29th March 2021 Product update: rapidvirology staff writer
New Saliva RT-LAMP COVID-19 Test Available from Indonesian Researchers
PT Kalbe Farma Tbk (Kalbe) has launched its state-of-the-art, saliva-based COVID-19 diagnostic test kit that employs Reverse Transcription Loop-Mediated Isothermal Amplification (RT-LAMP) to detect SARS CoV-2 nucleic acid.
As with Polymerase Chain Reaction, 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 coronavirus.
“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,” says Irawati Setiady, President Commissioner of PT Kalbe Farma Tbk.
“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, 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.
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.
Furthermore, 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 using a molecular method with simpler equipment and practical, applicative techniques, thus resulting in faster processing time and eventually providing a more economical solution.
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Date Published: 29th March 2021
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Note: This content has been edited by a rapidvirology.com staff writer for style and content.
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