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The Novel Coronavirus Detection Kit for Wipe Tests

Shimadzu Corporation has released the Novel Coronavirus Detection Kit for Wipe Tests. This reagent kit detects the novel coronavirus on surfaces quickly, easily, and with high sensitivity via the PCR test method. It is intended for use in hygiene management and health and safety checks in order to prevent the spread of the novel coronavirus. It combines the virus-concentrating techniques cultivated in the Norovirus Detection Kit for Wipe Tests (released in 2016) with the Novel Coronavirus Detection Kit (for research use), released in April of last year. Shimadzu will supply this product to medical institutions and contract testing companies which provide wipe test services for care homes, food production and distribution centers, commercial facilities, and transportation centers. Currently, the kits are only available in Japan

It is believed that the main infection routes for the novel coronavirus are droplet infection and contact infection. On cruise ships where group infections have occurred, the virus has been detected on the surfaces of toilet seats, floors, pillows, telephones, televisions, and remote controls, and the possibility of contact infection has been pointed out. It is reported that the novel coronavirus has remained on the surfaces of everyday items for up to several weeks. It is suspected that in some cluster cases, the virus was transmitted via objects touched by multiple people such as doorknobs, water faucets, or tablet computers. However, only trace amounts of the virus adhere to the surfaces of materials, so detection with a PCR test is difficult even when swabbing with a cotton swab.

The Novel Coronavirus Detection Kit for Wipe Tests consists of a special concentrating liquid and the reagents necessary for PCR tests. The surface of the material to be tested is swabbed with a commercially-available cotton swab, and the swab is immersed in normal saline solution. Adding the special concentrating liquid to this and then centrifuging the solution causes the virus to precipitate, concentrating it. The use of Shimadzu’s proprietary Ampdirect technology* reduces the time required for the PCR workflow from several hours to approximately 100 minutes, including the concentration and extraction steps. See the workflow diagram below for details.

• *Ampdirect technology suppresses the action of PCR inhibitors such as proteins and polysaccharides, enabling the direct addition of PCR reaction solution to biological samples without the need for extraction and purification of DNA/RNA. Ampdirect is a registered trademark of Shimadzu Corporation.

Features

1. Significantly reduces testing times

The virus concentrating process normally takes several hours or more, but with the special concentrating liquid provided, it can be completed in around 30 minutes. Ampdirect technology eliminates the need for labor-intensive RNA purification. With this kit, you can test for the novel coronavirus on surfaces in approximately 100 minutes.

2. Detects even trace quantities

Even trace quantities (0.25 copies/μL) of the novel coronavirus can be detected by simply swabbing the material to be tested with a cotton swab.

Caution: The reagents in the Novel Coronavirus Detection Kit for Wipe Tests are intended for research use only. They are not recognized or certified as in vitro diagnostics or medical devices under Japan’s Pharmaceutical and Medical Device Act. They cannot be used for therapeutic diagnostic purposes or in related procedures. The performance of this product was verified using inactivated novel coronavirus samples. To use this kit, specialist equipment is required such as a PCR device, dispensing pipettes, a thermal bath, and a small centrifuge, as well as equipment for appropriate handling of samples and genetic material. As such, there are no plans to sell this kit to individuals for personal use or to small businesses such as drug stores. Note that the Novel Coronavirus Detection Kit for Wipe Tests cannot be used in combination with the AutoAmp gene analysis instrument (released in November of last year).