BioChem SA Semi Automated Chemistry Analyzer

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The BioChem SA Semi Automated Chemistry Analyzer is a compact, semi-automated benchtop clinical chemistry system designed for low to medium-volume clinical laboratories, physician office labs (POLs), and small hospital laboratories . The analyzer performs colorimetric and kinetic analysis of patient samples (serum, plasma, whole blood, urine) using endpoint, kinetic, fixed-time, absorbance, monochromatic, and bichromatic assay types .
The optical system features a 6V 10W halogen lamp with 2000-hour lifespan, 7 standard filters (340, 405, 492, 510, 546, 578, 630nm with ±2nm accuracy), and a quartz glass flow cell (32µL, 10mm optical path) with 0.0001Abs resolution and <1.0% precision . The 37°C incubator with 10 round wells maintains temperature stability of ±0.1°C .
The analyzer features a 7 inch color LCD touchscreen interface , 80 user-defined programmable test profiles , internal storage for 100,000 patient results , internal thermal printer, RS-232 connectivity , and Levy-Jennings quality control with automatic statistical analysis . Calibration options include factor, one-point linear, and multi-point linear modes .
For the clinical laboratory scientist and pathologist, the BioChem SA provides reliable, entry-level chemistry testing for liver function (ALT, AST, ALP, bilirubin, total protein, albumin), renal function (BUN, creatinine, uric acid), lipid profiles (cholesterol, triglycerides, HDL, LDL), pancreatic enzymes (amylase, lipase), and glucose . For the patient, accurate chemistry results enable diagnosis of hepatitis, cirrhosis, chronic kidney disease, diabetes, hyperlipidemia, pancreatitis, and cardiovascular disease, guiding appropriate medical therapy and lifestyle interventions.
Description

BioChem SA Semi Automated Chemistry Analyzer

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Liver Function Testing (LFT) for Hepatic Disease Diagnosis
  • Primary Use: Performs semi-automated colorimetric and kinetic analysis of liver function parameters including ALT, AST, ALP, GGT, total bilirubin, direct bilirubin, total protein, and albumin using endpoint and kinetic assay methods .
  • How it helps: For the clinical laboratory scientist and hepatologist, the BioChem SA provides accurate measurement of hepatic enzymes and bilirubin using 7 standard wavelengths (340-630nm) with 0.0001Abs resolution . For the patient with suspected hepatitis, cirrhosis, fatty liver disease, or drug-induced liver injury, precise liver enzyme quantification enables early diagnosis, monitoring of disease progression, and assessment of treatment response, guiding appropriate hepatology referral and management.
2. Renal Function Testing for Kidney Disease Assessment
  • Primary Use: Measures renal function parameters including blood urea nitrogen (BUN), creatinine, uric acid, and electrolytes using endpoint and kinetic measurement modes .
  • How it helps: For the nephrologist and primary care physician, the BioChem SA’s programmable assay parameters (sample volume 0-3000µL, 37°C incubator with ±0.1°C stability) ensure precise creatinine and BUN quantification . For the patient with chronic kidney disease, diabetes, hypertension, or acute kidney injury, accurate renal function testing supports staging of kidney disease, monitoring of dialysis adequacy, and early detection of nephrotoxicity from medications, enabling timely intervention to preserve renal function.
3. Lipid Profile Testing for Cardiovascular Risk Assessment
  • Primary Use: Performs lipid panel analysis including total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, and VLDL cholesterol using enzymatic colorimetric methods .
  • How it helps: For the cardiologist and preventive medicine specialist, the BioChem SA’s 80 programmable user-defined profiles allow customization of lipid assay parameters for cardiovascular risk stratification . For the patient with hyperlipidemia, diabetes, metabolic syndrome, or cardiovascular disease history, accurate lipid profiling enables calculation of ASCVD risk scores, monitoring of statin therapy effectiveness, and lifestyle modification guidance to reduce myocardial infarction and stroke risk.
4. Pancreatic Enzyme and Diabetes Screening
  • Primary Use: Measures pancreatic enzymes including amylase and lipase for pancreatitis diagnosis, and glucose for diabetes screening and management using endpoint and kinetic methods .
  • How it helps: For the emergency physician and endocrinologist, the BioChem SA’s rapid warm-up time (10 minutes) and multiple assay capabilities (end-point, kinetic, fixed-time) support urgent amylase and glucose testing . For the patient with acute abdominal pain, suspected pancreatitis, or diabetes mellitus, rapid pancreatic enzyme and glucose quantification enables emergency diagnosis of pancreatitis, diabetes detection, and monitoring of glycemic control, facilitating appropriate acute care and long-term diabetes management.

