COVID-19 SARS-CoV-2 IgG/IgM Rapid Test

  • FDA (Emergency Use Authorization) approved COVID-19 rapid test kit.
  • CE certified. (Declaration of conformity)
  • Accurate (sensitivity/specificity: 93.75%/96.4%) COVID-19 results in 15 minutes. (Analytical test report)
  • Identify early asymptomatic coronavirus infection.
  • Isolate carriers and protect noncarriers immediately.
  • IgG and IgM test, indication of active and post infection.
  • For health care and professional use only.

In stock. Shipping from EU warehouse. 2-3 days shipping service to the US/CA/MX and Europe.

SARS-CoV-2 IgG/IgM Rapid Test

The Cellex IgG/IgM SARS-CoV-2 Rapid Test Kit is an accurate screening test for the diagnosis of COVID-19 (novel coronavirus). It is a rapid test that identifies early and late combined IgG/IgM antibodies of SARS-CoV-2. The IgG/IgM SARS-CoV-2 Rapid Test Kit provides you with results in 15 minutes and allows you to isolate carriers immediately.

coronavirus

Coronavirus human IgM/IgG combined antibody test

Rapid COVID-19 results

IgG/IgM SARS-CoV-2 Rapid Test Kit is for medical professional use only

How to read results

Negative Result 

Only the control (C) line appears, meaning no COVID-19 antibody has been detected. The individual is SARS-CoV-2 negative. 

Positive result

A positive result has two or three colored lines:

  • Either control (C) line and M line
  • Either control (C) line and G line
  • Either control (line), M line, and G line

Control (C) line and M line only

The coronavirus IgM antibody has been detected, and the result is IgM anti-COVID-19 positive.

Control (C) line and G line only

The coronavirus IgG antibody has been detected, and the result is IgG anti-COVID-19 positive.

Control (C) line, M line, and G line

Both coronavirus IgG and IgM antibodies have been detected, and the result is IgG and IgM anti-COVID-19 positive.

Mechanism of COVID-19 rapid kit test. How does it work?

Immunoglobulin M (IgM) is a first-line defense antibody that appears in response to an immune response, generated by exposure to an antigen. It is the largest antibody found in the human body and specifically provides defense against viral infections. Following the IgM antibodies initial action, we produce high-affinity IgG antibodies to establish long-term immunity and immunological memory to the specific virus. Therefore, the presence of IgM antibodies suggests a new or active infection whereas the presence of IgG antibodies suggests a later stage of infection. The Biobase® IgG/IgM SARS-CoV-2 Rapid Test Kit provides you with information regarding both antibodies, suggesting the stage of the infection. 

Schematic diagram of colloidal gold strip

Diagnose novel coronavirus with a rapid test cassette 

Frequently Asked Questions

It is widely accepted that Immunoglobulin M (IgM) provides the first line of defence during viral infections, followed by the generation of adaptive, high affinity Immunoglobulin G (IgG) responses for long-term immunity and immunological memory. Therefore, testing of COVID-19 IgM and IgG antibodies is an effective method for the rapid diagnosis of COVID-19 infection.

  • Detection of IgM antibodies tends to indicate a recent exposure to COVID-19.
  • Detection of IgG antibodies indicates a later stage of infection.

The testing device has a strip, which contains a colloidal gold-labelled recombinant novel coronavirus antigen and quality control antibody colloidal gold marker, two detection lines (G and M lines) and one quality control line (C) fixed on a nitrocellulose membrane. M is fixed with monoclonal anti-human IgM antibody for detecting the novel coronavirus IgM antibody. G is fixed with monoclonal antihuman IgG antibody for detecting the novel coronavirus IgG antibody.

Results are within 15 minutes after the blood sample and buffer have been combined in the testing device’s sample well.

We can confirm that the quality of the immunoassay screen is very high. The medical device contained within our kits has an EC-Declaration of Conformity with the Essential Requirements Annex I of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.

The sensitivity of our immunoassay is 86.8% (IgM), 97.4% (IgG), with a specificity of 98.6% (IgM), 99.3% (IgG).

A total of three detection lines are possible. The control (C) line appears when the sample flows through the testing device cassette.

Negative Result
If only the quality control (C) line appears, then no novel coronavirus antibody has been detected and the result is negative.

Positive Result, M only
If both the quality control line (C) and the detection line M appears, then the novel coronavirus IgM antibody has been detected and the result is positive for the IgM antibody.

Positive Result, G only
If both the quality control line (C) and the detection line G appears, then the novel coronavirus IgG antibody has been detected and the result is positive for the IgG antibody.

Positive Result, G and M
If the quality control line (C) and both detection lines G and M appear, then the novel coronavirus IgG and IgM antibodies have been detected and the result is positive for both the IgG and IgM antibodies.