An overview of the process and causes of backlog

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With 244,800 tests conducted to date, the Department of Health (DOH), in its May 18 Beat COVID-19 Virtual Presser,  went point by point in discussing the complexities of COVID-19 testing, the wide range of factors affecting its speed and  accuracy, as well as the health and safety of the healthcare workers facilitating the testing process.

Health Undersecretary Dr. Maria Rosario Vergeire was joined by ThinkWell’s Senior Policy Advisor Dr. Maria Eufemia Yap and the Executive Director of the University of the Philippines Manila – National Institutes of Health (UP-NIH) Dr. Eva Maria Cutiongco Dela Paz, who detailed the entire testing process— from specimen collection to data validation and analysis.

ThinkWell is an international health systems development organization that has been instrumental in maximizing the country’s testing strategy by ramping up the capacities of our current subnational laboratories and encouraging the private sector to set up COVID-19 laboratories and train laboratory personnel. The UP-NIH is a licensed COVID-19 laboratory and trains laboratory personnel for biosafety and molecular biology.

“Medyo masalimuot ang proseso ng testing para sa COVID-19. Una sa lahat, kailangan [sa] prosesong ito [ang] nirerekomenda ng WHO — ang RT-PCR methodology,” said  Yap, referring to  the  use  of  Reverse Transcription Polymerase Chain Reaction (RT-PCR) test, the gold standard for COVID-19  testing  worldwide, which remains unequalled to date in terms of accuracy.

According to Yap, COVID-19 testing is a manual process which starts with the arrival of sample specimens in the laboratory. “Tatlong malalaking bahagi po na ginagawa dito. Ang una, pagdating po ng samples sa laboratoryo…kailangan pong i-record ng mabuti ang datos tungkol sa sample na ito. Dapat siguraduhin [pong tama ang] pag-record at pag-label ng mga samples,” she explained.

The samples containing live viruses are unpacked inside a biosafety cabinet which should also be contained and situated inside a biosafety laboratory.

“Ang unang [step sa actual testing] ay ang pag-extract  ng  RNA.  Ito  po  ay  ginagawa  ng  isang  medical  technologist sa loob po ng apat na oras para [makuha nya] ang [komponent] ng virus na siya namang ilalagay sa tinatawag nilang PCR machine,” shared Yap, referring to the ribonucleic acid or RNA extraction process where the presence of the virus is then checked using the PCR machine for two hours.

In total, Yap estimated that it takes eight hours, more or less, to process a single COVID-19  sample  alone.

“Siyempre umiiksi ito kapag medyo sanay na yung ating mga [medical technologists.] Pero hindi po talaga mapapabilis ito sa kadahilanan na dapat may karampatang ingat talaga na kailangan gawin,” she further elaborated.

“Hindi po ito katulad ng nagpapa-test tayo ng sa diabetes o kaya sa cholesterol na pag kinuhanan tayo ng dugo, matapos ilagay sa makina, [at] makalipas ang ilang oras, nariyan na agad ang resulta,” Yap emphasized.

How is biosafety involved in the licensing process of a testing laboratory?

Before a COVID-19 testing laboratory is licensed by the DOH, it undergoes a 5-stage licensing process designed to ensure that the facility and its personnel are capable of handling the specimens without the risk of contamination and further spread of infection.

In going through this process, Dela Paz highlighted that it is not easy for a molecular laboratory to get licensed. According to her, the laboratory must have a safe facility, trained personnel, appropriate equipment, and adequate supply to be licensed.

“Sobrang importante po [nang] prosesong ito because we have to make sure na ligtas ang mga taong gagawa ng test sa loob ng laboratory,”  she  emphasized,  saying  that  the  accreditation  is  not  really  the end of the story. “May kasama pa pong proficiency testing na binibigyan po ang mga  (laboratories)  ng unknown samples ng RITM [na] tama po dapat ang mailabas nilang resulta ng ating mga pasyente na nag-undergo ng RT-PCR testing,” she added.

Dela Paz stressed the importance of biosafety training in assessing, mitigating, and protecting the laboratory personnel, which does not only pertain to the medical technologists processing the tests but also to the laboratory aides who transport the sample from the hospital to the laboratory.

“Kasama po sa mga biosafety training ang disinfection, sterilization, decontamination of materials  before  they are discarded. Lahat po ito ay tinutuunan ng mabuting pansin, tine-train po properly  ang personnel ng sa gayon tayo po ay nasa isang safe environment,” she elaborated.

One of the challenges in ramping up the country’s testing capacity is ensuring a stable supply of RNA extraction kits considering its shortage due to increased global demand.

While some laboratories have the needed machines which could have increased our testing capacity, the specific extraction kit requirement of these machines remains also a challenge.

“Hindi po lahat ng available sa merkado ay pwedeng gamitin ng ilan sa mga laboratoryo natin. Maliban po dun, medyo hirap po tayong kumuha dahil ang karamihan po nito ay inaangkat mula sa ibang bansa. Kung kaya’t nakikikompetensya tayo sa mga ibang bansa na pare-parehong nangangailangan ng kits na ito,” shared Yap.

The current supply is also depleting faster as we establish more swabbing centers and orders to replenish them usually take two weeks to arrive. “Kung mayroon mang kulang ngayon, hindi po pwede pumunta lamang sa tindahan at um-order at mag deliver agad,” she added.

When asked on how the government could possibly resolve these challenges, Yap highlighted the distribution efforts of the entire public sector and the generosity of several private partners who made available their extraction kits especially to provincial laboratories.

According to Yap, the backlog in reporting is a result of multiple factors. One of which is the reporting schedule or the cut-off time. She shared that test results are normally transmitted at the time the machine has not yet finished processing all samples.

“Yung makina po [ng] PCR, meron lang ho yan na 96 na butas pero 44 lang po ang pwedeng gamitin dun sa kadahilanan na meron pa pong kailangan na ilagay na ibang mga sample na pang-verify doon sa mga tine-test,” she explained.

The second factor is the human element. In the absence of an automatic extractor, Yap shared that extraction is done by the laboratory personnel. This according to her requires a certain degree of familiarity without which the process might take time to finish.

“Ikatlong factor ho nito, marami sa LGU [ang] nagsipag-swab na po. Ang dami ng sample so yung ating mga (laboratories) medyo nao-overwhelm din sila sa dami…kaya di rin  sila  nakakatapos,” she also  shared.

When asked for insights on how to possibly resolve these challenges, “Nakikita ko po na sa (pagtutulungan) po ng mga laboratoryo, tapos nandyan po ang DOH…at ang private sector  na  willing  naman pong tumulong sa amin, tingin ko po ay mararating din po at matatapos din po yang  backlog  natin,” Yap said./Stacy Ang

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