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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 Slide 2 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 Slide 3 OTHERS Informed consent to be obtained; pre and post test counseling to be given to individuals undergoing HIV testing Voluntary confidential screening of individuals Slide 4 Blood Safety Approaches Donor Selection Serological Screening NAT Testing Viral Inactivation Vaccination Slide 5 Remaining Risks Window Period (Pre-Seroconversion ) Viral Variants Atypical Seroconversion/ Immunosilent Laboratory Error Slide 6 Slide 7 PATHOGENESIS PHASE INFECTION ECLIPSE (ESTABLISHED/MULTIPLY) NO VIRUS FOUND IN THE BLOOD INFECTIOUS PHASE (WINDOW PERIOD ) (AFTER ECLIPSE & BEFORE SEROCONVERSION) SEROCONVERTION (ANTIBODY PRODUCTION) Slide 8 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 Slide 9 >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 Slide 10 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 Slide 11 Documentation Of All The Above Actions ! Slide 12 Screening DiseaseScreeningSupplemental Test Confirmation Test HIV 1&2 ( Anti-HIV) EIA PA ImmunoBlot (LIA ) HBV ( HBsAg ) EIA PA Anti-HBc Anti-HBe Anti-HBs HBe Neutralisation HCV (Anti-HCV ) EIA PA NONERIBA-3 (HCV-RNA) SyphilisVDRL RPR NONE VDRL (Dilution) TP-PA Slide 13 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 Slide 14 Pekerja dilogging camps dikawasan bermalaria Pelawat ke negeri-negeri berjiran yang bermasalah malaria Slide 15 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. Slide 16 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 Slide 17 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 ) Slide 18 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 ) Slide 19 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 ) Slide 20 Sample Referred for HCV 2002 Appendix for PD Presentation.doc Slide 21 Sample Referred for HIV 2002 Appendix for PD Presentation.doc Slide 22 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 Slide 23 Study/Research Appendix for PD Presentation.doc Slide 24 THANK YOU