mLabs® Covid-19 Antigen Test-MBI

COVID-19 is an acute respiratory infectious disease caused by SARS-CoV-2. People are generally susceptible. Most people with COVID-19 have mild symptoms, including fever, fatigue and dry cough, but some people become severely ill. The early diagnosis of COVID-19 is critical because it can greatly increase recovery rates and prevent the spread of diseases.

Micropoint mLabs® COVID-19 Ag test (for mLabs® Smart only) is a microfluidic-based Immunofluorescence assay for rapid qualitative detection of SARS-CoV-2 antigen.

Highlight

· Fast and Multichannel Detection

Qualitative results in 3 minutes and 10 tests every time

· Reliable Platform

Patented microfluidic technology enables more stable specimen flow and more completely immune reactions

· Data connectivity

Various solutions to transfer results to computers, smart phones and the cloud

Components of the kit

· 20 Test Cartridges

· 20 Sterilized Swabs

· 20 Extraction Tubes (with extraction buffer)

· 20 Nozzles with Filter

· 1 IC Card

· 1 Package Insert

Test item	Covid-19 Ag
Sample type	Nasal / throat / saliva swab
Sample volume	7 drops
Test time	3 mins
Storage and shelf life	12 months at 2~30 ºC

Clinical Performance

		RT-PCR
		Positive	Negative	Total
mLabs® COVID-19 Ag	Positive	361	2	363
	Negative	20	466	486
	Total	381	468	849
Sensitivity		94.8%
Specificity		99.6%
Positive Predictive Value		99.5%
Negative Predictive Value		95.9%