Nucleic acid technology screening of Australian blood donors for hepatitis C and human immunodeficiency virus‐1 RNA: comparison of two high‐throughput testing strategies

Mison, L; Seed, Clive R.; Margaritis, Angelo R.; Hyland, Catherine A.

doi:10.1046/j.1423-0410.2003.00246.x

Cited by 16 publications

(19 citation statements)

References 24 publications

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“…A high specificity (99.2-99.9%) and sensitivity (99.5-99.9%) of the Procleix assay, irrespective of whether a multiplex or discriminatory attempt is used, are reported in several studies [14,19,20]. The rate of NRR pools (initially reactive pools that failed to react on follow-up testing) of 0.09% in the present study was in the same range (0.09-0.25%) as previously described for screening pools of 24 samples [21,22]. The NRR values of 0.06-0.23% received by TMA testing of single donation samples [14,15] are not significantly different from those observed by pool screening, indicating that the tested sample itself did not affect the assay reaction.…”

Section: Discussionsupporting

confidence: 81%

Screening of Blood Donations for HIV-1 and HCV RNA by Transcription-Mediated Amplification Assay: One Year Experience

Schmitt¹,

Endres²,

Luz³

et al. 2004

Transfus Med Hemother

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Background: The number of transfusion-transmitted infections with HIV-1 and HCV has significantly decreased by careful donor selection and the introduction of serological assays. Nucleic acid techniques (NAT) have further contributed to minimize the residual risk of transfusion-borne infections. Here we describe our first year experience in routinely screening blood donations using a multiplex HIV-1/HCV NAT test system. Material and Methods: Since July 2002 the Stuttgart blood bank has utilized the Procleix HIV-1/HCV assay, which simultaneously detects HIV-1 and HCV by means of transcription-mediated amplification (TMA). The HIV-1/HCV TMA assay was carried out on plasma pools each containing a maximum of 8 single blood donations. Results: 5,615 plasma pools (41,830 blood donations) comprising 204 HIV-1/HCV TMA runs were tested. The rate of invalid runs was 1.5%. Invalid pools occurred at a rate of 0.5% and initially reactive pools at a rate of 0.1%, which were not confirmed by repeated testing. Failures turned out to be related to handling errors, insufficient mixing of reagents, and test equipment malfunctions. In order to assess the analytical sensitivity of the TMA assay, we used dilution series based on WHO international standards of HIV-1 and HCV. Probit regression analysis on the 95% level revealed an analytical sensitivity of 16.2 IU/ml for HIV-1 and 3.5 IU/ml for HCV. Conclusion: The Procleix HIV-1/HCV TMA assay represents a highly sensitive diagnostic tool and will contribute to the improvement of virus safety for blood products.

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Section: Discussionsupporting

confidence: 81%

Screening of Blood Donations for HIV-1 and HCV RNA by Transcription-Mediated Amplification Assay: One Year Experience

Schmitt¹,

Endres²,

Luz³

et al. 2004

Transfus Med Hemother

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“…Since the discriminatory assays have the same sensitivity as multiplex TMA, and retest and follow-up data excluded infection in 462 donors with nondiscriminative reactivity that could be reproduced in a study performed by McAuley and coworkers, the donor should not be notified or be deferred [27]. The specificity of the multiplex TMA is close to 100%, since the rate of nondiscriminative reactive results is very low (0.0053-0.082%) when the equipment is adequate and the technicians are experienced [25,27]. The rate of test failure related to human error, minute control contamination and insufficient mixing of reagents at the extraction stage is 4.7% [22].…”

Section: Technological Developmentsmentioning

confidence: 94%

“…Numerous protocols for in-house assays using different extraction, amplification and detection techniques have been described in the scientific literature [21][22][23][24][25][26]. Their uses include HIV-1 screening or HIV-1, HCV and, to a lesser extent, HBV multiplex amplification.…”

