Uji Saring Antigen dan Antibodi Hepatitis C Virus pada Darah Donor

According to the data from Central Blood Transfusion Unit, the prevalence of hepatitis C virus (HCV) in blood donors in Indonesia and especially Jakarta in 2012 were 0.39% and 0.36% respectively. Screening of blood donor may reduce the risk of HCV transmission. Aim of this study was to know the sensitivity and specificity of the antigen-antibody serology A local of test compared to Nucleic Acid Test (NAT), should 99.8 % sensitivity and 95% specificity. 135 samples were included, 35 samples NAT HCV positive and 100 samples negative. These samples will be screened by Chemiluminescent Microparticle Immunoassay (CMIA) anti HCV, HCV Ag-Ab by enzyme linked immunosorbent assays (ELISA) and if there were differences results of NAT HCV, HCV CMIA and ELISA HCV Ag-Ab, the samples were examined using immunoblot HCV. Of the 135 samples, the Ag-Ab ELISA against 35 HCV RNA positive samples showed positive results also, but at 100 HCV RNA negative samples, the results showed 3 reactive and 97 non reactive. Moreover, the 35 HCV RNA positive samples were tested by anti-HCV CMIA showing the reactive results on 35 samples and in 100 HCV RNA negative samples, the results showed 11 reactive and 89 non reactive. Sensitivity of CMIA and NAT was 100%, specificity 89%. Sensitivity of Ag-Ab ELISA and NAT was 100% and specificity 97%. We concluded that the analysis of HCV by ELISA meets the standard criteria for screening of donor blood but not for CMIA.Keywords : Hepatitis C, Anti-HCV, HCV Ab-Ag, NATAbstrakBerdasarkan data dari Unit Transfusi Darah Pusat, prevalensi hepatitis C virus (HCV) pada darah donor di Indonesia dan Jakarta pada khususnya tahun 2012 adalah 0,39% dan 0,36%. Uji saring darah donor dapat menurunkan risiko tertular HCV. Penelitian ini bertujuan mengetahui sensitivitas dan spesifisitas pemeriksaan serologi antigen-antibodi yang memenuhi standard metoda NAT, sensitivitas 99,8% dan spesifisitas 95%. Pemeriksaan 135 darah donor, terdiri dari 35 positif dan 100 negatif dengan NAT HCV, yang diuji saring anti-HCV dengan CMIA, Ab-Ag HCV dengan ELISA dan bila ada perbedaan hasil antara NAT HCV, CMIA HCV dan ELISA Ag-Ab HCV, maka dilakukan pemeriksaan menggunakan imunoblot HCV. Dari 135 sampel, hasil ELISA Ag-Ab HCV terhadap 35 sampel positif RNA HCV juga menunjukkan hasil positif pada seluruhnya, tetapi pada 100 sampel negatif RNA HCV terdapat 3 sampel reaktif dan 97 non reaktif. Hasil pemeriksaan CMIA anti-HCV pada 35 sampel positif RNA HCV menunjukkan reaktif pada 35 sampel dan pada 100 sampel negatif RNA HCV terdapat 11 reaktif dan 89 non reaktif. Sensitivitas CMIA dengan NAT HCV 100%, spesifisitasnya 89%. Sensitivitas ELISA dengan NAT HCV 100%, spesifisitasnya 97%. Kesimpulan dari penelitian adalah pemeriksaan Antigen-Antibodi HCV ELISA memenuhi kriteria standar untuk digunakan sebagai uji saring darah donor sedangkan pemeriksaan Antibodi HCV CMIA tidak memenuhi kriteria standar sebagai uji saring darah donor.Kata kunci : Hepatitis C, Anti-HCV, Ab-Ag HCV, NA