Voice of Customer

Matsudo City General hospital (600 beds, Hospital Director: Akira Ogata) has developed as the core hospital of Matsudo City since its opening in 1950. In 2017, the hospital moved to a new building at its current location and changed its name from Matsudo Municipal Hospital to its current name. It has 37 departments and serves the medical functions not only in Matsudo City but also in the northern Tokatsu region (Matsudo City, Noda City, Kashiwa City, Nagareyama City, and Abiko City) with a population of approximately 1.4 million.

The hospital plays a role as a core hospital in the northern part of Tokatsu, carrying advanced medical functions such as a regional base hospital for disaster prevention, a regional base hospital for cancer treatment, and a regional perinatal maternal and child medical center.

Since the center is a designated hospital for infectious diseases and a tertiary emergency medical institution, it has been actively accepting patients with moderate and severe cases of novel coronavirus infection (hereafter referred to as " COVID-19 "). The hospital has a dedicated ward for COVID-19 patients that can accommodate up to 43 patients in the phase 3 stage, and also accepts patients in the ICU (intensive care unit), pediatric ward, and NICU (neonatal intensive care unit).

For PCR testing, they introduced state-of-the-art testing equipment including our " ELITe InGenius^®" in August 2020, and in April 2021, they assigned two full-time medical technologists to operate these instruments, thereby establishing a PCR testing system with high speed and accuracy. As of December 31, 2021, 350-360 PCR tests are performed per month, mainly on adult patients scheduled for hospitalization or surgery.

Two ELITe InGenius^® machines are in full operation, performing 350-360 PCR tests per month, mainly on adult patients scheduled for hospitalization and surgery.

"The ability to perform PCR testing on a large number of people in a short period of time, without having to outsource, has contributed greatly to keeping our normal practice as uninterrupted as possible during the COVID-19 crisis and facilitating the return to normal practice once the epidemic is over."

However, there were twists and turns before the center was able to establish such a PCR testing system. As of March 2020, when COVID-19 began to spread in Chiba Prefecture, there was no laboratory system in place to perform PCR testing like other hospitals.

With the declaration of a state of emergency in April 2020 and the first wave of attacks, PCR testing through the public health department route took about two days before a determination result was available. Therefore, the center also decided to conduct PCR testing on its own and outsourced it to a private testing company in May.

"Even so, the earliest we could get the results was the evening of the day after the specimen was handed in, which greatly interfered with our medical activities in cases where patients were transported to emergency rooms with suspected COVID-19. It was unavoidable for us to conduct the PCR tests ourselves rather than outsourcing them."

Therefore, the clinical laboratory department, led by the staff of the bacteriology laboratory, has decided to implement a simple PCR test using the LAMP method starting in July. Like the PCR test, the LAMP method detects the gene for COVID-19 from specimens such as nasopharyngeal swab fluid, and is widely used in many medical institutions, both clinics and hospitals. While it can be done in a short period of time, it also requires skilled techniques to handle specimens, perform gene extraction, adjust reagents, and mix the reaction solution and extracted genes to avoid contamination. Therefore, it took some time for the clinical laboratory department to establish a testing system, including staffing, and to get it on track.

Masumi Suzuki (front row), Acting Chief Technologist, who was involved in the establishment of the in-house PCR testing system together with Hiroyoshi Kitsutaka, Chief Technologist. After establishing the testing system, they were able to assign medical technologists dedicated to PCR testing (back row, right: Satoshi Morimura; back row, second from right: Nobutake Maehara), which also reduced the burden on the entire clinical laboratory department.

"Because genetic testing is a relatively new technology, we put an elite group of young and capable staff in their 20s to 40s in charge. The department has a total of 50 staff, including reappointed and part-time staff, but we were forced to keep several dozen full-time staff only as PCR test personnel, which placed a heavy burden on the department as a whole. In addition, shortly after the LAMP method was launched, the laboratory was asked to work on weekends, which increased the workload on the technologists."

Amidst these days with extreme risk on the front lines of PCR testing, Matsudo City installed state-of-the-art testing equipment at the center in August 2020 and began operating PCR testing for patients scheduled for general anesthesia surgery in October.

One of the two PCR instruments used at this time was the ELITe InGenius^®. This testing equipment is characterized by its ability to simultaneously process specimens for up to 12 people in a fully automated process. The process of nucleic acid extraction, purification, amplification, detection, and analysis is performed in approximately 2.5 hours, helping to speed up testing.

