West Nile Egg Donor Testing

West Nile Virus Screening Underway At TWEB

West Nile Virus Egg Donor Screening

West Nile Virus (WNV) is an arbovirus spread principally by Culex mosquitos that occur widely in the continental US. Mosquitos pick up the virus from infected birds and transmit it to other birds, mainly in the summer.

After being bitten by an infected mosquito, most people with West Nile Virus are asymptomatic or mildly symptomatic with a flu-like illness with or without a rash (West Nile fever). However, encephalitis (WNE) or meningitis (WNM) may follow infection, with significant morbidity and mortality rates. A US outbreak in 2012 caused 286 deaths. Recovery from even milder cases may be lengthy with physical and cognitive/mental symptoms.

First noted in Uganda in 1937, and highly prevalent with serologic testing in Africa and India, the disease was detected in North America in 1999. Human-to-human transmission through transfusion was noted and US blood banks began testing in 2003.

Under the guidance of the US Food and Drug Administration (FDA), “establishments must perform donor testing to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents and diseases.”

Although donation of human oocytes has never been shown to cause infectious disease, oocytes fall under FDA jurisdiction under Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) regulations. West Nile virus was added to the list of recommended screening within the last year.

Oocyte donor testing involves a questionnaire regarding blood transfusion, rashes and febrile illnesses as well as testing a donor’s blood at specific intervals before oocyte retrieval. Nucleic acid testing (NAT) has higher sensitivity and specificity for most viruses than antibody tests that may be easier to implement for screening large populations. The FDA has authorized specific NAT assays that are now widely commercially available.

The World Egg Bank stays current with all suggested and recommended FDA protocols and has implemented WNV testing, along with HIV, Hepatitis B & C, and other infectious disease testing such as Chlamydia. We have undergone frequent inspections by the FDA and have had no major citations.

Clinics which do not perform oocyte or sperm donor screening and stimulation are exempt from FDA inspections. The onus of regulation and inspection falls upon the organizations, such as The World Egg Bank, doing the donor screening and testing.

from The World Egg Bank http://www.theworldeggbank.com/blogs/west-nile-egg-donor-testing/

Shipping Ooctyes

Our Proprietary Process For Shipping Oocytes

At The World Egg Bank, we strive to make our shipping and receiving procedures as straight forward as possible. For this reason, our shipping procedure starts days to weeks ahead of the planned shipping date. As soon as a patient has finalized the details of obtaining their eggs, an email is sent from the shipping team to the receiving clinic detailing the patient’s name, selected donor number, and date that we can ship the order, along with an estimated delivery date. This email asks for confirmation from the clinic that the proposed date(s) work, the shipping address is correct, and that the list of embryologists verified to perform our warming technique is up to date. Once we receive confirmation that all information provided is accurate and approved, the shipment is placed on the shipping team calendar and the proposed date is entered into the recipient’s file on our custom-built database.

Scheduling Shipments

To streamline the process, while managing clinic and patient expectations, we’ve learned how to limit the amount of potential weekend-time that the tanks are in transit by scheduling domestic shipments to Tuesdays and international shipments to Thursdays. The day prior to shipping, all paperwork and airway bills are created and the tanks to be used are filled with liquid nitrogen to ensure that they are charged and ready for their journey. The day of shipment, all orders are carefully packed and ready for pick up by 11:00 AM. This level of detail ensures a consistent process for every shipment that leaves our facility, thus nearly eliminating any unforeseen variables.

Verifying New Clinics

The process differs slightly for new clinics vs verified clinics. For clinics who have not worked with us before, we require them to go through our “verification process.” This is akin to training, but is limited to understanding and proper technique for our warming protocol only. Final authorization for performing any warming is left to the discretion of the laboratory director. When initially contacting a new clinic, a small packet of paperwork is sent that explains the details of our process, asks for a short equipment list to be filled out to ensure the clinic has the proper equipment to perform the task, and for information on the nearest airport and travel accommodations for our verifying embryologist. Once we receive this paperwork, the warming date can be established. Two weeks prior to the warming date the eggs are shipped from our facility. In that shipment is a packet containing a letter detailing the verification procedure, extra warming dishes, extra warming media, and a blank vitrification device. In the tank with the oocytes is one practice oocyte per embryologist being verified.

While sounding complex, these procedures are highly coordinated. Our top priority in the shipping department is to ensure success in transit. By putting these procedures in place, we have perfected minimizing issues related to the transit of oocytes.

from The World Egg Bank http://www.theworldeggbank.com/blogs/shipping-ooctyes/