Speeding up infectious disease diagnosis with POC testing

CHEMBIO has developed a new and innovative chromatographic immunoassay technology, the Dual Path Platform (DPP).
Founded in 1985, Chembio Diagnostic Systems Inc. (CHEMBIO) develops, manufactures, licenses, and markets point-of-care (POC) diagnostic tests and technology for the detection of infectious diseases. Larry Siebert, CEO, answers some questions regarding the products and technology.


TMD: How many products does CHEMBIO produce?
Larry Siebert: Our main revenue producers are three rapid HIV tests, though we have several other products close to market launch.


TMD: Tell us about the Dual Path Platform (DDP) POC technology.
Siebert: [DPP] is a patented technology that is an alternative to lateral flow technology and that enables certain performance features such as better performance (sensitivity and specifity) than lateral flow technology, improved ability to develop multiplexed tests, and more efficient use of and better control of samples.


TMD: What needs were there for developing the DPP POC technology?
Siebert: When developing tests using viscous samples, we saw some of the challenges inherent in lateral flow, where samples are combined with a labeling reagent forming a complex that can cause problems with such samples, whether multiplexing is involved, or where greater sensitivity is required.


TMD: Now, looking at the design, manufacturing, and components of the DPP POC, how many components go into the DPP POC?
Siebert: Well you could say three, the test strip, the sample strip, and the housing, but of course there are many components that comprise these items. For example, we use a proprietary conjugation of colloidal gold or latex as our labeling reagent, which itself is comprised of several formulations.


TMD: Was the development/design of the DPP POC done in-house or was a contract manufacturing and design facility used?
Siebert: Development and design was done 100% in-house and was led by our senior vice president of research & development and inventor of DPP, Javan Esfandiari


TMD: What materials are used for the various components?
Siebert: We use nitrocellulose membranes for the main strip that flow the materials, and use other porous substrates for receiving the sample on the separate sample strip and the buffer on the main strip. We also use various plastic injection-molded cassettes that house the strips, [together with] other plastic components.


TMD: What components are sourced for use in the DPP POC?
Siebert: We source all of our components except for the solutions that are printed, sprayed, or dipped onto the porous materials, although these solutions are made in our solutions laboratories with solution ingredients that we source


TMD: What type of machinery is used in the product manufacturing?
Siebert: We use equipment that we established in our industry from companies such as Bio-Dot, Imagene, Kinnematic, and have also had customized assembly equipment made for use by a specialty house that is experienced in our industry.


TMD: Does CHEMBIO offer design and engineering services for OEMs?
Siebert: We have several OEM programs in house from companies and other organizations that do not have the expertise and/or intellectual property rights that are part of our DPP technology capability.


TMD: What advances do you see CHEMBIO delivering five years down the road?
Siebert: We have a very active program of expanding our IP to provide innovative point of care solutions. We see opportunities for more over the counter products, as well as the opportunity to combine our platform with molecular and reader technologies.


TMD: How do you see the medical device market in future regarding the economy and the healthcare issues the country is facing?
Siebert: Accurate and rapid diagnosis can be a very useful tool for empowering patients/consumers, and promoting prevention through providing greater information. Prevention is the most effective long term means of reducing the cost of health care.


Chembio Diagnostic Systems Inc.
Medford, NY
chembio.com