Management of Risk and Blood Availability in Donor Populations with

High Prevalence of Blood Borne Pathogens

Ravi ReddyIBSF Meeting20 March 2015

SANBS Blood Supply Model• SANBS is a private not for profit company operating on a fee for

service basis• Provides a vein to vein blood transfusion service in 8 of the 9

provinces in SA.– WPBTS in Western Cape

• 823,000 units of blood collected annually (100% voluntary) – 2 800 units bled daily – 90 Fixed site donor centres as well as mobile drives daily

• 2 testing centres - Johannesburg and Durban (business continuity)• 7 blood processing centres strategically located in major cities• 84 blood banks managed by SANBS staff, serving > 600 hospitals

and clinics.• Significant transport and cold chain logistics infrastructure for

distribution of blood• Accredited by external agency - SANAS

Maintaining a Safe Blood Supply In South Africa• HIV prevalence began increasing significantly among SA

population in mid 1990’s• Prevalence in antenatal clinic attendees rose from 1.7% in 1991

to 22.8% by 1998• The increase in HIV prevalence varied significantly among the

different ethnic groups, likely as a result of socio economic conditions at the time– Prevalence in blood donors rose from 0.06% to 0.26% in this period– The prevalence among Black first time donors ranged from 3.5 to 6 %

(male and female respectively)

• Significant risk of window period HIV transmission • Risk model implemented to place donors in risk categories

based on ethnic group, gender and donation status– Limited collections and blood product issued from high risk categories

Impact of Risk Policy based on Donor Selection

1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 20070.0

5.0

10.0

15.0

20.0

25.0

30.0

35.0

-0.05

0.00

0.05

0.10

0.15

0.20

0.25

0.30

0.35

1.7

22.8

30.2

0.06

0.26

0.07

DoH SANBS

DoH SANBSImplementation of risk policy

based on eth-nicity & donor

status

Significant decrease in HIV in the donor population despite increasing prevalence in the antenatal and general population

Challenges with Risk Policy (1998 -2005)

• 86% of population is Black and majority of Black donors fell into high risk categories and cellular products not used– Black donor base decreased significantly

• Not sustainable – Diminishing donor base, and in medium term,

insufficient donors to meet demand• Significant political pressure and public outcry in

December 2004• Needed to revise the current policy and testing

strategy while maintaining a safe blood supply

New Risk Management Strategy Implemented in 2005

• Ethnic group was removed as a marker for risk• Implemented individual donation nucleic acid testing

(ID-NAT) using the ULTRIO® assay on the TIGRIS® platform for:– HIV-1 RNA, HCV RNA and HBV DNA

• Serology testing with Abbott Prism assay continued but stopped HIV p24 Ag testing

• Quarantine system for FFP maintained – donor retested plasma for therapeutic use

• Pooled platelets and paediatric cellular products made from very regular repeat donors.

HIV infections in 8 years of ID-NAT screeningof 6,237,803 donations in South Africa

11377 (96.8%)

HIV RNA +, anti-HIV– window period

362 (3.05%)

HIV RNA +, anti-HIV +concordant

HIV RNA –, anti-HIV + elite controller112 (0.95%)

HIV-RNA anti-HIV

131/362 (36.2%) HIV-Ag +

216 HIV-Ag-, RNA+ infections avoided (1:28,879)15 not tested

Analysis of Recent infections (anti-HIV negative, ID NAT positive Donations)

NAT YieldsNAT yield Rate in New Donors is 2.85 times higher than in Repeat DonorsYear Repeat 1:x New 1:x Lapsed 1:x Total 1:x

Year 1 10 1:58968 4 1:16078 2 1:37276 16 1:45652

Year 2 21 1:27598 5 1:15027 5 1:14444 31 1:23470

Year 3 19 1:30367 13 1:6534 4 1:19230 36 1:20535

Year 4 22 1:27268 14 1:7253 4 1:21604 40 1:19701

Year 5 24 1:26196 16 1:6175 2 1:44209 42 1:19427

Year 6 45 1:13859 14 1:7207 3 1:29823 62 1:13130

Year 7 38 1:16300 13 1:7806 6 1:15216 57 1:14249

Year 8 51 1:11857 21 1:5138 6 1:16284 78 1:10389

Total 230 1:20968 100 1:7350 32 1:21156 362 1:17232

HBV infections in 8 years of ID-NAT screeningof 6,237,803 donations in South Africa

5767 (82%)

HBV DNA +, HBsAg– 1104 (15.7%)

HBV DNA +, HBsAg +concordant

HBV DNA –, HBsAg + 182 (2.6%) (significant decrease annually after Ultrio Plus implementation

HBV-DNA HBsAg

WP= 450 (40.1%)OBI= 641 (58.1%)Unk=13

Blood Safety in SANBS• Implementation of new technology and donor

education by SANBS ensured:– Improved blood safety (no reported cases of HIV

transmission through blood transfusion since 2005, compared to an average of 2 cases a year prior to that)

• Increased blood supply to meet increasing demand by collecting blood from previously excluded communities– Black donors now comprise 37% of the blood donors in

SANBS

• Major public health success story in South Africa – high confidence in safety of blood.

Challenges in Africa• Inadequate blood donor panel ( low % of

voluntary non remunerated repeat donors)– Insufficient blood collected, higher discard rates

• Poorly defined donation testing strategies – most sensitive assays not utilised

• Lack of External quality assurance and audits• Inefficient processes (collection, transport,

production, storage)• No or very poor IT infrastructure

Challenges in Africa (cont’d)

• Lack of Government commitment (regulatory framework, funding, compliance)

• Significant financial and human resource challenges

• Not meeting Country Needs for Blood products and plasma derived medicinal products (PDMP’s)

• No or very poorly developed haemovigilance programmes

13

Country Group Countries (n) Total Blood Donations (n)

Population (n) Donation Rate (units/1000 people)

Group A (at least 80% VNRBD)

19 1,980,349* 437,286,128 4.5 (2.8 if SA excluded)

Group B (50 to 79% VNRBD)

7 666,783 91,255,989 7.3

Group C (<50% VNRBD

17 839,060 285,264,867 2.9

All Countries 43 3,486,192* 813,806,984 4.3

Source - WHO: Blood Safety in the Africa Region_ 2010 survey

* South Africa contributes over 900,000 donations with 52 million people

Number of Blood Donations and Donation Rates per Groups of Countries in Africa

14

HIV prevalence among Blood Donors

Table 2- MMWR / November 25, 2011 / Vol. 60 / No. 46

Mostly repeat reactive unconfirmed – When HBV, HCV and Syphilis positives added = large percentage of discards

15

TTI Testing Strategy

• 17/43 (39.5%) Countries performed confirmatory testing for TTI’s– Algorithms lacking for repeat testing in many

countries– No confirmatory testing in 26 Countries

• Significant percentage of blood donations with false positive results discarded– Contributes further to the shortages

• Donor deferral and counselling challenges– Loss of donors

What is Required• Commitment, led by Government, for a

sustainable Blood Service in many African Countries

• Resources to develop the various key elements of the Blood Supply Chain– Sustainable financial model (less reliance on donor

funding)– Programmes to strengthen and retain human

capital– Integrated IT systems, quality systems, M&E

Thank You