Laboratory Analyzer Technical Specifications

Clinical laboratory analyzers are sophisticated instruments that perform automated testing of patient samples for diagnosis, monitoring, and treatment guidance. This technical specification document covers chemistry analyzers, hematology analyzers, immunoassay systems, and point-of-care testing devices used in clinical laboratories.

Chemistry Analyzer Specifications

Clinical chemistry analyzers measure metabolites, electrolytes, enzymes, and other analytes in blood and other body fluids using photometric, electrochemical, and immunochemical methods.

System Classifications

Class	Throughput	Typical Setting
Benchtop/Small	100-400 tests/hour	POC, clinic, small hospital
Mid-Volume	400-1,200 tests/hour	Community hospital, reference lab
High-Volume	1,200-3,000 tests/hour	Large hospital, regional reference
Integrated Systems	3,000-10,000+ tests/hour	Major medical center, reference lab

Performance Specifications

Parameter	Mid-Volume	High-Volume
Test Menu	60-100 assays	100-200+ assays
Sample Types	Serum, plasma, urine, CSF	All body fluids
Sample Volume	2-50 µL per test	1-35 µL per test
First Result	5-15 minutes	5-10 minutes
Photometer	Diode array or filter	Multi-wavelength (12+)
Wavelength Range	340-800 nm	340-850 nm
ISE Channels	Na, K, Cl (Li optional)	Na, K, Cl, Li, Ca, pH
Reagent Positions	30-60	80-200+
Sample Positions	50-150	200-1000+

Analytical Methods

• Photometry: Absorbance measurement for enzyme activity, metabolite concentration
• Ion-Selective Electrode (ISE): Electrolytes (Na, K, Cl, Li, Ca, pH)
• Turbidimetry/Nephelometry: Protein quantification, drug levels
• Potentiometry: pH, blood gases
• Amperometry: Glucose, lactate sensors
• Homogeneous Immunoassay: Therapeutic drugs, specific proteins

Hematology Analyzer Specifications

Hematology analyzers perform complete blood counts (CBC) and differential analysis using impedance, optical, and flow cytometry methods.

Analyzer Classifications

Class	Parameters	Throughput
3-Part Differential	18-22 parameters	40-60 samples/hour
5-Part Differential	24-40 parameters	60-120 samples/hour
Advanced 5-Part	40-60+ parameters	100-150 samples/hour
High-Volume	60+ parameters	150-200+ samples/hour

CBC/Differential Parameters

Category	Parameters
RBC Parameters	RBC, HGB, HCT, MCV, MCH, MCHC, RDW, NRBC
WBC Parameters	WBC, NEU, LYM, MONO, EOS, BASO (3-part: Gran, Lymph, Mid)
Platelet Parameters	PLT, MPV, PDW, PCT, IPF
Reticulocytes	RET%, RET#, IRF, RET-HE
Research/Advanced	Cell morphology flags, scattergrams, cell population data

Measurement Technologies

• Impedance (Coulter Principle): Cell counting, RBC/PLT sizing
• Optical Detection: Light scatter for cell identification
• Flow Cytometry: Multi-angle scatter, fluorescence for differentiation
• Laser Diffraction: Hemoglobin measurement (SLS or cyanide-free)
• Fluorescent Markers: Nucleic acid staining for reticulocytes, NRBC

Immunoassay Analyzer Specifications

Immunoassay analyzers detect and quantify antigens, antibodies, hormones, drugs, and tumor markers using antigen-antibody reactions.

