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.

LabMedica

Download Mobile App
Recent News Expo Clinical Chem. Molecular Diagnostics Hematology Immunology Microbiology Pathology Technology Industry Focus

Hardy Diagnostics Releases Autobio’s One-Step Test for COVID-19

By LabMedica International staff writers
Posted on 31 Mar 2020
Print article
Image: Autobio’s One-Step Test for COVID-19 (Photo courtesy of Hardy Diagnostics)
Image: Autobio’s One-Step Test for COVID-19 (Photo courtesy of Hardy Diagnostics)
Hardy Diagnostics (Santa Maria, CA, USA), an FDA-licensed manufacturer of medical devices for microbiological testing, has begun accepting orders for a new rapid, one-step lateral flowassay that detects both IgG and IgM antibodies to the SARS-CoV-2 virus. The immunoassay intended specifically for determining the possibility of a COVID-19 infection was developed by Autobio Diagnostics Co., Ltd. (Zhengzhou, Henan, China), a microbiology medical device manufacturer. Hardy Diagnostics has entered into a strategic partnership with Autobio Diagnostics to become a US supplier of the new in vitro diagnostic medical device, Anti-SARS-CoV-2 Rapid Test.

The Anti-SARS-CoV-2 Rapid Test is a rapid, one-step lateral flow assay intended for the presumptive qualitative detection of IgM and IgG antibodies to the SARS-CoV-2 virus in patients suspected of a COVID-19 infection. By using a patient’s finger prick blood, serum, or plasma specimen, the Anti-SARS-CoV-2 Rapid Test offers a turnaround time of only 15 minutes. The simple-to-use test requires no equipment or special expertise or training to implement.

Through their partnership, Hardy Diagnostics and Autobio Diagnostics have begun opening up supply chains to deliver this rapid test to the US. The rapid market deployment of the new in vitro diagnostic medical device was made possible through the FDA Emergency Use Authorization (EUA) program, allowing for its simultaneous commercialization while the product is still under review, which enables Hardy Diagnostics to supply the test during this critical time.

“We are incredibly proud of the work our partners in China have accomplished,” said Andre Hsiung, Director of Technical Services at Hardy Diagnostics. “Because Autobio quickly developed this technology and because the FDA allowed Emergency Use Authorization, we will be able to more effectively leverage our sales network to get this product out to where it is needed the most.”

Related Links:
Hardy Diagnostics
Autobio Diagnostics Co., Ltd.


Gold Member
Flu SARS-CoV-2 Combo Test
OSOM® Flu SARS-CoV-2 Combo Test
Antipsychotic TDM Assays
Saladax Antipsychotic Assays
New
Adenovirus Detection Kit
REALQUALITY RQ-ADENO
New
ELISA System
ABSOL HS DUO

Print article

Channels

Clinical Chemistry

view channel
Image: The new saliva-based test for heart failure measures two biomarkers in about 15 minutes (Photo courtesy of Trey Pittman)

POC Saliva Testing Device Predicts Heart Failure in 15 Minutes

Heart failure is a serious condition where the heart muscle is unable to pump sufficient oxygen-rich blood throughout the body. It ranks as a major cause of death globally and is particularly fatal for... Read more

Molecular Diagnostics

view channel
Image: The FDA clearance for the QIAstat-Dx Respiratory Panel Mini test follows the recent approval of QIAstat-Dx Respiratory Panel Plus (Photo courtesy of QIAGEN)

Respiratory Panel to Help Clinicians Make Precise Treatment Decisions in Outpatient Settings

Respiratory tract infections are the primary reason for visits to emergency departments and subsequent hospitalizations. In the U.S., it is estimated that there are up to 41 million cases of influenza... Read more

Hematology

view channel
Image: QScout CBC will give a complete blood count in 2 minutes from fingerstick or venous blood (Photo courtesy of Ad Astra Diagnostics)

Next Gen CBC and Sepsis Diagnostic System Targets Faster, Earlier, Easier Results

Every hour is critical in protecting patients from infections, yet there are currently limited tools to assist in early diagnosis before patients reach a hospital. The complete blood count (CBC) is a common... Read more

Microbiology

view channel
Image: The InfectoSynovia test has the potential to revolutionize the diagnosis of periprosthetic joint infection (Photo courtesy of 123RF)

High-Accuracy Bedside Test to Diagnose Periprosthetic Joint Infection in Five Minutes

Periprosthetic joint infection (PJI) represents a significant global issue that is worsening as the number of joint replacements increases due to aging populations. In the United States alone, the anticipated... Read more

Pathology

view channel
Image: The new technique allows properties of cancer cells and their surrounding tissue to be analyzed in detail at single-cell level (Photo courtesy of Universität Helsinki/Karolina Punovuori)

New Imaging Method Opens Door to Precision Diagnostics for Head and Neck Cancers

Head and neck cancers, while considered rare, represent a significant portion of cancer cases and have seen a notable increase over the past 30 years. These cancers encompass various malignant tumors that... Read more