Press Release No. 015/KFCP-DIR/PR/III/21
Jakarta, March 25, 2021, The Ministry of Research and Technology (KEMENRISTEK)/National Research and Innovation Agency (BRIN) has expressed support for PT Kalbe Farma Tbk (Kalbe)'s saliva-based COVID-19 diagnostic test kits proudly developed by the nation's locally born researchers as part of #InovasiIndonesia.
Launched by Kalbe on Friday, 19 March 2020, the COVID-19 diagnostic test kit uses the RT LAMP (Reverse Transcription Loop Mediated Isothermal Amplification) method that is capable of specifically detecting the nucleic acid that constitutes the genetic material of the SARS CoV-2 virus that causes Covid-19. This novel diagnostic test kit, also known as the RT LAMP test kit, is the brainchild of the Stem Cell & Cancer Institute (SCI), which is Kalbe Farma's Research & Development arm, and has passed analytical and clinical performance tests that have previously been conducted domestically.
"This field-deployable saliva-based RT LAMP test kit can address the challenge posed by the limited availability of laboratories across Indonesia as not all regions in our country have these facilities. Hopefully, this non-invasive, practical, fast and economical way of testing for Covid-19 virus would make people willing to get tested for Covid-19, as it involves no discomfort, with results showing a high degree of accuracy," says Minister of Research and Technology / Head of National Agency for Research and Innovation (BRIN) Bambang Permadi Soemantri Brodjonegoro.
The Minister’s support for Kalbe’s saliva-based test kits was given on Thursday, March 25, 2021 during the third scientific discussion on the topics of e-health and medical devices that was held as part of the series of the RISTEK / BRIN Kalbe Science Awards (RKSA) 2021 Program’s public awareness-raising campaigns. The online discussion featured pharmacist Stefanus Nof, S.Si, Head of Health Business - Asia Pacific & Japan at Amazon Web Services (AWS) Dr. Julian Sham and In Vitro Diagnostics (IVD) Division Research Manager Akterono D. Budiyati, S.Si., M. Biomed as resource persons.
On this occasion, Mr. Brodjonegoro has also requested that Kalbe Farma should follow up the launch with a post-marketing survey and observations to compare the validity of the results of the saliva-based RT LAMP test with those of the real time Reverse Transcription Polymerase Chain Reaction (RT-PCR) swab test which is currently considered the gold standard in the diagnosis of Covid-19. The Minister has also expressed his gratitude to the Ministry of Health for granting a distribution license to Kalbe Farma’s saliva-based RT LAMP diagnostic test kits and also for encouraging private companies such as Kalbe Farma to continue with their research & development pursuits and come up with locally made products that promote Indonesia’s own innovations.
“Of course, the Ministry of Research and Technology / National Agency for Research and Innovation is all set and ready to support all the innovations originating from many different organizations in Indonesia, including from the ones that are outside the government or universities. Specifically, these saliva-based RT LAMP diagnostic test kits will soon be put into the National Public Procurement Agency (LKPP) innovation e-catalogs and more importantly, the effectiveness of this diagnostic test will be tested in public places. With this, I would like to invite all of you to help make this innovative product, which is the brainchild of our own nation’s sons and daughters, a resounding success," says Mr. Brodjonegoro.
PT Kalbe Farma Tbk President Commissioner Irawati Setiady explained that Kalbe, through its business units, starting from the research and development unit, the production unit up to the service unit, always strives to support the government in realizing the independence and competitiveness of the domestic health industry. "The easily deployable RT LAMP test using saliva samples will be very useful in accelerating the process of coping with the COVID-19 pandemic, helping the government carry out tracing and testing for coronavirus and enabling us to reach out to people who live in areas with minimal laboratory infrastructure," says Irawati.
The RT LAMP salivary diagnostic test is a molecular test in the same league with Polymerase Chain Reaction Rapid Test (RT–PCR) and Molecular Rapid Test (TCM) that belong to the NAAT (Nucleic Acid Amplification Test) category in line with the Decree of the Minister of Health of the Republic of Indonesia Number HK. 01.17/ MENKES/ 3602/2021. As a molecular test, the accuracy of the RT LAMP method is much higher than that of the antigen detection rapid diagnostic test (Ag-RDT) that detects viral proteins or antigen of SARS-CoV-2, the virus that causes COVID-19. The RT LAMP salivary diagnostic test offers many advantages and conveniences for patients or people who will be tested for COVID-19. It is a convenient, practical, fast and economical testing method with a high degree of accuracy.
