| Popis: |
Background: The use of sensitive antibodies has greatly reduced the risk of virus transmission following blood transfusion. There are various versions of NAT assays; they can be performed on individual samples or a pool of samples. Also, they can target individual viral nucleic acid or more than one type of viral nucleic acids simultaneously in the form of triplex or multiplex. Objectives: Compare the sensitivity and specificity of cubes 6800 and Procleix panther for the simultaneous detection of HCV, HIV and HBV and determine the HIV-1, HCV, and HBV analytical sensitivity of these assays. Subjects and methods: Procleix Ultrio assay and Cobas TaqScreen MPX assays were used for the detection of HBC, HCV, and HIV viruses in this study. The fully automated systems used were Procleix panther for Procleix Ultrio assay and Cobas 6800 for Cobas TaqScreen MPX assay. Testing was done according to manufacturer’s guidelines of each assay separately. All the tests were performed by the qualified staff of the laboratory. Assay detection limits and statistical difference calculations were carried out with computer software. The 95 percent and 50 percent detection limits, including 95 percent confidence intervals (CIs), were calculated by probit analysis on serial dilutions of reference materials. Results: A total of 9 (0.13%) donations (𝑁 = 5000) were found out to be reactive for either of the viral markers tested by Cobas 6800 and Procleix panther. Overall prevalence of viral markers was 1.44% for HBV, 0.4% for HCV, 0.25% for HIV, and 5 (0.05%) co-infections. Of the 7 samples’ RR for HBV DNA by both systems, all (100%) remained Procleix reactive when retested in pools of 4 but (94.4%) were Ultrioreactive when tested in a pool size of 8. One of the HBV NAT yield samples (HK5) was reactive in pools of both 4 and 8, but the other yield sample (HK1) was nonreactive in both pool sizes. Conclusion: Efficient function of both techniques were elaborated, however, Procleix Ultrio was slightly superior to Cobas 6800 in few situations, although, new Cobas version is much updated and sensitive from old releases. Keywords: HBV, immunoassays, NAT |
