The Success Story of Israel
by Urmi Prasad Richardson, Chiron
Along with a reputation for providing cutting-edge technology in multiple markets, notably the telecommunications and medical devices industries, Israel can now also boast of its decision to adopt the safest method of blood screening available. The primary blood bank institution of Israel, Magen David Adom [MDA] has decided to implement NAT for 100% of its blood donations.
Israel's population is close to 7 million, with a health care service on par with those of the western world, and a similar ratio of blood donations collected annually to the general population (approximately 4.5%). The blood collection system is entirely based upon volunteers with a large base of repeat donors.
The blood transfusion service in Israel is fully centralized with one testing center screening over 300,000 donations. In addition to this main center, there are a couple of hospital blood banks collecting less than 25,000 donations annually. Following NAT introduction as a mandatory test, it is expected that these blood banks will be required to send their samples to MDA for screening. MDA is a non profit organization, which, by law since 1950, provides blood donations and components on a cost recovery basis.
Unlike other examples, some recent, the decision to introduce NAT in Israel was not triggered by a blood transfusion infection scandal. The epidemiology indicates a negligible HIV prevalence (in the range of a couple of thousand diagnosed carriers among the general population), while HBV and HCV prevalence are in line with other western countries.
However the danger of window period infections and potential residual risk transmissions still exist. Introducing the safest screening method available, by adopting NAT technology, demonstrates MDA’s commitment to superior quality and service. Implementing the PROCLEIX® ULTRIO® Assay (HIV-1/HCV/HBV) [In the United States, the PROCLEIX ULTRIO Assay is approved for screening HCV and HIV-1 only]. Performing routine screening with this assay on the full-automated high-throughput PROCLEIX® TIGRIS® System allows MDA to test all of its donations in individual donor testing format.
The decision to implement required a lot of dedication and persistence from the Chiron team, ILEX, and key supporters within MDA. Dr. Moshe Benshaul, CEO of ILEX Biotech Ltd, Chiron distributor for Israel, states "After almost 2 years of discussions and support for implementing change, 100% of the Israeli blood supply will be tested with NAT. The mandatory decision to screen all blood donations using NAT could not have been reached without MDA's scientific and medical staff, led by Prof. Eilat Shinar, director of blood services. Her efforts were supported by the MDA executive management and members of the advisory committee on transfusion medicine to the Israeli Ministry of Health. The directive to replace donation screening using HCVAg by NAT will provide an additional safety layer to the country's blood supply."
Introducing ULTRIO/TIGRIS:
In early August MDA issued a public tender for the procurement of NAT screening systems. Towards the end of September, ILEX/Chiron was awarded the bid. Among several undertakings, ILEX had to plan the NAT laboratory, supply, install and commission 3 PROCLEIX TIGRIS Systems, link the NAT systems to the MDA host system, train 4-6 operators and complete systems validation (QA) – all within one month!
To meet these requirements, Chiron and ILEX followed a very tight schedule. Thanks to the support and dedication of the Chiron EMEA (Europe, Middle-East, Africa) supply chain team, 3 PROCLEIX TIGRIS Systems were delivered to MDA in 3 days.
Despite being delivered on the last day of September, just before the public holiday season, pre-installation of the systems was completed. By the end of the public holidays, the systems installation was resumed by 3 Israeli Field Service Engineers led by Oded Meron, a PROCLEIX TIGRIS System veteran, and assisted by JC Stolz, ILEX service manager in South Africa. All installations were done in parallel, a task that was completed in record time – in less than 9 days! We were a few days ahead of schedule.
ILEX's Technical Support Specialist team started the operator training, to be followed by the validation process. During initial phase of validation phase, blood donation samples will be tested in parallel with the HCV Ag method. The final phase of validation will require a full workload capacity testing (1,000 to 1,200 donations per day) to assess the system robustness.
Even though the tender award coincided with the public holiday season, ILEX has achieved the goal of routine testing right on schedule in the first week of January.
NAT implementation in Israel is yet another example of strong initiative and excellent collaboration between Chiron, our distribution partner ILEX, and the Israeli transfusion industry leaders.