US FDA authorizes first COVID-19 kit for self-testing at home

Robie de Guzman   •   November 18, 2020   •   329

The US Food and Drug Administration (FDA) announced it has approved the first novel coronavirus disease (COVID-19) diagnostic test for self-testing at home.

In a statement issued on Tuesday, the US FDA said it has issued an emergency use authorization (EUA) for the COVID-19 All-In-One Test Kit, made by Lucira Health, for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider.  

The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19, the US FDA said.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” said FDA Commissioner Stephen Hahn.

“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” he added.

The FDA said the test works by swirling the self-collected sample swab in a vial that is then placed in the test unit.

“In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus. Positive results indicate the presence of SARS-CoV-2,” it added.

Individuals with positive results are advised to self-isolate and seek additional care from their health care provider.

While those who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection.

The kit may also be used in point-of-care (POC) settings such as doctor’s offices, hospitals, urgent care centers and emergency rooms for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old.

The test is currently authorized for prescription use only, the FDA said.

FDA warns against purchase, use of certain brands of KN95, surgical masks

Marje Pelayo   •   November 17, 2020

MANILA, Philippines — The Food and Drug Administration (FDA) has warned all healthcare professionals and the general public not to purchase and use medical devices such as protective masks that are not certified by the agency.

In an advisory issued by the Department, these unverified products include the following brands of disposable masks:

Based on the agency’s post-marketing surveillance, the said products were found to lack any product notification certificates from the FDA. 

Thus, the agency cannot assure the safety and quality of these since they have not gone through proper evaluation process.

In addition, the agency warns traders that sale and distribution of unverified products are punishable by law pursuant to Republic Act No. 9711.

All establishments are warned not to sell or advertise these medical device products until they have met regulatory standards. 

According to the Department, it is always best to look for an FDA Notification number on the product label, and check if the product has been notified by using their Embedded Search Feature accessible at www.fda.gov.ph before purchasing such. MNP / Raymund David

Philippines extends VFA abrogation for another 6 months

Robie de Guzman   •   November 11, 2020

MANILA, Philippines – President Rodrigo Duterte has extended anew the suspension of the termination of its Visiting Forces Agreement (VFA) with the United States, Department of Foreign Affairs (DFA) Secretary Teodoro Locsin Jr. said Wednesday.

Locsin said Duterte has decided to extend for another six months the suspension of the defense pact’s termination amid lingering tensions in the South China Sea.

He said the move will enable both sides to “find a more enhanced,  mutually beneficial,  mutually agreeable, and more effective and lasting arrangement  on how to move forward  in our  mutual defense.”

“The past four years have changed the South China Sea from one of uncertainty about great powers’ intentions to one of predictability and resulting stability with regard to what can and cannot be done, what will and will not be acceptable with regard to the conduct of any protagonist in the South China Sea. Clarity and strength have never posed a risk.  It is confusion and indecision that aggravate risk,” Locsin said in a statement addressed to White House National Security Adviser Robert O’Brien.

“A great deal of credit for the renewal of stability and security goes to deft diplomacy, unequivocal expressions of policy, sturdy postures of strength combined with unfailing tact, and pragmatic national security advice exhibited by both our governments in the same period,” he added

Duterte first suspended in June 2020 the termination of the military accord “in light of political and other developments” in the United States.

The VFA came into force in 1999. It outlines the guidelines about the treatment of their troops when visiting the US or the Philippines. It includes provisions on visa and passport policies for US troops and the American government’s right to retain jurisdiction over its personnel, among others.

Duterte ordered the abrogation of the pact last year after the US revoked the visa of a senator and ally.

PHL hopes for shift in US immigration policies under Biden administration

Robie de Guzman   •   November 9, 2020

MANILA, Philippines – Malacañang on Monday expressed hope that immigration policies will change under the administration of United States President-elect Joe Biden.

Presidential Spokesperson Harry Roque said a policy shift in immigration would help undocumented Filipino immigrants to get a legal status in the US.

“Pagdating sa larangan ng immigration, inaasahan po natin na sana magkaroon ng policy shift under democratic administration dahil napakadami pong Pilipino na naninirahan sa Estados Unidos,” Roque said in an online briefing when asked about the Palace’s hopes for a Biden rule.

“Bagaman mayroong ilan sa kanila na tinatawag na TNT (tago nang tago), napakalaki naman po ng papel na ginagampanan nila sa Estados Unidos at mabigyan sana sila ng pagkakataon na maging legal sa Estados Unidos,” he added.

Under the administration of incumbent President Donald Trump, a one-year ban has been imposed on the issuance of nonimmigrant working visas, H-2A, and H-2B for Filipino workers from January 19, 2019 to January 18, 2020 over concerns of overstaying and human trafficking.

An immigration ban targeting many Muslim-majority countries was also imposed by the Trump government.

Biden has reportedly planned to issue executive orders to reverse several Trump policies, particularly those on immigration, climate change and the coronavirus pandemic.

Philippine Ambassador to the US Jose Manuel Romualdez said around 11 million immigrants, including Filipinos, will benefit should the Biden-led US government reforms its immigration policies.

Some 350,000 Filipinos are currently facing deportation cases in the US, he added.

Aside from a shift in immigration policy, Roque said President Rodrigo Duterte is “keeping an open mind” when asked about his stand on the incoming Biden government.

“I think the president is keeping an open mind as he should. It would be a new start but we have no pre-judgement as far as President-elect Biden is concerned,” he said.

Roque previously expressed confidence that the bilateral ties between the Philippines and the US will remain strong despite the outcome of the 2020 presidential elections. RRD (with details from Correspondent Rosalie Coz)

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