FDA approves five rapid test kits

March 30, 2020

The Food and Drug Administration (FDA) approved on Monday five rapid test kits for coronavirus disease 2019 (COVID-19).

In a televised announcement, FDA Director General Eric Domingo announced they have approved four rapid test kits from China and one from Singapore to be used in the Philippines.

"The FDA supports all efforts to address this pandemic. We approve kits that are registered and used in countries with advanced technology and wide experience with COVID-19," said Domingo.

The five rapid test kits are Nanjing Vazyme  2019-nCov IgG/IgM Detection Kkit of Biolidics Limited from Singapore; Novel Coronavirus  (2019 NCOV) IgM/IgG Antibody Detection Kit Collodial Gold Method  of Nanjing Vazyme Medical Technology Co. Ltd. from Nanjing, China; Diagnostic Kit for IgM/IgG Antibody to coronavirus  (SARS-CoV-2) Collodial Gold of Zhuhai Livzon Diagnostic Inc. from Guangdong, China; 2019-nCOV Antibody Test (Collodial Gold) ) Innovita (Tangshan) of Biological Technology Co., Ltd. from Hebei, China; and SARS-CoV-2 Antibody Test  (Lateral Flow Method of Guangzhou Wondfo Biotech Co. Ltd. from Guangzhou, China.

"These point-of-care test kits are registered for use in countries with reliable regulatory agencies such as China and Singapore," said Domingo.

The FDA said  proper guidelines and protocols in its usage must be laid down.Domingo said rapid test kits are not meant to be for personal use of the patient.

"We want the people to have access to testing. But, of course, proper evaluation and safeguards will still be in place," he said.

He said a trained health professional must evaluate and interpret the results.

"We ask doctors to help in testing and guide patients in the interpretation of the results," said Domingo.

He said results of the rapid test kits must not be taken as 100 percent accurate without confirmation.

"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," Domingo said. DMS