With increasing number of coronavirus cases worldwide, diagnostic capacity of nations and hospitals are under a lot of scrutiny by all the news channels. Reports of insufficient testing kits and false negative results can be seen all over the news. The first test developed by the CDC faced many technical challenges resulting in an acute shortage of diagnostic capacity for COVID-19 in the early weeks of the coronavirus pandemic.
Testing was limited to only people who were highly suspected of having the virus. This only included people showing flu like symptoms with recent travel history to coronavirus afflicted areas. With cases of COVID-19 found in patients who had been refused testing by the CDC as they were ruled out as low risk cases, this strategy of limited testing was found to be flawed and has since been stopped.
Diagnostic Basis for Coronavirus
Reverse transcriptase–polymerase chain reaction (RT-PCR) test is the main diagnostic test developed by the CDC for COVID-19, which identifies the virus’s genetic material in patient’s fluid samples. Although the FDA had not approved this diagnostic test via clinical trials of its efficacy, the FDA sanctioned the test by employing the Emergency Use Authorization (EUA). This provision allows non-approved drugs or devices to be used in cases of emergency such as the coronavirus pandemic.
Since the EUA approval, the RT-PCR test has been shipped to local and state health laboratories across the nation. However, the laboratories found these tests to have many problems with poor testing capacity.
Other tests designed for Coronavirus Diagnosis
The WHO adopted a different test than the test developed by the CDC. The test developed by Robert Koch Institute in Germany was slightly different to the CDC test. This test has faced much less drawbacks than the RT-PCR test developed by the CDC. The CDC developed test has many reports of inconclusive test results with invalid results.
The public health laboratories have requested the CDC for permission to develop their own tests to overcome the technical difficulties from the CDC distributed test kits. Initially, the FDA has permitted laboratories to use their own test kits as long as they get the EUA approval first.
As getting the EUA approval took significant time and the country faced a large deficit of coronavirus test, the FDA has now permitted all state and local public health laboratories to perform their own tests on suspected cases of coronavirus without obtaining a FDA EUA approval, enabling the nation to perform diagnostic tests on all suspected COVID-19 cases.