SECONDARY & SUPPORTIVE USES

1. Cardiac Biomarker and Protein Electrophoresis Screening: Performs albumin, total protein, and cardiac risk markers for nutritional assessment and heart disease risk evaluation .
2. Iron Studies and Anemia Workup: Measures serum iron, total iron-binding capacity (TIBC), and ferritin for iron deficiency anemia and hemochromatosis diagnosis.
3. Therapeutic Drug Monitoring (TDM): Quantifies drug levels for medications with narrow therapeutic indices (e.g., digoxin, theophylline, phenytoin) using programmable assay parameters .
4. Immunology and Inflammation Marker Testing: Measures C-reactive protein (CRP), rheumatoid factor (RF), and complement proteins for inflammatory and autoimmune disease assessment.
5. Bone and Mineral Metabolism Testing: Quantifies calcium, phosphorus, alkaline phosphatase (ALP), and magnesium for osteoporosis, hyperparathyroidism, and metabolic bone disease diagnosis .
6. Small and Medium Volume Laboratory Testing: Processes 60-100 samples daily in physician office laboratories, small hospital labs, clinic labs, and research facilities with low to moderate test volumes .
7. Emergency and STAT Testing: Provides rapid results for urgent clinical decisions with 10-minute warm-up and STAT testing priority protocols .
8. Point-of-Care and Physician Office Laboratory (POL) Testing: Compact benchtop design (49.5cm x 15cm x 33cm, 4.86kg) enables decentralized testing in physicians’ offices and outpatient clinics .
9. Teaching and Training Laboratory Use: Serves as educational instrument for clinical chemistry training in medical technology and pathology residency programs.
10. Veterinary Clinical Chemistry Testing: Analyzes serum, plasma, and whole blood samples from companion animals (dogs, cats, horses) and livestock in veterinary diagnostic laboratories.
11. Research and Reference Laboratory Backup: Provides backup testing capability for automated analyzers during maintenance, repair, or high-volume surges.
12. Pharmaceutical and Biotech Quality Control: Supports QC testing of raw materials, intermediates, and finished products in pharmaceutical manufacturing.
KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

  • Device Type: A semi-automated benchtop clinical chemistry analyzer (semi-auto biochemistry analyzer) that performs colorimetric and kinetic analysis through photometric measurement of patient samples .
  • Designation: BioChem SA Semi Automated Chemistry Analyzer, Semi-Auto Chemistry Analyzer, Clinical Chemistry Analyzer, HTI BioChem SA .
  • Key Components:
  • Optical System: 6V 10W halogen lamp (2000 hours lifespan) with 7 standard filters at wavelengths 340, 405, 492, 510, 546, 578, 630nm (±2nm) .
  • Flow Cell: Quartz glass, 32µL volume. Flow cell operating temperature: 37°C. Flow cell temperature control accuracy: ±0.1°C. Optical path length: 10mm .
  • Fluidics System: Programmable aspiration volume 0-3000µL with <1.0% carryover contamination . Cuvette: Optional .
  • Incubator: 37°C (programmable) with 10 round wells, temperature stability ±0.1°C .
  • User Interface: 7 inch (320 x 640 pixel) color LCD touchscreen. Display type: Color LCD touchscreen . Operating system: Windows-based or similar with simple graphic interface. Languages: English, Spanish, Russian .
  • Data Management: Internal storage capacity for 100,000 patient and QC results. Data storage capacity: 100,000 . Connectivity: RS-232 uni-directional (output only), plus options for external printer, barcode reader . Printer: Internal thermal printer .
  • Measurement & Calibration:
    • Assay Types: End-point, Kinetic, Fixed-Time, Absorbance, Monochromatic, Bichromatic .
    • Measuring Principles: Colorimetric, Kinetic .
    • Calibration Modes: Factor (K), One-Point Linear, Multi-Point Linear .
    • Quality Control: Levy-Jennings (L-J) charts with automatic statistical analysis and data storage .
  • Sample Type & Handling:
    • Sample Types: Serum, plasma, whole blood, urine, other body fluids .
    • Sample Volume: 0-3000 µL programmable .
    • Reagent Handling: User-defined chemistry profiles (80 programmable tests). Parameter settings include: measurement mode, primary & secondary wavelength, temperature, measurement time, sample volume, units, decimal point, linearity ranges .

