Detection of HIV-1 and HCV Infections among Antibody-Negative Blood Donors by Nucleic Acid–Amplification Testing

Stramer, Susan L.; Glynn, Simone A.; Kleinman, Steven; Strong, Douglas M.; Caglioti, Sally; Wright, David J.; Dodd, Roger Y.; Busch, Michael P.

doi:10.1056/nejmoa040085

Cited by 472 publications

(457 citation statements)

References 30 publications

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“…[23][24][25] Blood donations that were HCV EIA 3.0 -seropositive (specificity confirmed with RIBA 3.0) were originally tested for HCV RNA with TMA of plasma minipools of 16 or 24 donations, as is customary for all blood donations. 26,27 Seropositive index donations that were TMA minipool-positive were resolved to a single donor by TMA testing of the individual donations using the residual plasma, and donors were notified of their infection status. Frozen plasma aliquots from seropositive but minipool HCV RNA-negative index donations were subsequently tested in duplicate by individual donation TMA.…”

Section: Methodsmentioning

confidence: 99%

Clearance of hepatitis C virus RNA from the peripheral blood mononuclear cells of blood donors who spontaneously or therapeutically control their plasma viremia

et al. 2008

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We determined whether hepatitis C virus (HCV) RNA could be detected associated with peripheral blood mononuclear cells (PBMC) of seropositive blood donors who had spontaneously or therapeutically cleared their plasma viremia. Blood donor plasma viremia status was first determined with a highly sensitive transcription-mediated amplification (TMA) test performed in duplicate assays. PBMC from 69 aviremic and 56 viremic blood donors were then analyzed for the presence of HCV RNA with TMA adapted to detect viral RNA in PBMC and with a reverse transcription-nested polymerase chain reaction assay. PBMCassociated HCV RNA was detected in none of the 69 aviremic donors, including all 6 subjects with a sustained viral response following antiviral therapy. PBMC-associated HCV RNA was detected in 43 of the 56 viremic donors. The 13 viremic donors with no detectable PBMCassociated HCV RNA all had very low viral loads (6 positive only in 1 of 2 duplicate plasma TMA assays, 6 with viral loads below 100 HCV RNA copies/mL, and 1 with a viremia of 2700 HCV RNA copies/mL). The absence of detectable PBMC HCV RNA detection in all 69 aviremic donors reported here contrasts with prior studies, possibly as a result of the higher sensitivity of the TMA assay used to test for plasma viremia. Conclusion: Our results indicate that PBMC are unlikely to serve as a long-lived reservoir of HCV in aviremic subjects.

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Section: Methodsmentioning

confidence: 99%

Clearance of hepatitis C virus RNA from the peripheral blood mononuclear cells of blood donors who spontaneously or therapeutically control their plasma viremia

et al. 2008

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“…1,2 As the transfusion-transmission rates of these agents dropped, platelet bacterial contamination assumed a new prominence as the most frequent infectious risk of transfusion. Unlike red cells, which are stored under refrigeration, platelets are best stored at room temperature.…”

Section: Screening Platelets For Bacteriamentioning

confidence: 99%

Platelets: Testing, Dosing and the Storage Lesion—Recent Advances

Kaufman¹

2006

Hematology

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The demand for platelet transfusions continues to grow. Several complementary approaches that may help meet this demand in the future are reviewed. First, platelet bacterial testing is beginning to allow the extension of platelet storage beyond 5 days. Studies are also underway aimed at better preserving viability and function during ex vivo platelet storage: additive solutions and other approaches are being developed to try to negate the "platelet storage lesion." Finally, new approaches to dosing platelets may help extend the limited supply.

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“…So far, the yield of isolated NAT reactive samples is zero, probably because of the still relatively small number of donors tested. In fact, in the largest series published 35 , 170 HCV NAT-reactive/ anti-HCV non-reactive units were identified among 39,721,404 tested, giving a rate of 1:230,000.…”

Section: Discussionmentioning

confidence: 99%

Primary screening of blood donors by nat testing for HCV-RNA: development of an "in-house" method and results

Wendel

Levi

Takaoka³

et al. 2007

Rev. Inst. Med. trop. S. Paulo

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SUMMARYAn "in-house" RT-PCR method was developed that allows the simultaneous detection of the RNA of the Hepatitis C Virus (HCV) and an artificial RNA employed as an external control. Samples were analyzed in pools of 6-12 donations, each donation included in two pools, one horizontal and one vertical, permitting the immediate identification of a reactive donation, obviating the need for pool dismembering. The whole process took 6-8 hours per day and results were issued in parallel to serology. The method was shown to detect all six HCV genotypes and a sensitivity of 500 IU/mL was achieved (95% hit rate). Until July 2005, 139,678 donations were tested and 315 (0.23%) were found reactive for HCV-RNA. Except for five false-positives, all 310 presented the corresponding antibody as well, so the yield of NAT-only donations was zero, presenting a specificity of 99.83%. Detection of a window period donation, in the population studied, will probably demand testing of a larger number of donations. International experience is showing a rate of 1:200,000 -1:500,000 of isolated HCV-RNA reactive donations.

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Detection of HIV-1 and HCV Infections among Antibody-Negative Blood Donors by Nucleic Acid–Amplification Testing

Abstract: Minipool nucleic acid-amplification testing has helped prevent the transmission of approximately 5 HIV-1 infections and 56 HCV infections annually and has reduced the residual risk of transfusion-transmitted HIV-1 and HCV to approximately 1 in 2 million blood units.

Cited by 472 publications

References 30 publications

Clearance of hepatitis C virus RNA from the peripheral blood mononuclear cells of blood donors who spontaneously or therapeutically control their plasma viremia

Clearance of hepatitis C virus RNA from the peripheral blood mononuclear cells of blood donors who spontaneously or therapeutically control their plasma viremia

Platelets: Testing, Dosing and the Storage Lesion—Recent Advances

Primary screening of blood donors by nat testing for HCV-RNA: development of an "in-house" method and results

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