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Immunohistochemistry (IHC) is a key ihc cro services in modern biomedical R&D. It serves diagnostic, prognostic and predictive functions, guides therapeutic selection and informs patient stratification to accelerate clinical trial timelines.1 It also enables the validation and confirmation of target and biomarker discoveries through visual detection of antigens within tissue samples.

Developing an IHC laboratory in a resource-limited setting requires strategic investments and the coordination of multiple components. The physical housing of the IHC laboratory, the coordination and purchase of equipment, reagents and consumables as well as ongoing quality assessments were all required.

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The IHC laboratory was housed in the MTRH pathology lab in western Kenya and used existing histopathology equipment, including a tissue processor, tissue embedding station, convection oven and microtome. IHC reagents and equipment were obtained through repurposing, donations and direct purchases. A local company representative, DAKO, supplied servicing, technical support and reagents to the IHC laboratory.

The laboratory is run by one full-time pathologist and four pathology technicians. IHC staining is performed by both manual and automated methods. We compared the total cost and time to obtain IHC stained slides manually with IHC processing using an automated immunostainer (DAKO Autostainer Link 48, Part No AS48030). The comparison was conducted by analyzing the same volume of slide staining (48 slides, the maximum capacity of the automated stainer) over a single IHC cycle. Despite concerns of increased costs associated with automation, the study shows that investment in an automated immunostainer reduces overall costs. This is due to reduced salaries and the saving of the cost of reagents, consumables and annual instrumentation depreciation and service.