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Find Out if ATS is the Right Diagnostic Manufacturing Partner for you

Point of care diagnostic (PoC) testing is on the rise and for very good reasons. Having the ability to diagnose as near to the point of care as possible reduces the strain on clinics and hospitals, extends testing to remote communities and people who can not readily access care, results in faster decision making and earlier start of treatment, improves adherence to treatment, and reduces the incidence of complications. Patients with diabetes are by far the largest adopters of PoC diagnostics. Other major applications include; fertility testing, infectious diseases like COVID-19, cardiac markers, cancer markers, and urinary tract infections (UTI). Although laboratory testing offers quantitative, accurate, and robust results, data, and analytics, the convenience and rapid response of PoC testing guarantees that the demand for these products will continue to grow. So how will manufacturers meet this demand?

The form factors for PoC diagnostic tests vary dramatically from very rudimentary test strips like those used for blood glucose testing, to the highly complex microfluidic cartridges and wearable continuous glucose meters, and from single units of use to kits. As a result, the automated solutions for manufacturing tend to be customized and unique. An experienced supplier partner like ATS Life Sciences can help with product design for manufacturability and assembly (DFMA), manufacturing planning, automation design/build/commissioning and qualification, production ramp-up, and on-going services and support. For over 40 years, ATS Life Sciences has been solving product and process assembly problems for medical diagnostic companies. Contact us to learn more.

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Why Would You Choose our Automated Manufacturing Systems?

Our End-to-End Services Offering

Solutions for your PoC Platform

Arriving at an automated manufacturing solution requires a deep understanding of the product, the assembly processes, and the critical-to-quality attributes. But in addition, it is important to keep in mind the economics, schedule, available skill sets, marketing forecast, scalability, flexibility, and so on. There is no one-size-fits-all solution. Working with an automation partner with experience in a variety of PoC product types and designs will ensure that you secure the best solution for your business.

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Many PoC diagnostic tests require sample collection, preparation, and storage. From saliva in tubes to nasal swabs, the various sample components and the diagnostic test are assembled into trays and cartons for ease of use at the point of use. Typical assembly processes to be automated include:

Kits

Feeding/manipulation/orientation/placement of; plastic bottle, eye dropper tips, caps, swabs, droppers, test cartridge/card/chip/strips, trays, product inserts
Bottle filling and capping
Labeling
Cartoning

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This category comprises paper-based platforms that detect and (sometimes) quantify the presence of analytes in samples. Simple LFDs test for a single condition while more complex ones can test for multiple analytes. In some scenarios, the sample needs to be pre-treated (see Kits) while in others it is applied directly to the LFD. Typical assembly processes to be automated include:

Lateral Flow Devices

Feeding/manipulation/orientation/placement of; sample pads, conjugate release pads, adsorbent pads, plastic components
Dispensing
Fastening, bonding or sealing – snap, thread, laser, heat, ultrasonic
Labeling and/or direct printing
Pouching
Inspection

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Although not typically required for the patient, reagent packs are an essential part of many lab instruments. Some reagent packs travel with the sample while others are stored with the lab instrument. Typical assembly processes to be automated include:

Reagent Packs

Feeding/manipulation/orientation/placement of plastic components
Dispensing of reagent(s)
Fastening, bonding or sealing – snap, thread, heat, laser, ultrasonic
Surface treatment – corona, plasma
Labeling
Pouching, traying, or cartoning
Inspection

Automated Solutions for

Point of Care Diagnostics Manufacturing

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With the evolution of microfluidics, micromolding, 3D printing and other technologies, it has become possible to miniaturize the biochemical operations normally handled in the laboratory. Unlike some of the other diagnostic types, these generally require an external analyzer. Typical assembly processes to be automated include:

Lab-on-a-Chip and Micro Total Analysis Systems

Feeding/manipulation/orientation/placement of; plastic components, pre-filled reagent(s), mixing bead(s), filter(s), O-ring(s), spring(s), biosensor(s), valve(s), chip(s), battery(s), desiccant
Dispensing of; reagent(s), silicone, bonding agents
Placement or forming of micropump(s) and valves
Feeding of; foil(s), pad(s), paper(s), membrane(s) substrate(s), label(s)
Fastening, bonding or sealing and curing– snap, thread, heat, laser, ultrasonic
Surface treatment – corona, plasma
Pouching
Functional testing and inspection