Recently, the BioPerfectus Influenza A Virus (H1N1 & H3)  Real Time PCR Kit received approval from China’s National Medical Products Administration (NMPA).

This product further strengthens BioPerfectus’ respiratory pathogen detection portfolio. It enables the simultaneous detection of Influenza A virus H1N1 (2009) and seasonal H3 subtype nucleic acids in a single tube, providing an efficient molecular diagnostic tool for early influenza diagnosis, subtype differentiation, and epidemiological surveillance.

A Quick Overview of H1N1 and H3 Viruses

Influenza A H1N1 (2009 pandemic strain) and seasonal H3 are two major influenza subtypes that may circulate alternately or concurrently during flu seasons. Although both belong to Influenza A viruses, they differ significantly in viral evolution, antigenic variation, host adaptation, and clinical characteristics.

Influenza A H1N1 (2009) was a novel virus resulting from reassortment among swine, avian, and human influenza viruses in 2009, causing the first influenza pandemic of the 21st century.

Seasonal H3 has been a long-circulating influenza subtype since the 1968 “Hong Kong flu” pandemic. It evolves rapidly and can escape pre-existing immunity, which is one of the main reasons seasonal influenza vaccines require regular updates. During the 2025–2026 influenza season, H3N2 accounted for more than 96% of Influenza A cases.

Influenza A H1N1 (2009) initially had a marked impact on younger and middle-aged populations, while seasonal H3 poses a greater threat to older adults and individuals with underlying conditions, often leading to higher hospitalization rates.

The clinical manifestations of Influenza A H1N1 (2009) mainly include fever, cough, sore throat, myalgia, and fatigue, which are similar to those of seasonal influenza. Most cases are mild and self-limiting within one week, although some may progress to severe pneumonia or other complications.

Seasonal H3 infection typically presents with sudden high fever, dry cough, sore throat, muscle aches, and fatigue. Compared with other Influenza A subtypes, H3N2 is sometimes associated with more severe disease, more intense symptoms, a longer recovery period, and a higher risk of severe illness in high-risk populations.

Therefore, accurate differentiation of influenza subtypes is critical for early diagnosis, epidemiological surveillance, and informed prevention and control strategies.

Product Highlights: Dual Detection in One Tube, Accurate, Efficient, and Reliable

1. Simultaneous Detection of H1N1 (2009) and Seasonal H3 in One Tube

The BioPerfectus Influenza A Virus (H1N1 & H3)  Real Time PCR Kit enables the simultaneous detection of Influenza A virus H1N1 (2009) and seasonal H3 subtype in a single reaction, delivering clear and efficient results.

2. High Sensitivity for Early Detection

With a limit of detection as low as 500 copies/mL, the kit supports rapid screening and facilitates early-stage infection detection.

3. Internal Control for Reliable Results

The kit incorporates a human GAPDH internal control to monitor the entire testing process, including sample collection, transportation, and nucleic acid extraction, helping ensure reliable test results.

4. Clinically Validated Performance

Validated by three institutions, including Taizhou People’s Hospital, the kit demonstrated excellent clinical performance, with an overall agreement rate of 99.40% for H1N1 and 98.80% for H3.

Guidelines and Consensus Support Nucleic Acid Testing

According to the Diagnosis and Treatment Protocol for Influenza (2025 Edition), nucleic acid testing offers high sensitivity and specificity and enables differentiation of virus types and subtypes.

The Guidelines for Diagnosis, Treatment and Prevention of Influenza in Children (2024 Physician Edition) state that nucleic acid testing is the preferred method for laboratory confirmation of influenza infection, with a Grade 1A recommendation.

International consensus also recognizes nucleic acid amplification testing (NAAT) as the gold standard for the diagnosis of respiratory infections, enabling accurate differentiation of influenza subtypes.

BioPerfectus Comprehensive Respiratory Pathogen Detection Solution

The BioPerfectus Influenza A Virus (H1N1 & H3)  Real Time PCR Kit can be used in combination with the BioPerfectus fully automated nucleic acid extraction and amplification platform. It can also be integrated with assays for Influenza A/B, RSV, Mycoplasma pneumoniae, and other respiratory pathogens, enabling broad respiratory pathogen coverage and flexible testing workflows.

This solution supports both rapid screening in outpatient and emergency settings and accurate diagnosis for hospitalized patients.

With a product portfolio built on precision, flexibility, and needs-based coverage, BioPerfectus provides strong support for the prevention and control of respiratory infectious diseases.