Section: Technological Developmentsmentioning

confidence: 99%

“…The rate of test failure related to human error, minute control contamination and insufficient mixing of reagents at the extraction stage is 4.7% [22]. A significantly higher proportion of initial multiplex TMA reactives that failed to react on follow-up testing were observed for individual donation testing at sites, which screened donations exclusively in the individual donation format, in an Australian study where individual donation and minipool testing were compared [25]. These results indicate that the potential for contamination may limit the number of samples that can be processed optimally using individual donation testing.…”

Section: Technological Developmentsmentioning

confidence: 99%

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Screening of HIV infection: role of molecular and immunological assays

Weber¹

2006

Expert Review of Molecular Diagnostics

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Due to technical improvements and new developments of immunological assays, the reliability of serological laboratory diagnosis of HIV infection has improved considerably and the residual risk, due to the diagnostic window for transfusion-transmitted HIV, has been reduced significantly. Through the addition of nucleic acid amplification tests (NAT) to blood donor screening, the residual risk can de further decreased by up to 50%, depending on the sensitivity of the NAT protocol and whether individual or pooled blood donations are screened. In-house and commercially available NAT have been implemented in blood banks as HIV only or multiplexed HIV and hepatitis B or C virus assays. As an alternative to separate antigen and antibody screening, combined fourth-generation assays have been developed in 1997, and have achieved a high degree of sensitivity and specificity. Thus, they can replace stand-alone antigen and third-generation antibody assays. While they are used in the routine diagnostics of HIV infection in many countries throughout the world, they probably represent no alternative for NAT in blood-donor screening in industrialized countries. In the next few years, technical improvements will further simplify NAT screening. While there is still some potential to improve the detection threshold of NAT, the sensitivity of the antigen module of fourth-generation assays (a lowest concentration of 3-5 pg of p24 antigen) is probably very close to its technical limit.

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“…Blood samples (18 mL) were collected in tubes containing EDTA anticoagulant and transported to the tertiary ARCBS laboratory within the timeframes used for screening blood donors for labile viral RNA markers 17 . Plasma was separated from the cellular component using a two‐step centrifugation protocol and stored at − 70°C.…”

Section: Methodsmentioning

confidence: 99%

Evaluation of non‐invasive prenatal RHD genotyping of the fetus

Hyland

Gardener

Davies

et al. 2009

Medical Journal of Australia

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Objective: To evaluate a non‐invasive molecular test using free circulating fetal DNA in maternal plasma to predict the fetal RHD type. Design: A prospective cohort study. Participants and setting: Venous blood samples were collected from 140 Rhesus (Rh) D‐negative women booked for antenatal care in two tertiary maternity hospitals in Sydney and Brisbane between November 2006 and April 2008. Cell‐free DNA, including free maternal and fetal DNA, was extracted from maternal plasma in the tertiary Australian Red Cross Blood Service laboratory, and three exon regions of the RHD gene were amplified. Main outcome measures: Comparison of the predicted fetal RHD status and the infant's RhD serotype. Secondary analysis involved using SRY and RASSF1A assays as internal controls to confirm the presence of fetal DNA in RHD‐negative samples. Results: Of 140 samples tested, results for RHD status were assigned for 135, and all 135 predictions were correct. A result was not assigned in five cases: three did not meet strict threshold criteria for classification, and two were due to RHD variants. Fetal SRY status was correctly predicted in 137 of 140 cases. In 16 samples typed both RHD‐ and SRY‐negative, a positive RASSF1A result verified the presence of fetal DNA. Conclusions: Non‐invasive testing of multiple exons provides a robust method of assessing fetal RHD status, and provides a safer alternative to amniocentesis for the management of RhD‐negative pregnant women who are isoimmunised.

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Nucleic acid technology screening of Australian blood donors for hepatitis C and human immunodeficiency virus‐1 RNA: comparison of two high‐throughput testing strategies

Cited by 16 publications

References 24 publications

Screening of Blood Donations for HIV-1 and HCV RNA by Transcription-Mediated Amplification Assay: One Year Experience

Screening of Blood Donations for HIV-1 and HCV RNA by Transcription-Mediated Amplification Assay: One Year Experience

Screening of HIV infection: role of molecular and immunological assays

Evaluation of non‐invasive prenatal RHD genotyping of the fetus

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