Clinical Diagnostic Laboratory Services

Clinical Diagnostic

The clinical diagnostic industry plays a crucial role in healthcare by providing tools and technologies for accurately identifying diseases and conditions. This sector encompasses a wide range of diagnostic tests and equipment used in laboratories, hospitals, and clinics to detect, diagnose, and monitor various health issues. Innovations in this field, including molecular diagnostics, point-of-care testing, and personalized medicine, are driving advancements in patient care. By enabling early and precise detection of diseases, clinical diagnostics facilitate timely interventions, improving patient outcomes and reducing healthcare costs. The industry is pivotal in the fight against chronic diseases, infections, and emerging health threats, contributing to global public health and wellness.

Clinical Diagnostic Testing and Research Services

Contract Laboratory can help you with all your Clinical Diagnostic testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs including:

Sensitivity and Specificity Analysis: Measures the test's ability to correctly identify patients with and without a disease
Precision and Accuracy Evaluation: Assesses the reliability and correctness of test results in diagnosing conditions
Validation Studies: Confirm that diagnostic tests and equipment meet regulatory standards and are suitable for clinical use
Interoperability Testing: Ensures that diagnostic systems and software can exchange and interpret data across different healthcare IT systems

Type of Clinical Diagnostic Products

Contract Laboratory can assist your company, academic institution, government agency or organization in outsourcing contract laboratories to perform testing, analysis, and product development for many Clinical Diagnostic finished products, processes, systems, in-process materials, raw materials and components such as:

In Vitro Diagnostic (IVD) Devices: Instruments and reagents used for tests conducted on samples such as blood or tissue from the human body
Molecular Diagnostics: Technologies that analyze biological markers in the genome and proteome
including DNA and RNA sequencing
Point-of-Care Testing (POCT): Portable and rapid tests performed at or near the site of patient care
reducing the need for centralized laboratory facilities
Immunoassays: Tests that utilize the reaction between an antigen and an antibody to detect specific substances in a sample
Clinical Chemistry Analyzers: Equipment that measures concentrations of chemical components in body fluids
such as glucose
cholesterol
or electrolytes
Hematology Analyzers: Devices used to count and characterize blood cells for disease detection and monitoring
Microbiology Tests: Methods for detecting and identifying bacteria
viruses
and other pathogens causing infections

Clinical Diagnostic Test Methods and Standards

Contract Laboratory can help with testing, analysis, assays, evaluations, examinations, inspections and certifications to different Clinical Diagnostic test methods, standards, procedures or specifications.

EN 13612: - Performance evaluation of in-vitro diagnostic devices
AS 4760 - Procedure for specimen collection and the detection and quantification of drugs in oral fluid
CLSI M07 - Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
CLSI M34 - Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline, M34AE
CLSI D103 - Agglutination Analyses: Antibody Characteristics, Methodology, Limitations, and Clinical Validation; Approved Guideline
CLSI ILA20 - Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities
DIN C59 - Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics
ISO 20776 - Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Evaluation of performance of antimicrobial susceptibility test devices
ISO 15189 - Medical laboratories - Requirements for quality and competence
ISO 15190 - Medical laboratories - Requirements for safety
OPPTS 890.1200 - Aromatase (Human Recombinant)
OPPTS 890.1250 - Estrogen Receptor Binding
OPPTS 890.1300 - Estrogen Receptor Transcriptional Activation (Human Cell Line HeLa-9903)
OPPTS 890.1550 - Steroidogenesis (Human Cell Line - H295R)
ASTM E2125-19 - Standard Practice for Microcrystal Testing in Forensic Analysis for Phencyclidine and Its Analogues

Need Clinical Diagnostic Testing or Scientific Research Services?

We can help with all your Clinical Diagnostic lab testing and scientific research needs! Call 1-855-377-6821 or

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