System Specifications

Parameter	Mid-Volume	High-Volume
Throughput	100-200 tests/hour	200-400+ tests/hour
Menu Size	50-100 assays	100-200+ assays
Detection Method	Chemiluminescence	Chemiluminescence, Electrochemiluminescence
Sample Volume	10-150 µL	5-100 µL
First Result	15-30 minutes	9-20 minutes
Reagent Onboard	15-30 assays	30-50+ assays
Dynamic Range	5-6 logs	6-7 logs

Detection Technologies

• Chemiluminescence (CLIA): Acridinium esters, isoluminol derivatives
• Electrochemiluminescence (ECLIA): Ruthenium complex labels
• Fluorescence Polarization (FPIA): Therapeutic drug monitoring
• Enzyme Immunoassay (EIA): Colorimetric or fluorescent substrates
• Microparticle Enzyme Immunoassay (MEIA): Latex microparticle solid phase

Common Immunoassay Menu Categories

Category	Examples
Thyroid	TSH, FT4, FT3, T3, T4, Thyroglobulin
Reproductive	hCG, FSH, LH, Estradiol, Progesterone, Testosterone
Cardiac	Troponin, BNP, NT-proBNP, Myoglobin, CK-MB
Tumor Markers	PSA, CEA, CA 125, CA 19-9, AFP
Infectious Disease	HIV, HBV, HCV, Syphilis, CMV, EBV
Therapeutic Drug Monitoring	Tacrolimus, Cyclosporine, Digoxin, Vancomycin
Anemia	Ferritin, B12, Folate, EPO

Coagulation Analyzer Specifications

Coagulation analyzers measure hemostasis parameters for monitoring anticoagulant therapy and diagnosing bleeding disorders.

System Specifications

Parameter	Routine Lab	Specialized Coag Lab
Throughput	60-200 tests/hour	200-400+ tests/hour
Detection Methods	Optical, mechanical	Optical, mechanical, chromogenic, immunologic
Test Menu	PT, aPTT, Fibrinogen, D-dimer	Full clotting factors, inhibitors, platelet function
Sample Volume	25-100 µL	15-75 µL
Clot Detection	Photo-optical	Multiple detection technologies

Coagulation Test Categories

• Screening Tests: PT/INR, aPTT, TT, Fibrinogen
• Factor Assays: Factors II, V, VII, VIII, IX, X, XI, XII, XIII
• Inhibitor Testing: Lupus anticoagulant, factor inhibitors
• Fibrinolysis: D-dimer, FDP, plasminogen, α2-antiplasmin
• Platelet Function: Aggregation, VWF:RCo, VWF:Ag
• Anticoagulant Monitoring: Anti-Xa (heparin, LMWH, DOACs)

Point-of-Care Testing Devices

POCT devices provide rapid results at the patient bedside for immediate clinical decision-making. Understanding point-of-care testing protocols ensures quality results.

Common POCT Categories

Category	Tests	Sample Type	Result Time
Blood Gases	pH, pCO2, pO2, electrolytes	Arterial, venous blood	1-2 minutes
Glucose	Glucose	Capillary, venous	5-10 seconds
Cardiac Markers	Troponin, BNP	Venous, capillary	10-20 minutes
Coagulation	PT/INR, ACT	Capillary, venous	1-5 minutes
Urinalysis	Dipstick, pregnancy	Urine	1-2 minutes
Infectious Disease	Flu, RSV, Strep, COVID-19	Nasopharyngeal swab	10-30 minutes

Automation and Integration

Laboratory Automation Systems

• Pre-Analytical Automation: Centrifugation, aliquoting, sorting
• Track Systems: Sample transport between analyzers
• Total Laboratory Automation: Complete sample-to-result workflow
• Middleware: Rules-based result management, auto-verification
• LIS Integration: Bidirectional interface, result transmission

Connectivity Standards

Standard	Purpose
HL7 v2.x	Message format for lab results, orders
ASTM 1394	Instrument-to-host communication
POCT1-A2	Point-of-care device connectivity
LIS02-A2	Lab instrument interface standard
FHIR	Modern interoperability standard

Related Resources

For additional information on laboratory equipment and quality requirements, explore these resources:

• Documentation Hub – Technical equipment specifications
• Clinical Laboratory Quality Assurance
• Point-of-Care Testing Guide
• CLIA Laboratory Accreditation
• Compliance Standards Hub – Regulatory requirements
• Knowledge Base Hub – Healthcare equipment guides