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Recently, the "Burkholderia cepacia Complex / Escherichia coli / Enterobacter cloacae Complex Nucleic Acid Detection Kit (Fluorescent PCR Method)", jointly developed by China-Japan Friendship Hospital and XABT, has been reviewed and officially approved for marketing by the National Medical Products Administration (NMPA) (Approval No.: 20253402709).

This kit is used for the in vitro qualitative detection of nucleic acid DNA of Burkholderia cepacia complex, Escherichia coli, and Enterobacter cloacae complex in human sputum samples. The test results can assist in the early diagnosis of hospital-acquired pneumonia and support precision medicine.

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Project Background

Lower respiratory tract infections (LRTIs) are the deadliest infectious diseases worldwide, ranking fourth among the leading causes of death. In 2019, they caused 2.6 million deaths and ranked second in the disease burden among children aged 0-9 years [1].

Hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) are the most common hospital-acquired infections in China. Studies at home and abroad have shown that LRTIs, including HAP/VAP, account for the highest proportion of hospital-acquired infections [2].

Burkholderia cepacia complex, Escherichia coli, and Enterobacter cloacae complex are clinically predominant isolated flora and important pathogens of LRTIs. As opportunistic pathogens, they can cause infections in relevant sites and lead to pneumonia in severe cases.

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Target?Introduction

Burkholderia cepacia complex (BCC) includes Burkholderia cepacia, Burkholderia multivorans, Burkholderia cenocepacia, and other species. As opportunistic pathogens, they often colonize the lungs of patients with cystic fibrosis (CF) and chronic granulomatous disease (CGD). BCC is a highly virulent and lethal pathogen for CF patients and also a major cause of nosocomial infections in immunocompromised patients.

Escherichia coli belongs to the Enterobacteriaceae family and is one of the most common and important clinical strains. It has strong viability, rapid reproduction, and is prone to drug-resistant mutations, making it easy to spread and frequently cause nosocomial infections, mainly threatening immunocompromised individuals and hospitalized patients.

Enterobacter cloacae complex (ECC) includes Enterobacter cloacae, Enterobacter asburiae, Enterobacter hormaechei, and other species. As opportunistic pathogens, this flora can cause various local or systemic infections, including bloodstream and respiratory tract infections. Infections are more concentrated as hospital-acquired infections, especially in settings such as intensive care units (ICUs).

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Clinical Value

Rapid detection and accurate diagnosis of pathogens are important prerequisites for the effective treatment of infectious diseases. However, nearly 70% of patients cannot obtain a clear etiological diagnosis relying solely on traditional microbiological and immunological techniques [3]. In response, XABT and China-Japan Friendship Hospital reached a horizontal research collaboration in 2020 to develop a series of respiratory bacterial detection reagents and conduct relevant clinical value evaluations.

This launch marks the third bacterial product—the Burkholderia cepacia Complex / Escherichia coli / Enterobacter cloacae Complex Nucleic Acid Detection Kit (Fluorescent PCR Method). Focusing on high-incidence and highly pathogenic pathogens of HAP/VAP, it can quickly provide accurate test results to guide the rational use of antibiotics at an early stage; provide an effective molecular diagnostic strategy for the early identification of epidemic strains, implementation of isolation measures, and blocking of nosocomial transmission; and can be combined with other high-incidence pathogens, viruses, and fungi of HAP/VAP for joint testing according to clinical needs to identify mixed infections.

This detection solution further improves XABT's product matrix for respiratory bacterial infections and safeguards human health. With efficient and accurate detection performance, it provides strong support for the diagnosis and treatment of HAP and related respiratory diseases, driving the diagnosis of respiratory infectious diseases to a new level.

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References

[1]?Vos, Theo, et al. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. The Lancet, Volume 396, Issue 10258, 1204-1222.

[2]?Guidelines for the Diagnosis and Treatment of Adult Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia in China (2018 Edition).

[3]?Expert Consensus on the Clinical Application of Nucleic Acid Detection Technology for the Etiological Diagnosis of Adult Respiratory Tract Infections (2023).