San Diego, California, USA, October 22, 2026
SEKISUI Diagnostics has announced the launch of its OSOM® COVID-19/Flu A&B Combo Test, a rapid diagnostic solution that has received U.S. Food and Drug Administration (FDA) 510(k) clearance for detecting and differentiating COVID-19 and influenza A and B in professional healthcare settings. The test is designed to help healthcare professionals identify three common respiratory viral infections using a single anterior nasal swab specimen, supporting timely clinical assessment when patients present with similar respiratory symptoms. The assay uses lateral-flow immunochromatographic technology and is CLIA-waived for point-of-care testing, enabling use in eligible healthcare settings without requiring a high-complexity laboratory environment. The launch expands SEKISUI Diagnostics’ portfolio of rapid diagnostic products as healthcare providers prepare for respiratory virus season and the transition away from certain emergency-use-authorized testing products. The company says the new test offers a 510(k)-cleared alternative for customers seeking a diagnostic tool for respiratory infections.
One Rapid Test Detects Three Respiratory Viruses
The OSOM COVID-19/Flu A&B Combo Test is designed to detect and differentiate SARS-CoV-2, the virus responsible for COVID-19, and influenza A and influenza B from one nasal specimen. Specifically, the assay detects the SARS-CoV-2 nucleocapsid antigen and influenza A and B nucleoprotein antigens in anterior nasal swab samples collected from individuals showing signs and symptoms of respiratory tract infection. According to the company’s product information, the test delivers results in approximately 15 minutes, helping healthcare professionals obtain information during a patient visit. COVID-19 and influenza can cause overlapping symptoms, including fever, cough, fatigue and respiratory discomfort, making it difficult to distinguish between infections based on symptoms alone. A multiplex antigen test can help clinicians identify which of the three viral targets is detected and use that information alongside the patient’s symptoms, medical history and other clinical findings. By combining the targets in one assay, the test can support more efficient diagnostic workflows than ordering separate antigen tests for each virus. However, as with other rapid antigen tests, results must be interpreted according to the product instructions and clinical context; negative results may require confirmation with a molecular assay when clinically indicated.
FDA 510(k) Clearance Supports Point-of-Care Use
The product’s FDA 510(k) clearance represents an important regulatory milestone, allowing the test to be marketed for its cleared intended use in the United States. The assay is also CLIA-waived, supporting use in eligible point-of-care environments such as qualifying physician offices and urgent care facilities. This can help bring respiratory virus testing closer to patients and support clinical decisions without automatically requiring specimens to be sent to a centralized laboratory. The test is manufactured in the United States and is supported by SEKISUI Diagnostics’ technical services team, which includes medical laboratory professionals. The company is introducing the product as healthcare providers prepare for a respiratory season in which reliable access to diagnostic testing remains important. SEKISUI Diagnostics has also highlighted the changing regulatory environment for COVID-19 testing products that previously relied on the FDA’s Emergency Use Authorization pathway. Its new 510(k)-cleared product provides customers with an alternative regulatory pathway for professional testing. Regulatory clearance does not mean the test is infallible; healthcare professionals must follow the authorized instructions for use and consider clinical findings when interpreting results.
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QC Inside Feature Supports Quality Control
Another feature of the OSOM combo test is QC Inside®, which is intended to make quality-control procedures more convenient for testing sites. Each kit configuration includes two additional tests for external quality-control testing at no extra charge, helping facilities perform required quality-control checks without purchasing separate control tests for those included runs. The company says this feature can reduce separate quality-control costs and add value to each kit. Quality control is an important part of diagnostic testing because it helps facilities assess whether testing procedures and materials are functioning as expected. The product is offered in a configuration of 25 tests plus two additional quality-control tests, according to the company’s product information. For healthcare providers managing seasonal respiratory infections, the combination of rapid results, a single specimen and built-in quality-control support may help streamline point-of-care workflows. SEKISUI Diagnostics said the launch is intended to help new customers adopt the product and support existing customers transitioning to a 510(k)-cleared alternative. Overall, the launch strengthens the company’s respiratory diagnostics portfolio and gives professional healthcare settings another tool for detecting and differentiating COVID-19 and influenza A and B.
Source: SEKISUI Diagnostics press release
