Covid 19 test kits Philippines

The Philippines FDA sets new performance requirements for COVID-19 test kits

The Philippines FDA has set new performance requirements for the various types of COVID-19 test kits available on the market in the Philippines with immediate effect.

The PFDA issued Memorandum No. 2021-009 entitled “Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection” on 23rd March 2021 which applies to test kits seeking marketing authorization as well as those that have already been issued with Special Certification by the FDA and are currently placed on the market.

New Minimum Performance Requirements


In the absence of other available standard performance requirements set for COVID-19 test kits used in the screening of SARS-CoV-2 infection, the following minimum performance requirements have been set to ensure the quality of test kits available in the Philippines:

Type of COVID-19 Test Kits for Screening of SARS-CoV-2 Infection

Minimum Performance Requirements


a.   RT-PCR test kits

≥ 95% sensitivity and

≥ 99% specificity

Existing document used by National Regulatory Agencies which prescribe value for used sensitivity and specificity.

b. COVID-19 antibody test kits

>90% sensitivity and >95% specificity

Department Memorandum No. 2020-0439 entitled “Omnibus Interim Guidelines on Prevention, Detection, Isolation, Treatment, Reintegration Strategies for COVID-19”

c.    COVID-19 antigen test kits

≥ 80% sensitivity and

≥ 97% specificity

WHO Interim Guidance entitled “Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays”

These minimum performance requirements shall be revised accordingly when an internationally acceptable reference standard for each type of COVID-19 test kit has been established. 

All COVID-19 test kits that are already certified as well as those which are pending application prior to this memorandum coming into effect must now comply with these specified minimum performance requirements as validated by the Research Institute for Tropical Medicine (RITM). The RITM is the Philippines’ National Reference Laboratory in charge of conducting performance evaluation testing of Covid-19 test kits.

Test kits that have already been issued with Special Certification under FDA Memorandum No. 2020-006 shall benefit from a validity period of six (6) month from the date of this guideline (23rd March 2021). Following this period any affected Marketing Authorization Holders may apply for a re-issuance of their Special Certification following the new minimum performance requirements in the guideline.

All Special Certificates issued upon compliance of the minimum performance requirements stated in the memorandum shall be granted a validity period of one (1) year.

If a test kit fails to meet the minimum performance requirements, the FDA will issue a Notice to the Marketing Authorization Holder (MAH) notifying failed performance of COVID-19 test kits. At which point the MAH must stop distribution and sale of the test kits concerned. The MAH may request a re-evaluation by the RITM within twenty (20) days of receipt of the said Notice.

FDA Memorandum No. 2021-009 entitled “Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection” has immediate effect (date of issuance 23rd March 2021) and shall remain valid unless otherwise revoke, repealed, or rescinded.

Click here to read the full text of FDA Memorandum No. 2021-009. 

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