FDA approves 5 COVID-19 rapid test kits despite accuracy concerns; issues guidelines

Kristine Sabillo, ABS-CBN News

Posted at Mar 30 2020 01:28 PM | Updated as of Mar 30 2020 04:44 PM

Samples are tested for respiratory viruses during a visit of Britain's Chancellor of the Exchequer Rishi Sunak to the pathology labs at Leeds General Infirmary, in Leeds, Britain March 12, 2020. Danny Lawson, Pool/Reuters

MANILA — The Food and Drug Administration (FDA) announced on Monday that it has approved COVID-19 rapid test kits despite the Department of Health’s preference for real-time polymerase chain reaction (RT-PCR) based test kits.

FDA Director General Eric Domingo said they have approved the use of 5 brands of rapid test kits

"We approved kits that are registered and used in countries with advanced technology and wide experience with COVID-19,” he said in a statement.

These are the Nanjing Vazyme 2019-nCoV IgG/IgM Detection Kit, the Novel Coronavirus (2019-NCOV) IgM/IgG Antibody Detection Kit (Colloidal Gold Method), the Diagnostic Kit for IgM/IgG Antibody to Coronavirus (Sars-CoV-2) (Colloidal Gold), the 2019-nCoV Antibody Test (Colloidal Gold) and the SARS-CoV-2 Antibody Test (Lateral Flow Method). The test kits are from China and Singapore.

5-MINUTE TEST

Domingo also announced the FDA’s approval of the SARS Cov2 kit of Gene Xpert, as well as their coordination with Abbott Laboratories, which invented a test that can detect the COVID-19 virus within 5 minutes.

“Both tests were recently approved by the US FDA and can detect the virus in just a few minutes,” Domingo said in Filipino. He said they are awaiting for the production of the said test kits.

Unlike the rapid test kits, this one is PCR-based like the 17 other test kits already approved by FDA for commercial use.

For the past weeks, the FDA has only been approving PCR-based test kits, which the Department of Health considers the “gold standard” for COVID-19 testing. PCR-based test kits are used in laboratories to extract genetic material from throat and nose swab samples to compare it with the COVID-19 virus.

Rapid test kits, on the other hand, only measure the antibodies from a patient’s blood samples.

Domingo said that while the DOH does not believe that rapid test kits can be used for mass screening, it will yield a faster result, making it useful in some cases, such as when there is an immediate need to test a patient with severe symptoms or for communities where there is an outbreak. However, it is not as accurate as PCR-based kits.

During a televised briefing, Doming explained in Filipino that the results of rapid test kits must be interpreted by a health professional.

FDA is requiring all rapid test kits to have the following label: “This product is strictly for medical professional use only and not intended for personal use. The administration of the test and interpretation of results should be done by a trained health professional. Confirmatory testing is required.”

“The body takes time to develop antibodies and this might give a negative result for patients who have been infected but have not yet developed antibodies,” Domingo said.
“A positive result due to cross reaction with other bacteria or viruses is also possible, which is why a confirmatory PCR based test is still required,” he added.

He emphasized that the rapid test kits cannot be used at home as it requires the preparation of a solution and the proper handling of the drug samples. “This is important because blood can be used to transmit diseases like hepatitis or HIV,” Domingo said.

Because of the backlogs due to limited test kits and laboratories, it takes 5 to 7 days to get COVID-19 test results. But the DOH said it will soon go back to 24 to 48 hours once they are done testing backlog samples.

The FDA reminded local government units to be careful with the test kits they are using.

Recently, one mayor posted a photo of the rapid test kits that his LGU purchased for his city. However, the FDA said it cannot be used yet because it has not been approved.

It also called on the DOH to increase the number of laboratories for the PCR-based tests.

“We are also calling on doctors to help and guide in the use of test kits and to properly explain the results to patients,” Domingo said.

The FDA official also warned against fake or unregistered medicine and medical devices.