conditions	Refrigerated at 2-8°C
Sample	Serum
Serum storage conditions	Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.
Biosimilars	Internal evaluation studies have demonstrated that the Promonitor RTX kit is able to quantify drug levels for the following biosimilars: CT-P10 (Truxima/Blitzima/Ritemvia/Rituzema)

Promonitor-ANTI RTX

Product Detail

Method

Specification: Quantitative bridging ELISA

Microplate size

Specification: 96 wells

Kit storage conditions

Specification: Refrigerated at 2-8°C

Sample

Specification: Serum

Serum storage conditions

Specification: Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be
stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or
lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Product Detail	Specification
Method	Quantitative bridging ELISA
Microplate size	96 wells
Kit storage conditions	Refrigerated at 2-8°C
Sample	Serum
Serum storage conditions	Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Promonitor-ETN

Product Detail

Method

Specification: Quantitative sandwich ELISA

Microplate size

Specification: 96 wells

Kit storage conditions

Specification: Refrigerated at 2-8°C

Sample

Specification: Serum

Serum storage conditions

Specification: Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be
stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or
lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Biosimilars

Specification

Internal evaluation studies have demonstrated that the Promonitor ETN kit is able to quantify drug levels for
the following biosimilars :

SB4 (Benepali)
GP2015 (Erelzi)

Product Detail	Specification
Method	Quantitative sandwich ELISA
Microplate size	96 wells
Kit storage conditions	Refrigerated at 2-8°C
Sample	Serum
Serum storage conditions	Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.
Biosimilars	Internal evaluation studies have demonstrated that the Promonitor ETN kit is able to quantify drug levels for the following biosimilars : SB4 (Benepali) GP2015 (Erelzi)

Promonitor-ANTI ETN

Product Detail

Method

Specification: Quantitative sandwich ELISA

Microplate size

Specification: 96 wells

Kit storage conditions

Specification: Refrigerated at 2-8°C

Sample

Specification: Serum

Serum storage conditions

Specification: Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be
stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or
lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Biosimilars

Specification

Internal evaluation studies have demonstrated that the Promonitor ETN kit is able to quantify drug levels for
the following biosimilars :

SB4 (Benepali)
GP2015 (Erelzi)

Product Detail	Specification
Method	Quantitative sandwich ELISA
Microplate size	96 wells
Kit storage conditions	Refrigerated at 2-8°C
Sample	Serum
Serum storage conditions	Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.
Biosimilars	Internal evaluation studies have demonstrated that the Promonitor ETN kit is able to quantify drug levels for the following biosimilars : SB4 (Benepali) GP2015 (Erelzi)

Promonitor-GLM

Product Detail

Method

Specification: Quantitative capture ELISA

Microplate size

Specification: 96 wells

Kit storage conditions

Specification: Refrigerated at 2-8°C

Sample

Specification: Serum

Serum storage conditions

Specification: Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be
stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or
lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Product Detail	Specification
Method	Quantitative capture ELISA
Microplate size	96 wells
Kit storage conditions	Refrigerated at 2-8°C
Sample	Serum
Serum storage conditions	Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Promonitor-ANTI GLM

Product Detail

Method

Specification: Quantitative capture ELISA

Microplate size

Specification: 96 wells

Kit storage conditions

Specification: Refrigerated at 2-8°C

Sample

Specification: Serum

Serum storage conditions

Specification: Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be
stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or
lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Product Detail	Specification
Method	Quantitative capture ELISA
Microplate size	96 wells
Kit storage conditions	Refrigerated at 2-8°C
Sample	Serum
Serum storage conditions	Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Promonitor-VDZ

Product Detail

Method

Specification: Quantitative sandwich ELISA

Microplate size

Specification: 96 wells

Kit storage conditions

Specification: Refrigerated at 2-8°C

Sample

Specification: Serum

Serum storage conditions

Specification: Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be
stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or
lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Product Detail	Specification
Method	Quantitative sandwich ELISA
Microplate size	96 wells
Kit storage conditions	Refrigerated at 2-8°C
Sample	Serum
Serum storage conditions	Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Promonitor-ANTI VDZ

Product Detail

Method

Specification: Quantitative bridging ELISA

Microplate size

Specification: 96 wells

Kit storage conditions

Specification: Refrigerated at 2-8°C

Sample

Specification: Serum

Serum storage conditions

Specification: Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be
stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or
lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Product Detail	Specification
Method	Quantitative bridging ELISA
Microplate size	96 wells
Kit storage conditions	Refrigerated at 2-8°C
Sample	Serum
Serum storage conditions	Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Promonitor-UTK

Product Detail

Method

Specification: Quantitative sandwich ELISA

Microplate size

Specification: 96 wells

Kit storage conditions

Specification: Refrigerated at 2-8°C

Sample

Specification: Serum

Serum storage conditions

Specification: Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be
stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or
lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Product Detail	Specification
Method	Quantitative sandwich ELISA
Microplate size	96 wells
Kit storage conditions	Refrigerated at 2-8°C
Sample	Serum
Serum storage conditions	Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Promonitor-ANTI UTK

Product Detail

Method

Specification: Quantitative bridging ELISA

Microplate size

Specification: 96 wells

Kit storage conditions

Specification: Refrigerated at 2-8°C

Sample

Specification: Serum

Serum storage conditions

Specification: Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be
stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or
lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

Product Detail	Specification
Method	Quantitative bridging ELISA
Microplate size	96 wells
Kit storage conditions	Refrigerated at 2-8°C
Sample	Serum
Serum storage conditions	Sera can be stored or transported at RT (20-25°C) for up to 2 days. Alternatively, sera can be stored at 2-8°C for up to 5 days; if serum will not be processed within 5 days, freeze it at -20°C or lower. If frozen sera are used, mix thoroughly before analysis. Avoid repetitive freeze-thaw cycles.

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