Introduction
An immunoassay analyzer is a laboratory instrument used to perform immunoassays, which are analytical tests that use antibodies and antigens to detect and quantify substances, such as hormones, proteins, drugs, and disease markers, in biological samples, and it is used in clinical diagnostics, research, and many other fields. The analyzer performs immunoassays using various techniques, including enzyme-linked immunosorbent assay (ELISA), chemiluminescence immunoassay (CLIA), fluorescence immunoassay (FIA), and other methods, in which the analyte in the sample binds to a specific antibody or antigen, and the amount of the bound analyte is measured by a labeled antibody or a signal-generating system, such as an enzyme that produces a colored, fluorescent, or luminescent signal, and the signal is measured and converted to a concentration of the analyte using a calibration curve; the immunoassay analyzer automates the assay procedure, including pipetting, incubation, washing, and measurement, and it processes many samples with high throughput, with features such as random access, barcode reading, and data management. Immunoassay analyzers are used for measuring hormones, such as thyroid hormones and reproductive hormones, for measuring tumor markers, for measuring cardiac markers, for drug monitoring, for allergy testing, for infectious disease testing, for autoimmune disease testing, and for many other applications, in hospital and clinical laboratories, in research, and in the pharmaceutical industry, and they are available in various configurations, from compact analyzers to large automated systems. With their automation and sensitivity, immunoassay analyzers are essential for immunoassay testing in clinical diagnostics.
Automatic Immunoassay Hormone Analyzer LIHA-T2010
Automatic Immunoassay Hormone Analyzer utilizes advanced technology and delivers rapid results with an individual test speed of 15 seconds. This analyzer ensures highly accurate results ...
ELISA Analyzer LELISA-T2010
Analyzer is an automated unit consisting of a single sampling channel with a capacity ranging from 10µl to 1000µl. It features 8 independent photometric channels with both mono and di...
ELISA Analyzer LELISA-T2011
Analyzer features a photometric microplate reader with 8 channels, using silicon photodiode detectors and a tungsten halogen lamp, covering 340 to 750 nm wavelength range. It uses a sin...
Chemiluminescent Immunoassay Analyzer LCIA-T2010
Chemiluminescent Immunoassay Analyzer uses magnetic particle separation technology. The maximum speed analyzer can offer is 180 T/hr. Its excellent performance is contributed by tubular ...
Standards
IEC 61010-2-081:2015-Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
IEC 61010-2-101:2018-Particular requirements for in vitro diagnostic (IVD) medical equipment
ISO 15189:2022-Medical laboratories-Requirements for quality and competence
Complies with the above standards, but is not limited to them.
Features
1. Immunoassay analyzer for automated detection of analytes using antigen-antibody reactions.
2. Chemiluminescence, fluorescence or absorbance detection for high-sensitivity immunoassays.
3. Suitable for clinical laboratories, hospitals, blood banks, pharmaceutical and research.
4. Includes sample handling, reagent system, detection unit, controller, software and manual.
5. Supports automated immunoassay testing for hormones, tumor markers, infectious diseases.
FAQ
Q1: What testing scenarios is this analyzer mainly applied to?
A: The immunoassay analyzer is used in clinical laboratories, hospitals, blood banks, pharmaceutical research, academic institutions and healthcare to automatically detect and quantify analytes in biological samples (serum, plasma, whole blood, urine) using antigen-antibody reactions with chemiluminescence, fluorescence or absorbance detection for clinical diagnosis, disease monitoring, screening and research. It supports hormone testing (thyroid function TSH/T3/T4, reproductive hormones FSH/LH/estradiol/testosterone, cortisol, insulin), tumor marker testing (CEA, AFP, CA125, CA19-9, PSA, CA15-3), infectious disease testing (hepatitis B/C, HIV, syphilis, torch), cardiac marker testing (troponin, CK-MB, myoglobin, BNP), anemia testing (ferritin, vitamin B12, folate), therapeutic drug monitoring (digoxin, phenytoin, vancomycin), allergy testing, and pharmaceutical research immunoassays. The automated immunoassay analyzer provides high-sensitivity, high-throughput, reproducible testing for a wide range of clinical analytes, essential for modern clinical diagnostics.
Q2: What standards does the analyzer comply with?
A: The immunoassay analyzer follows relevant ISO, IEC, CLSI and GB/T standards for in vitro diagnostic medical devices, including ISO 13485 (quality management), IEC 61010 (safety), IEC 62304 (medical device software), and applicable medical device regulations (FDA 510(k)/PMA, CE IVD, NMPA). The test follows relevant clinical laboratory standards (ISO 15189, CAP, CLIA). Calibration should use manufacturer-provided calibrators traceable to international reference standards (where available, e.g., WHO international standards for hormones, infectious disease markers). Users should verify regulatory approval status in their jurisdiction. Reagents are typically proprietary to the analyzer system.
Q3: What is the warranty period for the whole analyzer and key components?
A: The whole immunoassay analyzer is covered by a 12-month warranty. The sample handling system, reagent system, detection unit (chemiluminescence/fluorescence/absorbance), fluidics, controller, software and housing are covered, while reagents, calibrators, controls, sample cups, tubing and fuses are consumables. Damage from improper use or unauthorized repair is excluded. Extended service contracts are standard for this clinical diagnostic equipment (typically includes preventive maintenance, calibration, technical support and software updates).
