KSL and COVID-19
Since its inception, KSL has been engaged in development and regulatory clearance of biomarker detection systems. These have application to COVID-19.
KSL Biomedical has been engaged with the COVID-19 outbreak since January, 2020. Our R&D team has worked closely with public health and biotech industry partners in China, particularly in Guangdong Province, where the highest per capita testing has been achieved outside S. Korea.(1)
Recognizing the need for inexpensive, scalable, effective screening for COVID-19 in China, public health has moved to a diagnostic model incorporating antibody testing.(2)
KSL CLIA Antibody Assays
Our R&D team has integrated COVID-19 antibodies and other biomarkers to assess severity into panel of high-throughput chemiluminescence immunoassays (CLIA). The CLIA instrument platform is capable of processing thousands of outputs per day with high sensitivity and specificity. The associated prognostic biomarkers may aid physicians in triaging positive patients. Specimens utilized are standard sera. This does not require specialized collection materials and methods, and phlebotomy is a safer method of collection than swabs which do not allow for N95 mask personal protective equipment (PPE).
These applications are undergoing validation for regulatory clearance in the United States. Updates regarding test availability will be provided on the KSL Diagnostics website.
In partnership with industry partners, KSL has also aided in development and validation of other diagnostic/prognostic applications, including:
Molecular diagnostics (PCR):
AmoyDx Novel Coronavirus Detection Kit
Point of Care (POCT) antibody assays:
SARS-CoV-2 IgG/IgM POCT lateral flow rapid test
Severe Respiratory Distress (SRD) cytokine panel
KSL continues to seek partners to aid in addressing the COVID-19 outbreak. Please contact us if you or your organization are able to help delivering improved diagnostic solutions to make an impact fighting COVID-19 and manage our transition into a safe post-COVID-19 world.
2. Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Provisional 7th Edition)