Photo by Juan D. Alfonso
The US Food and Drug Administration (FDA) has deemed a hospital-based test for the Zika virus “high risk,” as the test has not been cleared by the FDA.
The test was developed by scientists at Texas Children’s Hospital and Houston Methodist Hospital. It has been available at both hospitals since last month.
The FDA has requested more information on the test but has not asked the hospitals to stop using it.
According to the hospitals, the test identifies virus-specific RNA sequences to detect the Zika virus. It can distinguish Zika infection from dengue, West Nile, or chikungunya infections. And it can be performed on blood, amniotic fluid, urine, or spinal fluid.
In a letter to the hospitals, the FDA said this test appears to meet the definition of a device, as defined in section 201(h) of the Federal Food Drug and Cosmetic Act. Yet the test has not been granted premarket clearance, approval, or Emergency Use Authorization review by the FDA.
Therefore, the FDA has asked for information on the test’s design, validation, and performance characteristics. The agency said the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services asked the FDA to review the science behind the test.
The FDA has not asked the hospitals to stop using the test while the review is underway, according to a statement from Texas Children’s Hospital.
Nevertheless, the Association for Molecular Pathology (AMP) said it is “concerned and disappointed” to see the FDA taking enforcement action regarding this test. The AMP said these types of tests are critical for patient care and should be made available to patients in need.
In fact, the AMP said this is an example of how FDA regulation of laboratory developed procedures would hinder patient access to vital medical services. That’s because the FDA’s Emergency Use Authorization for antibody testing at the CDC or state public health labs does not provide results in the timely fashion needed for immediate patient care.
The FDA recently issued Emergency Use Authorization for the Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA), which was developed by the CDC.
The test was distributed to labs in the US and abroad, but it was not made available in US hospitals or other primary care settings.
