The Detection Of The Hepatitis C Virus Of Donors And The Blood Transfusion Safety

Objective: Explore the difference on anti-HCV between the two ELISA screening reagents; Study the effect of the ELISA balance time on the outcome of the grey zone specimens and the control materials; Discuss the feasibility of using nucleic acid detection technologies for the substitution of a single ELISA; Study the feasibility of the re-donation among the anti-HCV grey zone donors.Methods: Use two different kinds of anti-HCV(ELISA screening reagents) to detect the positive rate of anti-HCV among the serum of the donors; Meanwhile use these two reagents to detect the serum panels of anti-HCV and compare their outcomes;Change the balance time of the kit to explore the effects on S/CO; Detect and corroborate the anti-HCV grey zone and the positive specimens using RIBA; Discuss the feasitiliby of the re-donation of the donors by detecting the HCV RNA(using FQ-PCR) and ALT(using speed rate method) of the grey zone specimens after 3 to 6 months; Use Cobas s201 system to detect the HCV-RNA among the negative specimens screened beforehand by ELISA.Results: The positive rate on the detection of the specimens using the two sets of anti-HCV kits produced by Xinchuang & Kehua are respectively 0.263% (31/11766) and 0.102%(12/11766), and a statistic difference( x 2=8.395, P <0.01) notably appears between them; However the comparison on the anti-HCV serum panels of these two kits has got a coincidence rate of 100%; The S/CO value of the 1NCU/ml anti-HCV control materials and the anti-HCV grey zone specimens remarkably increases(P<0.05) when the ELISA kits' balance time are set to less than 30 minutes, on the other hand, with more balance time on these kits the S/CO value doesn't change significantly(P>0.05) The 5 pieces of grey zone specimens out of 32 pieces screened by the Murex reagent are detected by RIBA and it comes out that 2 pieces of them are suspicious and 3 of them are negative, and the result changes to all negative under the FQ-PCR detection after 3 to 6 months; The results of the anti-HCV grey zone serum specimens and the anti-HCV negative serum specimens detected by ALT(speed rate method) are respectively 19.20±7.38U/L and 16.58±7.08 U/L, both of them are <40U/L and this leads to no remarkable statistic difference(t=1.48,P>0.05); And only a single piece of HCV RNA positive specimen is detected by Cobas s201system during the screening among 3000 pieces of anti-HCV negative specimens.Conclusions: The positive rates of the two domestic anti-HCV reagents (Xinchuang & Kehua) on detecting anti-HCV of donors are obviously different, while the coincidence rate goes to 100% on detecting anti-HCV serum panels. A concurrent use of these two reagents could reduce the risks of HCV infections, and this is suitable in the screening and the detections among our general population. The anti-HCV kits should be balanced in room temperature for more than 30 minutes before any detection or this could reduce the S/CO value of the control materials and the grey zone specimens abnormally, and thus affect the result of the detection itself. The nucleic acid detection could discover a"WINDOW PHASE"of HCV infected specimen, while whether the substitution of the single-ELISA by the NAT detections is necessary in our domestic blood collection and supply system should be further confirmed under considerably large samples. The results of the ALT detections on anti-HCV grey zone and anti-HCV negative specimens are both in normal range and have no remarkable statistic differences with each other. The anti-HCV grey zone donors could somehow re-donate when the result of the nucleic acid detection is confirmed to be negative.