PCL

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pcl

PRODUCT
Multi-immune source technology-based platform capable of diagnosing various diseases
COVID-19 Total Solutions
Antibody diagnosis COV03
PCL COVID19 IgG/IgM Rapid Gold
Diagnostic kit​​
use
· Antibody diagnostic kit that detects IgG and IgM antibodies for the diagnosis of COVID-19 infection in human capillary blood ​
Performance Summary
· 10-minute qualitative detection of COVID-19 IgG/IgM antibody
· No analyzer required
· IgG : detection limit - 1:20000
· IgM : detection limit - 1:10000 ​
· Clinical sensitivity: 91.06% (112/123, after seroconversion*)
· Clinical specificity: 99.37% (1104/1111, after seroconversion *) ​
How to use: Specimen collection through capillary blood ​
Certification and Supply countries​
• CE Certificate
• Australia TGA
• Russia Federation
• India / Greece
• Bolivia
• MFDS (KFDA)
• FIND Listed
• UNGM Supplier
Exporting to more than 40 countries​
Recommended No. 1 in korea - PCL COVID19 Antibody kit ​
Recommended products by Korean doctors to WHO ​
PCL Rapid Antibody Diagnostic Kit shows equivalent or better performance to products of other companies that have received Emergency Use Authorization (EUA) in the evaluation of the US FDA. ​
The world's best performing diagnostic kit (provided by Seoul C University Hospital)
It was mentioned that the sensitivity of the PCL antibody diagnostic kit was 92.9% and the specificity was 96.2%. ​
*Performance paper of immunodiagnostic kit for rapid detection of IgM and IgG in 2019 coronavirus disease published by users of top university hospitals ​
Comparison with products from other companies that have received EUA​
As a result of the US FDA evaluation, PCL rapid diagnostic kits all proved excellent performance in sensitivity, specificity, PPV, NPV, and etc (refer to the yellow-green bar shown in the graph above).
Comparison with products of other companies that have applied for EUA ​
As a result of the US FDA evaluation, PCL rapid diagnostic kits demonstrated excellent performance in sensitivity, specificity, PPV, and NPV (refer to the graph above).