We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
PURITAN MEDICAL

ANALYTIK JENA AG

Analytik Jena is a leading provider of high-end analytical measuring technology, of instruments and products in the f... read more Featured Products: More products

Download Mobile App




Events

09 Apr 2024 - 12 Apr 2024
15 Apr 2024 - 17 Apr 2024
23 Apr 2024 - 26 Apr 2024

World’s First Approved Hepatitis D Virus Test Introduced

By LabMedica International staff writers
Posted on 06 Sep 2015
Print article
: RoboGene HDV RNA Quantification Kit 2.0 is the first CE-IVD certified kit for diagnostic quantification of Hepatitis delta virus (HDV) RNA
: RoboGene HDV RNA Quantification Kit 2.0 is the first CE-IVD certified kit for diagnostic quantification of Hepatitis delta virus (HDV) RNA (Photo courtesy of ANALYTIK JENA AG)
The first kit with CE-IVD certification for the molecular diagnostic quantification of Hepatitis delta virus (HDV) RNA is now available, thus reaching an important new milestone in standardization of HDV nucleic acid amplification tests.

Quantitative real-time PCR is the method of choice for diagnostics and therapy monitoring due to its outstanding range of sensitivity. Analytik Jena AG (Jena, Germany) now expands its hepatitis diagnostics line with RoboGene HDV RNA Quantification Kit 2.0. “Hepatitis-delta is viewed as one of the most severe forms of the viral hepatitis infection. It is solely connected to a coexisting Hepatitis B virus (HBV) infection and very frequently leads to chronic cirrhosis of the liver in cases of super-infection. We are very proud to have developed, in addition to RoboGene HBV DNA Quantification Kit 2.0, a corresponding diagnostic tool for HDV RNA, and to be the first company to receive CE-IVD certification applying the first WHO Standard for HDV RNA,” said Dr. Ingolf Lachmann, site manager for Analytik Jena subsidiary AJ Roboscreen GmbH (Leipzig, Germany).

Both the HBV and HDV RoboGene kits were validated with nucleic acid samples purified with the INSTANT Virus RNA/DNA Kit developed by another subsidiary, AJ Innuscreen, based on the patented Dual Chemistry (DC) Technology. This allows for simultaneous purification of high-purity viral RNA and DNA from serum and plasma samples, and provides a basis for the excellent output parameters of the RoboGene Hepatitis range of tests.

The combination kit thus offers a unique testing package for HBV positive patients who are additionally infected with HDV. “We will immediately begin to offer the kit, which was developed for routine diagnostics for HBV DNA and HDV RNA, and which involves nucleic acid extraction processes and subsequent detection. We are also working intensively on adapting the kit to Analytik Jena’s current automation platforms,” said Alexander Berka, general manager, Life Science business unit, Analytik Jena.

Related Links:

Analytik Jena


Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
HLX
POCT Fluorescent Immunoassay Analyzer
FIA Go
New
Gold Member
Plasma Control
Plasma Control Level 1
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get complete access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Clinical Chemistry

view channel
Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)

POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection

Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more

Molecular Diagnostics

view channel
Image: MOF materials efficiently enrich cfDNA and cfRNA in blood through simple operational process (Photo courtesy of Science China Press)

Blood Circulating Nucleic Acid Enrichment Technique Enables Non-Invasive Liver Cancer Diagnosis

The ability to diagnose diseases early can significantly enhance the effectiveness of clinical treatments and improve survival rates. One promising approach for non-invasive early diagnosis is the use... Read more

Hematology

view channel
Image: The low-cost portable device rapidly identifies chemotherapy patients at risk of sepsis (Photo courtesy of 52North Health)

POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy

Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections,... Read more

Pathology

view channel
Image: The OvaCis Rapid Test discriminates benign from malignant epithelial ovarian cysts (Photo courtesy of INEX)

Intra-Operative POC Device Distinguishes Between Benign and Malignant Ovarian Cysts within 15 Minutes

Ovarian cysts represent a significant health issue for women globally, with up to 10% experiencing this condition at some point in their lives. These cysts form when fluid collects within a thin membrane... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.