"The fully automated process is easier to operate than the LAMP method and can be performed reliably by any technician, which is important for maintaining the quality of the test. It also has the advantage of making mistakes such as specimen mix-ups and contamination less likely to occur, greatly reducing the risk of infection for technicians."

Compared to other PCR testing equipment, it is easier to operate and can be performed reliably by any technician, which leads to stability in testing.

ELITe InGenius^® is also recognized for its accuracy. "It has a total of three targets to detect, one of which is equipped with an internal control (IC) that can check the process from the nucleic acid extraction process to the PCR reaction for inhibition or abnormalities. In addition, because it targets two genetic locations of the virus, it can handle sudden genetic mutations, making it even more accurate than other PCR instruments with only one target or the LAMP method that preceded it."

When the fifth wave occurred in July and August 2021, PCR tests were performed smoothly, mainly on hospitalized and surgical patients, and there was no confusion at the testing site. Incidentally, the center has conducted PCR testing for 4,000 to 5,000 hospitalized and surgical patients since it began working on in-house PCR testing, and only two people have been found positive for COVID-19.

The number of positives is very low, partly because patients scheduled for hospitalization or surgery have good infection control measures in place. However, if all cases had not been tested, they might have been missed and a nosocomial cluster could have occurred; PCR testing is essential to ensure patient safety and prevent exposure to healthcare providers."

Because reagents for specimens cannot be added to the ELITe InGenius^® once they are initially set, it is difficult to meet the need for an emergency PCR test for a single case. Therefore, the center uses it in combination with other PCR testing equipment that can meet this need.

"ELITe InGenius^® is the best at handling large numbers of people, and in January 2021, we introduced an additional unit to increase the efficiency and speed of our PCR inspection system."

Once specimens and reagents are loaded and the device is running, the process of nucleic acid extraction, purification, amplification, detection, and analysis takes approximately 2.5 hours, contributing to faster testing.

ELITe InGenius^® operates on weekdays with PCR testing for patients scheduled for hospitalization and surgery. The team handles about 20 patients on Monday, Wednesday, and Friday, and 10-15 patients on Tuesday and Thursday, for a total of about 90 PCR tests over a five-day period. When a patient arrives at the clinic at noon, the nasopharynx is swabbed to collect the specimen, and the equipment is run in the afternoon, leaving the two testing machines in full operation.

"In July 2021, we began performing drive-through PCR testing at the request of the Matsudo City Medical Association, and at the end of December 2021, we began performing PCR testing on asymptomatic patients as a cooperating medical institution for the Matsudo Citizens PCR Testing Subsidy Project, which Matsudo City began undertaking, and ELITe InGenius^® is playing a major role as the number of such tests increases."

The center hopes to make effective use of ELITe InGenius^® in the post-COVID era as well. One of the most promising applications is in the field of cancer treatment. Ryo Yokoyama, a medical technologist who heads the pathology department, says the following:

Ryo Yokoyama, a medical technologist who heads the pathology department, has high hopes for the application of ELITe InGenius^® for cancer genetic testing.

"Genetic testing is also attracting attention in the field of cancer treatment, and in the past few years, the government has been developing a "cancer gene panel test" that simultaneously examines multiple gene mutations. However, this test is available only at advanced medical institutions designated as base hospitals for cancer genome medicine, and unfortunately, we are not able to offer this service at our center."

On the other hand, a genetic test called "companion diagnostics" is becoming a hot topic. This test looks for abnormalities in specific genes and is used to determine whether or not a drug with proven efficacy can be administered. Some of the latest companion diagnostics have developed multiple types that can examine multiple genes and therapeutic agents, and PCR tests can now do the same thing as cancer gene panel tests. Among others, it has been put to practical use in the fields of lung cancer and colorectal cancer.

"When the multi-type companion diagnostic reagents are covered by health insurance and ELITe InGenius^® becomes compatible with those reagents, we can immediately begin working on multi-gene PCR panel testing at our center," he said. "COVID-19 was the catalyst for the introduction of the latest PCR testing equipment, and it is very encouraging to have one more weapon in our arsenal for cancer diagnosis and treatment."

From the determination of COVID-19 to the diagnosis and treatment of cancer, Matsudo City General Hospital is working on the operation based on the characteristics of ELITe InGenius^®, and PCR tests are widely used to save patient's lives at the forefront of clinical practice.