μTAS Wako g1, a fully-automated gene analyzer manufactured by FUJIFILM Wako Pure Chemical Corporation, has been used mainly for tuberculosis diagnoses. Following a few minutes of manual work to set the sample and reagent, the machine automatically analyzes genes. This shortens the diagnosis time and eliminates the necessity of using experienced testers. As soon as we learned that demand for more PCR testing for COVID-19 had greatly increased, we knew that our analyzer could be adapted to become an efficient PCR tester. It was February 2020 when we started development of a COVID-19 detecting reagent to be used in the analyzer.
In the normal course of reagent development, a single researcher is responsible for the entire reagent development procedure. However, this time, multiple researchers worked in parallel in their respective specialized areas aiming to integrate their results into the single reagent. The procedure to develop a new reagent usually takes more than a year, but we needed only two and half months for this specific reagent. We also commenced structuring the production and sales processes concurrently with development, although this usually waits until the development is complete. With the united efforts of various departments, the reagent was launched on May 8, 2020. The combination of the newly developed reagent, μTAS Wako COVID-19, and the μTAS Wako g1 analyzer reduced the analysis duration to 75 minutes from the four to six hours usually needed. Introduction of this system will deliver satisfactory quality in test results regardless of the experience of the tester, and reduce the risks arising from manual handling, such as mixing up samples and concerns for the possible infection of the tester. This in turn enables medical professionals to concentrate on more important tasks.
The response to the launch of the product was remarkable and we received a number of technical questions. We are now directing our efforts to answering these questions and offering other after-sale services. We plan to increase the analysis coverage of this machine to offer our support for the diagnosis and treatment of a wider range of diseases.
There are five steps in the COVID-19 PCR test.
In step (2), the RNA is extracted from the virus in the sample and unwanted substances are removed. In step (3), the RNA is reverse-transcribed to the DNA using an enzyme, and in step (4) the virus DNA is amplified, separated, and studied.
The virus can be detected only when all the steps from (1) to (4) are correctly performed.
(1) The testing duration is approx. 75 min. (Max. 5 hours shorter than the conventional method.)
(2) Most of the testing processes are automated, reducing the work load.
(3) Stable test results regardless of the tester’s experience.