Significance of the signal‐to‐cutoff ratios of anti‐hepatitis C virus enzyme immunoassays in screening of Chinese blood donors

Ren, Fu Rong; Lv, Qiu Shuang; Zhang, Hui; Li, Jing Jing; Gong, Xiao Yan; Gao, Guo Jing; Liu, Chang Li; Wang, Jing Xing; Yao, Fu Zhu; Zhu, Fa Ming; Tiemuer, Mei Hei Li; Bai, Xu Hua; Shan, Hua

doi:10.1111/j.1537-2995.2005.00611.x

Cited by 33 publications

(43 citation statements)

References 7 publications

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“…(16,17), with sensitivity higher than 95%. A wide range of variation has been reported by Ren et al (18) for domestic EIA kits, such as 6.0 to 14.0, with ≥95% sensitivity. Reflex supplemental testing could be limited to screening test-positive samples with ratios below the cutoff value.…”

Section: Discussionmentioning

confidence: 92%

Cost-effective analysis of different algorithms for the diagnosis of hepatitis C virus infection

Barreto

Takei

Sabino

et al. 2008

Braz J Med Biol Res

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We compared the cost-benefit of two algorithms, recently proposed by the Centers for Disease Control and Prevention, USA, with the conventional one, the most appropriate for the diagnosis of hepatitis C virus (HCV) infection in the Brazilian population. Serum samples were obtained from 517 ELISA-positive or -inconclusive blood donors who had returned to Fundação Pró-Sangue/Hemocentro de São Paulo to confirm previous results. Algorithm A was based on signal-to-cut-off (s/co) ratio of ELISA anti-HCV samples that show s/co ratio ≥95% concordance with immunoblot (IB) positivity. For algorithm B, reflex nucleic acid amplification testing by PCR was required for ELISA-positive or -inconclusive samples and IB for PCR-negative samples. For algorithm C, all positive or inconclusive ELISA samples were submitted to IB. We observed a similar rate of positive results with the three algorithms: 287, 287, and 285 for A, B, and C, respectively, and 283 were concordant with one another. Indeterminate results from algorithms A and C were elucidated by PCR (expanded algorithm) which detected two more positive samples. The estimated cost of algorithms A and B was US$21,299.39 and US$32,397.40, respectively, which were 43.5 and 14.0% more economic than C (US$37,673.79). The cost can vary according to the technique used. We conclude that both algorithms A and B are suitable for diagnosing HCV infection in the Brazilian population. Furthermore, algorithm A is the more practical and economical one since it requires supplemental tests for only 54% of the samples. Algorithm B provides early information about the presence of viremia.

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Section: Discussionmentioning

confidence: 92%

Cost-effective analysis of different algorithms for the diagnosis of hepatitis C virus infection

Barreto

Takei

Sabino

et al. 2008

Braz J Med Biol Res

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“…Çin'de 7 farklı anti-HCV test kiti ile yapılan çalışmada, %95 oranında HCV-RNA tarafından doğrulanan S/Co değerlerin 3,8 ile 14 arasında değiştiği gösterilmiştir. 5 Ülkemizden yapılan bir çalışmada ise Sayan ve ark.nın bizimkiyle aynı ticari marka anti-HCV kiti ile yaptıkları çalışmada, S/Co için en uygun eşik değeri, 3,8 olarak tespit edilmiştir. 10 rında bildirmişlerdir.…”

Section: Discussionunclassified

“…Son zamanlarda bu konuda yapılan ça-lışmalarda, anti-HCV S/Co değerinin viremiyi kestirmede önemli olduğu ve yüksek S/Co değerlerinin HVR-RNA ile daha uyumlu olduğu belirtilmekte ve HCV enfeksiyonunu tanısında kullanılabilecek en iyi S/Co değerleri önerilmektedir. [5][6][7][8] Biz de bu çalışmada kullandığımız anti-HCV mikropartikül EIA testinin viremiyi öngörmedeki performansını, ve bu test için duyarlılık ve özgül-lük yönünden en uygun S/Co değerini tespit etmek istedik. Veri analizinde, HCV enfeksiyonu tanısında viremiyi belirleyen HCV-RNA testi altın standart olarak kabul edilerek, anti-HCV testinin viremiyi öngörmedeki performansı ve özgüllük, duyarlılık ve prediktif değerleri SPSS v15.0 istatistik programında hesaplanarak belirlendi.…”

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The Threshold Value of Anti-HCV Test in the Diagnosis of HCV Infection