Currently, the production of salivary RT LAMP reagents is carried out by PT KalGen DNA and their distribution is carried out by PT Enseval Medika Prima. These two companies are PT Kalbe Farma Tbk’s subsidiaries. “Currently, the company has the capacity to produce 460,000 saliva-based test kits per month but the company is now set to increase its capacity to produce 2 million test kits per month,” adds Irawati.
"We started carrying out the research process in June 2020. Earlier this month (March 2021) we received a license to distribute domestically-made medical devices from the Ministry of Health of the Republic of Indonesia (Distribution License No. KEMENKES RI AKD 20303120508) under the brand name ELVA Diagnostic SARS-CoV-2 Saliva Nucleic Acid Test Kit," says In Vitro Division Research Manager Akterono, D Budiyati from Kalbe’s Stem Cell and Cancer Institute. "This innovative salivary diagnostics test kit could be an excellent choice for the screening and detection of COVID-19 due to its high degree of accuracy, with 94% sensitivity and 98% specificity. What’s more, the test only involves the taking of saliva samples, which is previously unthinkable, thus making it much more convenient and practical to get tested when compared to other COVID-19 tests currently available. The taking of saliva samples requires no special equipment. Nor will it increase the risk of vomiting as it does not induce vomiting or cause extreme discomfort to people with sensitive nasal blood vessels, thus making it very easy for children and people with hypersensitive noses to get tested,” says Akterono, explaining the advantages of Kalbe’s saliva-based test kit.
Akterono adds that it only takes a few laboratory personnel with basic aseptic technical skills who are well versed in the working principle and application of molecular diagnostic tools in a molecular diagnostics facility to analyze saliva samples. The main tool that is used to carry out RT LAMP reactions is a water bath (also known as a heater) to heat samples in the laboratory.
As is known, currently there are only 721 laboratories in Indonesia that are clinically qualified to process saliva samples to test for COVID-19 infection. Such laboratories are neither evenly spread nor available across all districts or cities throughout Indonesia. Even though PCR COVID-19 rapid tests and antigen rapid tests are currently still regularly performed for diagnosing COVID-19, the RT Lamp saliva tests would certainly make inroads into the market and help expand testing for COVID-19 in many different parts of Indonesia.
On this occasion, those attending the discussion include Ministry of Research and Technology Secretary / Chief Secretary of the National Research and Innovation Agency Mego Pinandito, Head of the Research and Development Agency of the Ministry of Health dr. Slamet, MHP, Chairperson of the RKSA Board of Juries and Head of the Eijkman Institute for Molecular Biology Prof. Dr. Amin Soebandrio, Spokesperson for the National COVID-19 Handling Task Force Wiku Adisasmito, Acting Deputy for the Strengthening of Research and Development of the Ministry of Research and Technology / National Agency for Research and Technology Prof. Dr. Ismunandar, the National Agency of Food and Drug Control of Indonesia (BPOM)’s Drug Registration Director Dr. Lucia Rizka Andalusia, PT Kalbe Farma Tbk Founder Boenjamin Setiawan and his staff.
Kalbe at a Glance
PT Kalbe Farma Tbk (“Kalbe”) was founded in 1966 and is one of the largest publicly listed pharmaceutical companies in Southeast Asia. Kalbe has four main divisions that handle a portfolio of many different and time-honoured brands.
The four includes (1) the prescription drugs division, (2) the non-prescription medicine division that handles commonly used over-the-counter medicines such as Promag, Mixagrip, Komix, Woods, Fatigon, etc., (3) the multivitamin supplements, ready-to-drink beverages and nutrition division whose portfolio includes multivitamin supplements under the brand names Fatigon, H2, XonCe, Hevit-C, JossC1000 and RTD beverages such as Hydro Coco, Extra Joss, and (4) the nutrition division with products under the brand names ChilKid, Prenagen, Diabetasol, Zee, etc.); and the distribution division.
Kalbe currently has more than 40 subsidiaries and 16 production facilities with international standards, and employs around 16,000 employees spread across its 76 branches throughout Indonesia. Since 1991, Kalbe's shares have been listed on the Indonesia Stock Exchange (IDX: KLBF).