Notice ID: 75N92022Q0295
“Background
At-home COVID-19 tests support a larger effort to quickly identify, isolate, and treat individuals infected with SARS-CoV-2. Public health systems have been established to receive these results, in turn enabling public health activities such as contact tracing and disease surveillance. Tens of millions of OTC COVID-19 tests are being sold in the U.S. every month, and this number is expected to grow rapidly. However, at this time, only a very small fraction of those test results are being reported to public health authorities. This is because (1) individuals are not required to report OTC test results, (2) many test manufacturers to do not provide a mechanism for result reporting, (3) guidance on test results transmission standards and modes is limited, and (4) manufacturers are disincentivized to promote OTC result reporting due to high per-message costs.”
“Test manufacturers face a burdensome effort in establishing individual electronic communications with more than 50 state, territorial, and federal health systems. A service and infrastructure that provides a single destination for test results which are then forwarded to the health system(s) associated with where the test taker resides, would reduce the burden. The few services that exist charge relatively high fees. A free government solution called ReportStream is under development by CDC and USDS; however, ReportStream currently only connects to about half of U.S. states and lacks the capacity to support a large number of test manufacturers.”
“In order to lower barriers to OTC test result reporting, the NIBIB would like to engage with a service provider to make reporting free for test manufacturers. This will provide an OTC reporting solution in the immediate term, to be later transitioned to ReportStream when ReportStream is fully operational. The NIBIB intends to purchase messages in bulk from the service provider at a low cost, rather than having test manufacturers pay for those messages directly. In exchange for being able to send free messages, the test manufacturers will be expected to implement a connection to the hub and leverage a standard communication specification that was developed by NIBIB and endorsed by other federal government agencies.”
“Scope:
The Service Provider will provide the following services:
- A central destination for electronic transmission of test results from participating software applications
- Quality control on test results messages
- Routing of test results to appropriate state and federal health systems
- Technical and operational support services to assist test manufacturers with onboarding, maintenance, and troubleshooting…”
