Multicenter performance evaluation of a transcription‐mediated amplification assay for screening of human immunodeficiency virus‐1 RNA, hepatitis C virus RNA, and hepatitis B virus DNA in blood donations

Koppelman, Marco; Assal, Azzedine; Chudy, M.; Torres, Pilar; Villaescusa, Roberto; Reesink, H. W.; Lelie, P. N.; Cuypers, H. T. M.

doi:10.1111/j.1537-2995.2005.00197.x

Cited by 51 publications

(75 citation statements)

References 27 publications

(31 reference statements)

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“…(2) Plasma samples from 250,191 individual donations were tested by Ultrio TMA HIV1/HCV/HBV assay (Chiron, Emeryville, CA) in single-donation format able to detect 11 (7.3-22) IU/mL at the 95% limit. 6 Reactive donations were retested by discriminatory assays for HCV RNA, HBV DNA, and HIV RNA. Donations reactive with HBV discriminatory assay were considered positive for HBV DNA.…”

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confidence: 99%

Characterization of HBV DNA+/HBsAg− blood donors in Poland identified by triplex NAT

et al. 2006

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T he introduction of molecular methods to screen blood donors for hepatitis C virus (HCV), human immunodeficiency virus (HIV), and hepatitis B virus (HBV) has improved blood transfusion safety. [1][2][3] In addition, detection of molecular markers of infection in asymptomatic individuals with no serological markers, which are used for blood donor screening [hepatitis B surface antigen (HBsAg), anti-HCV, anti-HIV], provides new information on the natural course of these infections. Several aspects of the biology of HBV remain unclear. One of them is the detection of HBV DNA in the absence of HBsAg (occult HBV infection) and the determination of its frequency and characteristics. 4 Answering some of these questions became achievable in 2005 when HBV DNA screening of all seronegative blood donations was introduced in Poland. This report presents the analysis of such cases in asymptomatic blood donors identified during the first year of screening in a country with a medium level of HBV endemicity.The aim of this investigation was to analyze the frequency of HBV DNA-positive/HBsAg-negative donations and to use serological and molecular analysis of index samples and, when possible, follow-up and look-back samples to determine the HBV infection status of the donors. Materials and MethodsDonors and Sample Collection. The study was conducted in 2005, during which all blood donations collected in Poland were tested for anti-HCV (Ortho

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confidence: 99%

Characterization of HBV DNA+/HBsAg− blood donors in Poland identified by triplex NAT

et al. 2006

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“…However, discriminatory testing, which delayed the result by about 4 h, was required only in a single blood donor with an initially false-reactive result. This excellent specificity after the initial test run (99.99%) was slightly better than reported for the older Ultrio assay (99.83%) with semi-automated handling [13] and for the Ultrio Elite assay (99.95%) in a multicenter study [14]. Excellent results on specificity and robustness as well as the short turnaround time of the Procleix Ultrio Elite assay / Panther system suggested that ID-NAT seems to be feasible in the future also for granulocyte donors.…”

Section: Discussionmentioning

confidence: 92%

Evaluation of the Procleix Ultrio Elite Assay and the Panther-System for Individual NAT Screening of Blood, Hematopoietic Stem Cell, Tissue and Organ Donors

Heim¹

2016

Transfus Med Hemother

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Background: The performance of the multiplex Procleix Ultrio Elite assay as individual donor nucleic acid test (ID-NAT) for the detection of HIV-1, HIV-2, HCV, and HBV was evaluated in a retrospective, single center study. Methods: ID-NAT results of 21,181 blood donors, 984 tissue donors, 293 hematopoietic stem cell donors and 4 organ donors were reviewed in synopsis with results of serological screening and additional discriminatory and repetitive NAT in case of positive donors. Results: Specificity of the initial Procleix Ultrio Elite assay was 99.98% and after discriminatory testing 100.00%. Initially invalid results were observed in 75 of 21,181 blood donors (0.35%) but 16 of 984 tissue donors (1.62%, p < 0.001) which included non-heart-beating (‘cadaveric') donors. All these had valid negative ID-NAT results after repeated testing or testing of 1:5 diluted specimens in case of tissue donors. Occult hepatitis B (defined here as HBV DNAemia without HBsAg detection) was demonstrated by ID-NAT in two anti-HBc-positive tissue donors and suspected in two other tissue donors, where a definite diagnosis was not achieved due to the insufficient sample volumes available. Conclusion: The Procleix Ultrio Elite assay proved to be specific, robust and rapid. Therefore, routine ID-NAT may also be feasible for organ and granulocyte donors.

