Today, the FDA released industry guidance for reducing the risk of Zika Virus transmission through blood products. “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components” is for immediate implementation.
From the Washington Post:
“In a notice sent to blood centers and posted on the agency’s website Wednesday evening, the FDA said it is requesting all blood centers in Miami-Dade and Broward counties to ‘cease collecting blood immediately’ until those facilities can test individual units of blood donated in those two counties with a special investigational donor screening test for Zika virus or until the establishments implement the use of an approved or investigational pathogen-inactivation technology.”
On May 13th, altona Diagnostics received Emergency Use Authorization (EUA) from the FDA for their RealStar Zika Virus RT-PCR Kit U.S. for the qualitative detection of RNA from Zika virus in serum or urine (collected alongside a patient-matched serum specimen) from individuals meeting CDC Zika virus clinical criteria. This is the same kit that Houston Methodist Hospital and Texas Children’s Hospital used for their laboratory-developed Zika test.
In their most recent Morbidity and Mortality Weekly Report (MMWR), the CDC issued interim guidance for Zika Virus testing. From the report:
“On the basis of the newly available data, CDC recommends that Zika virus rRT-PCR be performed on urine collected <14 days after onset of symptoms in patients with suspected Zika virus disease. Zika virus rRT-PCR testing of urine should be performed in conjunction with serum testing if using specimens collected <7 days after symptom onset. A positive result in either specimen type provides evidence of Zika virus infection.”
On April 28th, the FDA granted Emergency Use Authorization to Quest Diagnostics for an RT-PCR test to detect Zika Virus in human samples.
“The test was developed by the reference laboratory business of Quest’s Focus Diagnostics, Inc., subsidiary. The proprietary molecular test is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from certain individuals. Quest Diagnostics plans to make the new test broadly available to physicians for patient testing, including in Puerto Rico, early in the week of May 2.
“Zika Virus RNA Qualitative Real-Time RT-PCR test is a real-time RT-PCR test intended only for the qualitative detection of RNA from the Zika virus in human serum specimens from patients meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated ). Testing is limited to qualified laboratories designated by Focus Diagnostics, Inc.
“This test is intended for use by trained clinical laboratory personnel qualified by state and federal regulations who have received specific training on the use of the test in qualified laboratories designated by Focus Diagnostics, Inc., and, in the United States, certified under CLIA to perform high complexity tests.”
According to a recent press release, Rheonix is pursuing a rapid Zika Virus diagnostic test. Lablogatory recently discussed this test with the senior vice president for scientific and clinical affairs at Rheonix.
Lablogatory: I understand this test is a so-called “self-confirming” assay; it corroborates serological results with a molecular confirmation. Can you tell readers a bit about the methodology behind this?
Richard Montagna, PhD, FACB: It works much like the “dual assay” for HIV that we recently developed. Using microfluidics, the sample will be split between two sections of the same cartridge. One section will test for antibodies in a methodology similar to ELIZA. The other section will use LAMP technology to lyse, extract, purify, and amplify Zika-specific RNA sequences.
Lab: Sounds efficient! How long do you anticipate the assay will take to run?
RM: We expect it would take less than an hour to perform. Using our existing equipment base, we anticipate the capacity to perform 24 tests in an hour.
Lab: Given the timeline of the impending outbreak, will you seek Emergency Use Authorization (EUA) from the FDA?
RM: Once development is complete, we’ll discuss EUA with the FDA to determine if that approach is feasible.
From the press release:
The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus.