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加拿大Spectral Diagnostics
The ability to rapidly and accurately make a definitive diagnosis remains one of the biggest challenges faced by healthcare professionals today.

Spectral is dedicated to the accelerated development and commercialization of innovative diagnostic solutions that will improve patient management. Our goals are to provide our customers with unique diagnostic products that will enable them to more rapidly and accurately diagnose their patients, enabling improved outcomes and better utilization of health care resources.

Competitive Advantage

Spectral possesses a breadth of experience in both the clinical diagnostic setting and the laboratory environment. Our competitive advantage is built upon the ability to identify a clinical need and provide rapid and reliable solutions. Spectral's product development cycle includes R & D activities, clinical investigation and validation studies led by an experienced in-house team of protein chemists, molecular biologists, immunologists and clinical scientists.

Products

The EAA? Endotoxin Activity Assay is the first FDA approved diagnostic test in the field of sepsis. Endotoxin is an important biomarker for the rapid identification of patients at risk for sepsis. With the ability to provide this unique diagnostic information within an hour, Spectral’s EAA? continues to expand its International customer base, supported by its Toronto, Canada manufacturing facility.


The RapidWN? West Nile Virus IgM Test is another of Spectral’s innovative products designed to meet the continually changing needs in the world of healthcare. With its flu-like symptoms, the West Nile virus is a rapidly growing healthcare concern, reaching epidemic proportions in some locations. Armed with this unique and rapid assay, physicians can quickly obtain diagnostic information regarding exposure to this potentially deadly virus.


Spectral continues its history of developing high quality, high performance monoclonal antibodies and recombinant proteins. These proprietary reagents are sought after by highly reputable and specialized research groups and commercial organizations worldwide.
 

Commitment to Quality

Spectral has a strong commitment to quality and following The Medical Device Regulations under CMDCAS as mandated by Health Canada, Spectral Diagnostics has received and continues to operate its development and manufacturing facility under cGMP (US 21 CFR Part 820), IS0-9001: 2000 and CAN/CSA ISO-13485-2003 certifications.