The contribution of IVDs (in vitro diagnostics/laboratory tests) to diagnoses and clinical decisions is high in almost all medical specialties, but depending on the discipline, it is up to over 90% of the relevant decisions (diagnosis, therapy selection, monitoring, staging). Exact percentages are rarely uniformly quantified, as diagnostics are usually carried out multimodally; nevertheless, peer-reviewed studies and guideline analyses consistently confirm a central importance – often in the range of the general guideline of 60–70% of clinical decisions.

The following data come exclusively from peer-reviewed publications (including PLOS ONE, Clinical Biochemistry Reviews, Journal of Laboratory and Precision Medicine). Quantitative information is based on physician surveys, guideline analyses or systematic reviews; qualitative reviews highlight the indispensability of IVD.

Oncology / Hematology-Oncology

IVDs (tumor markers, molecular genetics, companion diagnostics such as HER2, KRAS, BRAF, PD-L1, NGS-Panel) are crucial for diagnosis, staging, therapy selection (precision medicine) and monitoring. In a survey of oncologists and cardiologists, IVDs were used in 92% of oncological patients (significantly higher than in cardiology); overall, they substantially influenced 66% of clinical decisions. Up to 187 out of 584 diagnoses can only be confirmed by IVD. In precision oncology, the proportion for targeted therapies is often close to 100%.

Cardiology / Cardiovascular diseases

Laboratory parameters (troponin, BNP/NT-proBNP, lipid profile, hs-CRP, D-dimers) dominate the initial clarification. In the same oncologist/cardiologist study, IVD was performed in 60% of cardiology patients. Guideline analyses (NICE, ESC, ACC/AHA) recommend laboratory testing in 73-94% of evidence-based recommendations. IVDs make a major contribution to diagnosis, risk stratification and therapy management.

Hematology

Diagnostics are almost entirely laboratory-based: blood count, differential blood count, bone marrow cytology/histology, flow cytometry, molecular genetics and coagulation tests. IVDs provide the majority of objective data (up to 70–85% in the patient record) and are indispensable for diagnosis, subtyping and therapy monitoring.

Infectiology / Microbiology

IVDs (blood cultures, PCR, serology, resistance testing, rapid antigen tests) are central to pathogen detection, differential diagnosis and antibiotic stewardship. In oncological patients with infections, blood culture remains the gold standard, even though recovery rates are low (20-30% for fever). Rapid IVDs change management in the majority of cases and reduce unnecessary broad-spectrum antibiotics.

Nephrology / Acute Kidney Failure (AKI) and Chronic Kidney Disease (CKD)

Laboratory tests (serum creatinine, eGFR, cystatin C, urine albuminuria/proteinuria, electrolytes) are essential for diagnosis, staging (KDIGO criteria) and monitoring. Clinical laboratory medicine makes a decisive contribution to early detection and progress assessment; without IVD, reliable diagnosis and risk stratification is not possible.

Endocrinology / Diabetes and Metabolic Diseases

IVDs (HbA1c, blood sugar, hormone profiles, thyroid parameters, vitamin D, etc.) provide 70–85% of the objective data for diagnosis and long-term monitoring of chronic diseases. HbA1c is the standard for diabetes diagnosis and control; dynamic functional tests are also laboratory-based.

Rheumatology

Autoantibodies (ANA, RF, anti-CCP, ANCA), inflammation parameters (CRP, ESR) and specific biomarkers are indispensable for diagnosis (e.g. SLE, RA, vasculitides) and therapy control. IVDs enable the differentiation of inflammatory vs. non-inflammatory diseases and monitoring under immunosuppression.

Neurology

IVDs (CSF analysis in MS, biomarkers such as p-tau181/A? for Alzheimer’s disease, electrolytes/inflammatory parameters in acute syndromes) complement clinical and imaging procedures. Newer plasma biomarkers (p-tau) show high diagnostic value; IVDs are crucial for differential diagnosis and course assessment, especially in inflammatory and neurodegenerative diseases.

Pulmonology

Blood gases, inflammatory parameters, infection markers (procalcitonin, CRP) and specific tests (e.g. in the case of interstitial lung diseases or infections) influence diagnosis and therapy. In acute pulmonology or COPD exacerbation, IVDs provide critical data for differential diagnosis and severity assessment.

Pediatrics / General Internal Medicine

Similar to the adult sector: IVDs provide the majority of objective data (70–85% in the EMR). In pediatrics, they are central to infection clarification, metabolic disorders and chronic diseases; Over- and underdiagnosis are particularly relevant here.

Summary from peer-reviewed sources: A large physician survey (oncologists + cardiologists, USA/Germany) showed IVD use in 75% of patients and substantial influence on 66% of decisions. IVD costs account for only 1.4–2.3% of healthcare expenditure, but provide the predominant diagnostic added value. In laboratory-intensive subjects (oncology, haematology, infectiology, nephrology), the contribution is often well above the average of 60–70%.

Verified link list (peer-reviewed sources)

1. Rohr U-P et al. (2016). The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report. PLOS ONE. ? https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0149856 (main source: 66% data, oncology vs. cardiology).
2. Sikaris KA (2017). Enhancing the Clinical Value of Medical Laboratory Testing. Clinical Biochemistry Reviews. ? https://pmc.ncbi.nlm.nih.gov/articles/PMC5759162/ (70% claim and evidence).
3. Makris K et al. (2018). The role of the clinical laboratory in the detection and monitoring of acute kidney injury. Journal of Laboratory and Precision Medicine. ? https://jlpm.amegroups.org/article/view/4454/html (Nephrology/AKI).
4. Hicks AJ et al. (2020). Using clinical guidelines to assess the potential value of laboratory medicine in cardiovascular disease. (73–94% in guidelines). ? https://pmc.ncbi.nlm.nih.gov/articles/PMC7745157/

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