“With the endorsement from the RITM of the second version of the GenAmplify test kits, the Food and Drug Administration or FDA has issued a certification of validity and reliability. So the distribution of the new test kits under this project will continue,” Science and Technology Secretary Fortunato dela Peña said in an online public briefing before the weekend.
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2nd version of local test kit passes review
Ranier Allan Ronda (The Philippine Star) - July 4, 2020 - 12:00am

MANILA, Philippines  — Science and Technology Secretary Fortunato dela Peña said the department will resume the mass distribution of the second version or second generation GenAmplify rapid novel coronavirus disease 2019 (COVID-19) diagnostic kits after these passed confirmatory tests of the Research Institute for Tropical Medicine (RITM) and DOST’s committee of laboratory experts.

The kits were developed by Marikina City-based health technology startup Manila HealthTek of Dr. Raul Destura.

“With the endorsement from the RITM of the second version of the GenAmplify test kits, the Food and Drug Administration or FDA has issued a certification of validity and reliability. So the distribution of the new test kits under this project will continue,” Dela Peña said in an online public briefing before the weekend.

The distribution was halted early in June due to a contamination issue on the raw materials used in the manufacture of the test kits. This necessitated a new round of validation for the new batch of test kits.

Dela Peña also announced the start last Wednesday of the clinical study of the University of the Philippines-Philippine General Hospital (UP-PGH) on the transfusion of plasma taken from the blood of those who recovered from the disease to treat new COVID-19 cases.

As definite therapy for COVID-19 is still lacking, the project aims to evaluate the efficacy and safety of convalescent plasma transfusion as adjunctive therapy to prevent disease progression among hospitalized coronavirus patients.

Convalescent plasma is taken from the blood of patients who recovered from infection that contains neutralizing antibodies against it.

Jaime Montoya, DOST-Philippine Council for Health Research and Development executive director, said local clinicians already have the expertise on convalescent plasma.

“This was already tried during the SARS epidemic in 2003. And hematologists are familiar with this technology because this just involves harvesting of plasma from patients who have recovered from the natural infection,” Montoya told The STAR.

The UP-PGH team started the call for blood donations from COVID-19 survivors last April. The project will run for 12 months.

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