Screening for HBV, HCV and HIV genomes in blood donations: shortcomings of pooling revealed by a multicentre study simulating real-time testing

Lefrère, Jean‐Jacques; Cantaloube, Jean-François; Defer, Christine; Mercier, Bernard; Loiseau, Pascale; Vignon, Dominique; Pawlotsky, Jean‐Michel; Biagini, Philippe; Lerable, Joëlle; Rouger, Philippe; Roudot‐Thoraval, Françoise; Férec, Claude

doi:10.1016/s0166-0934(99)00028-2

Cited by 15 publications

(6 citation statements)

References 19 publications

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“…However, molecular amplification assays, although highly sensitive, have shown logistical problems. The introduction of this technology into blood banks' routine practice has been hindered by its complex methodology, high cost and unavailability of totally automated procedures allowing unitary screening of blood donations (Lefrère et al ., 1999; Loubière et al ., 2001). Therefore, a quick, cost‐effective, sensitive, specific test is clearly needed to identify potentially infective blood units that have not been detected by specific antibody tests.…”

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confidence: 99%

Application of a new enzyme‐linked immunosorbent assay for detection of total hepatitis C virus core antigen in blood donors

Cano¹,

Candela²,

Lozano³

et al. 2003

Transfusion Medicine

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Recent studies have shown that total hepatitis C virus (HCV) core antigen, both free and antibody bound, is an accurate indirect marker of viral replication that can be used in clinical practice. The aim of the present study was to evaluate the performance of a new total HCV core antigen enzyme-linked immunosorbent assay (ELISA) for detection and quantification of total core antigen in blood donors, testing positive for anti-HCV antibodies and for prospective low-risk population screening. A population comprising 257 samples, from blood donors detected reactive for anti-HCV antibodies [137 recombinant immunoblot assay (RIBA) positive and 120 RIBA indeterminate], were tested by using a new total HCV core antigen ELISA. HCV-RNA was quantified by using quantitative polymerase chain reaction (PCR) assays in all RIBA-positive samples and RIBA-indeterminate samples that were positive for the total core antigen. Specificity of the assay was studied in 1070 healthy blood donors negative for anti-HCV antibodies. Compared with quantitative PCR assays, the total HCV core antigen assay showed 97.37% sensitivity. The three HCV-RNA-positive samples, which tested negative for the total core antigen, had a low viral load (< 1.4 x 10(4) IU mL(-1)). All samples with more than 1.4 x 10(4) IU mL(-1) of viral RNA were positive for total core antigen, independent of the HCV genotype. Concentration of total core antigen correlated significantly with those of HCV-RNA (r = 0.614, P < 0.0001). Overall specificity in freshly collected blood donor specimens was 99.63%. Our data indicate that the total HCV core antigen ELISA has a sensitivity close to PCR assays in diagnosing HCV infection in blood donors with anti-HCV antibodies and shows an excellent specificity in volunteer donors. This assay, in combination with anti-HCV antibodies screening tests, could be an alternative to molecular assays for HCV infection screening in blood donors.

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confidence: 99%

Application of a new enzyme‐linked immunosorbent assay for detection of total hepatitis C virus core antigen in blood donors

Cano¹,

Candela²,

Lozano³

et al. 2003

Transfusion Medicine

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show abstract

“…Because current nucleic acid amplification technologies do not have sufficient throughput for testing individual units at a reasonable cost, testing of mini‐pools made up of small aliquots from many individual units has been proposed 1–3 . Several studies have shown that mini‐pool testing can be incorporated into existing blood donor screening programs and that it should be able to detect window‐period donations 4–7 …”

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confidence: 99%

Performance characteristics of the COBAS AmpliScreen HIV‐1 test, version 1.5, an assay designed for screening plasma mini‐pools

et al. 2001

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“…Considerable efforts have been made not only to develop more sensitive, reproducible and precise commercial NAT assays but also to standardize these assays (French Study Group, 1994;Gentili et al, 2003;Lefrère et al, 1999;Mancini et al, 2003;Saldanha et al, 1999Saldanha et al, , 2000Saldanha and Minor, 1996;WHO, 1997). Since June 2002, in accordance with Italian law, all transfusion centres have been required to subject donated blood to NAT testing for HCV RNA and to evaluate the performance of NAT over time.…”

Section: Discussionmentioning

confidence: 99%

Nucleic acid testing (NAT) for HCV RNA in Italian transfusion centres: An external quality assessment

Candido

Chionne

Milazzo

et al. 2008

Journal of Clinical Virology

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Screening for HBV, HCV and HIV genomes in blood donations: shortcomings of pooling revealed by a multicentre study simulating real-time testing

Cited by 15 publications

References 19 publications

Application of a new enzyme‐linked immunosorbent assay for detection of total hepatitis C virus core antigen in blood donors

Application of a new enzyme‐linked immunosorbent assay for detection of total hepatitis C virus core antigen in blood donors

Performance characteristics of the COBAS AmpliScreen HIV‐1 test, version 1.5, an assay designed for screening plasma mini‐pools

Nucleic acid testing (NAT) for HCV RNA in Italian transfusion centres: An external quality assessment

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