FUJIFILM Holdings

CSR activity report│Fighting Against COVID-19

Quick and Accurate Saliva PCR Test

Simultaneous virus and human gene detection reduces false negative rate

SARS-CoV-2 RT-qPCR Detection Kit Ver. 2 to detect COVID-19 virus

In FUJIFILM Wako Pure Chemical Corporation, we have cultivated extensive expertise about enzyme and genetic technology through our long-term research on reagents.*1 As COVID-19 spread across the world, we were eager to fulfill our duty as a healthcare company. This led us to accept the challenge of developing a real-time PCR test kit for the first time utilizing our research on reagent technology to help speed up the quest for the desperately sought after test.

A dedicated project team was established to develop the test kit and determined the proof of concept as early as February 2020. This was quickly followed by securing suppliers of the necessary enzyme for the kit and actual kit development. On April 15, 2020, we launched SARS-CoV-2 RT-qPCR Detection Kit to detect COVID-19 genes. Combining with other manufacturers’ RNA isolating kit, our kit significantly shortened the operation time to two hours from the four to six hours taken by conventional PCR tests.

The COVID-19 PCR test uses a sample of mucus from the subject’s nose or throat. However, rubbing the mucus to take the sample is uncomfortable for the subject and bears the risk of virus infection through sneezes and coughs caused by the rubbing. To replace this conventional method, a test that uses saliva as the sample has been long awaited.

In June 2020, the Ministry of Health, Labour and Welfare (MHLW) approved our saliva-based PCR test. Subsequently, on July 31, we released the SARS-CoV-2 Lysis Buffer, a pretreatment reagent for the PCR test, and the SARS-CoV-2 RT-qPCR Detection Kit Ver. 2. Using these two in combination, the result can be obtained just one hour after taking the sample.

The kit is designed to detect COVID-19 virus genes and human genes at the same time. This design helps identify whether the test was carried out successfully, because if the test result does not show any human gene, it means that the test was a failure. This reduces the chances of false negatives, which wrongly indicates that the result is negative even when in fact the retest is necessary.

After the announcement of the product release, we received a number of inquiries from overseas and an overseas version is now being developed.

  • *1 Reagent: A chemical used in analyses to detect a certain substance, in quantitative analyses, synthesis experiments, and measurements of physical characteristics. Basically, clinical diagnostics are types of reagents, however, they are designated as in vitro diagnostics by the MHLW to differentiate their administrative handling from general reagents.
  • * This page contains some excerpts from the Sustainability Report 2020.