Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Sensitivity, Specificity, and Predicted Value01:13

Sensitivity, Specificity, and Predicted Value

1.2K
In healthcare diagnostics, laboratory tests play a crucial role in identifying and diagnosing a wide range of medical conditions. However, interpreting test results is not always straightforward. An abnormal test result does not always confirm the presence of a disease, just as a normal result does not guarantee its absence. To assess the reliability of these diagnostic tools, healthcare practitioners rely on two key statistical indicators: sensitivity and specificity.
Sensitivity is the...
1.2K
Therapeutic Drug Monitoring: Drug Analysis Methods01:26

Therapeutic Drug Monitoring: Drug Analysis Methods

150
Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood or body tissues to tailor drug therapy effectively. This monitoring is critical for managing drugs with narrow therapeutic indices like digoxin and phenytoin, ensuring they are both safe and effective. For instance, monitoring theophylline levels in asthma patients involves precision and sensitivity to adjust doses according to individual responses to therapy, ensuring efficacy and...
150
Data Validation01:15

Data Validation

535
Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
535

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Validity of nutrition-related outcome measures in eating disorder treatment: a scoping review.

Eating disorders·2026
Same author

First Reported Human Cases of Urolithin A Renal Calculi.

Kidney international reports·2026
Same author

Identifying candidates for USP Compounded Preparation Monograph studies from ASHP and University of Utah Drug Shortages List.

American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists·2025
Same author

Establishment and verification of chromium and cobalt concentrations in joint fluids from a reference population.

Clinical mass spectrometry (Del Mar, Calif.)·2024
Same author

Safety and Efficacy of Biologic Medications and Janus Kinase Inhibitors in Patients with Down Syndrome: A Retrospective Cohort Study.

Clinical drug investigation·2024
Same author

Investigation of cofactor activities of endothelial microparticle-thrombomodulin with liposomal surrogate.

Biochemical and biophysical research communications·2023

Related Experiment Video

Updated: Jan 5, 2026

Detection and Quantification of Calcitonin Gene-Related Peptide CGRP in Human Plasma Using a Modified Enzyme-Linked Immunosorbent Assay
07:14

Detection and Quantification of Calcitonin Gene-Related Peptide CGRP in Human Plasma Using a Modified Enzyme-Linked Immunosorbent Assay

Published on: June 16, 2023

3.2K

Method Verification Shows a Negative Bias between 2 Procalcitonin Methods at Medical Decision Concentrations.

Valentinas Gruzdys1, Kenneth Cahoon2, Lauren Pearson3

  • 1Department of Pathology and Laboratory Medicine, Loyola University Medical Center, Maywood, IL; valentinas.gruzdys@lumc.edu.

The Journal of Applied Laboratory Medicine
|October 23, 2019
PubMed
Summary
This summary is machine-generated.

The Architect B·R·A·H·M·S PCT assay shows good precision and sensitivity for measuring procalcitonin (PCT). However, a negative bias was observed at higher PCT concentrations, impacting clinical decision-making.

More Related Videos

Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay
07:52

Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay

Published on: September 10, 2018

9.2K
Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody mAb by Neutralizing TNF Using an In Vitro Bioanalytical Method
16:07

Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody mAb by Neutralizing TNF Using an In Vitro Bioanalytical Method

Published on: September 16, 2017

9.6K

Related Experiment Videos

Last Updated: Jan 5, 2026

Detection and Quantification of Calcitonin Gene-Related Peptide CGRP in Human Plasma Using a Modified Enzyme-Linked Immunosorbent Assay
07:14

Detection and Quantification of Calcitonin Gene-Related Peptide CGRP in Human Plasma Using a Modified Enzyme-Linked Immunosorbent Assay

Published on: June 16, 2023

3.2K
Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay
07:52

Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay

Published on: September 10, 2018

9.2K
Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody mAb by Neutralizing TNF Using an In Vitro Bioanalytical Method
16:07

Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody mAb by Neutralizing TNF Using an In Vitro Bioanalytical Method

Published on: September 16, 2017

9.6K

Area of Science:

  • Clinical Chemistry
  • Biomarker Analysis
  • Infectious Disease Diagnostics

Background:

  • Procalcitonin (PCT) is a biomarker for bacterial infections and systemic inflammation.
  • Established PCT assays are validated, but new FDA-approved assays require rigorous method verification.
  • Accurate PCT measurement is crucial for guiding antibiotic therapy and patient management.

Purpose of the Study:

  • To verify the performance of the new Architect B·R·A·H·M·S PCT assay.
  • To compare the Architect assay's results against a validated reference assay (B·R·A·H·M·S PCT sensitive Kryptor).
  • To assess the clinical applicability of the Architect PCT assay based on its analytical performance.

Main Methods:

  • Method verification included precision, sensitivity, linearity, reportable range, and reference interval determination.
  • Accuracy was assessed by comparing patient results from the Architect assay with the Kryptor assay.
  • Statistical analysis focused on agreement at various medical decision concentrations (MDCs).

Main Results:

  • The Architect B·R·A·H·M·S PCT assay demonstrated acceptable precision (CV ≤4.6%), sensitivity (LOB 0.001 ng/mL, LOQ ≤0.01 ng/mL), and linearity.
  • Analytical measurement range (0.20-100.00 ng/mL) and reference interval (≤0.07 ng/mL) were verified.
  • High agreement was observed at lower MDCs (0.10, 0.25 ng/mL), but reduced positive agreement occurred at higher MDCs (0.50, 2.00 ng/mL) due to negative bias.

Conclusions:

  • The Architect B·R·A·H·M·S PCT assay generally meets manufacturer specifications for analytical performance.
  • A notable negative bias was identified at higher procalcitonin concentrations (0.50 and 2.00 ng/mL).
  • This bias may affect the interpretation of results at critical clinical decision points, warranting careful consideration during implementation.