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Press Release No. 034/KFCP-DIR/PR/VII/21

Jakarta, July 5, 2021, PT Kalbe Farma Tbk (Kalbe).  The increase in positive cases of COVID-19 in various regions in Indonesia has encouraged the government through the Ministry of Health to strengthen the implementation of 3T, namely Testing, Tracing, and Treatment. Testing, apart from screening, is also very necessary for tracking or tracing so that suspects and close contacts of confirmed cases can be found. Under the circumstances, Kalbe is trying to support the government, especially regional governments, by providing the infrastructure for testing the SARS-CoV-2 virus using the RT-LAMP Saliva examination method. The RT-LAMP method which is a biomolecular examination is categorized as the NAAT (Nucleic Acid Amplification Test) test in which the RT-PCR is of the same category.

"RT-LAMP Saliva can be a solution in helping the government to expand the scope of tests for the SARS-CoV-2 virus, especially in areas that do not have sufficient RT-PCR machine capacity," said Hari Nugroho, Head of External Communication at PT Kalbe Farma Tbk.  "The RT-LAMP Saliva method does not require expensive laboratory equipment, it only requires a water bath as the main tool plus other standard laboratory equipment such as pipettes, tubes, mini centrifuge, vortex mixers," Hari continued.

"In comparison with the RT-PCR examination, the Saliva RT-LAMP examination is also a form of biomolecular test that the target of examination is the genetic material of the SARS-CoV-2 virus, in this case, the N gene which has received EUA (Emergency Use Authorization) from WHO as one of the target genes that can be used. By identifying the N gene from the SARS-CoV-2 virus, RT-LAMP Saliva can identify several variants of mutations such as Alpha, Beta, Gamma, Delta, and several other viral mutation variants," said Retno Ambarwati, Director of KalGen DNA, a subsidiary of Kalbe that produces the RT-LAMP Saliva examination kit. 

Retno added that other comparisons between RT-PCR and RT-LAMP Saliva include, the working principle of the RT-PCR examination using several temperature settings (non-isothermal) while RT-LAMP Saliva uses a constant temperature (isothermal); RT-PCR processing time is approximately 240 minutes while Saliva RT-LAMP is approximately 65 minutes; RT-PCR results are quantitative (there is a CT value) while the Saliva RT-LAMP is qualitative without a CT value; the average sensitivity and specificity of RT PCR > 95%-100% while the last data RT-LAMP Saliva sensitivity: 92.6% and specificity: 93.3%; RT-PCR sampling requires trained personnel because it uses a swab while RT-LAMP Saliva can be done independently by the patient.

What the public needs to acknowledge is that the RT-LAMP Saliva examination will still require special treatments of the sample, i.e. reproducing the genetic material contained in the sample using standard laboratory reagents and equipment, thus the RT-LAMP Saliva will still require a laboratory to test the sample. RT-LAMP Saliva detects the genetic material of the virus in the same way as RT-PCR, not detecting viral proteins like the rapid antigen test.

"Therefore the RT-LAMP examination cannot be done independently, and thus the RT-LAMP Saliva kit is not sold over-the-counter, including in marketplaces," said Retno. "Only laboratories can buy the RT-LAMP Saliva kit," Retno continued.

The Saliva RT-LAMP kit with the brand ELVA Diagnostic SARS-CoV-2 Saliva Nucleic Acid Test is distributed by PT Enseval Medika Prima, a subsidiary of Kalbe. Clinical laboratories or hospitals can call +62 812-8757-6416 to get information on the availability of the Saliva RT-LAMP kit.

"We hope that the Saliva RT-LAMP examination can help the government achieve the target of testing 400 thousand cases per day," said Hari.

KalGen DNA at a glance

PT KalGen DNA was established in 2012, is 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.
PT KalGen DNA is committed to being a producer of high quality diagnostic products and continues to improve results, through the support of innovations, trained molecular expert staffs, and excellent management.  PT KalGen DNA has a production and distribution permit from the Ministry of Health of the Republic of Indonesia and follows the rules of good medical device production in accordance with CPAKB and ISO 13485.
The mission of PT KalGen DNA is improving health for a better life through innovative diagnostic products.

Kalbe at a glance

PT Kalbe Farma Tbk ("Kalbe") was established in 1966 and is one of the largest listed pharmaceutical companies in Southeast Asia. Kalbe has four main divisions that handle reliable and varied brand portfolio: prescription medicines (Cefspan, Hemapo, Broadced, etc.); health product division that handles over-the-counter medication (Promag, Mixagrip, Komix, Woods, Fatigon, etc.); as well as energy and ready-to-consume drinks (Extra Joss, Hydro Coco); nutrition division (ChilKid, Prenagen, Diabetasol, etc.); and distribution division. Kalbe currently has approximately 40 subsidiaries and 12 production facilities with international standard, and employs approximately 17,000 employees dispersed across more than 76 branches throughout Indonesia. From 1991, Kalbe is listed on the Indonesia Stock Exchange (IDX: KLBF).

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