How does the U.P.-developed coronavirus detection kit work?

MANILA, Philippines – One of the ways to slow down the spread of the pandemic COVID-19 is to detect it early and fast to enable professionals to provide proper treatment and trace how it might have spread soon enough.

Scientists at the University of the Philippines (UP) have developed a novel COVID-19 detection kit that could help slow down the spread of the disease and at the same time empower hospitals across the country to test suspected patients earlier and better.

In a press conference at the Philippine Genome Center (PGC) in UP Diliman, Quezon City, PGC deputy executive director and COVID-19 test kit lead developer Dr Raul Destura explained that after the Food and Drug Administration (FDA) greenlighted their field validation studies, his team intends to deploy the test kits soon to the respective hospitals across the country.

Among the hospitals that have agreed to be part of the field validation studies are the Philippine General Hospital in Manila, The Medical City in Pasig City, Vicente Sotto Memorial Medical Center in Cebu City, and the Southern Philippines Medical Center in Davao City.

Before a product such as the detection kit labeled as GenAmplifyTM COVID-19 rRT-PCR (rapid reverse transcription-polymerase chain reaction) Detection Kit can be commercialized, it has to undergo two tests: the laboratory performance testing and the field validation study.

Destura and his team have finished the laboratory performance testing and proceeded to apply for a certification for field validation from the FDA.

However, the FDA opted to give the team a Certificate of Exemption in lieu of a product certificate of registration so they could proceed with the field validation studies. The field validation studies are an important phase in testing a medical technology such as the GenAmplifyTM kit as it helps the researchers understand the behavior of the test kit in different locations.

“Ang pagdevelop ng technology kasi may proseso iyan. Hindi p’wedeng bara-bara, hindi p’wedeng shortcut. Our intention is to protect the public by developing the technology na may mga criteria na dapat sundin,” said Destura, adding that it will take them 2 to 3 weeks to complete the sample size they need to carry out a diagnostic clinical sensitivity testing, the final phase before they could take the product to market.

 

(There is a process in developing a technology. We can’t take a shortcut. Our intention is to protect the public by developing the technology with a set of criteria that has to be followed.)

The goal of this phase is to validate the ability of the test to correctly identify those patients with the disease.

All patients who will be tested using the GenAmplifyTM kit will still be tested using the internationally-acquired COVID-19 test kits currently being used by the government. At the same time, the samples will also undergo genome sequencing at PGC to verify the results obtained using the kits.

Genome sequencing

“The purpose of this is to protect the public. I know we need it very badly. But we have the moral responsibility to make sure that the technology we’re putting out there na gawa ng Pinoy, gawa ng Pinoy para sa lahat at para sa buong mundo ang kalidad (that is made by Filipinos for everyone and for the whole world is high-quality technology),” Destura said.

The GenAmplifyTM kit uses the same PCR technology as with other diagnostic kits for other diseases like HIV and hepatitis. Hospitals categorized as tertiary care centers in the Philippines have the capability to use PCR technology.

However, not all hospitals can acquire the GenAmplifyTM. Once commercialized, the institute requesting for the kits must adhere to certain criteria such as the biosafety level of their laboratories to ensure that they will be able to use them.

Destura also explained the procedure for using the test kit:

1. Two types of swabbing are done: nasopharyngeal brushing (done through the nose) and throat swabbing (done through the mouth).
2. The samples obtained are placed in a (viral transport media) solution and placed in a sealed container to avoid contamination.
3. The samples are brought to the laboratory with classification of safety of at least Biosafety Level 2. These laboratories have biological safety cabinets with controlled air to ensure the safety of the medical technologist when opening the sample.
4. RNA material is then extracted from the vials of samples obtained.
5. The RNA material is then mixed with the COVID-19 kit and amplified using the PCR machine.
6. The PCR machine then analyzes the virus content of the sample and prints out a result saying if the sample is negative or positive from COVID-19. The result is expected to come out within one and a half hours.

PCR testing, like the method used in the GenAmplifyTM, is one of the known ways of detecting COVID-19. Similar tests kits have been developed in South Korea, China, and the United States. Other countries employ other methods such as nucleic acid tests and antibody tests (drawing blood samples).

Destura noted that one of the main purposes of developing GenAmplifyTM and deploying them in hospitals across the country is to empower hospitals to be their own testing centers.

“Ang point kasi ng deployment is ma-create ‘yung environment of testing doon sa lugar nila para may empowerment mechanism ang technology. Kasi if we will go for centralized testing, ‘yung logistics talaga is crazy. So kung i-empower natin ang lahat ng ospital who [have] been doing PCR for years, basically, magiging mas malaki ‘yung reach,” said Destura.

(The point of the deployment is to create an environment of testing in their areas for empowerment mechanism and technology. Because if we will go for centralized testing, the logistics will really be crazy. If we empower all hospitals who have been doing PCR for years, basically, we will have greater reach.)

Meanwhile, Philippine General Hospital Director Dr Gerardo Legaspi said that the test kit is a huge help for health care workers as well.

“Ang COVID-19 test will greatly help us in rationalizing. Ibig sabihin, maibibigay natin ang atensiyon sa mga nangangailangan ng atensiyon, at maadvise-an natin ang mga pasyente na hindi naman kailangang nasa ospital,” Legaspi said.

(The COVID-19 test will greatly help us in rationalizing. Meaning, we will be able pay attention to those who need attention, and we can advise patients who don’t need to be hospitalized.)

“Kung available ang test, hindi na kailangang maghintay nung mga malalalang mga sakit kasi nakikita sa buong mundo na maaaring hindi kailangang lahat ng sintomas ay lumabas at ‘di lahat ay kailangan lahat ng factors ay nasasabi para kailangang mag-positive or mag-negative. So, sa pagka napaigi ang pag-screen ng mga pasyente, maaaring iwasan ang pagkalat nito,” Legaspi added.

(If the test is available, we don’t need to wait for severe symptoms, because as seen worldwide, it’s possible that not all symptoms will manifest, and not all factors need to be stated to be positive or negative. So, with better screening of patients, we can avoid the spread of this disease.) – Rappler.com