Biotechnology Empowers Diagnostic Reagents: New Trends in POCT and Precision Medicine

I. Technical Advances and Application Scenarios of Point-of-Care Testing (POCT)

Point-of-care testing (POCT) refers to rapid testing performed at or near the patient's side, emphasizing simple operation, short turnaround time, and miniaturized equipment. Advances in diagnostic reagent biotechnology have provided key technical support for POCT, such as lateral flow chromatography, microfluidic chips, miniaturized nucleic acid amplification, and electrochemical sensing. These technologies enable certain tests that were previously only possible in central laboratories to be performed in emergency departments, primary healthcare institutions, community health service centers, and even at home. Common POCT items include blood glucose, blood gases, cardiac markers, inflammatory markers, antigens or antibodies for certain infectious diseases, and coagulation function.

The value of POCT lies in shortening the waiting time for test results and helping clinicians make rapid decisions, which is of practical significance especially in scenarios such as emergency chest pain, infectious disease outbreaks, and diagnosis and treatment in remote areas. However, POCT also faces quality control challenges, such as insufficient operator training, fluctuations in ambient temperature and humidity, improper reagent storage, and result discrepancies between different devices. Therefore, institutions conducting POCT should establish corresponding quality management programs, including personnel training, internal quality control, external quality assessment, result recording, and abnormal result review mechanisms. The quality requirements of POCT should not be neglected simply because its operation is simple; otherwise, it may lead to risks of misdiagnosis.

II. Standardized Use and User Education of Home Self-Test Products

With the advancement of biotechnology and product design capabilities, some diagnostic reagents are now suitable for non-professional users to collect samples and interpret results themselves. Common home self-test products include early pregnancy test strips, ovulation prediction test strips, blood glucose test strips, urine microalbumin test strips, and infectious disease antigen self-test reagents approved for use in certain countries or regions. The convenience of home self-testing lies in protecting privacy, reducing the inconvenience of visiting medical institutions, and improving testing accessibility. At the same time, however, non-professional users may have deviations in their understanding of sample collection, operating procedures, reading time, and result interpretation. Therefore, product design should simplify operation as much as possible, and instructions should be illustrated and easy to understand.

It should be particularly emphasized that home self-test results are usually for preliminary screening reference only and cannot replace professional laboratory testing and physician diagnosis. Companies must not use promotional terms such as "guaranteed accurate" or "absolutely accurate," but should truthfully inform users of the testing window period, the possibility of false negatives or false positives, and recommendations for handling abnormal results. For infectious disease self-test products, a positive result should prompt users to promptly visit a medical institution for confirmation and follow public health guidance; a negative result also cannot completely rule out infection, especially in cases of high-risk exposure or persistent symptoms. User education is an important component of the full life-cycle management of home self-test products, and companies can provide ongoing guidance through instructions, official websites, customer service channels, and other means.

III. Coordinated Development of Companion Diagnostics and Precision Medicine

Companion diagnostics are diagnostic tests associated with specific therapeutic drugs, used to identify patient populations most likely to benefit from the treatment or likely to experience severe adverse reactions. In oncology precision medicine, companion diagnostics are relatively mature in application, for example, by detecting the specific gene mutation status of patients with non-small cell lung cancer to help determine whether they are suitable for the corresponding targeted therapy. The development of biotechnology has expanded companion diagnostic targets from a single gene to multiple genes, multiple proteins, and multiple signaling pathways, and detection technologies have also expanded from PCR and in situ hybridization to next-generation sequencing, multiplex immunohistochemistry, and others.

The development of companion diagnostic products usually needs to be conducted in parallel with drug clinical trials to verify the association between test results and treatment response. The registration review of such products often requires sufficient analytical performance data and clinical utility evidence to demonstrate that their test results can reliably guide treatment decisions. The promotion of companion diagnostics helps avoid ineffective treatment, reduce unnecessary drug exposure and waste of medical resources, but the applicable population and testing timing need to strictly follow the approved instructions and clinical guidelines. When interpreting companion diagnostic results, clinicians also need to comprehensively consider the patient's overall condition, pathological type, tumor stage, and other molecular characteristics, and avoid determining treatment plans based on a single marker alone.

IV. New Directions in the Integration of Multi-Omics and Data Intelligence

Traditional diagnostic reagents mostly target a single or a few indicators, while advances in biotechnology have made multi-omics testing possible, including genomics, transcriptomics, proteomics, metabolomics, and others. Multi-omics testing can provide richer information from different biological levels, helping to more comprehensively understand disease states and individual differences. For example, in infectious diseases, simultaneously detecting pathogen nucleic acids, host immune response markers, and metabolic changes can help determine the stage and severity of infection;In tumor diagnosis, combining genomic variation and protein expression information may improve the accuracy of molecular classification.

The high dimensionality, heterogeneity, and complexity of multi-omics data pose challenges to data analysis and result interpretation. Artificial intelligence and machine learning methods can assist in mining potential patterns in multi-omics data and establishing predictive models, but the generalizability, interpretability, and clinical utility of the models still need to be validated through large-scale prospective studies. Biotechnology companies developing diagnostic reagents should avoid exaggerating the "intelligent diagnosis" capabilities of artificial intelligence and truthfully explain the applicable scope and uncertainties of the models. The standardization, quality control, data privacy, and ethical issues of multi-omics testing also require joint exploration by the industry.

V. Rational Thinking and Industry Responsibility Under Innovation Trends

Biotechnology-driven innovation in diagnostic reagents has brought more possibilities to healthcare, but innovation itself is not the goal; it must ultimately serve clinical value and patient safety. For new technologies to move from the laboratory to clinical application, they must undergo rigorous analytical performance validation, clinical evaluation, quality system development, and accumulation of real-world evidence. Industry practitioners and users should remain rational, not blindly pursue concepts, but focus on whether products address clear clinical needs, whether they have reproducible performance, and whether they are used in appropriate scenarios.

For medical institutions and the public, when selecting diagnostic reagents, attention should be paid to product registration information, applicable scope, and operating requirements, and vigilance should be maintained toward unapproved products or those with overly broad claims. Companies should abide by regulatory and ethical bottom lines, avoid absolute language and efficacy promises in product promotion, and objectively convey product performance, limitations, and usage recommendations. The future development of biotechnology in diagnostic reagents requires not only technological breakthroughs but also industry self-discipline and social co-governance, jointly promoting precise, convenient, and reliable testing methods to benefit more people.