get results in 10 minutes independent clinical...
TRANSCRIPT
• Get point-of-care results in as little as 10 minutes• No need for special equipment, training, or laboratory processing• Test using whole blood, blood from a finger-prick, serum, or plasma samples• Get high levels of accuracy and sensitivity, along with low rates of false negatives and positives• Capable of detecting IgG and IgM antibodies to COVID-19 in individuals who are asymptomatic and immune, even months after infection
Collect whole bloodfrom a finger-prick, or aserum or plasma sample
Place collected bloodin the sample well and add
two drops of buffer solutionWait for 10 minutes Read and understand
the results
Key Features
Instructions For Use
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Get ResultsIn 10 Minutes
IndependentClinical Testing
High SpecificityAnd Sensitivity
Beverly Hills, CA 90210 | 1-888-691-4250 | [email protected]
In the absence of any other line,the result for COVID-19 is NEGATIVE
If either IgM or IgG lines appear,or if both lines appear, the result for COVID-19 is POSITIVE
• Botswana• Chile• Colombia• Denmark• Germany
In the absence of a control line “C”, the test is invalid.
Interpretation of Results
Extensive Clinical Testing
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Used Globally
• Greece• India• Indonesia• Israel• Italy
Beverly Hills, CA 90210 | 1-888-691-4250 | [email protected]
Antibody vs. PCR Testing
Antibody TestsThese detect presence of antibodies that are produced in response to a virus, usually collected using a blood sample. Individuals who have strong immune systems can produce IgM antibodies in detectable levels as early as three to five days from the onset of symptoms. Individuals with weaker immune systems may take up to 14 days.
Production of IgG antibodies takes place later. However, these remain in the body for a long time after the passing of the infection. This can be particularly beneficial when testing individuals who might have recovered in the preceding weeks or months.
PCR TestsThese tests detect the presence of viral RNA, usually collected through swab samples from the respiratory tract. Viral RNA is normally found in levels that most PCR tests can detect two to nine days after the onset of symptoms. However, as the immune system kills the virus, viral RNA starts disappearing. Antibody tests typically become more sensitive than PCR tests after around day-eight of the infection.
The Importance of TimingGiven that PCR and Antibody tests provide optimal results within time frames surrounding infection and the onset of symptoms, understanding just when to use each test is crucial. While the tests come with high levels of accuracy and sensitivity, using the wrong one at the wrong time may lead to inaccurate results.
There is no definitive proof that makes one test better than the other. In fact, both provide reliable results and valuable clinical data at varied stages of the infection’s lifecycle. Both tests may lead to false positives or negatives if used at the wrong time, or in an incorrect manner.
Need to Consider Individual VariabilityHow individual immune systems respond depends of factors such as age and overall health. The corresponding diagrams and recommendations rely on general findings of clinical research.
Development of antibodies might take a longer time in immunocompromised individuals. In such instances, PCR tests might produce more accurate results for severe and active infections.
When viral RNA decreases and antibodies increase – usually between day six and day 10 – carrying out both tests might be the way to go. This is because either could produce false negatives owing to low concentrations of antibodies or viral RNA.
As per Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019, businesses are permitted todistribute serological antibody test kits after providing notification to the FDA. Our company and manufacturers have providedthe required notification to the FDA.
We hope we have provided some useful information about COVID-19 testing by highlighting the differences between PCR andAntibody testing, letting you know when you should consider using each test, and how you need to understand the results.
If you wish to place an order or need more information about our kits,please visit our website, or feel free to contact us.
FDA Regulation
1-888-691-4250
www.globalmedsupp.com