618 Ridgewood AveDaytona Beach

FL 32117 USA

info@covidantibodydiagnostics.us

24/7 Customer Support

+1-855-752-6879

Issues which can occur with antibody testing: Abbott Covid 19

Issues which can occur with antibody testing Learn about the impact of Covid-19 in the world. Get information on concerns / issues surrounding Covid-19 testing kits.  

The COVID-19 pandemic has caused a health crisis of great magnitudes throughout the world. Since emerging in China in December 2019, the virus has spread throughout most states and countries in the world. Apart from being a health crisis, the pandemic has also affected the economies of these nations and is bound to cause further economic devastation. As a result of the disease, hundreds of thousands have lost their lives, and millions have lost their jobs. Countries and states are trying their best to slow down the spread of COVID-19 so as to avoid further devastation. Nations are running tests and trying to treat patients. They are tracing contacts of infected persons, putting travel limits, quarantining their citizens, and other measures intended to curb the spread of the disease. These measures also buy time for doctors to develop vaccines for this disease, which has no known cure yet.

Testing is very crucial in helping to bring the world back to normal. With testing, the governments are able to make guided decisions on how to proceed with the containment of this disease. Two types of tests available for testing whether a person is infected with this viral disease. The first is the viral test which lets you know if you are currently infected. The other test is the antibody test, which tells if you have been infected previously. There are known symptoms that can be an indication that you are infected with the disease. 

Such symptoms include; fevers, coughing, shortness of breath, along many others. These symptoms are different from person to person. Because these symptoms may also indicate, other conditions testing is the only way to ascertain whether you are infected or not. An important detail is that these antibody tests aren’t always able to detect a current infection. That’s because it takes from a week to three weeks after infection, for your body to produce antibodies. 

Abbott COVID-19 Antibody Testing Kits

The FDA is now cautioning you about the reliability of one of the rapid tests used to test for COVID-19. This test is an antibody test developed by Abbott Laboratories and has been linked with a decent number of inaccurate results. Tests giving incorrect results are dangerous, as they may lead you to think that you are not infected. If you then go about interacting with your family because of a false certainty that you are well, you may end up spreading the disease to many people. The FDA is also cautioning about this test because mortalities from this viral disease may increase when people do not seek any medical attention, yet they are infected.

Trump’s administration has been promoting this test as a crucial element in helping to control the coronavirus epidemic in the US. This test is used at the White House for daily testing. NPR was first to report that a shocking 15-20 tests out of every 100 tests are likely to give false-negative results. Another study has indicated that the tests by Abbott Laboratories may be missing up to 48% of COVID-19 infections.

This is what caused the FDA to issue an alert regarding the Abbott rapid test. The agency held a press release where they said that they were investigating if there’s any relationship between these inaccurate negative results and the swabs used, as well as the material in which these samples are stored as they are being transported.

The Food and Drug Administration also cautions that when a negative test does not correspond with the signs and symptoms that you are displaying, it should be backed-up with another test for certainty. Dr. Tim Stenzel, a director in the FDA, has assured that they are evaluating the reports on inaccurate results and communicating with Abbott. They have proclaimed their dedication to studying availed data and working with Abbott Labs to come up with more means of studying the rapid antibody test.

Stenzel has said that this Abbott Labs test can be used to identify COVID-19 positive patients. However, the negative results may have to be subjected to secondary processes to be sure. Press reports say that 15 adverse event reports have been handed over to the FDA regarding the rapid test’s inaccurate results. 

The FDA will continue working with Abbott Labs and monitoring the test’s data. Abbott has agreed to carry out post-market studies, which will include at least 150 persons previously tested positive for the virus. It will be a clinical test.

Following this announcement, the company’s shares dropped by about 3%. Abbott disclosed that the inaccuracies with these rapid tests might stem from how they are stored during transportation. This has prompted the company to direct users only to use samples stored directly inside the machine. Abbott has firmly stood their ground that their tests are accurate. During this pandemic, it has been challenging to test samples precisely and on time. Apart from issues with accuracy, it has been challenging to certify antibody tests in general.

Features of API Covid rapid test kits that make them superior

API COVID-RAPID Covid-19 kits are not the standard rapid test kits. They fill the gap the other test kits have not been able to fill. Here is what makes them unique.

As of May, 23 2020, our API kits show an aggregate of 93.44% Sensitivity & 98.04% Specificity on a sample size of 1,794. Switzerland, Belgium and Harvard showed 100% Specificity and accuracy on approximately 500 patients. 

Most of the test kits in the market have not been able to show accurate results, limiting the determination of the prevalence of the virus in a population. API kits have been shown to possess  100% specificity in the presence of Covid-19 antibodies. The best part is that the API kits capture even asymptomatic cases. That is 6 out of 10 of the cases. 

The kit is also able to capture current and past infections. Note that this is something that different agencies that are tackling Covid-19 are struggling with. This feature can be used as proof of immunity and play a big part in taking Covid-19 management to the next level. 

Paul Singh, MHA, BA

​Covid Antibody Diagnostics​™

A Natures Body Wellness Corporation, Lake Mary FL 32746 

Find us on Google under Antibody Diagnostics

Leave a Reply

Your email address will not be published. Required fields are marked *