Detection of Severe Fever with Thrombocytopenia Syndrome (SFTS) Virus in Cats Within Approximately 85 Minutes

HORIBA, Ltd. (Headquarters: Minami-ku, Kyoto City; President and CEO: Masayuki Adachi; hereinafter 'the company') has confirmed, in collaboration with Dr. Ken Maeda, Head of the Department of Veterinary Science, and Researcher Keita Ishijima from the National Institute of Infectious Diseases, National Institute of Biomedical Innovation, Health and Nutrition (Location: Shinjuku-ku, Tokyo; Director: Tetsuro Mekata), that its domestically marketed research-use nucleic acid analyzer 'POCKIT Central™ Nucleic Acid Analyzer (hereinafter 'POCKIT Central')' is effective for the rapid detection of the virus causing Severe Fever with Thrombocytopenia Syndrome (SFTS), a tick-borne zoonotic disease.

Testing and comparing serum samples from 40 cats suspected of SFTS virus (hereinafter 'SFTSV') infection using 'POCKIT Central' and conventional methods (RT-PCR) resulted in complete agreement across all samples. Additionally, evaluations using feline whole blood samples spiked with inactivated SFTSV demonstrated sensitivity sufficient for primary screening in veterinary clinical settings. This indicates the potential to simplify pre-processing steps such as serum separation required by conventional methods and obtain measurement results in approximately 85 minutes.

'POCKIT Central' automates the entire process from nucleic acid extraction to detection within the device, enabling simple operation and measurement. Furthermore, the device is designed to irradiate UV-C light internally after measurement, reducing the risk of secondary infection for operators. The results of this study have been published online in the scientific journal 'Journal of Virological Methods,' and the device is expected to contribute to rapid diagnosis and early treatment of SFTS.

The company aims to obtain manufacturing and marketing approval for 'POCKIT Central' as a veterinary medical device and promote its adoption in veterinary clinical settings.

POCKIT™ Central: Tick carrying SFTS virus attached to an animal (provided by the National Institute of Infectious Diseases)

【Background of the Study】

SFTS is a zoonotic infectious disease that can cause severe symptoms in both humans and animals. In addition to tick bites, transmission can occur through contact with body fluids from SFTSV-infected animals, and human infections via cats and dogs have been reported. Therefore, when diagnosing animals suspected of SFTSV infection, it is extremely important to determine the infection status as early as possible to reduce exposure risks for veterinarians and pet owners. However, when tests are outsourced to external research institutions, results may take several days, increasing the demand for rapid on-site testing in veterinary clinics. HORIBA has adopted the vision of 'Fun and Joy to All Life' and is committed to solving comprehensive challenges related to human and animal health and the environment based on the 'One Health' concept. In light of these factors, this study was conducted in cooperation with the National Institute of Infectious Diseases to promote the adoption of this device.

【Key Findings of the Study】

Serum samples from 40 cats exhibiting symptoms suggestive of SFTS, such as fever and loss of appetite, were measured and evaluated using 'POCKIT Central' and the conventional method (RT-PCR), resulting in complete agreement of test results across all samples.

Furthermore, testing with feline whole blood samples spiked with inactivated SFTSV also achieved sensitivity sufficient for primary screening in veterinary clinical settings. This demonstrates the feasibility of rapid whole blood testing using the device without the complex pre-processing steps, such as serum separation, required by conventional methods.

Illustration comparing measurements by conventional method (RT-PCR) and 'POCKIT Central'

【Future Developments】

For suspected SFTSV infection cases, it is crucial to promptly implement infection control measures such as isolation at the time of diagnosis and enhanced protective equipment for veterinary staff. This device, which provides measurement results quickly while considering safety, is expected to serve as a supportive tool for veterinary professionals. Moving forward, the company will work towards obtaining manufacturing and marketing approval as a veterinary medical device to promote widespread adoption, while also aiming to meet broader needs, such as SFTSV detection using other sample types like urine and evaluations in animal species beyond cats.

Additionally, leveraging the strength of 'POCKIT Central,' which offers a rich lineup of reagents targeting diverse infectious pathogens beyond SFTSV, the company will continue its initiatives contributing to the 'One Health' approach.

【Publication Information】

Paper Title

Fully automated sample-to-answer PCR detection of severe fever with thrombocytopenia syndrome virus in cat serum and whole blood

Authors

Shun Sasaki, Keita Ishijima, Ken Maeda, Marifu Yamagishi-Kondoh

Journal

Journal of Virological Methods

Publication URL

https://www.sciencedirect.com/science/article/pii/S0166093426000170

【Overview of 'POCKIT Central']

Product Name

Nucleic Acid Analyzer 'POCKIT™ Central Nucleic Acid Analyzer'

Testable Items

Over 190 test items related to various animal species (up to 8 samples can be tested simultaneously)

Measurement Time

Approximately 85 minutes

Required Sample Volume

200 µL

Device Dimensions (W×D×H mm)

310 (W) × 480 (D) × 400 (H) mm

Device Weight

21 kg

Measurement Principle

· Nucleic acid extraction using magnetic beads · Amplification and detection using Insulated Isothermal Polymerase Chain Reaction (iiPCR)

This device was developed and manufactured by GeneReach Biotechnology Corporation in Taiwan and is marketed domestically by the company.

Product Details (URL):

https://www.horiba.com/jpn/veterinary/products/detail/action/show/Product/pockit-central-ruo-6602/

※1 Research-use instruments and reagents are provided for research purposes only. At present, disease diagnosis should not be based solely on the measurement results of this product. Diagnosis must be made by veterinarians considering the patient's (animal's) condition and other test results.

※2 When blood is allowed to clot and centrifuged, solid components settle, leaving the liquid component on top. This supernatant is called serum and is used in biochemical tests.

※3 Reverse Transcription PCR. A method to detect RNA viruses like SFTSV by first converting the viral gene (RNA) into DNA, then amplifying and detecting it.

※4 Blood collected with anticoagulant added to prevent clotting, closely resembling the in vivo state without separating components.

※5 Extracting viral genetic