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Kalbe Launches the First Ever Saliva-Based COVID-19 Test Kit which is the Brainchild of Indonesia’s Own Researchers

Kalbe Launches the First Ever Saliva-Based COVID-19 Test Kit which is the Brainchild of Indonesia’s Own Researchers

Press Release No. 014/KFCP-DIR/PR/III/21

Jakarta, 19 March 2021-  PT Kalbe Farma Tbk (Kalbe) today launches its state-of-the-art, saliva-based Covid-19 diagnostic test kit, the first ever of its kind that has been successfully developed by the nation’s home-grown researchers. This diagnostic test kit that uses saliva to test for Covid-19 employs the Reverse Transcription Loop Mediated Isothermal Amplification (RT LAMP) method to specifically detect the nucleic acid that constitutes the genetic material of the SARS CoV-2 virus that causes Covid-19.  As with Polymerase Chain Reaction Rapid Test (RT–PCR) and Molecular Rapid Test (TCM), RT LAMP is a molecular test that falls into the Nucleic Acid Amplification Test (NAAT) category that has been approved by the Ministry of Health as stated on page 8 of the Decree of the Minister of Health of the Republic of Indonesia Number HK. 01.07/ MENKES/ 446/2021. As a molecular test, the accuracy of this RT LAMP method is far higher than laboratory-based antigen tests (frequently referred to as rapid tests) that detect protein fragments specific to the corona virus.

“Kalbe through its business unit, starting from the research and development unit, the production unit up to its service unit always makes effort to support the government in realizing the independence and competitiveness of the domestic healthcare industry,” says Irawati Setiady, President Commissioner of PT Kalbe Farma Tbk. “This saliva-based RT LAMP is a very useful tool for accelerating measures to cope with the COVID-19 pandemic as it can help the government reach out to people living in areas with no or minimal COVID-19 testing facilities and dramatically increase the availability and accessibility of testing for the general population,” adds Irawati.

“This RT LAMP, which uses saliva samples to test for Covid-19, offers patients many advantages and conveniences. The saliva spit test is easy and practical to use. It does not involve any discomfort. It is highly accurate. It is fast and more economic. With all these advantages, we hope that we can use the saliva-based RT LAMP method to reach out to a greater number of people and a much broader segment of society so that the government’s tracing and testing program could be optimized,” says Sie Djohan, Director of PT Kalbe Farma Tbk. “The launch of the saliva-based COVID-19 diagnostic test is part of Kalbe’s commitment and effort to continuously support the government to overcome the COVID-19 pandemic,” says Sie Djohan.

“This innovative test may constitute a very good choice for Covid-19 testing due to its high accuracy with 94% sensitivity and 98% specificity. Moreover, saliva samples are collected by requesting the patient to spit into a container. This procedure is unimaginably far more comfortable and practical than the other COVID-19 tests currently available. The taking of saliva samples requires no special equipment. Nor does it 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. It will also become a preferred COVID-19 testing method for those who are going to fast during the upcoming Holy Month of Ramadhan,” says Stem Cell and Cancer Institute’s In Vitro Diagnostics (IVD) Division Research Manager Akterono, D Budiyati.

Sie Djohan goes on saying that this saliva-based COVID-19 diagnostic testing kit is an innovative breakthrough developed by a home-grown team from Kalbe’s own research and development center – the Stem Cell and Cancer Institute (SCI) – through a series of testing processes that were conducted in compliance with required procedures. The testing kit has received official approval for distribution from the Ministry of Health of the Republic of Indonesia through the issuance of Distribution Permit Number AKD 20303120508. Produced by PT Kalgen DNA, the testing kit will be marketed under the brand name “ELVA DIAGNOSTIC SARS CoV-2 Saliva Nucleic Acid Test Kit” by PT Enseval Medika Prima.

