Sep 26, 2020

DOH clarifies use of rapid test kits

“Rapid Antibody-based Test kits (RAT) shall not be used as a stand-alone test to definitively diagnose or rule-out COVID-19 since it can only determine the presence of antibodies and not the viral load itself,” Baquilod said.

The Department of Health’s Center for Health Development MIMAROPA (CHD MIMAROPA) has cautioned local government units on the use of rapid test kits, noting that they are not to be used for detecting COVID-19 on patients.

In a statement, DOH Regional Director Mario Baquilod stressed that Rapid Antibody-based Test (RAT) kits only detect the presence of antibodies in a patient that is useful in fighting coronavirus.

“Rapid Antibody-based Test kits (RAT) shall not be used as a stand-alone test to definitively diagnose or rule-out COVID-19 since it can only determine the presence of antibodies and not the viral load itself,” Baquilod said.

“As of this time, the World Health Organization does not recommend RATs for clinical use but may be used as an adjunct tool to (1) discharge the patient from the isolation or quarantine, (2) determine the prevalence in the country for the purpose of research, and (3) to test patient in the Subgroup D or those patients or healthcare workers who are asymptomatic but with relevant history of travel or exposure,” he said.

The DOH also said that the Reverse Transcription–Polymerase Chain Reaction (RT-PCR) test remains as the “gold standard” in the diagnosis of Coronavirus Disease 2019 (COVID-19).

Baquilod also said that only the Food and Drugs Administration (FDA)-approved and Research Institute for Tropical Medicine (RITM)-validated Rapid Antibody-based Test kits may be used to ensure that the test falls within an acceptable range of quality.

“In light of the high-risk misinterpretation using RDT such as false positive or false negative, we would like to remind everyone that the administration of Rapid Antibody-based Test should be done only by trained health personnel and only medical doctors can prescribe the use and interpret its result. Thus, it cannot be used for mass testing or self-testing,” Baquilod said.

“To safeguard the health of our fellow MIMAROPANs during this difficult times and to ensure access to testing without compromising its quality, we would like to gently remind our local government units and health practitioner to be cautious and be vigilant with the procurement and administration of rapid antibody-based test kits as many companies have been marketing substandard and counterfeit products since the start of COVID-19 pandemic,” he added.

Meanwhile, Baquilod also said that the COVID-19 Testing Laboratory performing Rapid PCR testing has complied with the standard and requirements set by DOH-Health Facilities and Services Regulation Bureau (HFSRB) and RITM.

The laboratory’s license to operate is valid only until August 12, 2020, three months after its release. He said the ONP will undergo re-assessment to determine if an extension in the validity of DOH — LTO is warranted.

“Now that the ONP has already been provided with LTO, they can now commence COVID -19 testing using their GeneXpert machines on May 19, 2020, guided by the DOH RT-PRC guidelines. With this new development in our region, particularly in Palawan, more individuals will now be tested for COVID-19 and the laboratory results can now be released faster. This is one of our strategies to have a full and accurate picture of COVID-19 situation in the province and to immediately take the necessary action,” Baquilod said.

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