Anti-body COVID-19 rapid test kit detector (Pack of 10)
Specification: 10 piece/kit
- What does the COVID-19 Rapid Test detect? The Biopanda COVID-19 Rapid Test detects IgM and IgG antibodies to the SARS-CoV-2 virus in human whole blood, serum and plasma specimens.
- How soon can the COVID-19 Rapid Test detect an infection? In general, IgM antibodies appear a week after infection, and IgG antibodies appear two weeks after infection. However, we do not have exact data on the dynamics of the antibodies during this virus infection.
- How accurate is this test? To determine the Biopanda COVID-19 Rapid Test’s specificity, it has been continuously assessed using pre-pandemic serum and plasma samples. A sample that gives a positive result for either IgM and/or IgG is considered an overall positive result. Specificity: 99.2% (95%CI*: 98.5 – 99.7%) *Confidence Interval To determine sensitivity, samples were taken from 203 hospitalised patients of varying severity of illness, who were confirmed positive by PCR. Samples were taken at a range of times from onset of symptoms. 36 samples were also taken from asymptomatic patients who did not require hospital treatment.
- Limitations of the test?
- The Biopanda COVID-19 Rapid Test is for in vitro diagnostic use only.
- This test will only indicate the presence of IgM and IgG antibodies to SARS-CoV-2 in the specimen. Neither the quantitative value nor the rate of change of the titre of IgM or IgG antibodies to SARS-CoV-2 can be determined by this qualitative test.
- A negative result does not rule out the possibility of infection. A false-negative result can occur if the test is performed when the antibody titre is below the minimum detection limit, or if the antibodies have not yet appeared at the time of sample collection.
- The level of antibody response can vary significantly between patients. Studies suggest that some patients, particularly those with asymptomatic or mild illness, will not develop an antibody response that is detectable even using highly sensitive lab-based tests. This test has primarily been validated against hospital samples, so the sensitivity when used to test a community population is expected to be lower.
- Where both IgG and IgM lines are present, a false-positive IgM line is possible as a result of cross-reaction with IgG.
- If used as a method for diagnosing current COVID-19 infection, a definitive diagnosis should not be based on results from this test alone. The results must be considered with other clinical information available to the physician.
- What is the cross-reactivity of this test? The Biopanda COVID-19 Rapid Test has been tested with: anti-influenza A virus, anti-influenza B virus, anti-RSV, anti-Adenovirus, HBsAg, anti-Syphilis, anti-H. Pylori, anti-HIV, and anti-HCV positive specimens. The results showed no cross-reactivity with the aforementioned conditions. However, this does not preclude the possibility of cross-reactivity with the SARS or MERS virus.
- Is the COVID-19 Rapid Test Cassette CE marked? Yes the test is CE certified for use by Healthcare Professionals only.