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 hp
Sign In
Advertise with Us
PURITAN MEDICAL

Download Mobile App




Near-Patient Hepatitis C Assay Validated

By LabMedica International staff writers
Posted on 17 May 2018
Chronic infection with hepatitis C virus (HCV) is a major public health problem, estimated to infect 1.0% of the world’s population (71 million people) and to be responsible for 400, 000 annual deaths as a result of cirrhosis and liver cancer.

A hand-held, portable device that weighs approximately 600 grams or a little more than 21 ounces has been validated as a point-of-care molecular diagnostics system and assay for hepatitis C virus. More...
A new study demonstrated proof of concept for a semi-quantitative assessment of HCV viral load using melting peak ratiometric analysis.

A team of international scientists collaborating with those at the Institute Pasteur (Paris, France) tested 130 clinical plasma and serum samples across three instruments and four operators. Samples were collected from various African countries, including Ghana, Kenya, Mauritius, Mozambique, Nigeria, South Africa, Uganda, and Zimbabwe, as part of routine HCV diagnostic testing using the Abbott RealTime HCV Genotype II on the Abbott m2000.

The team validated the Genedrive HCV point-of-care (POC) assay, which is a two-step procedure requiring a plasma or serum preparation step, followed by a reverse transcription (RT) reaction to generate the complementary DNA (cDNA) from the target HCV RNA. This cDNA undergoes asymmetric polymerase chain reaction (PCR) to generate linear amplification of single stranded products, followed by detection using a secondary hybridization probe and dissociation curve analysis.

The point-of-care assay identified all major HCV genotypes, with a limit of detection of 2,362 IU/mL (95% CI 1966 to 2788). Using 422 patients chronically infected with HCV and 503 controls negative for anti-HCV and HCV RNA, the Genedrive HCV assay showed 98.6% sensitivity (95% CI 96.9% to 99.5%) and 100% specificity (95% CI 99.3% to 100%) to detect HCV. In addition, melting peak ratiometric analysis demonstrated proof-of-principle for semi- quantification of HCV. The test was further validated in a real clinical setting in a resource-limited country.

The authors concluded that they had provided proof of concept in a real-life clinical setting that the Genedrive HCV assay has great potential to provide an affordable and robust instrument for decentralized HCV Nucleic Acid Amplification Testing (NAAT). This highly sensitive and specific test has recently obtained CE-IVD certification and is positioned to enable real-time treatment management of patients with chronic HCV in any clinical setting. The study was published on April 3, 2018, in the journal BMJ Gut.

Related Links:
Institute Pasteur


Gold Member
Quantitative POC Immunoassay Analyzer
EASY READER+
3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler
New
Hand-Held Immunofluorescence Analyzer
WS-Si1500
New
Automated Microscope
dIFine
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get 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








DIASOURCE (A Biovendor Company)

Channels

Molecular Diagnostics

view channel
Image: The RNA-seq based diagnostic test for pediatric leukemia ensures better outcomes for children with this common cancer (Photo courtesy of Qlucore)

RNA-Seq Based Diagnostic Test Enhances Diagnostic Accuracy of Pediatric Leukemia

A new unique test is set to reshape the way Acute Lymphoblastic Leukemia (BCP-ALL) samples can be analyzed. Qlucore (Lund, Sweden) has launched the first CE-marked RNA-seq based diagnostic test for pediatric... Read more

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: A simple blood test could replace surgical biopsies for early detecion of heart transplant rejection (Photo courtesy of Shutterstock)

Blood Test Detects Organ Rejection in Heart Transplant Patients

Following a heart transplant, patients are required to undergo surgical biopsies so that physicians can assess the possibility of organ rejection. Rejection happens when the recipient’s immune system identifies... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.