ArticleTherapeutic drug monitoring2015
Describing Assay Precision-Reciprocal of Variance Is Correct, Not CV Percent: Its Use Should Significantly Improve Laboratory Performance.
Article in Therapeutic drug monitoring, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
25 citing papers in PubMed, 48 citations in OpenAlex.
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- Examining iPSC derived motor neuron variability and genome stability monitoring as a solution.Scientific reports · 2025Article
- Caloric Restriction, the Menstrual Cycle, and Sleep in Women Without Obesity.The Journal of clinical endocrinology and metabolism · 2025Article
- Performance of a novel DiaRD-HCV RNA RTqPCR kit for quantification of HCV RNA in clinical samples.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2025Article
- Evaluation of Proflo-U® Platform: A Novel Fluorescence-Based Point of Care Device for Quantitative Estimation of Urine Albumin.Indian journal of clinical biochemistry : IJCB · 2025Article
- Analytical Validation and Clinical Sensitivity of the Belay Summit Assay for the Detection of DNA Variants in Cerebrospinal Fluid of Primary and Metastatic Central Nervous System Cancer.The Journal of molecular diagnostics : JMD · 2025Article
- Differentiation of inflammatory pseudotumors and malignant pulmonary nodules using the time-to-peak in first-pass dual-input volume computed tomography-perfusion.Quantitative imaging in medicine and surgery · 2025Article
- Development of a Multiplex Real-Time PCR for Diagnosis of Tuberculosis and Multidrug Resistance.Current microbiology · 2025Article
- Validation of the method for determining lincomycin levels and calculating lincomycin levels in broiler chicken plasma using high-performance liquid chromatography.Open veterinary journal · 2024Article
- Therapeutic effects of lincomycin and level of drug degradation in broiler tissues after treatment.Veterinary world · 2024Article
- Modeling Pharmacokinetics in Individual Patients Using Therapeutic Drug Monitoring and Artificial Population Quasi-Models: A Study with Piperacillin.Pharmaceutics · 2024Article
- Validation and method comparison for a point-of-care lateral flow assay measuring equine whole blood insulin concentrations.Journal of veterinary diagnostic investigation : official publication of the American Association of Veterinary Laboratory Diagnosticians, Inc · 2023Article
- Individualized Patient Care Through Model-Informed Precision Dosing: Reflections on Training Future Practitioners.The AAPS journal · 2022Article
- A High-Throughput Clinical Laboratory Methodology for the Therapeutic Monitoring of Ibrutinib and Dihydrodiol Ibrutinib.Molecules (Basel, Switzerland) · 2022Article
- Vancomycin Pharmacokinetics in a Pregnancy Rat Model.Antimicrobial agents and chemotherapy · 2022Article
- Sensitive, High-Throughput Liquid Chromatography-Tandem Mass Spectrometry Analysis of Atorvastatin and Its Pharmacologically Active Metabolites in Serum for Supporting Precision Pharmacotherapy.Molecules (Basel, Switzerland) · 2021Article
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundDescribing assay error as percent coefficient of variation (CV%) fails as measurements approach zero. Results are censored if below some arbitrarily chosen lower limit of quantification (LLOQ). CV% gives incorrect weighting to data obtained by therapeutic drug monitoring, with incorrect parameter values in the resulting pharmacokinetic models, and incorrect dosage regimens for patient care.
methodsCV% was compared with the reciprocal of the variance (1/var) of each assay measurement. This method has not been considered by the laboratory community. A simple description of assay standard deviation (SD) as a polynomial function of the assay measurement over its working range was developed, the reciprocal of the assay variance determined, and its results compared with CV%.
resultsCV% does not provide correct weighting of measured serum concentrations as required for optimal therapeutic drug monitoring. It does not permit optimally individualized models of the behavior of a drug in a patient, resulting in incorrect dosage regimens. The assay error polynomial described here, using 1/var, provides correct weighting of such data, all the way down to and including zero. There is no need to censor low results, and no need to set any arbitrary LLOQ.
conclusionsReciprocal of variance is the correct measure of assay precision and should replace CV%. The information is easily stored as an assay error polynomial. The laboratory can serve the medical community better. There is no longer any need for LLOQ, a significant improvement. Regulatory agencies should implement this more informed policy.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.