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Potential Shortage of HIV-1/HIV-2 Plus O EIA Test Kits and Impact on Donor Screening and/or Testing

Updated: Sep 21, 2023

I wanted to share with you that the assay we currently use to screen HIV Ab. on donors Bio Rad HIV 1/2/O Ab. FDA Donor screen assay had a temporary disruption of supply for the GS HIV-1/-2 Plus O EIA 480-Test kit, catalog # 32588 and now has inventory for this product.


Due to this issue Unilab will be sending the HIV Ab FDA Donor screen assay to another FDA donor lab that is using the Abbott Alinity s HIV Ag/Ab Combo assay. The only other FDA approved HIV Ab. Screen test available.


Abbott Alinity s HIV Ag/Ab Combo assay: STN: BL125679

“This assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HIV-1/HIV-2 and HIV-1 p24 antigen. The assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing serum specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens.”


This will affect TAT by an extra couple of days.


This is a major disruption for the donor screen testing market. We have been told the assay by Bio Rad assay HIV 1/2/O Ab screen assay will have a release date of Sept. 1, 2023.


If you have any concerns or questions, please feel free to contact me anytime.

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