The SARS-CoV-2 IgM/IgG Antibody Rapid Test is an in-vitro diagnostic immunochromatographic assay used in the detection of SARS-CoV-2 antibodies (IgM and IgG) in whole blood or serum from individuals who are suspected of COVID-19 infection but display little to no symptoms. With only two drops of blood from the fingertip, the test can determine the presence of immunoglobulins IgM and IgG, which are found in the blood of people who have been exposed to the SARS-CoV-2 virus. With clear results in 15 minutes, healthcare professionals can make a quick, reliable diagnosis without the need for a laboratory. Precious time will be saved that will help contain the further spread of the virus. This test is most accurate in detecting antibody levels in patients after at least 14 days after the onset of symptoms.
HOW IT WORKS
When the body is exposed to a virus, the immune system begins to produce antibodies to fight the virus and future infections from it. Those antibodies remain behind after the virus is cleared from the body, which the tests detect. This confirms a previous infection. These tests could be especially useful for determining whether health care workers have some immunity and are at lower risk if they go back to work. Unlike other COVID-19 tests, the CoV-2 Rapid test can also determine current infection phase. A positive IgM value indicates an infection in the early phase of the disease (4 to 10 days), and a positive IgG value indicates a later phase (from 11 - 24 days).
YALE UNIVERSITY STUDY
This Yale University study concluded that this test is suitable for detecting IgM and IgG antibodies to SARS-CoV-2 with high levels of sensitivity and specificity. Test performance is maintained against diverse patient populations and matrices, and in the presence of numerous potentially interfering substances. IgG specificity is near-perfect (99.7-100%) over the entire cohort of 1,892 patient samples. This finding provides reassurance that the studied LFA assay will minimize false positive results. Such false positives are perhaps most problematic from a public health standpoint because they would lead individuals to believe that they are immune or exposed to the virus when in fact they are not. While this LFA cannot predict protective immunity, it can identify people who can be serially assessed for resistance to possible subsequent infection on a population basis. Overall, this LFA shows promise for use as a mobile diagnostic tool, and underscores the potential utility of such a simple and cost-effective assay for cataloging epidemiological data like prevalence and past infection status.
NATIONAL CANCER INSTITUTE (NCI)
As part of a collaboration with the FDA, the National Cancer Institute (NCI) conducted an independent evaluation of COVID-19 Serological Tests at the Frederick National Laboratory for Cancer Research (FNLCR). The evaluation study reported the Biohit SARS-CoV-2 IgM/IgG test kit results had a high level of sensitivity at 96.7% and specificity at 95%. The test was evaluated against "Panel 2", which included frozen SARS-CoV-2 antibody-positive serum samples (n=30) and frozen antibody-negative serum and plasma samples (n=80).
CLINICAL DATA (N = 1,892):
IgM / IgG Specificity (these high rates minimize false positives)
- IgM (97.6% - 100%)
- IgG (99.7% - 100%)
IgM / IgG Sensitivity
- IgM 1-14 days: 45.2%-77.4% (lower sensitivity due to low levels of antibodies at this early stage)
- IgG 1-14 days: 35%-77.4% (lower sensitivity due to low levels of antibodies at this early stage)
- IgM >14 days: 94.1%-100% (higher sensitivity due to more antibodies at this later stage)
- IgG >14 days: 92.4%-100% (higher sensitivity due to more antibodies at this later stage)
5-PK TEST KIT CONTAINS:
- 5 Test cassettes
- 1 Buffer reagent solution bottle
- 5 Sterile lancets
- 5 Capillary samplers
- 5 Alcohol pads
- 1 Package insert
NOTE: For in vitro diagnostic use only
Approved by the U.S. FDA for Emergency Use Authorization (EUA) under the provisions outlined in Section D of Policy for Diagnostic Tests for Coronavirus Disease-2019
European CE certified
Australian TGA approved
- 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
- 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.
ABOUT THE MANUFACTURER
Founded in 1988, Finnish biotechnology company Biohit Oyj develops in vitro diagnostic technology used routinely in clinical laboratories, endoscopy units and practice clinics as well as in academic and clinical research settings to promote early diagnosis. In June 2018, Biohit HealthCare (Hefei) Co. Ltd acquired Finnish Biohit Oyj and became the largest shareholder of the listed company. Biohit Oyj supplies the necessary raw materials and reagents used to produce serology test kits at the ISO 13485-certified manufacturing facility in China. On March 18, 2020, Biohit SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit passed the European CE certification and export qualifications. On June 18th 2020, Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold Method) was granted U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).