Automatic biochemistry analyzer

Introduction

An automatic biochemistry analyzer is a clinical chemistry analyzer with the fully automatic operation, used for the measurement of the biochemical parameters in the blood and the other biological samples, and it is used in the clinical, the medical, the research, and the many other applications. The automatic biochemistry analyzer measures the parameters, such as the glucose, the cholesterol, the proteins, the enzymes, and the electrolytes, by the photometric and the other methods, with the automatic sample and the reagent handling and the automatic measurement; the automatic biochemistry analyzer consists of a sample handling system, a reagent system, a reaction and a measurement system, a control and a data system, and the display, and it processes the samples in the batches, with features such as the automation, the random access, and the data management; the automatic biochemistry analyzer is used for the clinical chemistry tests, for the measurement of the metabolic parameters, for the monitoring of the diseases, for the screening, for the research, and for many other applications, and it is an essential instrument in the clinical laboratory. Automatic biochemistry analyzers are used in the clinical laboratories, in the hospitals, in the medical, in the research, and for many other applications. With their automatic operation, automatic biochemistry analyzers are essential for the efficient clinical testing.

Automatic Biochemistry Analyzer LBCA-T2013

Automatic Biochemistry Analyzer offers fast testing with a capacity of up to 34 parameters in just 12 minutes. It requires a low sample volume of 90 to 120 µL for efficient operation. T...

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Automatic Biochemistry Analyzer LBCA-T2012

Automatic Biochemistry Analyzer offers 200 tests per hour, low reagent consumption (150µl), and fully automated operation. The analyzer delivers fast, reliable results while reducing op...

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Automatic Biochemistry Analyzer LBCA-T2011

Automatic Biochemistry Analyzer handles sample sizes ranging from 2 to 50μL with precise 0.1μL incremental adjustments. Designed with user-friendly interface for seamless programming a...

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Automatic Biochemistry Analyzer LBCA-T2010

Automatic Biochemistry Analyzer supports sample volume from 1 to 100µl. Process up to 400 tests per hour. Referring spectrum of wavelengths 340 to 810 nm for better analysis. Fully inte...

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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. Automatic biochemistry analyzer for high-throughput clinical chemistry testing.

2. Fully automated analysis of blood/serum chemistry parameters with random access.

3. Suitable for hospitals, clinical laboratories, diagnostic centers, research and healthcare facilities.

4. Includes sample system, reagent system, reaction system, photometric detector, software and manual.

5. Supports automated clinical chemistry testing for diagnosis, monitoring and health screening.

FAQ

Q1: What testing scenarios is this analyzer mainly applied to?

A: The automatic biochemistry analyzer is used in hospitals, clinical laboratories, diagnostic centers, reference laboratories, veterinary clinics, research institutions, occupational health centers and healthcare facilities to perform fully automated clinical chemistry testing on serum, plasma, urine, cerebrospinal fluid and other biological fluids for diagnosis, disease monitoring, treatment management and health screening, measuring parameters such as liver function (ALT, AST, ALP, GGT, bilirubin, albumin, total protein), renal function (creatinine, BUN, uric acid, electrolytes), lipid profile (total cholesterol, HDL, LDL, triglycerides), glucose, cardiac markers (CK, CK-MB, LDH, troponin if supported), pancreatic enzymes (amylase, lipase), proteins, and other clinical chemistry analytes. It supports hospital clinical laboratory testing (inpatient and outpatient chemistry panels, emergency testing, routine health screening), diagnostic center and reference laboratory high-throughput testing (large volume of routine chemistry panels, fast turnaround time), veterinary clinical chemistry (animal serum/plasma - with species-specific reference ranges), research laboratory biochemical analysis, occupational health screening (pre-employment, periodic health examinations), and public health screening programs. The fully automated, random-access design provides high throughput (typically 200-800 tests/hour), walk-away operation, and consistent, reproducible results with minimal manual intervention, making it the core instrument in any clinical chemistry laboratory.

Q2: What standards does the analyzer comply with?

A: The automatic biochemistry analyzer follows relevant ISO, IEC, CLSI and regulatory standards for in vitro diagnostic (IVD) medical devices, including ISO 15189 (medical laboratory quality and competence), ISO 13485 (medical device quality management), IEC 61010 (safety requirements for electrical equipment for measurement, control, and laboratory use), IEC 60601 (medical electrical equipment safety), CLSI guidelines (clinical laboratory standards institute - various guidelines for method evaluation, QC, reference intervals), and applicable medical device regulations (FDA 510(k)/PMA in the US, CE IVD in EU, NMPA registration in China). The hardware complies with applicable EMC standards (IEC 61326). Calibration should use manufacturer-provided calibrators and controls (traceable to international reference standards where available - e.g., IFCC reference methods for enzymes, isotope dilution mass spectrometry for reference methods). For clinical use, the analyzer and reagents must be IVD-registered/approved in the jurisdiction of use. Users should verify regulatory approval status, intended use, and the specific test menu (which analytes are available) for their application.

