Objective: Infection by the Zika virus is a Public Health Emergency of International Concern as defined by the World Health Organization. Resolution no. 72, issued by the Collegiate Board of the Brazilian Health Surveillance Agency (ANVISA) on March 30, 2016, made ZKV testing mandatory prior to procedures involving germ cells and tissues. This paper aims to discuss the aforementioned Resolution from the standpoint of evidence and cost-effectiveness of the measures taken within the first two months of mandatory testing.
Methods: The medical staff at the clinic looked into the steps needed to comply with the new rules and checked laboratories in the city to perform the tests with their lead times and costs, health insurance refunds, data maintenance capabilities, how to contact patients, decision-making processes in ongoing cases, deadlines for implementation, in addition to exchanging ideas with other clinics and gathering information from the guidelines being produced. A SWOT analysis was performed.
Results: A total of 152 tests were performed within the first two months of mandatory testing, in five different clinical situations: one previously symptomatic woman with a negative PCR test before starting the cycle; two asymptomatic women had positive IgM (1.3%) and negative PCR tests on days 25 and 60; one husband enrolled as a suspect with a negative RT-PCR on day 13 and another untested suspected case; a couple decided to have their oocytes cryopreserved because the husband's test result was not available on pickup day. The mean cost of USD 200 per couple is equivalent to 1.2 day of the stimulation protocol. The staff worked more efficiently and was able to respond promptly to the increased demand for ZKV testing; however, the tests failed to reassure patients of the safety of the procedure and increased costs.
Conclusion: The testing requirement for asymptomatic patients prior to ART should be reviewed.
Keywords: Zika virus; immunology; in vitro fertilization.