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FDA opens application for certification of self-administered COVID tests

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Wena Cos, ABS-CBN News

<div class="embed-wrap"><figure data-feedback="fb:likes,fb:comments"><img alt="https://sa.kapamilya.com/absnews/abscbnnews/media/2021/news/06/04/20210504-covid-swab-test-davao-city-md-01.jpg" src="https://sa.kapamilya.com/absnews/abscbnnews/media/2021/news/06/04/20210504-covid-swab-test-davao-city-md-01.jpg"/></figure></div><p>MANILA (UPDATE) — The Food and Drug Administration (FDA) of the Philippines has opened applications for certification of self-administered or home COVID-19 test kits, amid demand for mass testing as cases of the virus surged anew.</p><p>&quot;I am calling all manufacturers to register their product,&quot; said Dr. Oscar Gutierrez, FDA Deputy Director General in Thursday&#x27;s Talk to the People with President Rodrigo Duterte. </p><p>Cabinet Secretary Karlo Nograles said that these test kits should have &quot;ease of use&quot; and accuracy at the same time, as they will not be administered by expert health professionals. </p><div> </div><ul class="op-related-articles">	<li><a href="https://news.abs-cbn.com/spotlight/01/06/22/covid-19-testing-policy-put-under-the-microscope">READ: COVID testing policy put under the microscope, as omicron sweeps world</a></li></ul><p>“Bago ma-approve, it should be simple to use dahil home test kits, hindi po health care workers, hindi doktor or nurse ang gagawa niyan. So they have to have ‘ease of use’. It has to be accurate,” he said. </p><p>(Before they are approved, they have to be easy to use, and at the same time accurate, because they will not be administered by health care professionals.)</p><p>Self-administered and home COVID-19 test kits are tests that will get samples from individuals orally (through the mouth), and nasally (through the nose). </p><p>Gutierrez clarified that nasal samples are different from nasopharyngeal samples taken in RT-PCR and other swab tests administered by health professionals in that home tests are less invasive and will not reach the pharnyx or the upper part of the throat found behind the nose. </p><ul class="op-related-articles">	<li><a href="https://news.abs-cbn.com/news/01/05/22/doh-adviser-no-link-between-flu-positive-rt-pcr-test">READ: DOH adviser: No, having influenza will not give you a positive RT-PCR result</a></li></ul><p>Alyssa, a marketing manager, sees the possible addition of self-administered and home COVID-19 test kits as a necessary to help people who are in need of testing.</p><p>Alyssa was recently exposed to a COVID-suspect case, and decided to self-isolate to protect members of her household. But because of the high demand in tests, she cannot secure a home service swab test schedule, and would rather not venture out into the public.</p><p>&quot;Yung anxiousness ko na lumabas kasi sa office familiar ka kung sino kasama mo, sa bahay, alam mo kung ano ginagawa nila, saan sila exposed as compared to going to high risk areas. Doon galing &#x27;yung pagiging hesitant ko,&quot; she explained.</p><p>(I got anxious because in the office you know who you&#x27;re with, at home you know what they do and where they are exposed as compared to going to high risk areas. That&#x27;s where my hesitation comes from.)</p><p>Because she has allergic rhinitis, symptoms of which are similar to COVID-19, she said having a cheaper and more accessible alternative to testing would help a lot as she would know how to manage symptoms in case she feels any. </p><p>The backlog in testing has also affected how Alyssa handled her situation. According to her, her co-worker had already begun to feel better, but their COVID-19 RT-PCR test results had yet to be released. </p><p>According to DOH USec. Maria Rosario Vergeire, testing has been affected by the increase in COVID-19 cases. </p><p>&quot;Tumatagal ang paglabas ng laboratory tests dahil sa biglang demand, at &#x27;yung mga health care workers manning our laboratories are getting sick also, so medyo bumaba ang kapasidad ng ating human resources sa laboratories,&quot; Vergeire explained. </p><p>(Laboratory test results take a while to be released because of suden demand and health care workers manning our laboratories are getting sick also, the human resource capacity of our laboratories declined.)