New Data from SANBS Reinforces 5 Years of Success Preventing HIV and Hepatitis Transmission from Donated Blood

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JOHANNESBURG, July 25, 2011 /PRNewswire/ -- 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."

Notes to Editors

About HIV

The human immunodeficiency virus (HIV) is a retrovirus that infects cells of the human immune system, destroying or impairing their function. The most common type of HIV is known as HIV-1, which is easily transmitted.

HIV-1 has caused the majority of AIDS cases(2) and represents 99.6% of all HIV infections.(3,4)  In addition, according to The World Health Organization (WHO), 5-10% of all HIV infections worldwide have been acquired through transfusions of infected blood and blood products.(5)

An estimated 5.6 million people were living with HIV and AIDS in South Africa in 2009, more than in any other country.(6) It is believed that in 2009, an estimated 310,000 South Africans died of AIDS.(6) Prevalence is 17.8 percent among those aged 15-49, with some age groups being particularly affected.(6) Almost one-in-three women aged 25-29, and over a quarter of men aged 30-34, are living with HIV.(7)

About Hepatitis C Virus (HCV)

HCV infection is a viral disease that leads to inflammation of the liver and may cause lifelong infection, cirrhosis (scarring) of the liver, and liver cancer.(8,9) An estimated 170 million people worldwide (3 percent) are chronically infected with HCV.(9) An estimated 3 to 4 million people are newly infected each year.(9) Most people who have been recently infected with HCV do not have symptoms, and in many cases, there may be no symptoms of the disease until cirrhosis has developed.(8)  The prevalence of HCV infection in South Africa is not known but has been estimated to be between 0.1 (2) and 1.7 %.(10)  HCV infection is more serious in persons with HIV, and leads to liver damage more quickly.(11)  Coinfection with HCV may also affect the treatment of HIV infection.(11)

About Hepatitis B Virus (HBV)

HBV infection is a major cause of acute and chronic liver disease. About one-third of the world's population has been infected with HBV.(12) Most of the serious consequences occur among people who develop chronic hepatitis B infection. About a million people with chronic hepatitis B die each year from cirrhosis and hepatocellular carcinoma.(12) HBV is second only to tobacco as the leading cause of cancer in humans.(12) It is estimated that over 50% of South Africans have been infected by the virus and at least 3 million people are chronic hepatitis B carriers.(12)

About SANBS

SANBS is a non-profit organisation, which provides a vein to vein blood transfusion service in 8 of the 9 provinces in SA. SANBS collects 780,000 units of blood annually (100% voluntary), and has two testing centres  (Johannesburg and Durban), seven blood processing centres, and 79 blood banks serving over 1,000 hospitals and clinics. SANBS is accredited with the South African National Accreditation System (SANAS).

References

1. Vermeulen, M., Reddy, R., Sensitivity of NAT Options: The SANBS Experience, South African National Blood Service (SANBS). (2011, June). Symposium conducted at the International Society of Blood Transfusion (ISBT) Congress, Lisbon, Portugal.

2. World Health Organization - About HIV page  http://www.who.int/hiv/abouthiv/en/

3. Kandathil AJ et al. 2005. Molecular epidemiology of HIV. Indian J Med Res. 121:333-344.

4. Buonaguro L et al. 2007. Human Immunodeficiency Virus Type 1 Subtype Distribution in the Worldwide Epidemic: Pathogenic and Therapeutic Implications. J. Virol. 81(19):10209-10219.

5. World Health Organization http://www.searo.who.int/en/Section980/Section1162/Section1167/Section1171_4810.htm

6. UNAIDS (2010) 'UNAIDS report on the global AIDS epidemic'

7. Human Sciences Research Council (2009), 'South African National HIV Prevalence, Incidence, Behaviour and Communication Survey, 2008: A Turning Tide Among Teenagers?'

8. PubMed Health http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001329/

9. World Health Organization - Hepatitis C page http://www.who.int/csr/disease/hepatitis/Hepc.pdf

10. WHO Weekly Epidemiologic Record. 1999;74:412-28

11. Centers for Disease Control and Prevention (CDC) http://www.cdc.gov/hiv/resources/factsheets/coinfection.htm

12. South African Vaccine and Immunisation Centre http://www.savic.ac.za/disease.php?sub3=88

SOURCE South African National Blood Service