1. Implementing NAT& Universal Parasitic Screening for Blood Donors
Prof.Dr.Ayesha Junaid
MBBS,MCPS,FCPS,MCCQE
Program Director Haematology
Incharge Blood transfusion Services
Shifa International Hospital Islamabad-Pakistan

2. Implementing NAT& Universal Parasitic Screening for Blood Donors
My Talk Today:
Transfusion Therapy
Donor Selection Criteria
& Infectious Screening
Transfusion in Pakistan
Our experience
Future vision

3. Implementing NAT& Universal Parasitic Screening for Blood Donors.
Transfusion Therapy:
Life Saving Intervention
>100 million donations collected globally/year
180 countries ( 7 billion/ 98.3%) of the global population: million blood donations were made
Global Status Report on Blood Safety and Availability,2016 WHO, Global Database
on Blood Safety (GDBS).

4. SAFE TRANSFUSION IS
CRUCIAL
IN PATIENT CARE

5. Blood Transfusion Centre
Safe Transfusion
Haemovigilance
Blood Transfusion Centre
Blood donor selection
Serological screening
Nucleic acid testing
Quality assurance
Safety checks
Pathogen inactivation
Clinicians
Rational blood component therapy
Clinical Audit
Development of Local guidelines
Hospital transfusion Committee

6. Implementing NAT& Universal Parasitic Screening for Blood Donors
Timely Access to Safe Blood
Uncertain
The safety and availability of
blood components requires
Voluntary Non-remunerated donors
Quality-assured Screening Protocols
Safe and rational clinical use of blood.

7. Implementing NAT& Universal Parasitic Screening for Blood Donors
Infectious Disease Screening:
13 million prospective donors deferred due to anaemia/medical conditions/ risk of TTI
1.6 million units are discarded due to the presence of infectious markers for TTI, including HIV, HBV,HCV and syphilis
WHO Global Database, WHO updates June, 2016

8. Implementing NAT& Universal Parasitic Screening for Blood Donors
Prior to 1985, only two infectious disease screening assays were performed on donated blood
MP NAT was added to routine serological screening in 1999.
Specific testing protocols
vary by country and sometimes by region

9. Implementing NAT& Universal Parasitic Screening for Blood Donors
Laboratory testing: of late 2016
ABO and Rh blood type
(HIV)-1, HIV-2,
HTLV-I, HTLV-II,
HCV,HBV,WNV,
Treponema pallidum,
Trypanosoma cruzi (on first donation)
Zika virus.
Literature review current through: Apr 2017,topic last updated: Apr 18, 2017. .

10. Implementing NAT& Universal Parasitic Screening for Blood Donors
All infectious disease screening assays must be negative
Some donated units are tested for
Babesia microti
CMV antibodies
All apheresis Platelet units:
bacterial contamination by an automated culturing technique initiated 24 hours after collection
Literature review current through: Apr 2017,topic last updated: Apr 18, 2017. .

11. Implementing NAT& Universal Parasitic Screening for Blood Donors
Window Period:
During which a donor can be infected, but have negative serological screening tests
Window phase for current antibody tests
22 days : HIV days
59 days : HBV days
70 days : HCV days

12. Nucleic Acid Testing (NAT) Reduction in Serological Window Period
NAT positive
Immune reaction
Serological positive
Virus
Infection
Time
Earlier detection

13. Implementing NAT& Universal Parasitic Screening for Blood Donors
NAT was adopted voluntarily by plasma fractionation companies in Europe in mid-1990s.
In the late 1990s in US. and many countries across Europe.
Initially, NAT became mandatory in the developed countries only for HCV & HIV-1 screening, but later started NAT for HBV especially in countries with a high prevalence.
Barbara JA. NAT: perspectives for cellular components. Biologicals 1999; 27:333-6
Roth WK, Weber M, Seifried E. Feasibility and efficacy of routine PCR screening of blood donations for HCV,HBV, & HIV-1 in a blood-bank setting. Lancet 1999; 353:

14. Implementing NAT& Universal Parasitic Screening for Blood Donors
Pakistan's annual requirement:
1.5 million units
Blood transfusion services: Mostly hospital-based.
1820 blood banks in the country.
> 90% of total blood transfused is replacement donation.
Report.
WHO EMRO Blood safety program.Annual report 2016

15. Implementing NAT& Universal Parasitic Screening for Blood Donors
The screening of blood in our country is not strictly regulated.
Safety of blood products: A great challenge
Limited resources & a high prevalence of HBV & HCV.
WHO recommends: syphilis and malaria in the basic blood screening criteria
NAT is performed in 06 centers only
Kazi BM. Standards and guidelines for blood transfusion services. Islamabad: Pakistan NIH, Federal Health Ministry, GoP Pakistan; 1999.

16. Implementing NAT & Universal Parasitic Screening for Blood Donors
Shifa International Hospital
550 bedded
Tertiary care Hospital
Cardiac Center
Oncology Center
Dialysis Center
Orthopaedic Center
Kidney, Liver & Bone
marrow transplant
Gynae & Obs. Clinic

19. Implementing NAT& Universal Parasitic Screening for Blood Donors
BLOOD TRANSFUSION SERVICES
SHIFA INTERNATIONAL HOSPITAL: 15,000/year
NAT SCREENING & Malaria
28th July, till 30th April 2017
24,439
Syphilis
4th January, th April 2017
18,616

20. Implementing NAT& Universal Parasitic Screening for Blood Donors
Universal malaria Screening
BTS-SIH has started on
ICT MP screening test on
all blood donations 2015
Initially started for liver transplant in 2012

