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
BIO-RAD LABORATORIES

Download Mobile App




First US FDA-Cleared Dengue Test Independently Evaluated for Detection Quality

By LabMedica International staff writers
Posted on 16 Jul 2013
Print article
Image: The dengue virus (DENV) Detect IgM Capture ELISA from InBios (Photo courtesy of Inbios).
Image: The dengue virus (DENV) Detect IgM Capture ELISA from InBios (Photo courtesy of Inbios).
Researchers have now reported results from a first evaluation of the FDA-cleared assay for diagnosis of dengue virus infection in patients with suggestive clinical symptoms.

A study from the laboratory of Prof. Vivek R. Nerurkar at the University of Hawaii at Manoa (UHM; Honolulu, Hawaii, USA) provides the first independently funded evaluation of the InBios "DENV Detect IgM Capture ELISA", a rapid in vitro assay based on technology patented by the US Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA). The assay, produced by Inbios International, Inc. (Seattle, WA, USA), is currently the only commercially available dengue infection assay cleared by the the US Food and Drug Administration (FDA; Silver Spring, MD, USA).

Diagnostic testing for dengue virus (DENV) infection is often time-consuming and complicated. The current study provides a comparative evaluation of the rapid (about five hours) InBios assay and a 2–3 day in-house "gold-standard" assay, and discusses some of the complicating factors. Well-characterized clinical serum samples obtained from 79 dengue-infected patients or suspected cases were performance-tested for qualitative detection of anti-DENV IgM antibodies, mainly in terms of sensitivity and specificity. The serum samples were collected from Hawaii, Vietnam, Niue, Singapore, and American Samoa, where dengue outbreaks have occurred in the past. Samples with equivocal results were repeated in duplicate, and samples that remained equivocal were further examined (e.g., using plaque reduction neutralization test (PRNT) where sufficient sample serum was available). Inclusion of positive as well as negative antigens was critical for interpretation of the results, as they detect background, nonspecific reactivity.

Sensitivity and specificity of InBios ELISA compared to the in-house "gold standard" ELISA were 92% and 94%, respectively. Out of the 79 serum samples tested, 22 samples were positive and 50 samples were negative by using both assays. Levels of agreement as defined by kappa values were also determined and the two assays showed near perfect agreement (κ = 0.87).

Overall, despite the relatively minor limitations of the study itself, the results indicate that the more rapid InBios DENV Detect IgM Capture ELISA is a reliable, sensitive, and specific serological test for detection of acute or recent dengue infections. It can also be used by public health laboratories for rapid confirmation of dengue cases during dengue outbreaks. Both tests show some cross-reactivity with West Nile and other closely related viruses and this must be considered, particularly when working in geographic regions where multiple flaviviruses co-circulate.

This study by Namekar M., et al. was published online ahead of print July 3, 2013, in the Journal of Clinical Microbiology.

Related Links:

UHM Dengue Test Publication Link
University of Hawaii at Manoa
InBios


Platinum Supplier
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Gold Supplier
Rapid Flu Test
Influenza A&B Rapid Test Kit
POCT Fluorescent Immunoassay Analyzer
FIA Go
New
Tick Borne Diseases Test
Savvygen Tick Borne

Print article

Channels

Clinical Chemistry

view channel
Image: A module with eight micro-devices, complete with microfluidic channels and drive motors (Photo courtesy of U.S Department of Energy)

Highly Sensitive pH Sensor to Aid Detection of Cancers and Vector-Borne Viruses

Understanding the acidity or alkalinity of substances through pH measurement is crucial in many fields, from environmental monitoring to healthcare product safety. In many cases, these measurements must... Read more

Molecular Diagnostics

view channel
Image: The PrismRA blood test helps target best treatments for patients with rheumatoid arthritis (Photo courtesy of Scipher Medicine)

Groundbreaking Rheumatoid Arthritis Blood Test Predicts Treatment Response

Rheumatoid arthritis (RA), an autoimmune disease affecting joints and other systems in the body, impacts millions globally. Typically, the initial biologic treatment involves anti-inflammatory drugs from... Read more

Hematology

view channel
Image: The QScout hematology analyzer has received US FDA 510(k) clearance (Photo courtesy of Ad Astra Diagnostics)

First Rapid-Result Hematology Analyzer Reports Measures of Infection and Severity at POC

Sepsis, a critical medical condition that arises as an extreme response to infection, poses a significant health threat. It occurs when an infection triggers a widespread inflammatory response in the body.... Read more

Immunology

view channel
Image: PointCheck is the world’s first device for non-invasive white cell monitoring (Photo courtesy of Leuko Labs)

World’s First Portable, Non-Invasive WBC Monitoring Device to Eliminate Need for Blood Draw

One of the toughest challenges for cancer patients undergoing chemotherapy is experiencing a low count of white blood cells, also known as neutropenia. These cells play a crucial role in warding off infections.... Read more

Pathology

view channel
Image: AI methods used in satellite imaging can help researchers analyze tumor images (Photo courtesy of Karolinska Institutet)

AI Approach Combines Satellite Imaging and Ecology Techniques for Analysis of Tumor Tissue

Advancements in tumor imaging technology have significantly enhanced our ability to observe the minute details of tumors, but this also brings the challenge of interpreting vast amounts of data generated... Read more

Industry

view channel
Image: The acquisition significantly expands Medix Biochemica’s portfolio of IVD raw materials (Photo courtesy of ViroStat)

Medix Biochemica Acquires US-Based ViroStat to Expand Infectious Diseases Antibody Offering

Medix Biochemica (Espoo, Finland), a supplier of critical raw materials to the in vitro diagnostics (IVD) industry, has acquired ViroStat LLC (Portland, ME, USA), a provider of infectious disease antibodies... Read more
Copyright © 2000-2023 Globetech Media. All rights reserved.