The 60-second rapid HIV test, INSTI, receives innovative technology award.
By Daphne Allen
HIV-positive patients may not always know they are infected. Routine screening has been a challenge, but one potential solution has just won an innovative technology award and a group purchasing contract with one of the largest healthcare services companies in the United States.
In its ongoing effort to enhance patient care and safety, healthcare services company Vizient Inc. has awarded a contract to bioLytical Laboratories Inc. for its INSTI HIV-1/HIV-2 Antibody Test. The point-of-care INSTI test uses immunofiltration flow-through technology, which enables the test to provide results in 60 seconds, reported Eva Siu, senior associate, sales & marketing, bioLytical Laboratories Inc. The test enables detection of HIV in as little as 21 days after infection, according to the company.
“Currently, there are 1.2 million people in the US living with the HIV virus, and 50,000 people become infected each year. One in every eight people who are infected do not know it,” Siu told Qmed. “HIV screening is important to eventually help eradicate the HIV virus.”
However, “one of the biggest challenges has been to offer a convenient, accurate, and easy-to-use method of screening that can be deployed in high-traffic areas like an emergency room or busy clinic,” Siu continued. “The CDC recommends that diagnostic HIV testing and opt-out HIV screening be a part of routine clinical care in all healthcare settings. The recommendations are intended for all providers in all health-care settings including hospital EDs, urgent-care clinics, inpatient services, STD clinics or other venues offering clinical STD services, tuberculosis clinics, correction health facilities and primary care settings.”
INSTI HIV-1/HIV-2 Antibody Test’s rapid results enable it to be used in various healthcare settings. “It enhances patient flow and aids in expedited linkage to care,” Siu said. “Clinical results show sensitivity of 99.8% in fingerstick blood and specificity of 99.5%.”
Siu said the INSTI test is waived under the Clinical Laboratory Improvement Amendments (CLIA), which sets criteria based on complexity levels of tests. “There are three levels of complexity, where the waived status means that the test is simple, low-risk, and can be performed with minimal training that does not require centrifugation of specimens for testing,” she said. “CLIA-waived status allows a product, such as INSTI, to be used in settings such as: community-based organizations, field testing, outreach activities, STD or other clinics, mobile clinics, non-traditional testing, or community/college clinics.
"Results from a prospective study using operators with no laboratory experience resulted in 100% accuracy for sensitivity in fingerstick blood and 99.8 specificity,” Siu reported. The product also has a built-in human IgG procedural control, which ensures that enough sample has been collected and applied to the test to obtain accurate results, she added.
Of the INSTI HIV test, Debbie Archer, director of procurement and leader of Vizient's Innovative Technology program for suppliers, said in the statement: "Due to the number of products and services being released and marketed as 'innovative', member hospitals truly value the thorough innovative technology review process in place at Vizient to help them identify products worth further evaluation at their own facilities. After a full review of the INSTI HIV Test, Vizient's member council agreed this solution offers unique and incremental benefit over other products available on the market today, and recommended it for an Innovative Technology contract. We are pleased to award this new contract to bioLytical."
Daphne Allen is executive editor of Pharmaceutical & Medical Packaging News and a contributor to Qmed. Reach her at firstname.lastname@example.org and on Twitter at @daphneallen
[Image of the 60-second rapid HIV test INSTI courtesy bioLytical Laboratories Inc.]
To learn about the "Next Big Thing" in healthcare, check out this conference at the upcoming BIOMEDevice Boston event on Wednesday, May 3:
"The Next Big Thing: Collaborating in Research, Design, and Development to Create the Future of Healthcare," by speaker Brian Mullen, Innovation Strategy Manager, Brigham Innovation Hub, Brigham and Women's Hospital
- Drowning in Big Data: Extracting Medical Device Quality and Safety Insights - Webcast
- Quality with Confidence – What You Need to Know About Digital Microscopes for Medical Device Quality Processes - Webcast
- Risk Management for Medical Device Manufacturers - Webcast
- 3 Steps for Designing the Ideal Medical Device Packaging System - Webcast
- Reducing Device Cost with Innovative Medical Materials - Webcast
- Automating your Quality Management System: Pitfalls & Essentials - Webcast