|Narottama Tunjung||Plastic Reconstructive and Aesthetic Surgery Division, Department of Surgery, Ciptomangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, 10430, Indonesia|
|Prasetyanugraheni Kreshanti||Plastic Reconstructive and Aesthetic Surgery Division, Department of Surgery, Ciptomangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, 10430, Indonesia|
|Yulia Rosa Saharman||Department of Clinical Microbiology, Faculty of Medicine, Universitas Indonesia, 10320, Jakarta, Indonesia|
|Yudan Whulanza||Department of Mechanical Engineering, Faculty of Engineering, Universitas Indonesia, Kampus UI Depok, West Java, 1625, Indonesia|
|Sugeng Supriadi||Department of Mechanical Engineering, Faculty of Engineering, Universitas Indonesia, Kampus UI Depok, West Java, 1625, Indonesia|
|Mochammad Chalid||Department of Metallurgy and Material Engineering, Faculty of Engineering, Universitas Indonesia, Kampus UI Depok, West Java, 1625, Indonesia|
|Margareth Ingrid Anggraeni||Plastic Reconstructive and Aesthetic Surgery Division, Department of Surgery, Ciptomangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, 10430, Indonesia|
|Agus Rizal A. H. Hamid||Department of Urology, Ciptomangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, 10430, Indonesia address|
|Chaula Luthfia Sukasah|
The coronavirus disease 2019 (COVID-19) pandemic has caused an international shortage of nasopharyngeal flocked swabs, which are one of the main supplies for diagnostic testing. In response to this issue, our institution developed locally made nasopharyngeal swabs. This report aims to provide a clinical evaluation by conducting a sterility test, reverse transcription polymerase chain reaction (RT-PCR) compatibility test, and a user-based survey test of two batches of locally made flocked swabs. Sterility and compatibility tests were conducted at our microbiology laboratory. Participants with clinical suspicion of COVID-19 were scheduled for swab tests using Flocked Swab HS-19 and samples obtained were tested using the RT-PCR method. The cycle threshold (Ct) value of the samples was recorded. A user-based survey was conducted to evaluate the swab stick and flocked-fiber tip performance. The sterility test showed no evidence of bacterial growth on both blood agar and thioglycolate medium. RT-PCR compatibility test from Ct value of 33 samples of the first batch and 30 samples of the second batch was recorded with a mean Ct of 27.17±2.96 and 23.99±2.18, respectively. Six parameters of the swab stick (comfortability, smoothness, flexibility, durability, applicability, and breakpoint performance) showed satisfactory scores with an average of 4.14 out of 5.0 for the first batch and 4.16 for the second batch, while 4 parameters of the flocked-fiber tip (fiber adherence, thickness, symmetricity, and sample collection sufficiency) revealed acceptable scores with an average of 3.6 out of 5.0 for the first batch and 3.75 for the second batch. This study indicates that locally made flocked swabs are satisfactory and clinically applicable for testing and diagnosing COVID-19. Furthermore, mass production and distribution across the country are expected. The development of these swabs, which involved multidisciplinary teamwork and various industrial partners, portrayed a valuable lesson on how to cope with the pandemic through innovation.
COVID-19; RNA extraction; Specimen collection; Swab
The coronavirus disease 2019 (COVID-19) was first reported in China in December 2019. Since then, the pandemic has exploded with more than 6.5 million cases globally and more than 380,000 deaths (National Institutes of Health, 2020). The World Health Organization (WHO) urged all nations to increase the testing for suspected cases in order to mitigate the spread of the virus (WHO, 2020). As a first-line method for diagnosing COVID-19, reverse transcription polymerase chain reaction (RT-PCR) molecular assays remain the gold standard test for the diagnosis of COVID-19 infection with isolated samples from respiratory tract specimens using nasopharyngeal flocked swabs (Ali et al., 2015; Ahn et al., 2020; WHO, 2020).
Indonesia remains in the escalating phase of the COVID-19 curve with 147,211 confirmed cases and 6,418 deaths (until August 20, 2020). The first case of COVID-19 in Indonesia was reported in March 2019 and 1.969.941 specimens have been tested (Kementerian Kesehatan Republik Indonesia, 2020). Moreover, with its 273 million population, Indonesia’s testing ratio in a million stands at 1,703, which is low compared to other countries. The government aimed to increase the daily testing of 20,000 specimens, and currently, there are 110 laboratories across the country that are capable of rapid molecular testing using the RT-PCR method (Maharani, 2020; Berawi, 2020). However, this procedure will involve a significant amount of human resources and diagnostic testing supplies, including the flocked swabs. Due to the increased global demand, flocked swabs are in shortage and the price is skyrocketing (The Organization for Economic Co-operation and Development, 2020). To date, all of the flocked swabs available in the country are imported.
In response to this issue, technology and university-industry collaborations need to be employed (Hanid et al., 2019; Berawi et al., 2020). In conjunction with industrial partners, our institution designed and manufactured a locally made nasopharyngeal swab called “Dacron Swab HS 19,” using food-grade resin material and flocked fiber. Series of tests for the mechanical properties have been conducted by the engineering team after developing the prototype. This study focuses on the clinical evaluation of the flocked swabs as the next step towards their mass production and distribution.
Sterility test, RT-PCR compatibility
test, and user-based survey test, comprising the swab stick performance
(comfortability, smoothness, flexibility, durability, applicability, and
breakpoint performance) and flocked-fiber tip performance (fiber adherence,
thickness, symmetricity, and sample collection sufficiency), were conducted. We
expected that these locally made flocked swabs would be clinically applicable
for testing and diagnosing COVID-19 and mass producing and distributing them
across the country.
To mitigate the spread of the virus, an increase in the testing of COVID-19 is needed for this vastly populated country. However, the pandemic has caused an international shortage of nasopharyngeal flocked swabs. As a result, this has led to the innovation and development of locally made flocked swabs, which involves multidisciplinary teamwork and various industrial partners. This study shows that locally made flocked swabs are satisfactory and clinically applicable for testing and diagnosing COVID-19. Further improvement and refinement are part of a learning process in product development and this report encourages further increase in mass-production and distribution capacity of flocked swabs in response to the pandemic. Future studies comparing locally made and imported flocked swabs are warranted.
Our industrial partners involved in this project: PT Chandra Asri Petrochemical Tbk., Dynapack Asia Pte Ltd, PT Ingress Malindo Venture, PT Langgeng Jaya Fiberindo, PT Sri Tita Medika, PT Indachi Prima, and PT Toyota Motor Manufacturing Indonesia.
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