Attention Turns to More Rapid Testing to Prevent the Donation of Infected Organs

A kidney recipient in a New York City hospital recently contracted HIV from the transplanted organ, which came from a living donor, according to the New York State Department of Health. Although an initial screening had been performed on the donor, he or she apparently had unsafe sex after the test but before donating the kidney. The Department of Health is now recommending that hospitals test donors for HIV, as well as the hepatitis C and B viruses, within 14 days of donating an organ.

"This unfortunate event, while quite rare, raises critical questions about the safety risks involved in organ transplantation, and specifically how and when donors are screened," says Lawrence Siebert, CEO of Chembio Diagnostics, a New York-based developer and manufacturer of rapid diagnostic tests for the growing point-of-care testing market. "The 14-day period recommended by New York State may not be good enough. We have a test that could screen for HIV and hepatitis on the very day an organ is donated."

Chembio has developed a patented, next-generation testing approach known as Dual Path Platform (DPP®) technology. The original focus for DPP® is rapid HIV testing, although it can be adapted to test for numerous infectious diseases, including influenza A/B and bird flu, as well as hepatitis B/C. These point-of-care assays are intended to significantly shorten the time to diagnosis and to lessen the costs of testing. They incorporate a range of features, including a good control of challenging sample types such as oral fluid, as well as an excellent capability for multiplexingthe ability to test for multiple diseases simultaneously. The Centers for Disease Control and Prevention (CDC) chose to implement a rapid influenza test created by Chembio because of its ability to test all at once for multiple strains.

"Our DPP® assays can incorporate a cassette with up to five test lines on it, each of which is capable of confirming the presence of a specific condition at the same time," Siebert says. "In a mere 15 minutes, with just one blood sample or oral fluid sample, we can determine to a very high degree of accuracy whether an organ donor is HIV-positive and whether he or she has HEP B/C. If performed immediately before an organ donation, this test would considerably lessen the chances of an infected organ being transplanted into a patient, and could deliver a result within minutes."

A new generation of rapid point-of-care tests for HIV and HEP B/Csuch as those being developed by Chembiocould help ensure that donated organs are healthy, and that unfortunate incidents like the one reported in New York City do not reoccur.