FDA Approves five brand of Rapid Antibody Test Kits for COVID-19

In what could be a critical turning point in the country’s battle against the spread of the COVID-19 coronavirus, the Food and Drug Administration (FDA) approved today, March 30, 2020, the use of five (5) brands of Rapid Test Kits for COVID-19.

 “We approve kits that are registered and used in countries with advanced technology and wide experience with COVID 19. We want the people to have access to testing but of course, proper evaluation and safeguards will still be in place,” FDA Director General Eric Domingo said in press statement posted in the FDA website.

According to the FDA Advisory No. 2020-483, approved where the following (with countries of origin): NANJING VAZYME 2019-nCoV IgG/IgM DETECTION KIT (Singapore); NOVEL CORONAVIRUS (2019-NCOV) IgM/IgG ANTIBODY DETECTION KIT (COLLOIDAL GOLD METHOD) (China); DIAGNOSTIC KIT FOR IgM/IgG ANTIBODY TO CORONAVIRUS (SARS-CoV-2) (COLLOIDAL GOLD (China); 2019-nCoV ANTIBODY TEST (COLLOIDAL GOLD) (China); and SARS-CoV-2 ANTIBODY TEST (LATERAL FLOW METHOD (China).

FDA also approved the SARS Cov2 kit by Gene Xpert  from Abbott Laboratories which can detect the virus within 5 minutes. This test kit is PCR based. To date, FDA has approved 17 PCR based test kits for commercial use.

RT SARS-CoV-2Amplification-Kit-with-Vials

As a safety precaution, the FDA shall require the product inserts or label of the Rapid Test Kits to state the following: “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 rapid test kits will yield a faster result compared to PCR based kits, but it is important that a trained health professional will evaluate and interpret the results,” Domingo stressed.

Earlier last week, affiliate chambers of the Philippine Chamber of Commerce and Industry (PCCI) in Mindanao urged President Rodrigo Duterte to ramp up of mass screening of possible COVID-19 cases in the country through the adoption of the Rapid Serologic Test (RST) as a surveillance tool and for the Food and Drug Administration (FDA) to grant Emergency Use Authority to approve the applications for registration of verifiable suppliers of RST Kits that already underwent the registration process with their respective FDAs in their country of origin.

 “We urgently need to check the health of our communities and this is only possible using mass testing in the field. Having statistics of sick patients in the hospital is just too late,” said Ma. Teresa R. Alegrio, PCCI area vice president for Mindanao.

“We need to know actual cases in the field even before they become symptomatic or no longer symptomatic (unknowingly healed) to make targeted decisions before they even get to hospitals,” she added.

PCCI is advocating the immediate rollout of the mass screening program using RST starting with all PUIs awaiting access to PCR testing, all PUMs, vulnerable persons within the vicinity of a cluster of Covid-19 outbreak, and among front liners in the hospital and in the field. Persons who test positive from RST mass screening should also be required to undergo priority confirmatory testing by PCR.

However, the FDA stresses the need for caution in the deployment of rapid test kits which should only be used by certified medical professionals, and called on local government chief executives, heads of agencies, hospitals and private companies to be cautious in using the approved test kits. Further, the agency asked doctors to help in testing and guide patients in the interpretation of the results.

“We have to be very cautious in using these rapid test kits because they measure antibodies and not the viral load itself. The body takes time to develop antibodies and this might give a negative result for patients who have been infected but antibodies have not yet developed antibodies. 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 noted.

Domingo also emphasized the need for the DOH to increase the number of capable laboratories accredited to perform the PCR confirmatory tests.

DOH-10 Regional Director Dr. Adriano Suba-an said they plan to convert the TB (tuberculosis) Reference Center at the DOH compound in Carmen, Cagayan de Oro City into a coronavirus disease COVID-19 testing laboratory during the Regional Inter-agency Task Force for the Management of Emerging Infectious Disease (RIATF-EID) held March 27 in Cagayan de Oro City.

The DOH-10 TB Reference Center has an RT-PCR (real time polymerase chain reaction) equipment that can actually be used for the testing subject to compliance with COVID-19 testing standards and other requirements of the Research Institute for Tropical Medicine (RITM).

The  Indonesian Society of Respirology  (PDPI) has said diagnostic test kits for tuberculosis could be modified and used for COVID-19 since Cepheid, the US-based molecular diagnostics company producing the Xpert TBM/RIF diagnostic kits, has redesigned its Xpress Flu/RSV cartridges so that they can detect the presence of SARS-CoV-2, the virus causing the deadly COVID-19 disease.

Genexpert system with Xpert Xpress SARS-CoV-2 test.

Dr. Faisal Yunus, a member of the PDPI advisory board, said regular tuberculosis diagnostic machines in Indonesia could now detect COVID-19 if their cartridges were replaced with the new redesigned cartridges, Faisal told The Jakarta Post recently.

The technology recently received Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA), and is now approved to run COVID-19 tests in the US.

 “FDA remains steadfast in its obligation to protect the public. Despite the global crisis we are faced with, FDA continues to safeguard public health by ensuring that health commodities, especially those related to addressing the COVID 19 emergency, are certified following regulatory standards – through streamlined processes,” Domingo noted.

“Let us remain vigilant and hopeful as we protect each other’s welfare against those who seem to take advantage of this vulnerable situation. During this rapid increase of COVID-19 cases in the country, the agency continues to serve the people by giving them access to testing without compromising our mandate of ensuring the safety, efficacy and quality of every health product for the public,” he added.

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