2. TECHNICAL & PERFORMANCE PROPERTIES

  • Measurement Range (Absorbance): 0.0 to 3.5 Abs .
    Resolution: 0.0001 Abs (displayed), 0.00001 Abs (calculated) .
    Precision: < 1.0% (flow cell) .
    Wavelength Accuracy: ±2nm .
    Carryover Contamination: ≤ 1.0% .
    Temperature Control: Incubator: 37°C (programmable). Temperature stability: ±0.1°C .
    Analytical Throughput: Approximately 60-100 tests per hour depending on assay type.
    Sample Volume: 0-3000 µL programmable flow cell aspiration .
    Reaction Cuvette Volume: Optional cuvette, or directly in flow cell. Volume: not specified.
    Programmable Tests: 80 user-defined chemistry profiles .
    Data Storage Capacity: 100,000 patient results and QC records .
    QC Storage: L-J charts; automatic statistical analysis (Mean, SD, CV%) of QC data .
    Display: 7 inch color LCD touchscreen, 320 x 640 pixels .
    Printer: Internal high-speed thermal printer; external printer option .
    Connectivity: RS-232 serial port (uni-directional, results output only). Connectivity options: LIS via RS-232 .
    Language Support: English, Spanish, Russian .
    Electrical Requirements: 100-240 VAC ±10%, 50/60Hz, 120VA .
    Operating Conditions: Temperature 10-30°C (50-86°F), Humidity ≤85% non-condensing .
    Storage Conditions: 0-50°C, ≤90% humidity (packaged).
    Dimensions (W x H x D): 19.5 x 5.9 x 13 inches (49.5 x 15 x 33 cm) .
    Weight: 10.7 lbs (4.86 kg) .
    Warm-up Time: 10 minutes .
    Programmable Standby: 30, 60, 90, 120 minutes (automatic lamp shut-off to prolong lamp life) .

3. PHYSICAL & OPERATIONAL PROPERTIES

  • Construction: Compact, lightweight benchtop design (4.86 kg) with durable exterior housing .
    User Interface: 7 inch color LCD touchscreen for intuitive operation; virtual keypad for test selection and patient data entry .
    Workflow: Semi-automated operation: operator pipettes sample and reagent into cuvette or reaction well; instrument measures, calculates, and stores results.
    Reagent Compatibility: Open reagent system; compatible with most commercial clinical chemistry reagents.
    Maintenance: Programmable automatic cleaning cycles; easy access to flow cell and tubing for routine maintenance.
    Calibration: Factor, one-point linear, and multi-point linear calibration modes; automatic curve fitting.
    Safety Features: Enclosed optics; automatic lamp shut-off in standby mode for energy efficiency, safety, and prolonged lamp life. Over-temperature protection.

4. SAFETY & COMPLIANCE ATTRIBUTES

  • Regulatory Status: In Vitro Diagnostic (IVD) medical device; requires country-specific registration per local regulations. CE marked for European market .
    Safety Compliance: Complies with IEC 61010-1 (safety requirements for electrical equipment for measurement, control, and laboratory use). Designed with safety features including enclosed optics, non-slip feet, and proper insulation.
    Electrical Safety: Wide voltage compatibility (100-240VAC, 50/60Hz) for international use. Over-voltage category II. 120VA maximum power consumption. Double-insulated construction.
    Infection Control: Semi-closed system reduces biohazard exposure. Standard precautions required.

5. STORAGE & HANDLING ATTRIBUTES

  • Storage: Store in a clean, dry environment at 10-30°C (50-86°F). Protect from dust, vibration, and direct sunlight. Keep covered when not in use.
    Cleaning: Regular cleaning of flow cell and external surfaces. Follow automated cleaning protocols daily.
    Maintenance: Monthly preventative maintenance per manufacturer guidelines. 12 month manufacturer warranty typical.
    Installation: Benchtop installation requires 20x14 inch (51x36 cm) footprint with access to electrical outlet. LIS connectivity via RS-232 cable.

6. LABORATORY & CLINICAL APPLICATIONS

  • Primary Application: Semi-automated clinical chemistry testing for medium-volume laboratories including physician office labs (POLs), small hospital labs, clinic labs, and research facilities .
    Clinical Role: Essential diagnostic instrumentation for hepatology (liver function testing), nephrology (renal function testing), cardiology (lipid profiling), endocrinology (diabetes screening), and emergency medicine (pancreatitis diagnosis).
SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

  • Biohazard Exposure: Treat all samples as potentially infectious. Use standard precautions (gloves, lab coat, eye protection). Decontaminate spills immediately.
    Electrical Safety: Use properly grounded outlet. Wide voltage tolerance (100-240V, 50/60Hz).
    Reagent Handling: Use reagents as directed. Consult SDS for each reagent. Avoid skin and eye contact. Use appropriate ventilation for volatile reagents.
    Glassware Handling: Handle cuvettes and glassware carefully to prevent breakage and injury.
    Quality Control: Run QC materials per laboratory schedule. Verify calibration before patient testing.

2. FIRST AID MEASURES

  • Blood/Body Fluid Exposure: Wash exposed skin immediately with soap and water; flush eyes with water for 15 minutes. Follow institutional exposure management protocol.
    Reagent Spill: Ventilate area; use absorbent materials; dispose as chemical waste per SDS.
    Electrical Malfunction: Disconnect power immediately; do not attempt repair; contact service provider.

3. FIRE FIGHTING MEASURES

  • Flammability: Electrical hazard; some reagents may be combustible.
    Extinguishing Media: Use CO2 or dry chemical extinguisher for electrical fires.
    Fire Response: Disconnect power; use appropriate extinguisher; do not use water on electrical fire.