Realizing Medical Device Independence, Indonesia Launches A COVID-19 Test With Saliva

JAKARTA - The government continues to encourage Indonesia to achieve self-sufficiency in medical devices. After previously issuing a COVID-19 health test with a breath or GeNose, now Indonesian researchers are bringing back the COVID-19 test using saliva. PT. Kalbe Farma Tbk (Kalbe) launched a Saliva Test Kit created by Indonesian researchers to detect COVID-19. Unlike the Polymerase Chain Reaction (PCR) test swab which uses swab samples from the back of the throat (nasopharynx) and back of the nose (oropharynx), the saliva test only requires a small sample of saliva. The COVID-19 test with this saliva sample uses the RT-LAMP method. which can specifically detect the nucleic acid which is the genetic material of the SARS CoV-2 virus. The results were similar to those with the RT-PCR. Director of PT. Kalbe Farma Tbk Sie Djohan claims the test results are accurate and relatively more comfortable when used compared to RT-PCR. Not only that, he said, this test can easily be done in laboratories or clinics in general. Because only using relatively simple equipment. Djohan said that sampling can be done independently. This means that users can put their own saliva samples in the tube that will be provided. So there is no need to use experts to take samples such as the RT-PCR test. "The accuracy is also very good. Because RT-LAMP also uses the same technology, namely the same molecular test as RT-PCR which is detected with nucleic acids instead of proteins and Our test has been validated, compared to RT-PCR with relatively similar accuracy," he said in a virtual press conference, Friday, March 19.

The quick results of the COVID-19 saliva test

Djohan said that the advantages of this test compared to the RT-PCR test are that the results obtained can be faster, not more than 24 hours and there is no need to wait for many samples first to be processed in the laboratory. "It can be done in a matter of fewer than 2 hours. There is no need to wait for samples, for RT-PCR we wait for quite a lot of samples first. We don't need to do that. One or two, we can immediately do it, the tests are run without having to be fulling first. This makes the test much faster," he explained. Djohan said that the COVID-19 health test is 100 percent of the work of the nation's children developed at the Sten Cell and Cancer Institute, which is a research unit at Kalbe Farma. "It is hoped that this innovative test can help accelerate and expand the need for screening, identification, and testing or contact tracing," he said.

Safe for children

IVD Division Research Manager for Stem Cell and Cancer Institute, Akterono D. Budiyati, said the presence of this innovative test could be a very good choice because it has high accuracy performance, with a sensitivity of 94 percent and a specificity of 98 percent. Based on a study from the Yale School of Public Health, said Akte, levels of the COVID-19 virus in saliva, comparable to that of a nose or mouth swab. He also conveyed that Saliva specimens from 20 positive individuals with COVID-19 could be stored at room temperature or 19 degrees Celsius for up to 5 days. "Saliva samples do not require special tools and do not pose a risk of vomiting or sensitive nose, which makes it very easy for children, People who are hypersensitive and are the right choice when fasting is approaching, "he said. Furthermore, Akte said that his party was conducting research on the COVID-19 test with saliva starting mid-2020. The test kits were able to distinguish individuals infected with SARS-CoV- 2 with those who did not experience an infection. Meanwhile, the Director of PT. International Innolab Sains (KALGen Innolab) Henry Sukardi said that this test can be used by anyone from children to adults. However, Henry advised those who want to use this COVID-19 medical test kit, fast first for 30 minutes so that get more accurate results. "Who can use it? As long as the patients are able to produce saliva, it can be examined," he said.

Cheaper than the RT-PCR test

Director of PT. Innolab Sains Internasional (KALGen Innolab), Henry Sukardi said that to carry out the COVID-19 saliva test, the public had to pay Rp. 488,000. However, he said, there was a special price until March 31, 2021, where people only need to pay as much as Rp. IDR 400,000. With this price, this test is considered more economical. "Compared to the price of PCR, especially those with same day services, this price is very much more efficient (only Rp. 400 thousand)," he said. Henry said this COVID-19 test kit with saliva will be sold. on a Business to Business (B2B) basis and will be sent to interested laboratories throughout Indonesia. Currently, Kalbe Farma can only produce half a million or 500,000 saliva test kits. It is planned that the production capacity will be increased to one million saliva test kits.

A travel requirement

Furthermore, Henry Sukardi said the salivary COVID-19 test used RT-LAMP technology. The molecular test is included in the category of Nucleic Acid Amplification Test (NAAT) together with RT-PCR and TCM according to the Decree of the Minister of Health of the Republic of Indonesia Number HK.01.07/MENKES/446/2021. So, it can be used as a travel requirement. "Because this is already included in KMK 446. For (requirements) travel within the country or in Indonesia, it can be used," he said. However, Henry said he could not confirm whether the COVID-19 test with this saliva can also be used as a condition for traveling abroad. This is because the rules in each country are different. "If you leave the country, each country has its own policies. So that further policy should be seen," he explained. Previously, some time ago the Minister of Research and Technology/Head of the National Research and Innovation Agency (Menristek/Head of BRIN) Bambang Brodjonegoro is considering the use of the saliva test method to test for COVID-19. That way it is hoped that the testing process can be faster and sampling can be easier because it only uses saliva.