China Gold Supplier for One Step Rapid Diagnostic Test - COVID-19 IgGIgM Diagnostic Rapid Test – Immuno

COVID-19 IgG/IgM Rapid Test Description

IMMUNOBIO COVID-19 IgG/IgM Diagnostic Rapid Test is for detection of IgG and IgM antibodies to COVID-19 virus. Anti-human IgG and anti-ligand are separately coated in the test line region 1 and region 2. During testing, the specimen reacts with COVID-19 antigen-coated particles in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG and the ligand anti-human IgM. COVID-19 IgG or IgM antibodies, if present in the specimen, reacts with the anti-human IgG in region 1 or the ligand anti-human IgM. The complex is captured and forming a colored line in the Test line region 1 or 2.

The Coronavirus COVID-19 IgG/IgM Antibody Rapid Test contains COVID-19 antigen-coated particles. Anti-human IgG and anti-human IgM are coated in the test line regions.

TEST PROCEDURE

Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.

2. Place the test device on a clean and horizontal surface.

For Serum or Plasma Specimens:

Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 10 μL), and transfer the specimen to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 90 mL) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).

For Whole Blood (Venipuncture/Fingerstick) Specimens:

To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 1 drop of whole blood (approximately 10 µL) to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 90 uL) and start the timer. See illustration below.

To use a micropipette: Pipet and dispense 10 µL of whole blood to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer. See illustration below.

Authorized certifications

1. ISO 13485

2. CE

3. China’s white list

Main Advantages

1. It only takes 10-15 minutes to wait for test results

2. Accuracy>98%

3. Easy to operate, no equipment required

4. Simple , time-saving procedure

Company introduction

Hangzhou Immuno Biotech Co., Ltd. is a biotechnology enterprise mainly engaged in production and sales. It was registered in 2014 at Building 2, No. 28, No.3 Street, Hangzhou Economic and Technological Development Zone.The main business of the company is the production and sales of recombinant antigen technology, the development, production and sales of rapid diagnostic reagents, and the import and export of related raw materials products and technologies.

FAQ