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Posted on Tue, Jul 08, 2014

Five critical mistakes when using Biomagnetic Separation in CLIA IVD-kits manufacturing

“Using a high throughput method such as Chemiluminescence is very advantageous for settings such as hospital labs that need to analyze, for example, thousands of patient samples a day. If you want to look at 5-10 analytes per patient, you will be performing tens of thousands of tests daily. This becomes an impossible task using ELISAs or other older techniques, but with high throughput techniques such as automated Chemiluminescent Immunoassays (CLIAs), this task becomes quite doable.”

Dr. Fabrice Sultan

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Chemiluminescence Immunoassay (CLIA) provides a sensitive, high throughput, and economical alternative to conventional colorimetric methodologies, such as Enzyme-linked immunosorbent assays (ELISA). As result of their success, the number of IVD-test based in this technique has exploded. Moreover, anytime a CLIA analyzer is installed in a Hospital or Diagnostic laboratory, the demand increases by tens of thousands of kits by day.

As consequence, the production volume of CLIA-IVD kits has sky-rocketed. The small volume, manual handling, as well as the Quality Control methods used during the development and early production stages become inadequate. Increasing the number of kits to cope with demand implies keeping the consistency between lots, but also raises new concerns related the in-lot consistency due the different scales involved in manufacturing (liters) and final application (less than few hundred of microliters in the analyzer).

Since 2004, SEPMAG® is working with leading IVD companies Production Managers, R&D scientists, Lab Technicians and Quality Assurance personnel to guarantee high performance, well parameterized Biomagnetic Separation Processes.

During these last 10 years developing, manufacturing and marketing Advanced Biomagnetic Systems, we have detected 5 recurrent critical mistakes. These mistakes lead customers to experience project delays, important economic losses and in some cases, they even put the production in risk.

FREE Download: Five critical mistakes in CLIA IVD-kits manufacturing

Provide technical information and training about the Biomagnetic Separation processes is a critical part of out. The better the potential users of our technology understand how to avoid those mistakes, the easier would be for them to benefit from our technology.

During the next weeks we will start reviewing the basics of Biomagnetic Separation processes. Then, using these concepts we will explain with detail the 5 critical mistakes we have identified and how to avoid them.

You can find additional resources on the subject in our Free ebook page, and checking our most recent guide Five critical mistakes when using Biomagnetic Separation in CLIA IVD-kits manufacturing.

 

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