Mumbai: The South African National Blood Service (SANBS) presented new data which demonstrated that its use of Novartis nucleic acid testing (NAT) products to screen donated blood for HIV and Hepatitis has resulted in a significant increase in the safety of the South African blood supply. The data underscores SANBS’ recent celebration of five years of successful effort to prevent the spread of HIV and Hepatitis from transfusion of infected blood.

In addition to reinforcing a remarkable public health story, the data provides further evidence that nucleic acid testing of each unit of blood individually (called individual donor testing, or ID-NAT) – rather than in pools of multiple donors – is the most sensitive method available for detecting HIV type 1 (the virus type responsible for 99.6% of all HIV infections), Hepatitis C virus, and Hepatitis B virus (HBV) in donated blood.

“Prior to NAT testing, transmission of HIV and Hepatitis infections from donated blood were not uncommon in South Africa,” said Mr. Ravi Reddy, chief operations officer at SANBS. “Since we started performing ID-NAT, we have virtually eliminated the risk, with no reports of HIV-1 infections from transfused blood or blood products. This represents a significant increase in patient safety in South Africa, and I hope this serves as a model for other countries.”

Since 2005, SANBS has screened 3.8 million blood donations for HIV-1 RNA, HCV RNA, and HBV DNA using the Novartis Diagnostics Procleix Ultrio assay on the Procleix Tigris NAT blood screening platform. Because NAT provides highly sensitive detection of the genetic material of the virus itself (RNA and DNA), it can detect active infections that traditional serology testing can miss, shortening the time between infection and when detection of that infection is possible and also enabling detection of very low-level chronic infections. The full integration and automation of all steps of the NAT process, which are possible only with the Procleix TIGRIS system, enables efficient workflow for the laboratories performing the testing of large numbers of specimens daily. SANBS also conducts serology testing, which detects evidence of the body’s immune response to infection (anti-HIV, anti-HCV, and HBsAg), on all samples.

The SANBS results showed that the Novartis Diagnostics Procleix Ultrio assay identified 6,487 HIV-1-positive units of donated blood, 96 of which were not detected by serology and HIV p24 antigen testing alone.1 In addition, there were 3,007 Hepatitis B-positive units of which 346 were not detected with serology testing alone, and 250 Hepatitis C-positive units of which 5 were not detected with serology testing alone. These units of infected blood would have tested negative and been made available for transfusion to patients if not removed from the blood supply following NAT testing.

According to UN AIDS, in 2007 there were 5.3 million HIV-infected people in South Africa, representing an overall national HIV prevalence rate of 11 percent. This creates a greater risk of HIV-infected blood entering the blood supply, with some estimates showing that in South Africa there are as many as one HIV-1 infected unit of donated blood per 600 blood donations.

“As in any country, not all of those infected with HIV or Hepatitis are aware of their infection or of the dangers of having HIV and hepatitis enter the blood supply. This makes it essential that our blood screening programs employ a testing method that will help us deliver the safest possible blood,” said Mr. Reddy. “The data shows that NAT in IDT has achieved that result in South Africa.”