Setting the

Boston Cell Standards’ IHCalibrators® are traceable to:

National Institute of Standards & Technology (NIST)

Standard Reference Material® 1934

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IHControls® are on-slide IHC staining controls that use proprietary tagged peptide or protein targets. This technology provides for analytic traceability to an international concentration standard 1. This assures consistency day-to-day, lot-to-lot, and lab-to-lab and confirms that an assay worked properly. The performance of IHControls® in checking primary antibodies, detection kits, and antigen retrieval has been validated and published 2-4.

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IHCalibrators® are similar in construction but provide for precise measurement of the limit of detection, the most important parameter of analytic sensitivity. With IHCalibrators®, clinical IHC laboratory staff can ensure that their immunostain is configured correctly, capable of sensitively detecting the cellular biomarker in question.

Product Benefits

Improved test accuracy
and reproducibility

Proactive early-warning of
assay deviations

Simplified, quantitative
regulatory compliance

Rapid, exact troubleshooting
when needed

Direct quantitative readout for
optimizing reagent concentrations

Ensures standardization among
multiple instruments

IHControls® are ½ -¼th the true
cost of homemade controls

Purchasing on-slide controls in a
ready-to-use format is
convenient; simpler workflow.

IHControls® have been extensively
tested and validated, as described
in a series of published papers

These advancements place the
clinical IHC lab on par with other
types of clinical diagnostic labs
which already have commercial
standardized test controls.

Learn how they work, and why they’re important


Multiplexed. IHControls® are grouped together so that a single control will be useful for multiple different primary antibodies, often to different protein biomarkers. The groups are usually organized by analyte or subject area. For example, HER2, ER, and PR are grouped together as a breast cancer panel.

Matched. In addition to the different analyte specificities, there are also multiple different concentrations of each that are often available. This ensures that your lab uses a concentration matched to your stain. Our studies have demonstrated that controls with too high a concentration are insensitive 1. There is an approximately ten-fold difference in antigen concentration between each level. We recommend using the lowest antigen concentration that provides an easily detectable stain. That concentration may not be the same for HER-2, ER, and PR and should be determined in your lab.

IHControls® Safety Data Sheet

IHControls® Product Menu

Marker Description Level Target Antibodies Product Code Regulatory Status
Breast Cancer Panel ER/PR/HER2 multi-controls High Optimal: ER EP1, PR 636, PR 16, HER2 CB11, HER2 4B5
Also binds: HER2 polyclonal
Breast Cancer Panel ER/PR/HER2 multi controls Medium Optimal: PR 1294, ER 1D5, ER 6F11, PR 1E2, HER2 SP3, HER2 polyclonal
Also binds: ER SP1, Targets of BRLS11 (high)
Breast Cancer Panel ER/PR/HER2 multi controls Low Optimal: ER SP1
Also binds: Targets of BRL2U04
PD-L1 PD-L1 controls High Optimal: SP142, ZR3
Also binds: SP263, 28-8, 22C3, E1L3N, 73-10
PD-L1 PD-L1 controls Medium Optimal: SP263, 22C3, 28-8, ZR3, 73-10, E1L3N
Also binds: SP142
PD-L1 PD-L1 controls Low Optimal:
Also binds: SP263, 22C3, 28-8, ZR3, 73-10, E1L3N
Alk Alk controls High 5A4, D5F, SP8 AlkLH RUO
Ki67 Ki67 controls High 30-9, MIB1 K67LH RUO
P53 P53 controls High DO-7, P53-11, P53-12 p53LH RUO

*IHControls® levels are intended to be matched to the customer’s IHC test. Optimal levels based on company experience is shown but should be verified in customer’s lab

**IHControls® are designed to serve as positive controls for assays testing for the human form of the above-described markers


IHCalibrators® are provided as a series of up to 10 dots, already positioned on a microscope slide, ready for use. Each of the calibrators has a different pre-measured concentration ranging from approximately 1,000–1,000,000 molecules per microbead. The concentrations are traceable to a NIST standard reference material. Our current product menu is as follows:

IHCalibrators® Safety Data Sheet

IHCalibrators® Product Menu

Marker Intended Use Target Antibodies Product Code Regulatory Status
Alk Alk calibrators D5F, ALK1, OTI1​ ALKD5R RUO
Alk Alk calibrators SP8 ALKSP8R RUO
bcl2 Bcl2 calibrators​ 100/20, 124​ bclR RUO
CD20 CD20 calibrators​ L26 CD20R RUO
ER SP1​ ER SP1 calibrators​ ER SP1​ BRRSP1​ RUO
ER EP1 ER EP1 calibrators​ ER EP1​ BRREP1​ RUO
ER 6F11​ ER 6F11 calibrators​ ER 6F11​ BRR6F​ RUO
HER2 C-terminus HER2 calibrators​ HER2 CB11, HER2 4B5, HER2 polyclonal​ BRRCB​ RUO
HER2 SP3​ HER2 SP3 calibrators​ HER2 SP3​ BRRSP3​ RUO
Ki67​ Ki67 calibrators​ 30-9, MIB1​ Ki67R​ RUO
MLH1 MLH1 calibrators​ ES05​ ES5R​ RUO
MSH2 MSH2 calibrators​ G219​ G219R​ RUO
MSH6​ MSH6 calibrators​ EP49​ EP49R​ RUO
MSH6​ MSH6 calibrators​ SP93 SP93R RUO
NTRK​ NTRK calibrators​ EPR17341​ NT41R​ RUO
PD-L1 intracellular​ PD-L1 calibrators​ E1L3N, ZR3, 73-10, SP142, SP263​ PDR​ RUO
PD-L1 extracellular​ PD-L1 calibrators​ 22C3, 28-8​ PDEXR​ RUO
PMS2 PMS2 calibrators​ EP51, EPR3947​ EP51R​ RUO
PR 1E2​ PR 1E2 calibrators​ PR 1E2, PR 1294​ BRR1E2​ RUO
PR 636​ PR 636 calibrators​ PR 636​ BRR636​ RUO
PR 16​ PR 16 calibrators​ PR 16​ BRR16​ RUO
p53​ p53 calibrators​ DO7, BP53-11​ p53R​ RUO
p63​ p63 calibrators​ 4A4​ p63R​ RUO
ROS1 ROS1 calibrator​ ROS1D4D6​ ROSR​ RUO
Human IgG​ Human IgG protein calibrators​ Human IgG​ hIgG​ RUO
Uromodulin Uromodulin calibrators​ Uromodulin rb polyclonal​ UDR​ RUO
CD3​ CD3 calibrators​ CD3 Rb polyclonal​ CD3R​ RUO
Aquaporin 1 Aquaporin calibrators​ Aquaporin 1/22​ AQPR RUO
Myeloperoxidase MPO calibrators​ Rb polyclonal​ MPOR​ RUO

*IHCalibrators® are designed to serve as positive controls for assays testing for the human form of the above-described markers.

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