The document discusses procedures for screening donated blood for infectious diseases at a regional laboratory and blood bank. It provides details on: 1. The viruses, bacteria, parasites, and prions that are screened for, including HIV, HCV, HBV, HTLV, syphilis, malaria, and vCJD. 2. The screening markers and recommended tests used to detect these infectious agents, such as ELISA, chemiluminescence, and nucleic acid amplification technologies. 3. Protocols for quarantining and properly disposing of reactive blood units based on screening results, as well as archiving donor samples and blood components for further testing and research.

1. D R . R A F I Q A H M A D
R E G I O N A L L A B O R A T O R Y & B L O O D B A N K
D A M M A M , K . S . A .
Blood Screening, Quarantine
and Release

2. Blood Screening
 Viruses:
Human immunodeficiency virus, type 1 and type 2 (HIV 1/2)
Hepatitis C virus (HCV)
Hepatitis B virus (HBV)
Human T-cell lymphotropic virus, type I and type II (HTLV-I/II)
 Bacteria:
Syphilis
 Parasites:
Plasmodium species (Malaria)
Trypasonoma cruzi
 Prions:
New variation of the Creutzfeldt-Jakob disease (vCJD).

3. Screening Markers of Blood
 CBAHI standards 2015 -07460
 HBV: HBsAg , anti-HBc total (HBV-DNA recommended)
 HCV: anti-HCV and (HCV-RNA recommended)
 HIV 1/2: anti-HIV 1/2 (HIV-RNA recommended)
 HTLV 1/2: anti-HTLV 1/2
 Syphilis: RPR or TPHA
 Malaria: Anti-malarial antibody & Blood smear

4. Serological techniques of infectious agent
detection
Serological techniques have been developed in the course
of time:
 1969 - Immunodiffusion (two-dimensional precipitation)
 1970 - Complement fixation.
 1971 - Immunoelectrophoresis.
 1972 - Radioimmunoanalysis (RIA)
 1974 - Passive hemagglutination.
 1975 - Inert particle agglutination.
 1976 - Enzymoimmunoanalysis (EIA)
 1990 - Chemiluminiscence (ChLIA)

5. Fundamental parameters in the
Serological/Screening techniques
 Sensitivity: of all the positive analyzed samples, this is the
proportion of positive results returned by the test
 Specificity: of all the negative analyzed samples, this is the
proportion of negative results returned by the test
 PPV: it is the probability that one individual is actually
positive for the marker (or disease) when the test has had a
positive result
 NPV: it is the probability that one individual is actually
negative for the marker (or disease) when the test has had a
negative result

6. Fundamental parameters in the
Serological/Screening techniques
The practical calculations of the parameters which
were described before are:
 Se = True +ve/True +ve + False -ve
 Sp= True -ve/True -ve + False +ve
 PPV= True +ve/True +ve + False +ve
 PNV= True -ve/True -ve + False -ve

7. Complementary Testing
 If everything is negative: OK.
 If there is any reactive result: confirm the
result with other serological methods.
 Complement the information with the
molecular marker, if it is available and
appropriate.
- Immunoblot or western blot techniques

8. Classic agents of transmission
HIVHCVHBVMeans of
transmission
XXXXXXXXXParental
XXXXXXXSexual
XXXXXXXVertical
Transmission routes of HBV, HCV and HIV

9. Screening algorithms for infectious diseases in
the blood bank
HBsAg, Anti-HB c total antibodies, Anti-HBs
antibodies
HIV I/II Antigen/antibodies
Anti-HCV antibodies
Anti-HTLA I/II antibodies
Anti-Treponema Pallidum antibodies
NAT Tests (HBV-DNA, HIV-RNA, HCV-RNA)

10. Serological testing of blood
 ELISA:
Developed in 1970 by Eva Engvall in Sweden Upgradation –
1st, 2nd, 3rd and 4th generation Quantitative measurement of
antigen/antibody

11. Serological testing of blood
 ChLIA:
 A highly sensitive and selective method
 The antigen or antibody is labeled with a molecule capable of
emitting light during a chemical reaction; this light is used to
measure the formation of the antigen-antibody complex
 Luminescence produced during electrochemical reactions in
solutions

12. Molecular testing of blood
NAT (Nucleic acid Amplification Technology)
techniques applied to the pathogen screening are
usually based on two principles:
Principle of PCR (Polymerase Chain Reaction)
Principle of TMA (Transcription Mediated
Amplification)

13. Molecular testing of blood

14. Algorithm for Blood Unit Screening
Architect
(Negative)
NAT (Negative)
Architect
(Positive)
NAT (Negative)
Architect
(Negative)
NAT (Positive)
Architect
(Positive)
NAT (Positive)
Approval of Blood
& its Component
validity
(Donor Accepted)
Isolation of Blood Component Units (Not
to be issued), including all samples
accompanying the Positive one’s
Double repeat the test for both donor sample
along with the blood unit sample to make sure
that no error in the sample is identitfied
-If the initial results and repeated results
mismatch
-Keep isolation of the bags and its components
-Examine new samples from all the bags to
determine the Positive bag & discard by
correct method
- If the initial result matches the repeated
results
- Discard the blood bag and all its components
- Release the other Negative sample results

15. Quarantine of blood and blood components
prior release and discard
The Blood Bank should ensure that separate blood
storage equipment is clearly designated for:
 Unscreened units
 Reactive/positive units
 Unresolved/indeterminate units
 Units suitable for clinical use: i.e. available blood
stock.

16. Use of quarantined blood and and its
components
Reactive or positive units of blood or plasma are
valuable resources for
Quality control samples
Panels, evaluations and validations
Research purposes
Proficiency panels
Blood screening laboratories can provide blood or
plasma to be used as reagents to institutions
involved in research or to quality assessment
schemes for the production of proficiency panels

17. Long-term Storage of donation serum/plasma
 Investigation of adverse transfusion events and transfusion
transmitted infections
 Evaluation of new screening assays or reagents
A number of crucial issues should be considered before
building a sample archive. These include:
 System for the identification and history of each sample in
the archive related to its use and length of time of storage
 Type of storage containers required
 Specified temperature at which samples are to be stored
 Volume of samples to be archived
 Criteria and documentation of the reasons for the recovery
of an archive sample.

18. Release of blood and blood components
The Blood banks should have appropriate Inventory
management systems that includes:
 Proper stock information
 Proper documentation and labeling of blood and blood
components as ready for clinical use
 The label on each blood unit should contain the relevant
details of the donation and the tests carried out on the
donation. When this has been carried out, the screening
process is considered to be complete
 Blood transfusion infection disease testing safety
certificates

19. The End!!!
Thank you