COVID-19 IgG/IgM Duo [Quick Diagnosis Kit]

www.medko.co.kr

3 minutes - Fast result  

2 steps - Easy to use  

LIS Connectivity - Data management



FRENDTM COVID-19 IgG/IgM Duo

The FRENDTM COVID-19 IgG/IgM Duo is a point-of-care testing (POCT) which can be used to  check whether patients have developed immune responses to SARS-CoV-2 using human serum or plasma. For COVID-19 IgG/IgM Duo, its detection is based on a fluorescent immunoassay showing QUALITATIVE result. Originally, the FRENDTM System is a quantitative assay and it can  be used to detect additional markers for additional studies.



Clinical Performance Evaluation

The total of 59 clinical specimens (43 positive and 16 negative) confirmed with RT-PCR were tested with the FREND™ COVID-19 IgG/IgM Duo. It shows 93% PPA (Positive Percent Agreement) and 100% NPA (Negative Percent Agreement) 

For specimens collected after day 8 from the onset of symptoms, the FRENDTM COVID-19 IgG/IgM  Duo shows 100% PPA. Therefore, it is recommended to test specimens at a minimum of day 8. A similar tendency was found in another cohort study.



Why serological test is necessary?

Molecular diagnostic kit such as RT-PCR is very useful in detecting the presence of viral genes.  However, this cannot tell whether the person has developed an immune response to SARS-CoV-2.  Therefore, serological test using blood samples is required to detect whether symptoms  developed from infection or the infection was asymptomatic (Centers for Disease Control and Prevention is also developing its own serological test using IgG and IgM).





-Serological test is required to check presence of immune response to SARS-CoV-2.  -Useful source to distinguish symptomatic and asymptomatic patient.





After the onset of symptoms, the sensitivity of positive PCR result showed higher than 90% from  day 1 to day 3. However, it decreased below 80% and 50% on day 6 and day 14, respectively. The combination of PCR with serological test increased the positive sensitivity by 47%.



Using FRENDTM System for Extension Study

Most of the rapid kits only offer test on Serological Diagnostic Kits using IgG and IgM.  However, the FRENDTM System can also be used to manage and assess COVID-19 patient in  secondary infection or comorbidities that could follow using the additional markers, D-dimer, Troponin I, PCT, IL-6, and CRP (C-reactive protein) through QUANTITATIVE detection.

Laboratory Information System Connectivity

In the event of a pandemic, the management of a vast amount of clinical result is important.  However,   many   laboratories   face   the   challenge   in   arranging   the   essential   information effectively. The FRENDTM System which is LIS compatible provide following features:


Paperless
Time-saving
Automatic Data Transfer & Collect
Convenient Data Management
Can Help Monitoring (serosurveillance)