Q4: Is this device difficult to operate? Is professional training required?
A: Operation requires trained clinical laboratory personnel familiar with immunoassay testing, clinical chemistry and laboratory quality management. We provide comprehensive training, operation manuals and application support. Proper sample handling (serum/plasma separation, sample volume), reagent management (storage, loading, lot tracking), calibration, quality control (normal/abnormal controls per batch), result review (delta checks, critical values), maintenance (fluidics, probe cleaning) and regulatory documentation are important for accurate, reliable clinical immunoassay results.
Q5: What is the typical lead-time for order delivery?
A: Standard models require 7-30 working days. In-stock units can ship within 3-7 working days. Custom configurations or large built-to-order systems may require additional time, and we confirm the exact schedule before order confirmation.
Q6: Is regular calibration required? What is the recommended calibration cycle?
A: Calibration with manufacturer-provided calibrators recommended per reagent lot change or per schedule (typically every 2-4 weeks, or per manufacturer instructions). Quality control (normal and abnormal levels) per day or per batch for clinical use. Probe and fluidics maintenance per schedule. Routine performance verification with certified controls. Full system performance verification annually. Software updates and data integrity checks per regulatory requirements (21 CFR Part 11 for clinical use). Reagent lot verification per new lot.
Q7: Are supporting consumables universal?
A: Reagents (assay-specific kits), calibrators, quality control materials, sample cups, tips, tubing, cleaning solutions and fuses are available from the manufacturer or authorized distributors, and are typically proprietary to the analyzer system (closed system). Long-term consumable cost is significant and depends on test menu and test volume (reagent cost per test is the primary ongoing expense).
Q8: Can I customize parameters or supporting accessories?
A: Customization includes test menu (hormones, tumor markers, infectious disease, cardiac, anemia, TDM - specific assays available depend on manufacturer), throughput (tests per hour), sample type (serum, plasma, whole blood, urine), automation level (standalone, integrated with clinical chemistry analyzer, track-based automation), reagent on-board capacity, sample capacity, STAT priority, software features (LIS connectivity, autoverification, delta check, critical value alert, 21 CFR Part 11), connectivity and accessories. Additional reagent kits and accessories can be ordered separately. Custom orders extend delivery lead-time significantly, and test menu availability depends on regulatory approval in the user jurisdiction.
Q9: Does the purchase include on-site installation and commissioning service?
A: Yes, immunoassay analyzers include on-site installation, commissioning, calibration, validation support (IQ/OQ/PQ for clinical use), operator training and application support by certified clinical diagnostic specialists. Site preparation guidance is provided before delivery, including utility, environmental and reagent storage requirements.
Q10: What types of samples are compatible with this equipment?
A: The immunoassay analyzer measures analytes in serum, plasma (heparin, EDTA - depending on assay), whole blood (for some assays), urine (for some assays) and other biological fluids within the sample type, analyte range and assay specification. Different assays require specific sample types and anticoagulants (e.g., heparin plasma for some hormone assays, serum for most immunoassays, EDTA plasma for some infectious disease tests - verify per assay instructions). Hemolysis, lipemia and icterus can interfere with some immunoassays (check assay interference data). Very high or very low analyte levels may require dilution or re-testing. Users should use proper sample collection tubes per assay instructions (serum separator tube for serum, specific anticoagulant for plasma), allow proper clotting time for serum (30 minutes at room temperature), separate serum/plasma from cells promptly (within 2 hours for most analytes), store samples properly (refrigerated 2-8 degrees C for short-term, frozen -20 degrees C or -70 degrees C for long-term - verify stability per analyte), avoid repeated freeze-thaw cycles, calibrate per reagent lot with manufacturer-provided calibrators, run quality control (normal and abnormal) per day or per batch, review results with delta checks (compare with previous result for the patient) and critical value alerts, follow proper result interpretation (reference ranges vary by age, sex, assay method - use assay-specific reference ranges), report results with assay method and units specified, and for clinical use, follow validated assays and regulatory requirements (CLIA, CAP, ISO 15189). The analyzer should be maintained per manufacturer schedule (probe cleaning, fluidics maintenance, replacement of peristaltic pump tubing). The sample probe should be inspected for clots (clogged probe causes sample volume errors - use clot detection feature if available). The reagent should be stored properly (on-board refrigeration for most reagents, or 2-8 degrees C for off-board storage - verify per reagent insert). The reagent should be used within expiration date and on-board stability (once loaded, reagents have limited on-board stability - typically 1-4 weeks depending on reagent). For high-throughput laboratories, consider integration with clinical chemistry analyzer or track-based automation for efficient workflow. The analyzer should have proper LIS connectivity for automatic result reporting and QC management. Waste (reagent waste, sample waste, used tips) should be disposed of per biohazard and chemical waste regulations. For STAT (urgent) testing, use the STAT priority feature to interrupt routine testing. The analyzer should be placed in a temperature-controlled environment (15-30 degrees C typical) with proper ventilation (some analyzers generate heat). For assays requiring specific sample handling (e.g., light-sensitive analytes like bilirubin, vitamin B12), use proper sample protection (amber tubes, avoid light).
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