The Biohit Healthcare SARS-CoV-2 IgM/IgG Antibody Rapid Test is an in-vitro diagnostic test used in the detection of SARS-CoV-2 antibodies (IgM and IgG) in whole blood or serum. 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 with a near perfect specificity (98.8%) and extremely high sensitivity (94.9%).
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. Thus, these tests detect the body's immune response to the infection caused by the virus rather than detecting the virus itself. Serology tests could play a role in the fight against COVID-19 by helping healthcare professionals identify individuals who may have developed an immune response to SARS-CoV-2. 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). In the early days of an infection when the body's immune response is still building, antibodies may not be detected. This limits the test's effectiveness for diagnosing COVID-19 and should not be used as the sole basis to diagnose COVID-19.
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 test 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 simple and cost-effective test shows promise for use as a mobile diagnostic tool, and underscores the potential value for cataloging epidemiological data like prevalence and past infection status.
Download Instructions for Use here.
Download FDA EUA Letter of Authorization here.
YALE UNIVERSITY STUDY
In a recent Yale University study in collaboration with four study sites in China, it was concluded that this test is reliable for detecting IgM and IgG antibodies to SARS-CoV-2 with high levels of sensitivity and specificity. The test results demonstrated a specificity of 97.6% for IgM, 100% for IgG, and sensitivities of 100% respectively for IgM, IgG and total antibodies. These results are very similar to those reported by the manufacturer. This finding provides reassurance that this test will minimize false positive results.
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%
- IgG: 100%
IgM / IgG Sensitivity
- IgM / IgG 1-14 days: 77.4% (lower sensitivity due to low levels of antibodies at this early stage)
- IgM / IgG 14+ days: 100% (higher sensitivity due to more antibodies at this later stage)
TEST KIT CONTAINS:
- 25 Test cassettes
- 25 Capillary samplers
- 1 Buffer reagent solution bottle
- 1 Package insert
MATERIALS REQUIRED BUT NOT PROVIDED:
- Alcohol pad
As of July 16, 2021, the FDA has granted an additional shelf-life extension for this test, from nine months to twelve months. Please view the official statement for more information on expiration dates.
NOTE: For in vitro diagnostic use only
Authorized 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).
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I have been waiting for these tests from the beginning of the pandemic and I’m super happy I can order them on Verboden. Super easy to use and quick results.
They are easy to use and simple to read.