COVID-19 antibody test from Abbot gets emergency approval from FDA

Normally, the Food and Drug Administration (FDA) follows an approval process wherein it may take six to 10 months for any medical-related products. However, the ongoing coronavirus health crisis is forcing the government and its agencies to make special exceptions. With many companies now dedicating their resources to develop an effective treatment or vaccine for COVID-19, reliable testing methods are likewise essential. Thus, reports confirm that a new antibody test from Abbott has been cleared for use.

Aside from clinical trials, healthcare experts rely on testing to properly diagnose those who are infected by the coronavirus. Moreover, patients who eventually recover are subjected to another round of tests to ensure that they are no longer contagious. Some of the early testing kits were deemed inaccurate, which is why officials are open to alternatives. Studies show that the former regularly presented false negatives.

What Abbott is offering is a serology blood test using its Alinity i system. The test boasts 100 per cent sensitivity and is 99.6 specific. "Having more options of highly reliable tests across our platforms will help health care workers and health officials as they conduct broad-scale testing for COVID-19," as stated by company CEO Robert Ford.

He then added that "Abbott is a leader in providing antibody testing at large scale on multiple systems, which is helping meet the needs of laboratories as they look to build testing capacity." The company hopes to ship close to 90 million of its new testing kits globally with 30 million due this month and another 60 million in June.

Researchers have been highlighting the importance of mass testing in order for governments to have a comprehensive overview of where everything stands. This is also a clear indicator that shows if the precautionary measures in place have indeed slowed down transmissions. Despite the evident dangers presented by COVID-19, the majority are still adamant when it comes to restrictions.

In the past few weeks, countries that have prematurely lifted their respective lockdowns have reported an upsurge of new COVID-19 cases. Therefore, more testing needs to be done before infections get out of hand. Abbott is just one of the many manufacturers that offer testing kits for SARS-CoV-2.