Transcript Panduan and Polisi Mengenai Proses Penyaringan Darah

Panduan & Polisi Mengenai
Proses Penyaringan Darah
Oleh:
En. Abd. Hamid Bon
B.Sc(Hons), M.Sc.,D.M.M.,D.A.P&E
Pegawai Sains Kanan
Pusat Darah Negara
Policy On Screening Activities
( Ref: (21)dlm.KKM-171(9971)Bhg.2 bth. 2 March 1998 )
Safety of blood transfusion services through;
• Mandatory screening of blood donors
through donated blood
• Blood products to be used judiciously
• Imported blood to be certified free of HIV
OTHERS
•Informed consent to be
obtained; pre and post test
counseling to be given to
individuals undergoing HIV
testing
•Voluntary confidential
screening of individuals
Blood Safety Approaches
• Donor Selection
• Serological Screening
• NAT Testing
• Viral Inactivation
• Vaccination
Remaining Risks
• Window Period
(Pre-Seroconversion )
• Viral Variants
• Atypical Seroconversion/
Immunosilent
• Laboratory Error
PATHOGENESIS PHASE
INFECTION
ECLIPSE
(ESTABLISHED/MULTIPLY)
NO VIRUS FOUND IN THE BLOOD
INFECTIOUS PHASE (WINDOW PERIOD )
(AFTER ECLIPSE & BEFORE SEROCONVERSION)
SEROCONVERTION
(ANTIBODY PRODUCTION)
Screening for Infectious Markers
( (Transfusion Practice Guidelines: update version )
Specific approach to ensure quality
of the screening procedure rely on;
• Training of staff
• Assessment of staff capability
• Maintenance and calibration of
equipments
• Monitoring of storage conditions
• of test materials and reagents
>Include external control and to monitor
through statistical process control
>Use validate/approved test kit by
authorized body/organisation
>Repeat testing of Initial Reactive in
duplicate together with blood bag sample by
the same assay
>Take part in external proficiency exercises
• Removal of all reactive
blood/products from the
quarantine refrigerator
• Disposal off all reactive
blood/products
• All the results must be verified
by authorized personnel
Documentation
Of All
The Above
Actions !
Screening
Disease
Screening Supplemental Confirmation
Test
Test
HIV 1&2
•EIA
•PA
ImmunoBlot
( Anti-HIV)
•PA
(LIA )
Anti-HBc
HBV
•EIA
Neutralisation
Anti-HBe
( HBsAg )
•PA
Anti-HBs
HBe
HCV
(Anti-HCV )
Syphilis
•EIA
•PA
•VDRL
•RPR
NONE
NONE
VDRL (Dilution)
RIBA-3
(HCV-RNA)
TP-PA
Others
• Malaria
(Ref: Bil(41)dlm.RKPBV/S/80/98 bth. 2 Feb. 1989 )
Penderma-penderma dari kumpulan
berisiko tinggi
• Anggota tentera
• Anggota polis hutan
• Penduduk dirancangan Pembukaan
Tanah (Felda, Felcra dll) dikawasan
bermalaria
• Pekerja di”logging camps”
dikawasan bermalaria
• Pelawat ke negeri-negeri
berjiran yang bermasalah
malaria
Simple Rapid Test
( Ref: bil(55)dlm. KKM-87(467)Bhg. 18 bth. 27 Feb. 1995 )
• Simple Rapid Test is NOT Recommended
for Donor Screening ( HIV )
• Simple Rapid Test for HIV Testing
MUST always be Backed up by the EIA
Test.
Blood Screening/Release Flow-Chart
Ref: bil(2)dlm. K31350 Bhg. 12 bth.3 Okt.1991
Ref: Transfusion Practice Guidelines for Clinician & Lab. Personel
• Algorithm for HIV_HBV_HCV.xls
Management of Reactive Sample
(Ref: bil (2)dlm. K31358 Bhg.12 bth.3Okt.1991
and Transfusion Practice Guidelines-Update Version )
• Initial Reactive Donation Sample must be
Retested in Duplicate by the same assay
• If Any of the Repeat Test are Reactive, then the
donations are considered as Repeatedly
Reactive
• To check and tally results of PT/SG
• The status of Repeatedly Reactive Donation
Sample should be confirmed ( Sent to PDN for
HIV and HCV )
Sample Referred for Confirmation
( Ref: bil.(41) dlm. KKM.87( P20505 ) Bhg.4 bth. Feb.2001)
• Donation samples of Repeatedly Reactive
for HIV and HCV
( Sample from Blood Bag )
• Fill-up the form
– HIV ( Borang 1 : TML-PDN-1 )
– HCV ( Borang 2 : TML-PDN-2 )
Sample Referred for HCV-RNA PCR
• Sample Repeatedly Reactive with AntiHCV EIA
• RIBA-3 Indeterminate Twice
• Time period between first and second
RIBA-3 Indeterminate results must be in
6 months
• Fill-up form Borang 3 ( TML-PDN-2A )
Sample Referred for HCV 2002
• Appendix for PD Presentation.doc
Sample Referred for HIV 2002
• Appendix for PD Presentation.doc
Algorithm
• WHO Algorithm for HIV
( Ref: bil(55) dlm. KKM-87(467) Bhg.18
bth.27 feb. 1995 )
• Lampiran 5 ( Strategy III )
• Algorithm for HIV_HBV_HCV.xls
Study/Research
• Appendix for PD Presentation.doc
THANK YOU