“Saliva-based RT LAMP service can be accessed at the Kalgen Innolab Clinical Laboratory (Kalbe Farma Laboratory) under the brand name “InnoLAMP”. The clinical laboratory serves the general public. It also receives referrals from the healthcare facilities that have entered into a contract with it, especially in Jakarta and the Greater Jakarta area (Bogor, Depok, Tangerang and Bekasi). Kalgen Innolab is the main clinical laboratory that provides COVID-19 test services (PCR and antigen rapid tests). Kalgen Innolab is part of the Ministry of Health’s network and is one of the partners of the Provincial Health Department of the Special Capital Region of Jakarta and has a comprehensive portfolio for COVID-19 tests. Kalgen Innolab is the first private clinical laboratory that administers PCR COVID-19 rapid tests. From April 2020 to present, the clinical lab has tested almost 180,000 samples. InnoLAMP complements the series of COVID-19-related tests administered by Kalgen Innolab, including PCR and antigen rapid tests, SARS-COV-2 antibody (serology) tests, IL-6, D-Dimer, PT, PTT, etc.,” says Kalgen Innolab Director Henry Sukardi. 

Furthermore, Henry also says that for health facilities, this method provides an additional advantage in terms of sample management. For the taking of samples, only sterile containers are needed and no medical personnel with special swab training are required. The risk of transmission at the time of sampling is minimized as the patient is requested to spit into a container and the saliva remains stable at room temperature. The work of examining saliva in the laboratory involves the use of a molecular method with simpler equipment and practical, applicative techniques, thus resulting in faster processing time and eventually providing a more economical solution. 

Henry adds that saliva-based RT LAMP marks the most recent development in COVID-19 testing in line with the regulations of the Ministry of Health. However, the use of the testing results as a mandatory document for travelling will have to be coordinated with the relevant authority.

“Kalbe hopes that this new breakthrough in the way people get tested for COVID-19 a will open up a greater opportunity and a better access for people from different walks of life, ages and geographical regions to get screened and tested for the SARS CoV-2 virus. This would hopefully enable Indonesia to have a greater ability to reduce the rate of COVID-19-related spread, incidences and deaths," concludes Sie Djohan.

For more or further information about the RT LAMP, please contact the following hotlines:
- For inquiries about RT LAMP, contact 0812-8056-8046 (Kalgen Innolab Hotline)
- For inquiries about RT LAMP technology, contact dr. Angela C. Ardhianie at 0856-8818899
- For inquiries about RT LAMP kits, contact Jennifer Silalahi at 0812-87576416

Kalgen DNA at a Glance
PT Kalgen DNA was founded in 2012 as a joint venture between PT Bifarma Adiluhung (a subsidiary of PT Kalbe Farma Tbk.) and a Malaysian company, DNA Laboratories Sdn. Bhd. which is engaged in products and molecular tests for genetic screening and diagnostic tests in Malaysia.
Our vision is embodied in our commitment to continuously improving ourselves to become a company that is known for manufacturing high quality diagnostic products and also for its innovation, supported by trained molecular experts and excellent management. 
PT Kalgen DNA possesses a production and distribution license from the Ministry of Health of the Republic of Indonesia and follows the principles of producing good medical devices according to Good Manufacturing Practices for Medical Devices (CPAKB) and ISO 13485.
Our mission is to improve health for a better life through innovative diagnostic products.

Kalgen Innolab at a Glance
Kalgen Innolab Clinical Laboratory is a major clinical laboratory owned by PT Innolab Sains Internasional, a joint venture company between PT Kalbe Farma Tbk and Toyota Tsusho Corporation (TTC) and the Health Sciences Research Institute, Inc. (HSRI) of Japan. 
Its vision is to become the leading Referral Clinical Laboratory in Indonesia. Kalgen Innolab has a comprehensive range of features for laboratory examinations, both for Clinical Pathology and for Anatomical and Molecular Pathology. 
As a pioneer in molecular examination, especially for oncology, Kalgen Innolab always strives to innovate and implement the latest technology platforms to provide the best service for customers.

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).


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