FDA approves 16 rapid test kits for COVID-19

MANILA, Philippines — The Food and Drug Authority (FDA) has approved the use of 16 COVID-19 rapid test kits.

The test kits, which detect antibodies produced by the body in the presence of a virus, have completed the necessary documentary requirements and have undergone review and evaluation, the FDA assured.

“These test kits are independent of each other and each product has different specifications. These are manufactured by different companies in various countries and settings. Each uses a technology and validation technique that may vary from others,” the agency said in a statement on Monday.

It also reminded the public that the test kits are not intended for personal use and should be administered by trained health professionals. Licensed physicians should likewise interpret the test results.

While test kits may give immediate results, confirmatory tests are also still a must, the FDA added.

“It is important to consider the timing of the infection and the condition of the patient during the time of specimen collection,” the agency said.

“The selection of the type of kit to be used is also dependent on the indication, the information the doctor wants to obtain, and the specifications of the kit. Interpretation must be done with caution and clinical correlation,” it added.

FDA Director General Eric Domingo earlier said that the test kits would only detect antibodies produced by the patient and not the virus itself. The patient could have a “false positive” or a “false negative result.”

A false-negative result may occur when the patient that has contracted the coronavirus has not yet produced antibodies when the test was taken, while a false positive result could emanate when there are antibodies detected but it is not for COVID-19.

The kits could be useful in some instances such as testing patients with severe symptoms but have no capability to get tested in the Department of Health (DOH) laboratories, Domingo said.

It can also be used in health centers or clinics in areas where there are suspected outbreaks of the disease, he added.

READ: FDA approves 5 rapid COVID-19 test kits

So far, 6,459 individuals were confirmed to have the COVID-19, 428 of whom have already died, while 613 were able to recover.