Important Notice for Distributors
We, at AdvaCare, have been working around the clock to address this global pandemic, with a special focus on the early detection of COVID-19, to expedite development of our revolutionary testing solution. We stand on the front lines in the fight against novel coronavirus (COVID-19)!
As AdvaCare production lines are running at full capacity to meet demand, delivery times are according to when orders are placed.
Contact us today to Receive Prices, Specifications and Shipment Schedule.
The COVID-19 IgM/IgG Rapid Test is a lateral flow immunoassay test device for the rapid presumptive qualitative simultaneous detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimens from patients suspected of having a SARS-CoV-2 infection by a healthcare provider. Results from the COVID-19 IgM/IgG Rapid Test should not be used as the sole basis for diagnosis. Results for this device must be considered in combination with clinical observations, patient history, epidemiological information, and other relevant diagnostic test results.
In the IgG component of the COVID-19 IgM/IgG Rapid Test, anti-human IgG is coated in the IgG test line region. During testing, the specimen reacts with SARS-CoV-2 antigen-coated particles in the Test Cassette. The mixture then migrates upward on the membrane by capillary action and reacts with the anti-human IgG in the IgG test line region. If the specimen contains IgG antibodies to SARS-CoV-2, a colored line will appear in IgG test line region. In the IgM component of the COVID-19 IgM/IgG Rapid Test, anti-human IgM is coated in the IgM test line region.
During testing the anti-SARS-CoV-2 IgM antibodies, if present in the specimen, react with the SARS-CoV-2 antigen-coated particles in the Test Cassette, and this complex is captured by the anti-human IgM, forming a colored line in the IgM test line region. Therefore, if the specimen contains anti-SARS-CoV-2 IgG antibodies, a colored line will appear in the IgG test line region. If the specimen contains anti-SARS-CoV-2 IgM antibodies, a colored line will appear in the IgM test line region. If the specimen does not contain anti-SARS-CoV-2 antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
IgG and IgM are the first antibodies appearing in the human immune system during infection. Because of their high specificity, when detecting acute COVID-19 infection, IgG and IgM antibodies have the advanages of high sensitivity, early diagnosis, and the ability to judge wheather a suspect is infected.
IgG and IgM antibodies can only be produced after several days of viral infection and differ between individuals.
WHAT MAKES AccuQuik™ COVID-19 RAPID TESTS MORE RELIABLE THAN OTHERS?
AccuQuik™ COVID-19 Rapid Tests utilize ONLY high quality monoclonal antibodies (anti-human IgG and anti-human IgM) in the capture zone of our test. The human antibodies in the blood sample attach to a recombinant antigen (the imitation COVID virus) as the specimen flows up the test strip, therefore creating the visible lines that show results (negative, IgG, IgM). The quality of the monoclonal antibodies used in a test determine the intensity and accuracy of the detection lines.
Firstly, the membrane used in AccuQuik™ COVID-19 Rapid Tests are the highest quality ensuring an even flow of antibodies through the capture zone. Secondly, the quality of antibodies in capture zones equate to a higher probability of catching the antibodies to give accurate line results.
FALSE NEGATIVE RESULTS FROM FALSIFIED CLAIMS
Another issue tainting the image and perceived effectiveness of COVID serology tests (rapid tests) is that many rapid test manufacturers simply are untruthful about the claims of the sensitivity of their tests. Several public and private blind trials conducted on many subpar manufacturers have revealed that sensitivity is lower than claimed, resulting in false negative results. The truth is that quality serology tests are effective and dependable – the problem is not the test itself but rather subpar quality of raw materials utilized by manufacturers attempting to cut costs.
False negative results, the most serious impact of low quality COVID serology tests, are life threatening and we fully support the validation of our tests and further regulation by national authorities to eliminate the use of subpar serology tests.
WHY SENSITIVITY OF A RAPID TEST IS MOST IMPORTANT?
The key to the accuracy of a COVID Rapid Test is SENSITIVITY, which measures how often a test generates a positive result for an infected person, influences how visible the detection lines reflect accurate results. Some people naturally have a lower antibody response, depending on the individual and especially common in asymptomatic infected persons, which will not be detected by COVID Rapid Tests with low sensitivity.
HOW TO DETERMINE SENSITIVITY?
The high sensitivity of the AccuQuik™ COVID-19 Rapid Test reflects the high quality of raw materials we utilize. The superior performance of the AccuQuik™ COVID-19 Rapid Test has been validated through a series dilution of COVID-positive reference samples. During the series dilution study, the IgM and IgG test lines of our test remained visible and the test results positive well beyond that of competing tests.
- For professional in vitro diagnostic use only. Do not use after expiration date;
- Do not eat, drink or smoke in the area where the specimens or kits are handled;
- Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens;
- Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are being tested;
- Humidity and temperature can adversely affect results.