Abstract:Newer HBsAg tests would be expected to detect an additional 15 to 21 infected units per 107 donations, compared to licensed HBsAg tests. Sensitivity, WP closure, and yield projections for newer HBsAg assays and pooled-sample NAT are comparable. Single-sample NAT would increase yield by 13 to 15 units per 107 donations over pooled-sample NAT and newer HBsAg assays and by 35 to 50 units per 107 donations over currently licensed HBsAg assays.
“…In the remaining five series of panels, the BLEIA and PCR detected positive samples with the same detection rate. There was little or no difference in the number of days to the first detection of a positive sample between the BLEIA and PCR (0 versus Ϫ1.7 Ϯ 3.0 days), in agreement with the previous study reporting that HBV DNA and HBsAg detections have a good correlation in the early phase of infection (45). Of note, no other HBsAg measurement methods, including the CLIA2 (another commercial CLIA kit), the ECLIA (an electrochemiluminescent immunoassay), or the FEIA1 (a commercial fluorescence enzyme immunoassay kit) were able to detect HBsAg earlier than the BLEIA, and the BLEIA detected HBsAg 5.8 Ϯ 3.7 days earlier than these three HBsAg measurement methods.…”
bHepatitis B virus (HBV) infections are sometimes overlooked when using commercial kits to measure hepatitis B virus surface antigen (HBsAg) due to their low sensitivities and reactivities to mutant strains of various genotypes. We developed an ultrasensitive bioluminescent enzyme immunoassay (BLEIA) for HBsAg using firefly luciferase, which is adaptable to a variety of HBsAg mutants, by combining four monoclonal antibodies with a polyclonal antibody against HBsAg. The measurement of seroconversion panels showed trace amounts of HBsAg during the early infection phase by the BLEIA because of its high sensitivity of 5 mIU/ml. The BLEIA detected HBsAg as early as did PCR in five of seven series and from 2.1 to 9.4 days earlier than commercial immunoassay methods. During the late infection phase, the BLEIA successfully detected HBsAg even 40 days after the disappearance of HBV DNA and the emergence of antibodies against HBsAg. The HBsAg BLEIA successfully detected all 13 recombinant HBsAg and 45 types of HBsAg mutants with various mutations within amino acids 90 to 164 in the S gene product. Some specimens had higher values determined by the BLEIA than those by a commercial chemiluminescent immunoassay; this suggests that such discrepancies were caused by the dissociation of preS1/preS2 peptides from the particle surface. With its highly sensitive detection of low-titer HBsAg, including various mutants, the HBsAg BLEIA is considered to be useful for the early diagnosis and prevention of HBV infection because of the shorter window of infection prior to detection, which facilitates early prediction of recurrence in HBV-infected individuals.
“…In the remaining five series of panels, the BLEIA and PCR detected positive samples with the same detection rate. There was little or no difference in the number of days to the first detection of a positive sample between the BLEIA and PCR (0 versus Ϫ1.7 Ϯ 3.0 days), in agreement with the previous study reporting that HBV DNA and HBsAg detections have a good correlation in the early phase of infection (45). Of note, no other HBsAg measurement methods, including the CLIA2 (another commercial CLIA kit), the ECLIA (an electrochemiluminescent immunoassay), or the FEIA1 (a commercial fluorescence enzyme immunoassay kit) were able to detect HBsAg earlier than the BLEIA, and the BLEIA detected HBsAg 5.8 Ϯ 3.7 days earlier than these three HBsAg measurement methods.…”
bHepatitis B virus (HBV) infections are sometimes overlooked when using commercial kits to measure hepatitis B virus surface antigen (HBsAg) due to their low sensitivities and reactivities to mutant strains of various genotypes. We developed an ultrasensitive bioluminescent enzyme immunoassay (BLEIA) for HBsAg using firefly luciferase, which is adaptable to a variety of HBsAg mutants, by combining four monoclonal antibodies with a polyclonal antibody against HBsAg. The measurement of seroconversion panels showed trace amounts of HBsAg during the early infection phase by the BLEIA because of its high sensitivity of 5 mIU/ml. The BLEIA detected HBsAg as early as did PCR in five of seven series and from 2.1 to 9.4 days earlier than commercial immunoassay methods. During the late infection phase, the BLEIA successfully detected HBsAg even 40 days after the disappearance of HBV DNA and the emergence of antibodies against HBsAg. The HBsAg BLEIA successfully detected all 13 recombinant HBsAg and 45 types of HBsAg mutants with various mutations within amino acids 90 to 164 in the S gene product. Some specimens had higher values determined by the BLEIA than those by a commercial chemiluminescent immunoassay; this suggests that such discrepancies were caused by the dissociation of preS1/preS2 peptides from the particle surface. With its highly sensitive detection of low-titer HBsAg, including various mutants, the HBsAg BLEIA is considered to be useful for the early diagnosis and prevention of HBV infection because of the shorter window of infection prior to detection, which facilitates early prediction of recurrence in HBV-infected individuals.
“…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) .…”
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
“…Bu nedenle HBsAg testlerinin duyarlılığını artırmak amacıyla Chemiluminescence Immunassay (CLIA), HBsAg yoğunlaştırma ve immünkompleks ayrıştırması gibi yöntemler ile ilgili çalışmalar yapılmakta veya uygulanmaktadır [61][62][63]. OHB'nin özellikle transfüzyon ile HBV bulaşına neden olabileceği bilinmektedir ve HBsAg testlerinde yenilikler olsa da HBV belirteci olarak tarama testlerinde HBsAg'nin kullanımında bazı problemler oluşabilir.…”
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