1. And the order changeth …. Evolving protocols for TTI testing
Dr. Saranya Narayan M.D. (Micro)
Medical Director
Jeevan Blood Bank

2. The Road travelled 1995 – 2012 (March 31st 2012) DONATIONS – 1.1 lakhs
ISSUES lakhs
NO reported Post transfusion infection.

3. Jeevan protocols Voluntary, non –remunerative, non-replacement donors.
Walk-in donors – % to < 1%
Kits - CE /FDA and DCI approved kits
All new kits evaluated and validated before routine use.
Interpretation - All reactive and half the kit cut off samples excluded

4. S/C.O RATIO = 0.5 OR >

5. Kits used 1995 2012 YEAR HBsAg HCV HIV SPECIFICITY 98%
SENSITIVITY 100%
2nd & 3rd gen
HCV Ab
SPECIFICITY 99.5 %
SENSITIVITY 100 %
HIV P24 Ag KIT + HIV 1&2 Ab*
SPECIFICITY 99 %,
* 82-98%
2012
SPECIFICITY ~100%
4th generation
HCV Ag + Ab
SPECIFICITY %
HIV Ag + Ab
SPECIFICITY 98.3 – 99.7%

6. TTI Trend

7. Algorithm for Hepatitis B screening
HBsAg
Anti-HBc Total
Positive
Negative
Ant-HBc
Positive
Anti-HBc
Negative
and
HBsAg
Reject the
unit
Core Ab
Perform
Anti-HBs
Titre
Anti-HBc
Total
Positive
Anti-HBc
Total
Negative
Release
the unit
Release
the unit
Perform
Anti-HBs
Titre
Anti-HBs Titre
> 200 mIU/mL
Release the sample
< 200mIU/ml
Reject the sample

8. HBsAg Trend

9. Algorithm for Hepatitis C screening
Hepatitis C (Ag and Ab)
If HCV
is Negative
If HCV
is Positive
Release
the unit
Reject the
unit

10. HCV Trend

11. Algorithm for HIV screening ( Ag + Ab)
Negative
HIV
Positive
Repeat with
Sample from segment
Release
the unit
If Positive
If Negative
WB Not Required
Reject the
Unit
Confirm with
Western Blot
Reject the
unit

12. HIV Trend

13. Algorithm for Syphilis screening (RPR)
If Negative
If Positive
Repeat the test
with Dilutions
1:2,1:4 and 1:8
respectively
Release
the unit
Titre
1:8 or >
confirm with
STS
If the titre is
1:2 and 1:4
reject the unit
Reject the
unit

14. Leptospirosis (1997 March – Aug 2002)
~ donations
DFM
CULTURE
AP-PCR*
IgM Ab
POSITIVE
(3.9%)
155 /155
( 100 % )
88/155
( 57 % )
22/26
( 85 % )
19/155
( 12 % )
EQUIVOCAL -
20/155
( 13 % )
NEGATIVE
67/155
( 43 % )
4/26
( 15 % )
119/159
( 75 % )
* AP PCR - Strains : L. Louisiana - 15, L. Canicola - 6,L.Pomona - 1

15. HUMAN LEPTOSPIROSIS : GUIDANCE FOR DIAGNOSIS, SURVEILLANCE AND CONTROL
2003
                   
I L S
International Leptospirosis Society

16. Transmission and Exposure
Can leptospires be transmitted by blood transfusion ?
It is not known precisely when leptospires appear in the blood after infection. It is possible that, during the incubation period, before the infected person becomes ill, leptospires may circulate in the blood and be transmitted via blood transfusion.
Perhaps, in the future, it will be possible for rapid methods such as PCR to be used to check for leptospires in transfusion blood.

17. Enhancing Blood Safety
AGENT
Window Period
NAT
Jeevan protocols
ELISA
Residual risk
HBV
23.9 days
26 days
(HBsAg ULTRA)
1:7.64 lakhs
HCV
3.1 days
7.5 days
(Ag + Ab)
< 1 in a million
HIV
5.6 days
7 days

18. First case of HIV from blood transfusion traced to Missouri donor AABB Smart Brief Friday, October 22, :00 am
"Even the most sensitive screening technologies currently available cannot identify the presence of HIV infection during the first few days after infection," the report concludes. "Eligibility screening questions, if answered accurately, would have excluded the donor because of his sexual history. It is the responsibility of persons who donate blood to answer screening questionnaires accurately to ensure the safest blood supply possible."

19. Things we have done Questionnaire modifications History of jaundice.
Question regular donors who have missed donation.
Number of hours of sleep the previous night.
Food eaten prior to donation.

20. Take Home Message - 1
Cost effective & equally sensitive protocols for TTI screening must be adopted in resource restricted settings.

21. Voluntary Blood donors
Take Home Message - 2
Voluntary Blood donors
Pre-donation screening – stringent. Investment on creating awareness on VBD should take priority.