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DOH, FDA set saliva test approval

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The Department of Health (DoH) and the Food and Drug Administration (FDA) are expected to approve this week the use of saliva for testing coronavirus disease (Covid-19).

Dr. Paulyn Jean Ubial, head of Philippine Red Cross Molecular Laboratories, said that the PRC has completed the saliva pilot run required by the DoH and the FDA to secure the certification from the two government agencies.

“We conducted the saliva pilot run as we already finished the research study on saliva and concordance with the swab,” Ubial said.

Ubial added that the Red Cross was able to get 1,080 saliva samples which were used in the laboratory examinations.

“There were nine tested positive for Covid-19, 1,044 tested negative and we conducted re-run on 27 after saliva samples were not read by the machine, so we repeated the tests,” Ubial added.

According to Ubial, the PRC used the same reagent in the swab testing in the experiment conducted for saliva testing.

“We got positive cases of coronavirus. The sensitivity of the reagent used for saliva and the swab testing was the same,” she explained.

She added that aside from the 1,080 sample cases, the DoH also required the PRC another set of experiments which was also compiled by the Red Cross.

“The DoH required that for every 10 individuals who donated their saliva, a swab test will be made on them. All in all, we conducted swab tests on 106 individuals,” Ubial noted.

Ubial said that based on the test conducted by PRC, at least three from the 106 samples tested positive for Covid-19.

“Although our statisticians and doctors are still debating on the issue and we are set to present the findings with the Covid laboratory experts of the DoH, the accuracy rate that we got from the saliva versus the swab testing, is at 98.11 percent,” Ubial added.

Ubial said that aside from the DoH certification, the PRC also sought the approval of the FDA on the saliva test kits.

“We also applied for the FDA registration and we are just awaiting the FDA to certify the kits as applicable for the saliva testing,” she said.

She said that the PRC expects to secure the DoH and FDA certifications this week.

“We hope to get the approval both from the FDA and the DoH,” Ubial added.

The official said that once approved by the DoH, the saliva testing can now be used for the government’s campaign against the coronavirus.

“This is a public domain, in fact, the procedures for this were already published in the paper of the University of Illinois. So, it has no patent and no rights. It is a public document and it can be done by any laboratory,” Ubial stated.

“But the problem there is they must be using the same reagent we are using. If they are using a different reagent, they have to do the validation study that we did. In Illinois, they are using Thermo Fisher. We did not use that, so we have to do the validation study,” she explained.

Ubial said that the saliva test, once approved by the DoH, can now be classified as a gold standard just like the swab testing.

“This would mean cheaper, faster, more convenient alternative which is just accurate as of the swab test,” Ubial said.

 

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