Ecemiş¹,

Akçalı²,

Dündar³

et al. 2012

Turkiye Klinikleri J Med Sci

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Ö ÖZ ZE ET T A Am ma aç ç: : Hepatit C virüs (HCV) enfeksiyonunun tanısında ilk basamak anti-HCV antikorlarının taranması ve pozitif sonuçların genellikle nükleik asit amplifikasyon testleri ile onaylanması şeklindedir. Son yıllarda yapılan çalışmalarda, anti-HCV enzim immünoassay (EIA) testi için, rutin reaktivite eşiği olan S/Co'nun (signal to cut-off) 1'den büyük değerlerde kullanılmasıyla HCV-RNA testi ile daha uyumlu sonuçların elde edileceği bildirilmektedir. Biz de bu çalışmada anti-HCV EIA testi için, HCV enfeksiyonunu öngören en uygun S/Co değerini tespit etmek istedik. G Ge er re eç ç v ve e Y Yö ön nt te em ml le er r: : Mikropartikül EIA yöntemiyle anti-HCV ve hibridizasyon yöntemiyle HCV-RNA testleri çalışılmış 387 hastanın sonuçları karşılaştırıldı. HCV enfeksiyonu için HCV-RNA testi altın standart olarak kabul edilerek, EIA testinin özgüllük, duyarlılık ve prediktif değerleri belirlendi ve en uygun reaktivite eşiğini tespit etmek amacıyla istatistiksel "receiver operating characteristic" (ROC) analizi uygulandı. B Bu ul lg gu ul la ar r: : EIA sonuçlarına göre; 197 (%49,1) pozitif, 190 (%50,9) negatif sonuç elde edildi ve testin duyarlılığı %94,9, özgüllüğü %60,4 bulundu. Pozitif ve negatif prediktif değerleri sırasıyla %38,1 ve %97,9 olarak hesaplandı. ROC analizine göre en uygun S/Co değeri 5 olarak belirlendi ve bu değere göre duyarlılık %92,4, özgüllük %76,6 bulundu. Pozitif ve negatif prediktif değerleri ise sırasıyla %50,3 ve %97,5 olarak hesaplandı. S So on nu uç ç: : HCV enfeksiyonu tanısında kullanılabilecek en uygun anti-HCV EIA reaktivite değerleri araştırıldı ve S/Co ≥5 bulundu.A An na ah ht ta ar r K Ke el li im me el le er r: : Hepatit C antikorları; immünoenzimatik yöntem; eşik limit değerler

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“…Specimens with a signal/cutoff (S/CO) ratio <1.0 were considered negative and not tested any further; specimens with a S/CO ratio between 1.0 and 3.8 were reported as low-positive and those with a S/CO ! 3.8 as high positive [Ren et al, 2005].…”

Section: Laboratory Assaysmentioning

confidence: 97%

Seroprevalence of hepatitis B and C viruses among HIV‐infected pregnant women in Uganda and Rwanda

Pirillo

Bassani

Germinario

et al. 2007

Journal of Medical Virology

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A retrospective survey to estimate the prevalence of hepatitis B (HBV) and C (HCV) infections was conducted on the samples of 247 African HIV-1 positive pregnant women who had participated to a mother-to-child prevention trial carried out in urban settings in Kampala, Uganda and Kigali, Rwanda. Hepatitis B markers studied were HBs antigen (HBsAg) and, if positive after confirmatory testing, HBe antigen/anti-HBe antibodies and HBV DNA. A fourth generation HCV enzyme immunoassay (EIA) was used for primary HCV screening. Positive samples were analyzed further with a second different EIA. Both for HBV and for HCV the use of confirmatory tests allowed the removal of frequent false-positive screening results. HBsAg was found in 10/246 women (seroprevalence 4.1%, 95% confidence interval (95%CI) 1.7-6.8): 8/164 (4.9%) in Uganda and 2/82 (2.4%) in Rwanda. HBe Ag was found in 33% of HBsAg-positive patients and HBV DNA was quantifiable in 71%. Anti-HCV antibodies were found in 5/247 women (seroprevalence 2.0% 95%CI 0.3-3.9): 1/165 (0.6%) in Uganda and 4/82 (4.9%) in Rwanda. There was no interrelation between HCV and HBV markers. There was no difference between patients with and without co-infection with HBV or HCV with regards to CD4+ cell count. Overall, hepatitis B and C co-infection was relatively infrequent in this group of pregnant women. However, since approximately 6% of HIV-positive women in these countries had a co-infection with one hepatitis virus, caution should be used in the monitoring of possible hepatotoxicity related to antiretroviral drugs in these populations.

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Significance of the signal‐to‐cutoff ratios of anti‐hepatitis C virus enzyme immunoassays in screening of Chinese blood donors

Cited by 33 publications

References 7 publications

Cost-effective analysis of different algorithms for the diagnosis of hepatitis C virus infection

Cost-effective analysis of different algorithms for the diagnosis of hepatitis C virus infection

The Threshold Value of Anti-HCV Test in the Diagnosis of HCV Infection

Seroprevalence of hepatitis B and C viruses among HIV‐infected pregnant women in Uganda and Rwanda

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