An Ov16 positive control has been developed: a recombinant, monoclonal human IgG4 antibody to Ov16.

Two ELISA methods for anti-Ov16 human IgG4 were assessed using the Ov16 positive control.

• HRP-based ELISA results in a lower limit of detection and superior detection of clinical pool and control positives as compared to AP-based ELISA.
• Dried blood spots are an acceptable specimen type with both ELISA methods.

The anti-Ov16 antibody has been further developed as a quality control and quality assurance reagent for:

• ELISA standardization and quality control
• Manufacturing control of Ov16 RDT
• Field-stable RDT control to support training and as quality assurance reagent for RDTs at different points of the supply chain from manufacturer to use.