? Characteristics of TTI
? Mandatory TTI
? Methods/Technologies for TTI Testing
? TTI Notification
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? Why & How To NotifyTRANSFUSION CHAIN
Human
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beingBlood donors
(Donor)
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Each link consists of
several
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Collectionsmaller links
(primary processes)
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Processing
Screening
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and testing
The quality of the BTS is
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Blood coldinfluenced by the quality
chain
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of each of the links
Transfusion
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Humanbeing
(Patient)
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TTI = TRANSFUSION TRANSMISSIBLE INFECTIONSA pathogen :
? Able to transmit through blood or blood components
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? Able to survive outside human body? Able to survive through range of temperatures
? Able to replicate and re-establish following transfusion
? Exists naturally either free in plasma or in cellular component
INFECTIOUS AGENTS
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1. Virus ? most commonly transmitted
2. Bacteria
3. Protozoa
4. Fungi ? not accepted as blood donor(too sick)
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5. Parasite6. Prion
VIRUS
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1. Hepatitis: Hep B, Hep C, Hep D2. Human immunodeficiency virus (HIV)
3. Human T-cell Lymphotrophic virus (HTLV-1,2)
4. Epstein barr virus (EBV)
5. Cytomegalo virus (CMV)
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6. West nile virus (WNV)7. Human herpes virus (HHV)
BACTERIA
1. Treponema pallidum
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2. Yersinia enterocolitica3. Pseudomonas
4. Propionibacterium acnes
5. Staphylococcus epidermidis
6. Bacillus cereus
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PARASITES
1. Plasmodium species
2. Babesia microti
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3. Trypanosoma Cruzi4. Leishmania species
5. Toxoplasma gondi
PRIONS
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Creutzfeld Jacob disease / Variant Creutzfeld Jacob disease
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CHARACTERISTICS OF TTI
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? Asymptomatic or only mild symptoms in donors ?hence passdonor screening criteria
? Long incubation period before clinical signs and symptoms
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appear
? Stability in blood at 4OC or lower
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? Might cause a carrier state of infection (HBV, HCV)HOW AND WHAT TO TEST ?
? Identify structural protein
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? Identify antibody produced
? Identify antigen
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? Identify nuclear materialHOW TO TEST?
? Rapid tests
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? ELISA
? Chemiluminescence assay(CLIA)
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? Nucleic Acid Amplification Testing (NAT)SELECTION OF SCREENING ASSAYS
? What is the test?
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? Who is going to use it?? Is the staff experienced or newly recruited?
? What are the constraints?
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? Are resources available?
? Are results needed in a very restricted period of
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time?? How is it to be used? Large or small number of
specimens?
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? What are the existing systems?
MANDATORY TTI TESTING
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Under Drugs and Cosmetic Act 1940Rules 1945 amendments thereafter, (SCH. F, Part XI B)
Ministry of Health And Family Welfare
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Government of India
Screening of each blood & blood components is Mandatory
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? HBsAg? Anti HIV 1 & 2
? Anti HCV
? VDRL
? Malarial parasite
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MANDATORY TTI TESTINGHIV 1 & 2, Hepatitis C,, Hepatitis B Syphilis & Malaria
1. Screening for antibodies to HIV-1 & 2
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( Rapid/3rd or 4th generation ELISA /Chemiluminescence and / NAT )2. Screening for antibodies to HCV
( Rapid/3rd or 4th generation ELISA /Chemiluminescence and / NAT )
3 Hepatitis B Surface Antigen
( Rapid/ 3rd or 4th generation ELISA /Chemiluminescence and / NAT )
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4. Syphilis ( TPHA/VDRL/RPR )
5. Malarial parasite (PBF / Rapid card test )
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MANDATORY BLOOD SCREENING FOR INFECTIOUS MARKERSInfectious
Year of
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Mandatory Testing
Newer Technologies
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MarkersEnforcement Technology
Syphilis
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1975
RPR/VDRL/TPHA
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ELISAHepatitis B
1975
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ELISA/Rapid
Chemiluminescence/NAT
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virusMalaria
1975
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Smear/Rapid
ELISA
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HIV1988
ELISA/Rapid
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Chemiluminescence/NAT
Hepatitis C
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2001ELISA/Rapid
Chemiluminescence/NAT
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Virus
RECENT CONCERNS
? Latency and carrier state leading to persistent infections: HIV,
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HBV, HCV were major concerns but Hep A and Hep E
? Emerging infections like Dengue Virus ,West Nile Virus, Zika Virus,
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and others are posing risk for infectionVARIOUS TESTING TECHNOLOGIES
Technology
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Window Period
HIV
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HCVHBV
ELISA-I I Generation
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20.6 days
58.3 days
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36.3 daysELISA-IV
13.7 days
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9.4 days
24 days
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GenerationID NAT
5.6 days
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4.9 days
20.6 days
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IDEAL ELISA PLATE(96 wells) LAYOUT
RAPID TESTS
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Employ a variety of techniques
? Dot blot assays
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? Particle agglutination? Spot tests
? Immuno- chromatographic tests or Card Tests
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? Most have sensitivities and specificities of 99% and 98%
respectively
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Applications of Rapid tests? Useful in small blood banks
? Useful in emergency
RAPID IMMUNOCHROMATOGRAPHIC ASSAY
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POSITIVE
NEGATIVE
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INVALIDMALARIA CARD TEST
NEGATIVE
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POSITIVEINVALID
CHEMILUMINESCENCE IMMUNOASSAY
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? Principle: It is the production of light [Luminescence] from an
oxidation-reduction chemical reaction.
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? Two chemicals react to form an excited (high-energy) intermediate,which breaks down releasing its energy as photons of light and
interpreted as Optical density value.
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NAT
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NAT TESTING
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DONOR NOTIFICATIONWhy should the donors be informed of test results?
? Results are significant to their health
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NBTC/NACO
? Ensures no further donations
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Recommendation? Unethical to hold information
? Informing about Pathology - acute and chronic
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? Secondary transmission - sexual, mother to child, close physical contact? Mode of infection-why not excluded by donor selection
? Treatment and management
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? General surveillance and epidemiology
? acute infection (WP)
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? To improve testing methodologyHOW TO NOTIFY ?
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? Follow NACO/NBTC policy on how to notify donors about positive TTI
? Tell the results on a face-to-face basis
? Counsellor - well-trained in counselling skills
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? Given in person, never on telephone? Maintain confidentiality
? Opportunity to ask questions / discussion
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? Further appointment offered
REFERRAL
? Refer the donor to other sources of advice and support
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HIV - ICTC (Integrated Counselling and Testing Center)HBV/HCV - Medicine / Gastro/ Hepatologist
Syphilis - Dermatology / STD Clinic
Malaria - Physician /Medicine
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IMPACT ON BLOOD DONORS
? What will the test result mean?
? Will I become ill?
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? What about my partner / offspring?? Am I infectious?
? How did I become infected?
? Is infection treatable?
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