Contact: LaShon S. Beamon, (202) 480-0777
The DC Department of Forensic Sciences (DFS), has released the serology Zika re-test results following human errors being self-reported at the District’s Public Health Lab (PHL). Federal approved serology testing at three other public health labs and the Centers for Disease Control and Prevention (CDC) have confirmed that three patients tested positive for the Zika virus, 26 patients are left with inconclusive results and 394 remain negative. DFS has alerted all providers of the test results and further confirmed that all those with positive and inconclusive results were made aware of their status.
“We have retooled the test and are ready to re-implement testing following review from our Science Advisory Board,” said Dr. Smith, Director of the Department of Forensic Sciences. “We have demonstrated quality to our regulatory agencies and we will continue to look vigorously and consistently evaluate our procedures to ensure that they fall squarely in line with the best standards available. We are stronger and better for this. Science is always evolving, so should our laboratories and tests.”
Following the self-suspension of the Zika, MAC-ELISA serology testing, a federal audit, conducted at the District’s PHL, within days of announcing the re-test plans, unveiled that the test instructions were not in compliance with the Clinical Laboratory Improvement Amendments (CLIA) testing requirements. Subsequently, the CDC issued updated procedures, to public health labs nationwide, alerting them that an additional negative control was required by CLIA to run the test in accordance with their requirements.
DFS has maintained its CLIA laboratory certification, without any sanctions, and the corrective actions presented and implemented satisfied the accrediting body.
On March 10, 2017, DFS was granted permission to resume Zika MAC-ELISA testing following PHL staff satisfactorily passing a recent proficiency panel test. DFS is continuing the self-suspension and currently submits Department of Health approved samples to the CDC. DFS will consider implementation of any new future tests that are approved by FDA.