</p><p>Once self-administered and home test kits are approved, guidelines on their use will be created by the COVID-19 Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF) and the Department of Health (DOH), said Gutierrez.</p><p>This includes guidelines on the interpretation of the test results, reporting of results, waste disposal, and actions to be taken in the event of a positive result.</p><p>The guidelines may be expected on January 17. </p><p>Department of Health Undersecretary Myrna Cabotaje said that the public&#x27;s cooperation in reporting is integral once self-administered and home COVID-19 test kits become available for commercial use. </p><p>&quot;Kailangan lang sa mga gagawa nito, i-link pa rin nila sa LGU at epidemiology and surveillance unit, kasi ang pakay naman ng testing ay para makita kung sino ang positive at magkaroon ng contact tracing sa mga nahawa o na-expose sa positive case na ito,&quot; she explained.</p><p>(People should still report to their local government units and the epidemiology and surveillance unit, because the point of testing is to identify who is positive and trace those exposed to them.)<br/> </p><ul class="op-related-articles">	<li><a href="https://news.abs-cbn.com/news/01/06/22/manila-city-govt-offers-free-covid-drugs-swab-tests">READ: Manila City gov&#x27;t offers free COVID-19 drugs, antigen and swab tests - mayor</a></li></ul><p>While self-administered and home COVID-19 test kits are yet to be used legally and commercially, Gutierrez assured that there are 89 approved test kits that the public can avail of from accredited testing centers. </p><div class="embed-wrap"><figure data-feedback="fb:likes,fb:comments"><img alt="First page of the List of Other Approved COVID 19 Test Kits for Commercial Use as of 08 APRIL 2021. Find out more at www.fda.gov.ph/fda-covid-19-updates/" src="https://sa.kapamilya.com/absnews/abscbnnews/media/2022/news/01/07/fda.jpg"/><figcaption>First page of the List of Other Approved COVID 19 Test Kits for Commercial Use as of 08 APRIL 2021. Find out more at www.fda.gov.ph/fda-covid-19-updates/</figcaption></figure></div><p>Infectious disease expert Dr. Marissa Alejandria reminded the public that individuals should isolate after each test prior to receiving their results. </p><p>&quot;Ang advise natin sa public is to isolate right away even if with just very mild symptoms, kahit wala pang result, walang test, o wala pang result ang test, isolate, kasi baka mahawa ang buong household,&quot; she said. </p><p>(Our advise to the public is to isolate right away even if with just very mild symptoms, even without results or test yet, isolate because you might infect your entire household.)</p><p>But Alyssa lamented that not everyone has access and can afford these tests and the isolation period necessary while waiting for their results.</p><p>&quot;&#x27;Yung iba hindi afford yun, I can afford it but to a certain extent only, hindi ko sya afford na every day, every week magpapatest ako. Corporate worker ako so I can afford working from home, paano yung mga kailangan lumabas every day?&quot; she said. </p><p>(Others can&#x27;t afford that. I can, only to a certain extent but I can&#x27;t afford to be tested every day, every week. I&#x27;m a corporate worker so I can afford to work from home, how about those who have to go out every day?)</p><p>On Thursday, the Philippines recorded 17,220 new COVID-19 cases, with the country&#x27;s positivity rate to 36.9 percent. </p><div><strong>RELATED VIDEO: </strong></div><figure class="op-interactive"><iframe allow="autoplay; fullscreen" frameBorder="0" height="100%" id="ivsplayer01" scrolling="no" src="https://player.ivideosmart.com/ivsplayer/v4/dist/html/iframe-src.html?iframeid=ivsplayer01&amp;key=e8c22c015ca9eafa76f1e3edfa03c603&amp;spid=3001339&amp;vid=1880992" width="100%"></iframe></figure><div class="iwantbar">Watch more in <a href="//www.iwantv.com.ph/">iWantv</a> or <a href="//tfc.tv/">TFC.tv</a></div><div> </div>

The Philippines will finally begin accrediting self-administered and home COVID-19 test kids, with guidelines on use to follow.

FDA opens application for certification of self-administered COVID tests

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FDA opens application for certification of self-administered COVID tests

Wena Cos,

ABS-CBN News

Published Jan 07, 2022 01:33 PM PHT

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Updated Jan 07, 2022 04:45 PM PHT

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