COVID-19 IgG/IgM Rapid Test

New
COVID-19
COVID-19 IgG/IgM Rapid Test

COVID-19 Binding Antibody ( IgM/IgG) Rapid Test

Supplementary indicators to assist clinical diagnosis.

Product Description

    COVID-19 IgM/IgG rapid test is for identify past infections (immune response) for COVID-19 patient. It is suitable for define which stage are patient are and for follow-up recover status. Part of the immune response to infection is the production of antibodies including IgM and IgG.

    According to the FDA, IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. 

    IgG antibodies to SARS-CoV-2 generally become detectable 10–14 days after infection although they may be detected earlier, and normally peak around 28 days after the onset of infection.

Features of Product
Less Sample To Get 2 Test Result in Sametime

Use 10ul serum/plasma through test card can get qualitative results of IgM and IgG antibodies of COVID-19.

Fast

Results available within 15 mins

Clear

Provide clear results that are easy to read

Easy & Reliable 

Require minimal hands-on time

Provide accurate results and includes internal controls

Expected Usage

20 tests each. Suitable for the qualitative detection of Coronavirus (SARS-CoV-2 / COVID-19) S-Protein IgM/IgG antibodies in human serum, plasma.

This product is for in vitro diagnostic use, following guidance from the FDA for Emergency Use Authorizations of tests submitted for approval on March 16, 2020.

This test should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

SPECIFICATIONS

  Sample Types & Volume:10ul of Serum/Plasma

  Method of Detection: Colloidal Gold

  Detection Time: 15~20 mins

  Storage & Shelf Life: 2-35℃, 24 months

  Sensitivity: IgM: 100% , IgG: 100% (After 21 days RTPCR confirmed)

  Specificity: IgM: 100% , IgG: 100% (After 21 days RTPCR confirmed)

  Kit sizes: 20 tests

  Kit Contents: 20 Test Cards, 3ml of Dilution Buffer, 20 pieces of Dropper, Packing Insert

REFERENCES

Jhong-Lin Wu, et al.Four point-of-care lateral flow immunoassays for diagnosis of COVID-19 and for assessing dynamics of antibody responses to SARS-CoV-2,

Journal of Infection,Volume 81, Issue 3, 2020.