Figure 1: Shimadzu Ampdirect 2019-nCoV Detection Kit

2021 has started on a good note for the collaboration between Qualtech Consulting Corporation and our client Shimadzu Corporation. We are happy to announce that Shimadzu Corporation, Japan has obtained provisional authorisation from the Health Sciences Authority (HSA) in Singapore for its Ampdirect 2019-nCoV Detection Kit.

To address the urgent need for timely detection of COVID-19 infection, HSA has set up a provisional authorisation process for tests intended for the detection and/or diagnosis of COVID-19 infection. Being a market leader in analytical and measuring instrument, Shimadzu Corporation took this opportunity to make available its state-of-the-art reagent system for the detection of the novel Coronavirus (2019-nCoV), in the continuing fight against the raging pandemic.

Ampdirect Technology works without RNA purification

The Shimadzu Ampdirect 2019-nCoV Detection Kit is an in vitro diagnostic medical device designed for qualitative detection of the novel coronavirus SARS-CoV-2 RNA in upper respiratory specimens/oral secretion (such as nasopharyngeal swabs/saliva) through a rapid sample preparation for real time Reverse Transcription -Polymerase Chain Reaction (RT-PCR) testing.

Typically, PCR inhibition appears to be caused by positively-charged substances in the biological sample (some types of protein etc.) which are adsorbed to the DNA/RNA template, and some negatively-charged substances (some sugars, pigments etc.) which are adsorbed to the DNA polymerase. In order to overcome such challenges, Shimadzu’s cutting-edge Ampdirect technology has the effect of suppressing these substances, enabling direct RT-PCR of biological samples. This Ampdirect technology can eliminate the need for DNA/RNA extraction and purification, enabling tests to be conducted much faster with the same accuracy.

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(1) Shimadzu Corporation - Ampdirect™