Diagnostic reliability of Architect anti‐HCV assay: Experience of a tertiary care hospital in India

Abstract

Architect can be used as a screening assay because of its high sensitivity, high throughput, and short turnaround time. However, S/Co ratios of ≥1 to <8 in Architect necessitates HCV PCR to identify current infection and or EIA to distinguish true positivity from false biological positivity.

Screening haemodialysis patients for hepatitis C in Vietnam: The inconsistency between common hepatitis C virus serological and virological tests

“…An in‐house quantitative HCV PCR was developed for research purpose and validated with the lower limit of detection was 93 IU/mL of HCV‐RNA. The quality of all these assays is described in detail elsewhere . All PCR positive results were tested for HCV genotype by TRUGENE HCV 5′NC Genotyping kit (SIEMENS) that had a lower limit of detection of 5000 IU/mL of HCV‐RNA .…”

“…The quality of all these assays is described in detail elsewhere. 9,13,20 All PCR positive results were tested for HCV genotype by TRUGENE HCV 5′NC Genotyping kit (SIEMENS) that had a lower limit of detection of 5000 IU/mL of HCV-RNA. 21,22 All PCR confirmed HCV-infected patients were excluded from subsequent two-monthly screenings.…”

“…However, anti‐HCV antibodies cannot be detected in the window period of the first 4‐6 weeks post‐infection and may even become undetectable in haemodialysis patients . In addition, a positive anti‐HCV does not guarantee viremia and the diagnosis of a current infection requires verification with reverse transcription polymerase chain reaction (RT‐PCR) technique . As such, RT‐PCR technique is not appropriate for routine screening .…”

“…3,11,12 In addition, a positive anti-HCV does not guarantee viremia and the diagnosis of a current infection requires verification with reverse transcription polymerase chain reaction (RT-PCR) technique. 10,13 As such, RT-PCR technique is not appropriate for routine screening. 3 Recently, HCV-core antigen (HCV-coreAg) assay has been suggested as a reliable screening method.…”

Architect anti HCV testinin düşük riskli popülasyondaki tanısal güvenilirliği

“…Buna göre yüksek değerlerin aktif enfeksiyon, orta derecedeki yüksekliklerin geçirilmiş enfeksiyon, düşük pozitifliklerin ise yalancı pozitif olarak yorumlanabilir. Hindistan'dan bildirilen bir çalışmada 1 S/CO değeri ile Architect için duyarlılık %100 iken özgüllük ancak %36.1 olarak saptanmış, S/CO oranı >8 olduğunda test doğruluğunun çok yüksek olduğu bildirilmiştir (13). Çalışmada Architect'in yüksek duyarlılığı dolayısı ile tarama testi olarak iyi bir test olduğu fakat 1 ile 8 arasındaki değerlerin EIA veya HCV PCR ile doğrulama gerektirdiği sonucuna varılmıştır.…”