Q3: What is the warranty period for the whole analyzer and key components?

A: The whole automatic biochemistry analyzer is covered by a 12-month warranty. The sample system (autosampler, probes, wash station), reagent system (reagent trays, probes, bar code reader), reaction system (reaction cuvettes, incubator, mixer), photometric detector (lamp, monochromator, photodetector), electronics, software and housing are covered, while reagents, calibrators, controls, reaction cuvettes (disposable), sample cups, probes, lamps, filters, wash solution and fuses are consumables or accessories. Damage from improper use, reagent spillage, probe damage, contamination or unauthorized repair is excluded. Extended service contracts are standard for this clinical diagnostic equipment (typically includes preventive maintenance, calibration, reagent support, software updates, priority response, often with guaranteed uptime). Photometric lamp may have separate lifespan/warranty terms (typically 2000-5000 hours).

Q4: Is this device difficult to operate? Is professional training required?

A: Operation requires trained medical laboratory technologists/technicians familiar with clinical chemistry, laboratory procedures, quality control and regulatory requirements. We provide comprehensive training, operation manuals and application support. Proper sample handling (serum/plasma separation, proper sample tubes, no hemolysis/lipemia/icterus unless method tolerates - sample quality is critical for accurate results), reagent management (proper storage, on-board stability, bar code reading, reagent inventory), calibration (per reagent lot, per schedule, per manufacturer - two-point or multi-point calibration), quality control (daily QC - normal and abnormal levels, Westgard rules, QC records), maintenance (daily: probe wash, cuvette check, waste empty; weekly: deep cleaning, probe check; monthly: preventive maintenance), result review and verification (delta checks, critical values, reference ranges, auto-verification rules), regulatory compliance (CAP, CLIA, ISO 15189, 21 CFR Part 11 for electronic records), and LIS connectivity are important for accurate, reliable clinical chemistry testing.

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 calibrators recommended per reagent lot (new lot calibration), per schedule (typically every 30 days or per manufacturer - some reagents require more frequent calibration), after maintenance (lamp change, probe change, optical service), and when QC indicates drift. Routine quality control (QC) daily or per batch (normal and abnormal control levels - verify within acceptable ranges; follow Westgard rules for rejection; maintain QC records and charts). Full analyzer performance verification annually (or per accreditation requirement - CAP, CLIA, ISO 15189). Photometric system verification (wavelength accuracy, absorbance linearity) every 6-12 months. Sample/reagent probe volume verification every 3-6 months. Reaction temperature verification every 3-6 months. Software updates and data integrity checks per regulatory requirements. For clinical use, follow applicable accreditation calibration/QC schedules and maintain complete records.

Q7: Are supporting consumables universal?

A: Reagents (assay-specific reagents - typically proprietary to the analyzer manufacturer; common tests: ALT, AST, ALP, GGT, bilirubin, albumin, total protein, creatinine, BUN, uric acid, glucose, cholesterol, HDL, LDL, triglycerides, electrolytes, amylase, lipase, CK, CK-MB, LDH, etc.), calibrators (reagent-specific calibrators), controls (normal and abnormal levels - multi-analyte controls), reaction cuvettes (disposable plastic or reusable glass), sample cups/tubes, wash solution (concentrated detergent for probe/cuvette washing), system fluid, printer paper, lamps, probes and fuses are available from the analyzer manufacturer or authorized distributors, though reagents, calibrators and cuvettes are typically proprietary and not universal across brands. Long-term consumable cost is high (reagents are the primary ongoing cost - per-test cost depends on test menu and volume; reagent cost per test is typically moderate but adds up for high-throughput labs; controls and calibrators add additional cost; consider total cost of ownership including reagents, maintenance, and service contract). Some analyzers support open reagent systems (can use third-party reagents) which can reduce cost but may affect regulatory compliance and warranty - verify before purchase.

Q8: Can I customize parameters or supporting accessories?

A: Customization includes throughput (tests/hour - 200, 400, 600, 800+; higher throughput for larger labs), test menu (which analytes are available - standard chemistry panel, extended menu including specific proteins, therapeutic drugs, hormones if supported; verify available reagents), sample type (serum, plasma, urine, CSF, whole blood for some tests), automation level (random access, priority/STAT samples, continuous loading), reagent capacity (number of reagent positions - 20-60+), sample capacity (number of sample positions - 40-200+), STAT capability (priority sample insertion), auto-verification (rules-based result auto-release), LIS connectivity (HL7 interface, bidirectional communication), data management, barcode reading (sample and reagent), printer, language, STAT module, and accessories. Additional reagents, calibrators, controls, sample racks and accessories can be ordered separately. Custom orders extend delivery lead-time significantly, especially for high-throughput models.

Q9: Does the purchase include on-site installation and commissioning service?

