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

ACE COVID-19 IgG / IgM Dual Detection Kit

 

ACE COVID-19 IgG / IgM Antibody Rapid Test Kit  | 新型冠狀病毒抗體快篩試片

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

 

  1. 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.
  2. Open the inspection card aluminum foil bag. Remove the test card and place it horizontally on a table.
  3. 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.
  4. 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

ACE COVID-19 Dual Antibody Detection Kit

Pos

26

0

26

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

 

Contact us for more information

 

 

 

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 :

 

 

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