Coronavirus Antibody IgM/IgG Rapid Test Kit
The Shanghai Liangrun Coronavirus Antibody IgM/IgG Rapid Test Kit is a serology test.
It detects the presence in the blood of IgM and IgG antibodies for SARS-CoV-2 (the coronavirus that causes COVID-19). Presence of these antibodies indicates that a person has been exposed to the virus and that their immune system has developed antibodies specifically to combat the disease.
The test is easy to use and needs only a finger-prick sample of blood to give a qualitative yes/no result within 10 minutes.
Implementing rapid screening for COVID-19 offers a tremendous time and cost savings when compared to laboratory screenings and will help to control the spread of the virus by identifying infection rapidly and accurately.
Individual results are available in 10 minutes.
95.14% of cases were correctly diagnosed in a study of 370 patients.
Offers significant cost savings over laboratory methods and gets results in minutes instead of days.
Ease of Storage
Fully self-contained with no refrigeration required.
Easy to Use
Taking the test is easy and results are simple to read.
Portable and can be performed at any location. No special medical equipment is needed.
Stops Viral Transmission
Provides an ideal tool for screening to assist in the control of viral transmission.
Compatible with Whole Blood, Serum and Plasma.
The Shanghai Liangrun Coronavirus Antibody IgM/IgG Rapid Test Kit has obtained international registration certificates and been approved for sale in over 30 countries.
The list of countries to certify the Rapid Test Kit is growing quickly and it is currently undergoing the approval process of the United States FDA.
The Shanghai Liangrun COVID-19 IgG/IgM Rapid Test is being marketed in accordance with the U.S. Food and Drug Administration’s (FDA’s) recent guidance, titled “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.” FDA issued this guidance to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency. This test has not been reviewed by the FDA. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Negative test results should be viewed cautiously, especially for individuals in higher-risk groups like healthcare workers. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E, or past or present infection with SARS virus (no. 6). Distribution is limited to facilities appropriately licensed / certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a. If you need help determining your status, contact our team. Results are for the detection of SARS-CoC-2 antibodies. Laboratories within the United States and its territories are required to report results to the appropriate public health authorities, with the extent of reportable data differing between jurisdictions. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes and may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E, or past or present infection with SARS virus (no. 6). Your healthcare provider will work with you to determine how best to care for you based on the test results along with medical history, and your symptoms. Not for screening of donated blood. At this time, it is unknown for how long IgM or IgG antibodies may persist following infection. Orders for the test should come through properly licensed health care personnel only. Definitions of those authorized to order a test vary between jurisdictions. For in vitro diagnostic use only.