A: Yes, automatic biochemistry analyzers include extensive on-site installation, commissioning, calibration, method setup, LIS integration, IT setup and operator training by certified clinical laboratory specialists. Site survey and preparation guidance are provided before delivery. Installation and commissioning typically take several days, including performance verification, initial calibration, QC setup, and operator training.

Q10: What types of samples are compatible with this equipment?

A: The automatic biochemistry analyzer analyzes clinical chemistry parameters in serum (most common - from coagulated blood, centrifuged to separate serum from clot), plasma (from anticoagulated blood - heparin plasma is most compatible with chemistry tests; EDTA and citrate plasma may interfere with some tests due to calcium binding or dilution), urine (for urine chemistry - urine creatinine, urine protein, urine glucose, urine electrolytes; requires proper sample collection and may require dilution), cerebrospinal fluid (CSF - for CSF protein, glucose, lactate; requires small sample volume and sensitive methods), and other biological fluids (ascites, pleural fluid, synovial fluid - for protein, glucose, LDH; requires proper handling and may require dilution) within the sample volume, analyte concentration range, matrix and specification. Different sample types require specific handling: serum (allow blood to clot for 30-60 minutes at room temperature, then centrifuge at 1000-3000 g for 10 minutes; separate serum from clot promptly - prolonged contact with clot can cause analyte changes (e.g., glucose decreases, potassium increases from hemolysis); use serum separator tubes (SST) for convenience; verify no hemolysis, lipemia, or icterus - these can interfere with photometric methods), plasma (use heparin (lithium heparin or sodium heparin) as anticoagulant for most chemistry tests; do not use EDTA for calcium, magnesium, ALP (EDTA chelates metals); do not use citrate for most chemistry tests (dilution effect and calcium binding); centrifuge promptly and separate plasma from cells), urine (collect 24-hour or random urine per test requirement; mix well before sampling; may require dilution for high-concentration analytes; urine matrix can interfere with some methods - use urine-specific reagents), CSF (collect in sterile tubes; analyze promptly - glucose decreases rapidly in CSF at room temperature; protein is stable; small sample volume - analyzer may require minimum sample volume; handle as potentially infectious). IMPORTANT PRE-ANALYTICAL CONSIDERATIONS: Sample quality is the most critical factor for accurate clinical chemistry results - pre-analytical errors account for the majority of laboratory errors. Hemolysis (red blood cell rupture) releases intracellular components that interfere: potassium increases (K is high inside RBCs), AST/ALT/LDH increase (enzymes are high inside RBCs), hemoglobin interferes photometrically at certain wavelengths (absorbs light, causes spectral interference). Lipemia (high triglycerides/chylomicrons) causes turbidity that interferes with photometric methods (light scattering, false absorbance) and can affect electrolyte measurement (pseudohyponatremia in indirect ISE methods). Icterus (high bilirubin) interferes photometrically at certain wavelengths (absorbs blue light, interferes with some assays). Users should inspect samples for hemolysis/lipemia/icterus (many analyzers have auto HIL detection), flag affected samples, and use appropriate corrections or alternate methods if interference is significant. Proper sample collection (correct tube/additive, proper fill volume, gentle mixing - do not shake, timely centrifugation and separation) is essential. The analyzer should be operated per manufacturer instructions and regulatory requirements (CLIA, CAP, ISO 15189, JC), with proper calibration, QC, maintenance, and documentation. For clinical use, results must be reviewed by qualified laboratory professionals before release (auto-verification can be used for routine results within defined rules, but abnormal/critical results require manual review). Critical values (life-threatening abnormal results) must be reported immediately to the ordering clinician with proper documentation (time, person notified, read-back). The analyzer should have proper LIS connectivity (bidirectional HL7 interface for orders and results) to reduce manual data entry errors. Reagent management is important (reagents have on-board stability - typically 1-4 weeks depending on test; track expiration dates and lot numbers; do not use expired reagents; store reagents properly - some require refrigeration, others are stable at room temperature on-board; proper reagent inventory to avoid stockouts). Waste management (liquid waste from wash and reaction - may contain biological material and chemicals; collect in proper waste container and dispose per biohazard/chemical waste regulations; solid waste - disposable cuvettes, sample cups, used reagents - dispose per regulations). The analyzer should be placed in a dedicated clinical chemistry area with proper environmental control (stable temperature, humidity, no direct sunlight, no vibration, adequate ventilation), proper power (dedicated circuit, UPS for power continuity - power loss during analysis can ruin samples and reagents), and proper water supply (pure water for wash system - type II or better, continuous supply; verify water quality - impurities can cause background interference and damage the analyzer). For high-throughput laboratories, consider automation track systems (connecting biochemistry analyzer with immunoassay, hematology, and other analyzers for total laboratory automation - TLA). The analyzer should be validated for clinical use (IQ/OQ/PQ for regulated laboratories, with documented validation). For veterinary use, verify species-specific reference ranges (analytes may have different reference ranges in animals; some reagents may not be validated for veterinary use - verify before use).