Ultra-fast,High Accuracy: Zybio's rapid PCR system detects Flu A, Flu B & RSV with over 97% sensitivity and 98% specificity—identifying positive sample in 12 Mins!
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In ESCMID 2025, Zybio has 4 posters successfully accepted, which were showcased in ESCMID hall during the congress. One of them, titled “Accelerating Molecular Diagnostics: Development of a Novel Rapid, Integrated PCR System for Acute Respiratory Infections Detection” presented our cutting-edge PCR platform for acute respiratory infections. Ideal for ED & clinics, it empowers clinicians with speed and accuracy. Zybio’s rapid PCR kit for Flu A, Flu B and RSV, and finds reliable sensitivity of over 97% and specificity of over 98%.
· Common Respiratory Infection Pathogens in Clinical Diagnostics
Acute Respiratory Infections (ARI) include common cold, influenza, RSV infection, acute bronchitis, pneumonia, and such. ARI often present with overlapping symptoms (e.g., fever, cough, sore throat), and accurate and early differentiation is crucial as treatment strategies vary significantly among FluA, FluB, and RSV.
Pathogen | Clinical Features | Main Symptoms | Treatmeng |
FluA | Highly contagious Incubation period of 1~4 days | Sudden high fever (>38℃) Muscle aches,Sore throat, Headache | Antiviral drugs + supportive care |
FluB | Similar to FluA Usually triggers local outbreak | Sudden high fever (>38℃) Muscle aches, Cough, Sore throat, Headache | Antiviral drugs + supportive care |
RSV | Incubation period of 2~8 days Mainly in infants/elderly Easily lead to lower respiratory tract infections | Initial symptoms : Cold-like symptoms May develop into wheezing and shortness of breath | Supportive therapy only No specific antiviral drugs available |
According to data published in BMC infectious diseases, a multi-center clinical epidemiological survey conducted in China in 2024 showed that influenza A virus, influenza B virus, and respiratory syncytial virus are the main pathogens causing respiratory infections and hospitalizations in elderly people over 60 years old. These three viruses together account for over 58% of all types of infectious pathogens.
Figure 1: A multicenter clinical epidemiological survey
Joint detection through PCR enables clinicians to determine the exact pathogen quickly and tailor treatment strategies accordingly—minimizing misdiagnosis, inappropriate antiviral use, and delayed care.
Study Highlights: 97%+ Sensitivity, 98%+ Specificity, Identifying Positive Sample in 12 Mins
The study analyzed Zybio’s rapid PCR kit for Flu A, Flu B and RSV, which identifies positive samples in 12 minutes and complete a full PCR cycle in 20 minutes. The experiment included 154 clinical samples for comparison between Zybioʼs rapid PCR and reference qPCR, achieving 99.30% total agreement with reference qPCR (Kappa = 0.9833). Influenza A detection showed a 97.67% sensitivity and 100% specificity, Influenza B achieved 100% sensitivity and specificity, and RSV achieved 100.00% sensitivity and 98.98% specificity.(Table 2)
By continuously optimizing the reaction system, the detection sensitivity of this kit is as low as 200 copies/mL, which helps to detect respiratory viruses early, prevent virus transmission and disease progression, and accurately assist patients in diagnosis and treatment . (Table 2)
Clinical samples | Pathogen | Sensitivity | Specificity | Kappa | A Detection Limit |
143 | FluA | 97.67% | 100% | 0.9833 | 200 copies/mL |
FluB | 100% | 100% | |||
RSV | 100% | 98.98% |
Table 2:Involving 143 clinical samples, Zybio PCR VS reference qPCR
In a broader evaluation involving 686 samples, there were 407 males (59.33%) and 279 females (40.67%) .This includes common subtypes of influenza A virus H1N1 and H3N2, subtypes of influenza B virus Victoria and Yamagata, and respiratory syncytial virus anti-type subtypes RSV-A and RSV-B.
Figure 1: In a broader evaluation involving 686 samples, Zybio PCR kit VS NMPA-approved PCR kit
The study shows 100.00% sensitivity and 99.77% specificity for FluA, 99.53% sensitivity and 99.58% specificity for FluB, and 100.00% sensitivity and 99.60% specificity for RSV.(Figure 1) Overall agreement reached 99.85% (Kappa = 0.9969), confirming the assayʼs high accuracy and reliability. Reducing time by approximately 50% compared to traditional qPCR,high sensitivity, and specificity address clinical emergencies and public health needs.
How does Zybio MALDI-TOF MS Facilitate Clinical Microbiology
The newly developed system can identify positive samples of either Flu A, Flu B or RSV within 12 minutes and complete a full PCR cycle in just 20 minutes, making it ideal for clinical settings requiring urgetn decision-making, such as emergency departments and outpatient clinics.
Zybio has been and will always be committed to the concept of "Dedication to Accuracy" and constantly go further in technology of laboratory testing. Meanwhile, we, with customer-centered notion in mind, will improve our services in an all-round and multi-angle manner to provide more comprehensive and efficient solutions for healthcare providers, and in this way, we safeguard patients' lives and health.