79. Complete the actions necessary to expand the product claim originally submitted to and listed by WHO PQ for the use of the professional use product to allow caregivers to test children 24 months and older by end Q1 2019.
80. Develop and execute a study by end Q2 2019 to verify usability in adult caregivers testing children with OraQuick HIV Self-Test.
81. Work with partners to develop and execute a more comprehensive study to assess social consequences of the use of the OraQuick HIV Self-test in testing children by parents or caregivers for consideration by WHO in self-testing guidelines
79. A change notification was submitted to and was approved by WHO PQ in November 2019 to reduce the age limitation for the OraQuick Rapid HIV-1/2 Antibody Test to allow testing of children 24 months and older in a professional setting. Data to support the validation of the age reduction was provided through collaboration with the Biomedical Research and Training Institute B-GAP study in Zimbabwe and the University of Washington STEP-UP study in Kenya.
80. A study to verify the usability in adult caregivers testing children 24 months and older with OraQuick HIV Self-Test have been completed (B-GAP study in Zimbabwe). A change notification was submitted to and was approved by WHO PQ in November 2019 to reduce the age limitation for the OraQuick HIV Self-Test (community and pharmacy versions) to allow testing of children 24 months and older. However, WHO PQ has requested that the following limitation appear in the product labelling: “This product has not been evaluated for use in self-testing for individuals younger than 12 years of age. For children ages 2-11, testing must be performed by a trained healthcare worker.”
81. OraSure will be providing OraQuick HIV Self-Test devices for use in the CDC and CRS studies of acceptability, feasibility and impact of HIV screening of children through index testing services in Zambia and Uganda, with enrollment expected to begin in H1 2020. These studies are not designed to explicitly assess the potential consequences (or social harms) related to the use of the OraQuick HIV Self-test in testing children by parents or caregivers; therefore it is unclear if WHO self-testing guidelines on caregiver-assisted testing will be influenced by the study results.
22. Make every effort to stay in the EID market to ensure there is a sufficient testing capacity to reach and maintain accelerated Fast Track targets (95% of HEI tested by 2020 and beyond).
23. Ensure consistent reagent pricing across partners within countries and within regions, and provide a transparent breakdown of pricing for the products and services sold.
24. Consider moving from separate instrument, consumable, and service procurement towards more consolidated, ideally all-inclusive pricing models.
25. Provide service level agreements that clearly spell out key performance indicators POC, near POC, and high-throughput laboratory instruments, including target up-times and failure rate threshold (with consideration for different causes), plus a mitigation plan when the threshold is exceeded.
26. Consider the inclusion of a clinical indeterminate range in test result reports for more accurate diagnosis of infants per WHO guidelines.
27. Rapidly communicate stock shortages with major buyers and work on joint mitigation strategies.