Point-of-Care Nucleic Acid Testing Technology

The development and clinical application of nucleic acid detection technology has significantly improved the diagnostic capability for respiratory pathogens. How to appropriately select nucleic acid testing technology based on patients' underlying conditions, types of respiratory infections, and pathogen spectrum, and correctly understand its clinical application value has become an important clinical issue.

To address this, the Chinese Laboratory Medicine Training Project Expert Committee organized multidisciplinary experts to jointly write the "Expert Consensus on Clinical Application of Nucleic Acid Detection Technology for Adult Respiratory Infection Pathogen Diagnosis (2023)." Professor Xu Yingchun from the Laboratory Department of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and Professor Qu Jieming from the Department of Respiratory and Critical Care Medicine, Ruijin Hospital Affiliated to Shanghai Jiao Tong University served as corresponding authors. This article introduces point-of-care nucleic acid testing technology based on the expert consensus.

✧ Recommendation: Point-of-care nucleic acid testing is primarily suitable for detecting specific pathogens in respiratory infection patients in settings with limited testing facilities or requiring rapid screening, such as fever clinics, emergency departments, and ICUs.

✧ Expert consensus: 97.6%

Point-of-care nucleic acid testing refers to a broad category of POCT technologies involving nucleic acid detection, integrating nucleic acid extraction technology and molecular amplification technologies (including real-time fluorescent PCR, nested PCR, isothermal amplification, digital PCR, etc.). Its main characteristic is that nucleic acid extraction, amplification, and detection all occur within a single reaction device, completing target nucleic acid screening through specific equipment detection of amplification signals. Currently, nucleic acid POCT primarily uses fully automated closed management systems.

Application

Unlike traditional POCT, respiratory pathogen nucleic acid POCT requires biosafety assessment of the detected pathogens. Nucleic acid POCT products for respiratory pathogens such as influenza virus, Chlamydia pneumoniae, Mycoplasma pneumoniae, and Bordetella pertussis have emerged as representative products in this category.

Technical Characteristics

Nucleic acid POCT has higher sensitivity and specificity than immunological POCT but comes at a higher cost. Although most nucleic acid POCT products are closed systems, the possibility of PCR contamination still needs attention. Additionally, while the testing equipment is generally small and portable, this results in lower throughput, making it unsuitable for large-scale population screening. Large hospitals often need multiple sets of equipment to meet clinical testing demands.

Performance Validation Requirements

Qualitative detection performance validation indicators must include:

• ☑️Concordance rate ≥90%
• ☑️Consistent results for negative and weakly positive sample precision testing
• ☑️100% detection of target genes in 5 repeated tests, and at least 18 detections out of 20 tests

Quantitative detection performance validation indicators must include:

• ☑️At least 80% of sample results within ±7.5% bias range
• ☑️Intra-batch and inter-batch precision meeting product specifications
• ☑️Linear range meeting product specifications
• ☑️≥18 out of 20 test results showing bias within ±7.5% range compared to reference values

Experts point out: "Different pathogen diagnostic methods each have their own applicable scenarios and prerequisites. The selection of suitable testing methods should be based on patient population, disease characteristics, suspected pathogen types, and local laboratory capabilities."

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