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“…HCV araştırmasın-da kullanılan kitlerin paraproteinemi, üremi, RF pozitifliği gibi durumlarda yalancı pozitifliği de söz konusudur (35) . HCV antijen testi ve NAT kullanımı ile kan güvenliğinin arttırılması sağlanabilir (20,(22)(23)(24)(25)(26)(27)(28)(29)(30)36) . Amerika Birleşik Devletlerinde NAT kullanımı sonrası kan ve bileşenleri ile HCV bulaş riski 1:1,935,000 ünite olarak hesaplanmaktadır (21) .…”

Section: Hepatit C Virüsü (Hcv)unclassified

“…NAT sistemlerin etkinliğinin araştırıldığı çok sayıda karşı-laştırmalı çalışma mevcuttur. NAT'ın transfüzyon bulaş riskini azalttığını, ancak sıfırlayamadığını da belirtmek gerekir (20,(22)(23)(24)(25)(26)(27)(28)(29)(30) .…”

Section: Introductionunclassified

Infectious Agents Transmitted by Blood and Blood Component and Impacts of Nükleik Asit Amplifikasyon Test (NAT)

Savasci¹,

Avcı²

2016

IKSST

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ÖZ Kan ve kan¸bileşenleri ile bulaşan enfeksiyonlar, özellikle viral hepatit virüsleri ve insan immün yetmezlik virüsü¸ (HIV), ABSTRACT Especially viral hepatitis viruses and human immunodeficiency virus (HIV) which are transmitted by the transfusion of blood and blood products have been an important public health problem for a long time in the world. Transfusion of blood and blood products is an ideal, easiest and a simplest route for transmission of infectious diseases. It is known that many infectious agents, either bacterial, viral, parasitic and fungal agents may be transmitted by the transfusion of blood and blood products. Nucleic Asit Amplification Test (NAT) provides additional layer of safety to the blood supply because it allows the detection of infectious agents during their incubation periods. Keywords: blood, blood center, infection, nucleic acid amplification test GİRİŞKan ve kan bileşenleri hayati tehlikeye neden olan birçok hastalık ve travmalarda tedavi amaçlı kullanı-lan bileşenlerdir. Kan ve kan bileşenlerinin tek kaynağının insan olması nedeniyle temini çok zor ve maliyet açısından oldukça pahalı bileşenlerdir. Kan naklinin güvenli bir şekilde yapılması, nakil sonrası ortaya çıkabilecek enfeksiyonların önlenebilmesine bağlıdır. Dünyada her yıl milyonlarca ünite kan ve kan bileşenleri kullanılmakta ve alıcıların bir kısmın-da transfüzyona bağlı enfeksiyonlar ortaya çıkmakta-dır. Kan ve kan bileşenlerinin kullanımı aracılığıyla bağışçıda mevcut enfeksiyon etkeninin alıcıya aktarılması tamamıyla engellenememektedir. Bu nedenle amaç, bu tip bulaşma risklerini "kabul edilebilecek kadar düşük" düzeylere indirgemek olmuştur (1) .Kan ve kan bileşenleri ile birçok enfeksiyon etkeni bulaşabilmektedir. Tarama testlerine rağmen neden enfeksiyon bulaşır sorusuna yanıt şu şekilde verilebilir. Transfüzyonla bulaşan enfeksiyon etkenlerinin dolaşımda uzun süre kalmaları, uzun inkübasyon süreleri, mutant suşların varlığı, asemptomatik klinikle seyretmeleri, kan ve kan bileşenlerinde stabilitelerini korumaları önemli özellikleridir. Enfeksiyon etkenleri arasında virüsler en önemli grubu oluştur-maktadır. En fazla sorun olan virüsler; hepatit B

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Multicenter performance evaluation of a transcription‐mediated amplification assay for screening of human immunodeficiency virus‐1 RNA, hepatitis C virus RNA, and hepatitis B virus DNA in blood donations

Cited by 51 publications

References 27 publications

Characterization of HBV DNA+/HBsAg− blood donors in Poland identified by triplex NAT

Characterization of HBV DNA+/HBsAg− blood donors in Poland identified by triplex NAT

Evaluation of the Procleix Ultrio Elite Assay and the Panther-System for Individual NAT Screening of Blood, Hematopoietic Stem Cell, Tissue and Organ Donors

Infectious Agents Transmitted by Blood and Blood Component and Impacts of Nükleik Asit Amplifikasyon Test (NAT)

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