Panduan & Polisi Mengenai Proses Penyaringan Darah Oleh: En. Abd 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 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

(ESTABLISHED/MULTIPLY) NO VIRUS FOUND IN THE BLOOD 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 Test Confirmation Test HIV 1&2 ( Anti-HIV) EIA PA ImmunoBlot (LIA ) HBV ( HBsAg ) Anti-HBc Anti-HBe Anti-HBs HBe Neutralisation HCV (Anti-HCV ) NONE RIBA-3 (HCV-RNA) Syphilis VDRL RPR VDRL (Dilution) TP-PA

Others Malaria Penderma-penderma dari kumpulan berisiko tinggi (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 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 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 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 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 Anti-HCV 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

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