ACE COVID-19 IgG / IgM Dual Detection Kit <img src='/product_image/images/new.gif' alt='new' style='vertical-align:top'>

ACE COVID-19 IgG / IgM Dual Detection Kit

The ACE COVID-19 IgG / IgM Dual Detection Kit provides information about the COVID-19 antibodies in human serum or plasma.

Testing Principles

The ACE COVID-19 IgG / IgM Dual Detection Kit is a lateral flow chromatographic immunoassay which can detect antibodies against the SARS-CoV-2 virus. The test card consists of:

1) Binding pad: colloidal gold-labeled recombinant SARS-CoV-2 (2019-nCoV) antigens and quality control antibody;

2) NC membrane: coated with two Test Lines (G and M lines) and a quality Control line (C line). M-line coated with mouse anti-human IgM monoclonal antibody for detection of SARS-CoV-2 IgM antibodies; G-line coated with mouse anti-human IgG monoclonal antibody for detection of SARS-CoV-2 IgG antibodies; C-line coating with quality control antibody.

Testing Principles of ACE COVID-19 IgG/IgM Rapid Test Kit: The SARS-CoV-2 antibody was detected by IgG/IgM and indirect principle and colloidal gold immunochromatography.

Testing Procedure

If the reagent is stored in a refrigerator at 2-8°C, remove the reagent card and equilibrate at room temperature for more than 30 minutes.
Open the inspection card aluminum foil bag. Remove the test card and place it horizontally on a table.
Use pipette to aspirate sample (serum, plasma or whole blood) and add 10 μl to the sample hole of the test card, and then add 4-5 droplets of sample dilution solution (60~75 μl) immediately.
Read the result at 15min. Results after 20 minutes are invalid.

Use Steps of ACE COVID-19 IgG / IgM Dual Detection Kit

Performance - Clinical Studies

		PCR Comparator*		Total
		Pos	Neg	Total
ACE COVID-19 Dual Antibody Detection Kit	Pos	26	0	26
ACE COVID-19 Dual Antibody Detection Kit	Neg	1	51	52
Total		27	51	78

*Note: Serum and plasma samples were collected from the same patients for serology testing between 1 day and > 45 days after PCR sample collection.

Positive Percent Agreement (PPA)= (Antibody positive)/(PCR positive)

PPA: 96.80% (26/27)

Negative Percent Agreement: (NPA) = (Antibody negative)/(PCR negative)

NPA: 100.00% (51/51)

Performance - Cross-Reactivity

Cross-reactivity		High-risk groups				Total
		Medical staff¹		Suspect symptoms²
		Serum	Plasma	Serum	Plasma
ACE COVID-19 Dual Antibody Detection Kit	POS	0	0	0	0	0
	NEG	69	0	57	6	132
Total		69		63		132

With the now global outbreak of COVID-19, SARS-CoV-2 early diagnostics and infection prevention and control has become critical. ACE Biolabs can provide COVID-19 Total Solutions for Detection and Surveillance :

Download eDM

ACE COVID-19 IgG / IgM Dual Detection Kit 2020/07/07