FDA approves rapid test kits for COVID-19

Maria Rosario Vergeire and Eric Domingo

MANILA, Philippines — The Food and Drug Administration (FDA) approved on Monday the use of five rapid test kits for the new coronavirus but only under the supervision of trained health professionals as these may show false positive or negative results.

The FDA decision came a day after more than 30 business leaders and heads of chambers of commerce proposed the use of rapid test kits to curb the pandemic.

Joey Concepcion, presidential adviser for entrepreneurship, commended the government for fast-tracking the approval of rapid test kits, the same used by other countries in combating COVID-19, the disease caused by the coronavirus.

“To win this war, we have to have a clearer view of COVID-19 in the country. We cannot emphasize enough; it is critical that we do rapid testing now,” Concepcion said in a statement.

“Hopefully, this rapid testing will help prevent another lockdown from happening.”

The Department of Health (DOH) on Monday said the number of COVID-19 cases in the country would further rise in the coming days despite Malacañang’s claim that the lockdown of Luzon had prevented the further spread of the coronavirus disease.

Death toll now 78

As of 4 p.m. on Monday, the confirmed cases nationwide had totaled 1,546, with 128 new ones. The number of patients who recovered remained 42, while the death toll rose to 78, including seven new fatalities.

FDA Director General Eric Domingo said results from the use of the rapid antibody test kits would still need confirmatory testing to verify if the patient really contracted the disease. The test kits just measured the antibodies that a person had developed from an infection and not the coronavirus, he said.

Similarly, a person may be found false negative if testing was done way too early when his body had yet to develop any antibodies against the virus.

“Interpreting the results of these rapid test kits is not simple. This is why it is important that a doctor reads the results so that he could give [the patient] the right advice and guidance on what should be done after the test,” Domingo said.

“Equally important is the confirmatory testing [for positive cases] using the PCR (polymerase chain reaction)-based kits in our laboratories to be certain of the results,” he added.

The PCR-based test is considered the “gold standard” in testing for COVID-19 cases since it is the virus itself that is being detected through swab samples. This, however, can only be done in laboratories and results typically come out within a day or two.

Locally developed test kits

The locally developed test kits will be commercially available starting April 3, according to Science Secretary Fortunato de la Peña. Field validation was expected to be finished by April 1.

Health Undersecretary Maria Rosario Vergeire said the number of cases would still go up because hospitals were expanding their testing capacity and contact tracing was continuing.

Vergeire did not respond to reporters’ queries on the scientific basis of presidential spokesperson Salvador Panelo’s claim that the Luzon quarantine had slowed down the spread of the coronavirus.

On Sunday, Panelo disputed criticisms that the lockdown had been inefficient in curbing the spread of the virus, pointing out that had the government not imposed the measure, “the coronavirus would have an untrammeled leap-frogging from one person to another.”

Backlog

As Luzon enters the third week of the quarantine, Health Secretary Francisco Duque III said the current data was not yet reflective of the real situation, noting the backlog in getting the results of tests done on people suspected of contracting the disease.

“We need to zero out our backlog because it’s not going to be reflective of our actual COVID-19 situation if you still have tests from the past week or two,” he said in a radio interview.

Duque said any decision to continue or lift the lockdown rested on determining the correct status of the COVID-19 situation in the country.

Last Friday, Vergeire said the Research Institute for Tropical Medicine (RITM) had committed to solve in three days its backlog brought about by the surge in cases.

Of those who died on Monday, five are from Metro Manila while two are from Davao City. All of the patients — who are on average 60 years old — neither went abroad recently nor had been exposed to a known positive case.

They either died of acute respiratory failure secondary to community-acquired pneumonia or acute respiratory distress syndrome. Three had preexisting ailments, such as diabetes, hypertension and cardiac disease.

Results after death

Four of the patients knew they were positive for the virus days before their death, while three got results postmortem. The families of the two Davao patients and the one Quezon City patient got the confirmatory results six days after the death of their loved ones.

Apart from the RITM, laboratories that can test for COVID-19 are San Lazaro Hospital, Lung Center of the Philippines and the University of the Philippines’ National Institute of Health in Metro Manila; Baguio General Hospital in Baguio City; Vicente Sotto Memorial Medical Center in Cebu; and Southern Philippines Medical Center in Davao City.

The RITM can conduct up to a thousand tests a day, while the other laboratories can process a total of 200 daily. Results from the RITM typically come out in two to three days.

—WITH A REPORT FROM DEXTER CABALZA