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Infectious Diseases
AMD Distributed by Goffin Diagnostics

Hepatitis E Virus (HEV) PCR Kit

The Hepatitis E Virus (HEV) PCR Detection Kit is a high-sensitivity one-step real-time RT-qPCR assay designed for the detection of HEV RNA in human clinical samples. Based on advanced hydrolysis probe (TaqMan) technology, the assay enables highly specific and reliable identification of HEV, the leading cause of acute viral hepatitis worldwide. Targeting conserved regions of the HEV genome, the kit ensures accurate detection even in low viral load samples. An integrated internal control monitors RNA quality and detects potential PCR inhibition, providing confidence in diagnostic results. With a detection sensitivity down to 10 copies per reaction and compatibility with widely used real-time PCR platforms, this kit is ideal for clinical diagnostics, blood screening, and infectious disease research laboratories.

Real-Time PCR CE-IVD AMD 1 Unit (100 Reactions)
Technique
Real-Time PCR
Brand
AMD
Packaging
1 Unit (100 Reactions)
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Product details

This kit in detail

The Hepatitis E Virus (HEV) PCR Detection Kit is a high-sensitivity one-step real-time RT-qPCR assay designed for the detection of HEV RNA in human clinical samples. Based on advanced hydrolysis probe (TaqMan) technology, the assay enables highly specific and reliable identification of HEV, the leading cause of acute viral hepatitis worldwide.

Targeting conserved regions of the HEV genome, the kit ensures accurate detection even in low viral load samples. An integrated internal control monitors RNA quality and detects potential PCR inhibition, providing confidence in diagnostic results.

With a detection sensitivity down to 10 copies per reaction and compatibility with widely used real-time PCR platforms, this kit is ideal for clinical diagnostics, blood screening, and infectious disease research laboratories.

  • High sensitivity (≥10 copies/reaction)
  • Dual-channel FAM/HEX with internal control
  • One-step RT-qPCR, ready-to-use workflow
  • High specificity for HEV DNA

Qualitative Detection of Hepatitis E Virus (HEV)

The HEV PCR Detection Kit is an in-vitro diagnostic one-step real-time RT-qPCR assay developed for the detection of HEV RNA in human samples. The assay combines reverse transcription and PCR amplification in a single reaction, delivering high sensitivity and specificity.

The kit includes a ready-to-use master mix containing primers and probes for both HEV detection and an internal control, enabling simultaneous verification of RNA quality and amplification efficiency.

Molecular Background

Hepatitis E Virus (HEV) is a single-stranded RNA virus belonging to the Hepeviridae family. It is transmitted primarily through the fecal-oral route, most commonly via contaminated drinking water.

HEV infection is typically self-limiting, resolving within 2–6 weeks, but can lead to severe complications such as fulminant hepatitis, particularly in immunocompromised individuals. The virus includes multiple genotypes, some of which are zoonotic and capable of infecting humans through animal reservoirs.

Accurate molecular detection is essential for diagnosis, outbreak control, and monitoring of HEV infections, particularly in high-risk populations.

Assay Performance & Utility

The HEV PCR Detection Kit utilizes one-step RT-qPCR technology, combining reverse transcription of viral RNA into cDNA with amplification and detection in a single tube. Detection is based on dual-channel fluorescence: the FAM channel identifies HEV RNA, while the HEX channel serves as an internal control to verify RNA integrity and detect PCR inhibition.

The assay incorporates “hot start” PCR technology to minimize non-specific amplification and enhance sensitivity. Uracil-DNA glycosylase (UDG) is included to prevent carry-over contamination, ensuring reliable and reproducible results.

With high analytical sensitivity and near 100% specificity under validated conditions, the kit enables accurate detection across a range of viral loads. Included quantification standards support assay calibration and performance verification.

Technical Specifications

  • Assay Type: One-step Real-Time RT-qPCR
  • Target: Hepatitis E Virus (HEV) RNA
  • Detection Channels: FAM (HEV), HEX (Internal Control)
  • Sensitivity: ≥10 copies per reaction
  • Sample Types: Serum, plasma (EDTA), stool samples
  • Input Material: Extracted RNA
  • Compatible Instruments: ABI 7500, QuantStudio 3/5/7, Bio-Rad CFX, Rotor-Gene Q, LightCycler 480, and equivalent systems
  • HEV one-step RT-qPCR M. Mix
  • HEV Standard 1 (1.0 x 10⁸ copies/ml)
  • HEV Standard 2 (1.0 x 10⁷ copies/ml)
  • HEV Standard 3 (1.0 x 10⁶ copies/ml)
  • HEV Standard 4 (1.0 x 10⁵ copies/ml)
  • Nuclease-free Water
Documentation

Datasheets and regulatory documentation

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