21. Implementing NAT& Universal Parasitic Screening for Blood Donors
Syphilis as TTI by WHO:
173 countries: policy of performing syphilis testing for all donations
12 million new cases of syphilis each year, with >90% occurring in developing countries
In the past 30 years, through its association with an increased risk of HIV infection, syphilis has acquired a new potential for morbidity and mortality
World Health Organization. Global prevalence and incidence of selected curable sexually transmitted infections: overview and estimates [Accessed on 14/05/2014]. Available at:

22. NAT PROTOCOL Blood donors Nucleic Acid Amplification Testing
DNA & RNA testing of HBV, HCV and HIV
Window period infections
Donor questionnaire & selection
Screening by CLIA for HBV, HCV, HIV
Negative for HBsAg, anti-HCV, anti-HIV,
Nucleic Acid Amplification Testing
Release of NAT negative blood

23. Implementing NAT& Universal Parasitic Screening for Blood Donors
Serological Screening
ROCHE cobas e 601
Qualitative testing
CLIA based
Window period
Nonspecific binding

24. Implementing NAT& Universal Parasitic Screening for Blood Donors
Initial sample is below the cutoff :
Negative
If the sample exceeds that of
the cutoff: Initially Reactive.
All IR are retested in duplicate
If one or both of the duplicate
tests are also reactive:
repeat reactive..Positive.
A Positive Screening Test :
DISCARD

25. Implementing NAT& Universal Parasitic Screening for Blood Donors
Cobas Taq Screen MPX Test, v2.0
Real-time, PCR technology
Four channel multi dye detection
Real time virus detection in blood
plasma
(mini pool of 6 samples)
simultaneously detected and
discriminated for
HIV, HCV and HBV

26. Implementing NAT& Universal Parasitic Screening for Blood Donors
MP-NAT :
Cost-effective, comprehensive viral genotype
Limitations:
The whole pooled donations is blocked until the
NAT report is available. 
Viral nucleic acid concentration gets diluted in the large pool of samples, the sensitivity of NAT might decrease
if a pool is tested reactive, the whole pool requires resolution to identify the single positive unit . an additional step.

27. Implementing NAT& Universal Parasitic Screening for Blood Donors:
NAT SCREENING PROTOCOL In the case of reactivity by NAT, further NAT testing of an alternate sample source the plasma component bag or follow-up sampling of the donor is needed to confirm the test results.

28. Implementing NAT& Universal Parasitic Screening for Blood Donors:
Total blood donor: 24,439
Total donors for syphilis: 18,479
Serologic Screening : 817 ( 3.3%)
ROCHE: cobas e 601
CAP accredited for
HCV,HBV, HIV, Syphilis
Malaria: SD Bioline

29. Implementing NAT& Universal Parasitic Screening for Blood Donors
Serologic Positive blood donors : 817
Malaria out of total donation: 24,439
HBV: (1.1%)
Anti-HCV: (1.3%)
HIV: (0.16%)
Syphilis: (0.97%)
Malaria: ( 0.01%)

30. Implementing NAT& Universal Parasitic Screening for Blood Donors
Total NAT tested : 23,622
Minipool : 06
HBV: ( 0.04%)
HCV: ( 0.008%)
HIV: NIL

31. Implementing NAT& Universal Parasitic Screening for Blood Donors
Serologic screening : 2334
HBV: (1.27%)
Anti-HCV: (1.84%)
HIV: (0.02%)
Syphilis: (0.98%).
Impact of nucleic acid amplification test on screening of blood donors in Northern Pakistan.S.K. Niazi, F.A. Bhatti, TRANSFUSION 2015 Jul;55(7): doi: /trf Epub 2015 Feb ;00;00–00

32. Implementing NAT& Universal Parasitic Screening for Blood Donors:
54,438 Seronegative donors
27 NAT-reactive donors (1in 2016 donors)
HBV: 23 DNA
HCV: 04 RNA
HIV: NIL
Impact of nucleic acid amplification test on screening of blood
donors in Northern Pakistan.S.K. Niazi, F.A. Bhatti, TRANSFUSION 2015 Jul;55(7): doi /trf Epub 2015 Feb ;00;00–00

33. Implementing NAT& Universal Parasitic Screening for Blood Donors
Pakistani blood donors
Blood donors:16,602
Males:16,557 females 45
Mean age: 28.6 ± 2
Positive Screening: 973 (5.8%)
58 (0.35%) donations reacting in more than one assay.
Prevalence of transfusion transmissible infections in blood donors of PakistanA Arshad,
M.Borhany, BMC Hematology BMC series – open, inclusive and trusted201616:27
DOI: /s ©The Author(s). 2016 Published: 18 November 2016

34. Implementing NAT& Universal Parasitic Screening for Blood Donors
Pakistani Blood Donors
HBV: 1.84%
HCV: 1.7%
HIV: %
Syphilis: 2.1%
Malaria: %
Prevalence of transfusion transmissible infections in blood donors of Pakistan
A Arshad, M.Borhany, BMC Hematology BMC series – open, inclusive and trusted201616:27
DOI: /s ©The Author(s). 2016 Published: 18 November 2016

35. Implementing NAT& Universal Parasitic Screening for Blood Donors
Impact of Current Screening A single unit of whole blood collected from a donor in the WP of infection may be transfused into up to 04 recipients NAT testing Saved 48 infected component transfusion 180 syphilis positive: 720 components 4 Malaria Positive: 16 components

36. Implementing NAT& Universal Parasitic Screening for Blood Donors
Future Tasks:
JCIA Inspection
CAP accreditation
ISBT 128
X-ray Irradiator
Transfusion Nurses
Shift: Replacement to voluntary donation

37. Implementing NAT& Universal Parasitic Screening for Blood Donors
ISBT 128:
Gobal standard for
Identification
labeling
Information transfer of medical
products of human origin
(blood, cells, tissues, milk, and organ products) across international borders and disparate health care systems

39. THANK YOU