Human Corona Virus Disease 2019 (COVID-19) IgG/IgM Lateral Flow Assay Kit (Whole Blood/ Serum/ Plasma)

Catalogue Number: E-HD-C044-ELA

Shelf Life:18 Months
Type:COVID-19 Rapid Diagnostic Kits
Shipping Condition:RT
Unit(s): 41 Tests
Sample type: Serum, Plasma or Whole Blood
Sample size:
Application: LF


Description: Advantages

Easy: No special equipment needed, visual interpretation.

Rapid: Quick sampling by fingertip blood, in 10mins.

Accurate: Results with IgG and IgM respectively, validated with PCR and CT.

Application: Security test with symptoms, mild symptoms, also for testing people without symptoms but with close contact with infected cases

Intended use
This kit is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies specific to SARS-CoV-2 (2019-nCoV) in human whole blood, serum or plasma as an aid in the scientific research of primary and secondary SARS-CoV-2 (2019-nCoV) infections.

Test principle
This kit applies the GICA(Gold Immunochromatography) method for the detection of IgG and IgM specific to SARS-CoV-2 (2019-nCoV) in human whole blood, serum, or plasma. It consists of two test lines, an IgG line and an IgM line, and a control line. The anti-human IgG mouse monoclonal is pre-coated in IgG test line region while the anti-human IgM mouse monoclonal is pre-coated in IgM test line region. And the antimouse IgG goat polyclonal is pre-coated in the control line region.
During testing, the sample reacts with SARS-CoV-2 (2019-nCoV) antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region. If the sample contains IgG antibodies to SARS-CoV-2 (2019-nCoV), a colored line will appear in IgG test line region. In the same way, if the sample contains IgM antibodies to SARS-CoV-2 (2019-nCoV), a colored line will appear in IgM test line region. And if the tested sample does not contain antibodies specific to SARS-CoV-2 (2019-nCoV), no colored line will appear in either of the two test line regions, which indicates a negative result.
To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of sample has been added and membrane wicking has occurred. 

Interfering substances:

1) When the bilirubin concentration is ≤ 250 μmol/L, the hemoglobin content is ≤ 9 g/L, the triglyceride content is ≤ 15 mmol/L, the rheumatoid factor content is ≤ 80 IU/mL, and the antinuclear antibody (ANA) titer is ≤ 1: 240, anti-mitochondrial antibody (AMA) ≤ 80 U/mL, mouse IgG content ≤ 1000 μg/mL, will not interfere with the detection results of this product.

2) Histamine hydrochloride, alpha-interferon, zanamivir, ribavirin, oseltamivir, peramivir, lopinavir, ritonavir, abidol, levofloxacin, azithromycin, Ceftriaxone, meropenem, and tobramycin have been validated to have no effect on the test results of this product.

5. Hook effect: Within the titer range of positive samples of the new coronavirus antibody, the test result of this product does not show a hook effect.

The test results of this product are not affected by the disrupted new coronavirus-specific IgM antibodies.


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