General Population Diagnostic
- Allows rapid examination
Hospitals, Physician Offices, Laboratories
- Can be use for a diagnostic of carriers who are asymptomatic
- Can help determine if patient recently affected by virus, even if virus is no longer present
*This test is only approved in a Point-of-Care setting
*CLIA Certificate of Waiver number required for purchase
Frequently Asked Questions
Our Rapid IgM-IgG Combined Antibody Test for COVID-19 is a lateral flow immunoassay used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.
This test should not be used with heat inactivated or other inactivated human specimen (blood, serum, plasma). Fresh samples should be collected and tested immediately.
The test strip contains a colloidal gold-labeled 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. The quality control antibody is fixed on the C line.
Results are read at 10 minutes after sample and buffer are combined in the cassette sample well.
The FaStep COVID-19 IgM-IgG Rapid Test was tested using clinical samples at Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu CDC), Nanjing, China. The COVID-19 IgM-IgG Rapid Test is intended to test IgM and IgG separately. The test was validated against a panel of previously frozen samples consisting of twenty six (26) SARS-CoV-2 antibodies (both IgM and IgG) positive and eighty (80) antibody-negative plasma samples. The antibody-positive samples were collected from clinically-confirmed COVID-19 infected patients and the presence of anti-SARS-Cov-2 antibodies were confirmed with a chemiluminescent IgM and IgG assay (magnetic particles). Within the 26 positive samples, 22 samples tested positive for both IgM and IgG antibodies by FaStep COVID-19 IgM-IgG Rapid Test, 4 samples tested positive for only IgG. All 80 negative specimens were collected from healthy donors and confirmed SARS-CoV-2 antibody negative with both the COVID-19 IgM-IgG Rapid Test and the chemiluminescent IgM and IgG assay. Testing was performed using one lot of the COVID-19 IgM-IgG Rapid Test. Confidence intervals for sensitivity and specificity were calculated per a score method described in CLSI EP12-A2 (2008). The results and data analysis are shown in the tables below.
The FaStep COVID-19 IgM-IgG Rapid Test displayed a combined sensitivity of 100% (95% CI:86.77%-100%) and a combined specificity of 98.75% (95% CI:93.23%-99.97%).
A total of three detection lines are possible, with the control (C) line appearing when sample has been flowed through the cassette.
- Negative Result: If only the quality control line (C) appears and the detection lines G and M are not visible, 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.
The COVID-19 IgM/IgG Rapid Test can be used for a diagnostic of patients suspected of having been affected by the novel coronavirus. However, results of test should not be the only basis for diagnosis.
Results should be used in combination with clinical observations and other testing methods such as nucleic acid PCR test.
COVID-19 IgG/IgM Rapid Test Device
Assure has developed and launched one of the world’s best rapid point-of-care lateral flow immunoassays to aid in the diagnosis of coronavirus infection. The test detects both early marker and late marker, IgM/IgG antibodies in human finger-prick (capillary) or venous whole blood, serum, and plasma samples. The COVID-19 IgM/IgG Rapid Test by Assure. demonstrates a combined sensitivity and specificity of 100% and ~99% respectively, making it one of the most accurate and reliable tests in the world.
Features & Benefits
FaStep Rapid IgM-IgG Combined Antibody Test for COVID-19 is used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.
- Works with whole blood, serum, & plasma
- Tests for both IgM and IgG antibodies
- Validated using PCR
- 10-15 minutes read per test
- Intuitive visual interpretation
- No special equipment needed
How it Works
- Collect blood/serum/plasma sample.
- Add blood/serum/plasma sample to sample well.
- Place 2-3 drops of buffer in sample well.
- Read results after 10 minutes and no more than 15 minutes.
FaStep COVID-19 IgM/IgG Rapid Test Brochure (English/Spanish)
Healthcare Professionals: https://www.cdc.gov/coronavirus/2019-nCoV/guidance-hcp.html
Information for Laboratories: https://www.cdc.gov/coronavirus/2019-nCoV/guidance-laboratories.html
Laboratory Biosafety: https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html
Isolation Precautions in Healthcare Settings: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html
Specimen Collection: https://www.cdc.gov/coronavirus/2019-nCoV/guidelines-clinical-specimens.html
Infection Control: https://www.cdc.gov/coronavirus/2019-
EUAs:(includes links to patient fact sheet and manufacturer’s instructions) https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas