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

By South African National Blood Service, PRNE
Sunday, July 24, 2011

JOHANNESBURG, July 25, 2011 -


Since 2005, SANBS
Has Eliminated Thousands of Transfusion-Transmittable Infections
from the Blood Supply

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   href="www.who.int/hiv/abouthiv/en/">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 href="www.searo.who.int/en/Section980/Section1162/Section1167/Section1171_4810.htm">
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 href="www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001329/">www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001329/

9. World Health Organization - Hepatitis C page href="www.who.int/csr/disease/hepatitis/Hepc.pdf">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) href="www.cdc.gov/hiv/resources/factsheets/coinfection.htm">www.cdc.gov/hiv/resources/factsheets/coinfection.htm

12. South African Vaccine and Immunisation Centre href="www.savic.ac.za/disease.php?sub3=88">www.savic.ac.za/disease.php?sub3=88

 

Mr. Ravi Reddy, Chief Operating Officer, Tel No: +011-761-9292

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