Novel Coronavirus COVID-19 IgG/IgM Diagnostic Rapid EKONRPA69

Quick Details

COVID-19 Anti- 2020-nCoV New Coronavirus coronavirus test kit COVID-19 rapid test kit IgM/IgG test TUV Novel Coronavirus COVID-19 IgG/IgM Diagnostic Rapid

Specifications

Novel Coronavirus COVID-19 IgG/IgM Diagnostic Rapid EKONRPA69 PRINCIPLE

The COVID-19 IgG/IgM Rapid Test kit (Whole Blood/Serum/Plasma) is a lateral flow immunochromatographic assay. The test uses anti-human IgM antibody (test line IgM), anti-human IgG (test line IgG) and goat anti-rabbit IgG (control line C) immobilised on a nitrocellulose strip. The burgundy colored conjugate pad contains colloidal gold conjugated to recombinant COVID-19 antigens conjugated with colloid gold (COVID-19 conjugates) and rabbit IgG-gold conjugates. When a specimen followed by assay buffer is added to the sample well, IgM &/or IgG antibodies if present, will bind to COVID-19 conjugates making antigen antibodies complex. This complex migrates through nitrocellulose membrane by capillary action. When the complex meets the line of the corresponding immobilized antibody (anti-human IgM &/or anit-human IgG) the complex is trapped forming a burgundy colored band which confirm a reactive test result. Absence of a colored band in the test region indicates a non-reactive test result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands. Otherwise, the test result is invalid and the specimen must be retested with another device.

TEST PROCEDURE For Serum or Plasma Specimens: Allow test kit, specimen, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing. 1. Remove the test strip/cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour. 2. Place the test kit on a clean and level surface. Strip:Add 2uL of serum/plasma to the sample pad(purple place with Colloidal gold) of the test strip,then add 2 drops (about 60 μL) of sample buffer to the buffer pad (top of the strip) immediately.

Cassette: Add 2uL of serum/plasma to the specimen well(A) of the test cassette, then add 2 drops (about 60 μL) of sample buffer to the buffer well (B) immediately. 3. Wait for the colored line(s) to appear. The result should be read at 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes