Medical Biotechnology Diagnostics

Medical biotechnology diagnostics encompasses a suite of techniques that harness molecular and cellular insights to detect, characterise and monitor disease. Core approaches include nucleic acid amplification methods (such as PCR and isothermal amplification), next-generation sequencing for pathogen profiling and genetic risk assessment, and immunoassays that quantify proteins, hormones and small-molecule markers. Liquid-biopsy platforms analyse circulating cell-free DNA, microRNAs or extracellular vesicles to provide minimally invasive windows into tumour burden, organ injury and infectious agents. Advances in microfluidics have enabled complex sample preparation and multiplexed assays to be miniaturised into point-of-care devices suitable for decentralised settings. Biosensors based on nanostructured electrodes exploit surface-enhanced Raman scattering, electrochemical transduction or optical resonance to achieve rapid, label-free detection of biomolecules at femtomolar to nanomolar concentrations. Emerging CRISPR-based diagnostics combine target recognition by Cas nucleases with simple readouts on lateral-flow strips or in microtitre plates, offering ultra-sensitive pathogen detection without extensive instrumentation. Across all modalities, rigorous assay design, blocking strategies and digital calibration are essential to avoid interference from endogenous antibodies or sample matrix effects. Integration with smartphone interfaces and cloud-based analytics is driving the real-time reporting of results, opening new possibilities for personalised treatment decisions, public-health surveillance and large-scale screening programmes.

Research from Nature Portfolio

A saliva-based surface-enhanced Raman scattering assay has been developed to detect current and past SARS-CoV-2 infection. By analysing biochemical changes in salivary metabolites and immunoglobulin levels, distinct Raman fingerprints were identified. Coupling these spectral patterns with a deep-learning classifier yielded signal-level diagnostic accuracy exceeding 95 %, with patient-level sensitivity and specificity near 90 %, demonstrating the potential for rapid, non-invasive screening.

Studies characterising endogenous anti-animal antibodies have revealed the diversity and binding specificities of anti-mouse immunoglobulins in canine serum. These antibodies target multiple regions of murine IgG, cross-react with other species and belong to all major immunoglobulin classes. The heterogeneity of interfering antibodies underscores the need for combined mitigation strategies—such as reagent modification, sample pre-treatment and alternative detection platforms—to preserve immunoassay accuracy in both veterinary and human diagnostics.

Medical Biotechnology Diagnostics publication trend

The graph below shows the total number of articles in medical biotechnology diagnostics across all publications each year (not limited to Nature Index journals).

Technical terms

Biomarker: A measurable molecule in body fluids or tissues indicating a biological state or condition.

Liquid biopsy: A minimally invasive test analysing circulating nucleic acids, proteins or vesicles in blood or other fluids to detect disease.

Surface-enhanced Raman scattering (SERS): An analytical method that amplifies Raman signals of molecules near nanostructured metal surfaces for ultrasensitive detection.

Lateral-flow assay: A paper-based platform that provides rapid, qualitative or semi-quantitative readouts of target analytes at the point of care.

Lipoarabinomannan (LAM): A glycolipid component of the Mycobacterium cell wall, detectable in urine during disseminated tuberculosis.

Chemiluminescence assay: A detection technique that measures light emitted by a chemical reaction to quantify target molecules.

Deep learning classifier: A computational model using neural networks to recognise complex patterns in high-dimensional data.

Point-of-care testing: Diagnostic testing conducted at the time and place of patient care, enabling immediate results without central laboratories.

References

1. COVID-19 salivary Raman fingerprint: innovative approach for the detection of current and past SARS-CoV-2 infections. Scientific Reports (2021).
2. Characterization of canine anti-mouse antibodies highlights that multiple strategies are needed to combat immunoassay interference. Scientific Reports (2019).
3. Diagnostic yield of urine lipoarabinomannan and sputum tuberculosis tests in people living with HIV: a systematic review and meta-analysis of individual participant data. The Lancet Global Health (2023).
4. Diagnostic value of chemiluminescence for urinary lipoarabinomannan antigen assay in active tuberculosis: insights from a retrospective study. Frontiers in Cellular and Infection Microbiology (2023).
5. Use of the urine Determine LAM test in the context of tuberculosis diagnosis among inpatients with HIV in Ghana: a mixed methods study. Frontiers in Public Health (2024).