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Background: Monitoring trends in residual risks of transfusion-transmitted viral infections (HIV, HTLV, HBV, and HCV) is important to assess improvements in blood safety. In France, theses trends were analyzed between 1992 and 2000., Study Design and Methods: As risk is predominantly associated with the window period, residual risks were estimated by multiplying incidence rates by the durations of the window periods. Incidence rates were calculated from the data collected by the blood transfusion centers belonging to the Transfusion-Transmissible Agents Working Group, which currently collects more than 50 percent of the 2.5 million blood samples donated each year in France., Results: Trend analysis showed a significant decrease in residual risks for HCV (p = 0.01) and HBV (p < 0.001). Although residual risks decreased for HIV and HTLV, the trends were not significant. In 1998 through 2000, residual risks were estimated to be 1 in 470,000 donations for HBV, 1 in 860,000 for HCV, 1 in 1,370,000 for HIV, nil for HTLV, and 1 in 250,000 for the four viruses combined., Conclusions: In France, the current risk of a blood recipient becoming infected with a retrovirus or a hepatitis virus is extremely low. The implementation of NAT in July 2001 is predicted to reduce the residual risk to 1 in 2,700,000 donations for HIV and 1 in 8,300,000 for HCV.

Background: The purpose of this study was to compare the performances of HCV core antigen (HCV Ag) testing with HCV RNA detection during the preseroconversion period., Study Design and Methods: Six HCV antibody (HCV Ab)-negative and HCV RNA-positive blood samples from 6 donors and 135 serial samples from 28 patients who had undergone hemodialysis, collected a mean of 90 days before the detection of HCV Ab, were tested by ELISA for the detection of HCV Ag and by PCR to quantify HCV RNA., Results: Five of the six donors were positive for HCV Ag. The donor with a negative HCV Ag test had the lowest viral load. In the hemodialysis patients, the 43 first specimens of the series were HCV RNA negative. Of the 92 specimens that were HCV RNA positive, 81 (88%) were positive for HCV Ag. Among the 74 samples with more than 10(5) RNA copies, 71 (96%) were HCV Ag positive. Average time from first viremic bleed to first HCV Ag-positive bleed was estimated at 2.0 days and that to first HCV Ab-positive bleed at 50.8 days., Conclusion: HCV Ag testing permits the detection of an HCV infection about 1.5 months earlier than the HCV Ab screening tests and an average of only 2 days later than quantitative HCV RNA detection in individual specimens.

Background: To verify the criteria for human T-lymphotropic virus (HTLV) seropositivity in Western blot (WB) proposed by the Retrovirus Study Group of the French Society of Blood Transfusion, 186 blood donations that were repeatedly reactive in HTLV enzyme-linked immunosorbent assay, selected according to their WB pattern, were tested by polymerase chain reaction (PCR) and radioimmunoprecipitation assay (RIPA)., Study Design and Methods: In two commercially available WBs, 12 samples were confirmed as positive (rgp21+p19+p24) and 174 were interpreted as indeterminate (one or two reactivities to these proteins). The primer pairs used for the PCR allowed the amplification of type I (HTLV-I) or type II (HTLV-II) (or both) sequences. The RIPA was performed with two 35S-labeled cell lines: HTLV-I infected HUT 102/B2 and HTLV-II-infected MoT., Results: Of the 12 positive samples, 11 were classified as HTLV-I-positive and one as HTLV-II-positive. Among the 174 indeterminate samples, three (WB pattern: rgp21+, p19+, p24-) were HTLV-I positive in PCR (one of them was positive in RIPA also); the other 171 were HTLV negative., Conclusion: In the study of a population in which 97 percent of HTLV infections are due to HTLV-I, these data support the three-protein criteria (rgp21, p19, and p24) for a positive blot reading. No HTLV infection was observed when rgp21 did not react. Consequently, p19 and/or p24 band patterns represent false reactivity and do not require PCR or RIPA confirmation. To discriminate between false- and true-positive results in the absence of MTA-1 or K55 reactivity, PCR and/or RIPA is required only when rgp21 reactivity is associated with one gag band (p19 or p24).

Background: The results obtained in sequential specimens from recently infected subjects generally provide the best means of comparing the sensitivity of assays., Study Design and Methods: The sensitivity of second- and third-generation assays for antibody to hepatitis C virus (HCV) was compared on sequential specimens, generally collected at monthly intervals from 45 patients undergoing hemodialysis who seroconverted for HCV between 1980 and 1990., Results: Fifteen patients (33%) were positive earlier in the third-generation enzyme-linked immunosorbent assay (ELISA), with a mean difference of 17 days (range, 7-30) between the last negative and the first positive specimens. At the first rise in alanine aminotransferase, and at its peak, 63 and 91 percent of the patients, respectively, were anti-HCV positive in the third-generation ELISA. Third-generation recombinant immunoblot assay (RIBA) reacted at the same time as third-generation ELISA. Of the first specimens that were positive in second-generation ELISA, 44 percent reacted and 56 percent were indeterminate in third-generation RIBA, while 10 percent reacted, 72 percent were indeterminate, and 18 percent did not react in second-generation RIBA. From the beginning to the end of the follow-up, antibody to c33c was the most prevalent, followed in descending order by antibody to c22-3, antibody to c100-3, and antibody to NS5: 56, 54, 26, and 18 percent, respectively, at time 0, and 100, 86, 83, and 31 percent, respectively, 12 months later., Conclusion: Third-generation assays (both ELISA and RIBA) were more sensitive than second-generation assays in the diagnosis of HCV infection, in that positive results were obtained earlier and a higher proportion of specimens were confirmed positive in RIBA testing.

Twelve serum samples from French blood donors that were uniformly reactive in tests for antibody to human immunodeficiency virus type 2 (anti-HIV-2) also were reactive in 92 to 100 percent of tests with three anti-HIV type 1 (anti-HIV-1) enzyme-linked immunoassays currently in widespread use for donor screening in the United States. Supplemental tests for anti-HIV-1 on these anti-HIV-2-reactive samples differed in their responses. All samples reacted in a licensed anti-HIV-1 Western blot, but there was an atypical band near the p41 position, which could be a clue to the fact that this result was a cross-reaction with anti-HIV-2. A recombinant immunoblot gave an indeterminate result for anti-HIV-1 in all 12 samples. A local immunofluorescence assay for anti-HIV-1 reacted with 92 percent of the samples, but a commercial one detected only 58 percent.

The possible existence of human immunodeficiency virus type 1 (HIV-1) infection in asymptomatic seronegative at-risk individuals was investigated in a prospective study of 55 seronegative high-risk individuals (42 homosexual men and 13 heterosexual individuals) and 32 seronegative hemophiliacs treated with factor VIII or IX concentrates before viral inactivation by heat treatment and systematic screening of blood donations. Tests used include the polymerase chain reaction assay with three primer pairs (one in the gag region and two in the pol region) and tests for serum p24 antigen, anti-nef serology (Western blot), and five biologic markers frequently altered by HIV infection (CD4 lymphocyte count, serum beta 2-microglobulin and neopterin concentration, and serum IgG and IgA concentration). Although 91 of 92 HIV-1-seropositive persons were positive in testing with at least one primer pair, no positive result was observed in seronegative at-risk individuals or in 117 seronegative low-risk controls. No nef antibody was found in seronegative at-risk individuals or seronegative controls, but 44 (47%) of 92 HIV-1-seropositive persons had nef antibodies. These findings do not support the existence of frequent HIV-1 infection in seronegative at-risk individuals.