top of page

FDA Donor Screen

FDA-certified for donor eligibility testing

Unilab's focus is strictly on delivering the highest quality egg and sperm donor testing in the industry.

Unilab has over 30 years of reproductive testing experience. We have taken this knowledge and created the most specialized reproductive lab in the U.S. No one in the industry matches our specialized testing menu and our personalized customer service. In May of 2005, the FDA imposed regulations in the screening of egg and sperm donors. Unilab offered its IVF clients the donor testing that was required by the FDA to test donors. Unilab’ s long history in the reproductive testing field has set us apart from any lab in the U.S.

About FDA Donor Testing at Unilab

  • We hold all sperm and egg donor blood samples for one year

  • We immediately contact your office if a donor has a positive result, which will immediately alert your office to act swiftly to cancel a donor cycle if needed

  • Offer both out of town and international donor testing

  • Our international IVF donor testing department can accommodate international shipping needs

  • Open access policy allowing your staff to speak directly to testing staff

  • Web/mobile access to your results through our web portal 

  • Can send results via a secure email platform or by fax or mail

  • Can integrate with your EMR at no cost to your facility

  • We offer STAT FDA donor testing (Additional cost will apply)

  • Free consulting/guidance for any FDA donor testing questions you may have

  • We do NOT pool any samples for FDA donor tests

  • Only use FDA licensed test kits approved and cleared for donor screening

  • We can produce and provide your IVF center with any time frame (quarterly, semi-annual or annually) summarization reports of your donors results. These reports can help facilitate an FDA inspection.

  • Highly trained accessioning staff carefully reviews all FDA donor requisitions to ensure that the proper required tests have been properly ordered

  • We provide your office phlebotomy supplies free of charge 

International FDA Donor Testing

Many of our clients have had cases in which couples choose to use a donor from an agency or have a specific person (relative, friend) in mind. In some cases this can make the entire process more challenging when the donor does not reside within a reasonable driving distance of the IVF clinic. The only options at this point are to send them to the most convenient lab that can draw blood and run the tests or fly the donor in for testing. The first option has limited appeal because it would cause the IVF clinic performing the procedure to potentially use a lab other than the one they have been for their donor testing. This introduces potential variables that can make maintaining full FDA compliance difficult at best. The option of flying the donor in increases the cost for the entire procedure for the recipient couple.


We have developed a service to maintain the consistency of donor testing and FDA compliance for the IVF clinic while minimizing the additional cost of airfare. The solution is our Out of Town Donor Testing Service. With this service the consistency and quality of our FDA donor testing can be done without additional cost.


The IVF clinic responsible for testing, the donor and the drawing physician’s office or draw station need to follow these simple steps:


  1. IVF clinic for recipient couple fills out & faxes an Out of Town Donor Test order form.

  2. We then send out a complete donor kit with all necessary supplies, shipping materials and instructions to the donor.

  3. The donor then takes the kit to a physician’s office (typically the IVF clinic that will be doing the hormone monitoring is used since they are very familiar with the whole procedure) or a draw station.

  4. All specimens are collected, packaged up and shipped back to Unilab for testing.

bottom of page