Plus Semi-Automated Urine Analyzer (CL-50)

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The Plus Semi-Automated Urine Analyzer (CL-50) is a portable, semi-automated urine test strip analyzer that uses LED reflectance photometry (at 550nm, 620nm, and 720nm wavelengths) to measure up to 14 urinary parameters for rapid, objective urinalysis in clinical and point-of-care settings . Throughput is up to 120 tests per hour (continuous mode) or 60 tests per hour (single strip) with a test time of 60 seconds .
The analyzer measures 14 parameters: pH, nitrite, specific gravity, blood (hemoglobin), glucose, bilirubin, urobilinogen, ketones, leukocytes, protein, calcium, creatinine, microalbumin, and ascorbic acid, with automatic result correction eliminating interference from pH, specific gravity, and urine color .
The instrument features an LCD display, built-in thermal printer, internal memory storage for 1,000 test results, connectivity options (RS-232, PS/2, parallel port), optional barcode reader, and automatic calibration for strip sensitivity . Compact (240 x 190 x 115mm) and lightweight (1.3 kg), the CL-50 Plus is briefcase-portable, designed for use in physician office labs, mobile health units, rural health posts, pharmacy screening programs, school health initiatives, and hospital laboratory backup applications .
For the primary care physician and clinical laboratory scientist, the CL-50 Plus enables rapid UTI diagnosis (leukocyte, nitrite detection), diabetes screening (glucose, ketones), preeclampsia detection (protein, microalbumin), chronic kidney disease monitoring (microalbumin, creatinine, ACR), liver disease screening (bilirubin, urobilinogen), and hydration/acid-base assessment (pH, specific gravity). For the patient, rapid, objective urinalysis enables early detection of urinary tract infections (preventing pyelonephritis and sepsis), timely diagnosis of diabetes and preeclampsia (reducing maternal-fetal complications), and early identification of chronic kidney disease (preserving renal function), particularly in underserved communities where traditional laboratory access is limited .
Description

Plus Semi-Automated Urine Analyzer (CL-50)

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Urinary Tract Infection (UTI) Diagnosis and Screening
  • Primary Use: Provides a semi-automated urine test strip analyzer using LED reflectance photometry at 550, 620, and 720nm wavelengths to detect leukocytes (white blood cells) and nitrites, the primary indicators of urinary tract infection .
  • How it helps: For the primary care physician and clinical laboratory scientist, the CL-50 Plus delivers objective, reproducible detection of leukocytes and nitrites—eliminating the subjectivity of visual strip reading and enabling rapid, accurate UTI diagnosis. For the patient presenting with dysuria, frequency, or urgency, rapid UTI confirmation allows immediate antibiotic therapy, reducing symptom duration and preventing progression to pyelonephritis or urosepsis.
2. Diabetes and Metabolic Disorder Screening
  • Primary Use: Measures urine glucose and ketone levels for diabetes screening, management monitoring, and detection of diabetic ketoacidosis (DKA) .
  • How it helps: For the endocrinologist and primary care physician, the CL-50 Plus quantifies glucose and ketones with 60-second results—enabling rapid screening for hyperglycemia and detection of ketosis in diabetic patients. For the patient with known diabetes, glucose monitoring via urinalysis helps assess glycemic control; for the undiagnosed patient, glucosuria detection prompts timely diabetes evaluation and intervention, preventing complications such as neuropathy, nephropathy, and retinopathy.
3. Preeclampsia and Pregnancy Complication Screening
  • Primary Use: Detects proteinuria and microalbuminuria, critical markers for preeclampsia and gestational diabetes screening in pregnant women during routine antenatal care .
  • How it helps: For the obstetrician and midwife, the CL-50 Plus provides rapid, objective protein and microalbumin measurement—enabling early detection of preeclampsia in pregnant women during routine antenatal visits, particularly in mobile maternal health programs reaching remote villages where traditional laboratory access is limited. For the pregnant patient, early detection of proteinuria triggers timely referral and management, reducing the risk of eclampsia, preterm delivery, and maternal-fetal mortality.
4. Chronic Kidney Disease (CKD) Screening and Monitoring
  • Primary Use: Measures protein, microalbumin, creatinine, and microalbumin-to-creatinine ratio (ACR) for early detection and monitoring of chronic kidney disease, diabetic nephropathy, and hypertensive renal damage .
  • How it helps: For the nephrologist and primary care physician, the CL-50 Plus enables quantification of urinary protein, microalbumin, and creatinine—critical parameters for the diagnosis and staging of CKD using the albumin-to-creatinine ratio (ACR). For the patient with hypertension, diabetes, or known kidney disease, regular microalbumin and protein monitoring enables early detection of nephropathy, allowing timely initiation of renoprotective therapy (ACE inhibitors, ARBs) to slow disease progression and preserve renal function.

SECONDARY & SUPPORTIVE USES

1. Liver and Hepatobiliary Disease Screening: Measures bilirubin and urobilinogen for detection of hepatitis, cirrhosis, biliary obstruction, and hemolytic disorders .
2. Hematuria and Renal Stone Detection: Detects blood (hemoglobin/myoglobin) in urine for evaluation of hematuria, renal calculi, glomerulonephritis, and urinary tract malignancy .
3. Acid-Base and Hydration Status Assessment: Measures urine pH and specific gravity (SG) for evaluation of acid-base disorders, hydration status, and renal concentrating ability .
4. Nutritional and Metabolic Assessment: Detects ascorbic acid (vitamin C) levels which can interfere with other test parameters, and calcium for metabolic bone disease assessment .
5. Mobile Health and Outreach Programs: Portable design (240 x 190 x 115 mm, 1.3 kg) enables deployment in mobile health units, rural health posts, NGO health campaigns, and disaster response settings .
6. Physician Office Laboratory (POL) Testing: Compact benchtop design fits in small office spaces, enabling point-of-care urinalysis without dedicated laboratory facilities .
7. Pharmacy-Based Health Screening: Supports pharmacy screening programs for diabetes risk, kidney function in elderly patients, and UTI confirmation before antibiotic dispensing .
8. School Health Screening Programs: Portable unit moves between schools for annual health checks, screening hundreds of children for UTIs, diabetes, and kidney disease .
9. Emergency Backup for Hospital Laboratories: Serves as backup urinalysis system when main analyzers are down for maintenance, repair, or reagent discontinuation .
10. Rural and Remote Healthcare Delivery: Essential for health posts in isolated communities where full laboratory setup is not justified but objective urinalysis is needed .
11. Veterinary Urinalysis: Can be used for urinalysis in companion animals (dogs, cats) for UTI detection and kidney function assessment.
12. Antibiotic and Antimicrobial Stewardship: Supports UTI diagnosis confirmation before antibiotic dispensing, supporting antimicrobial stewardship programs .
13. NGO and Ministry of Health Outreach: Supports health campaigns funded by NGOs and ministries of health for population-based screening programs .
14. Disaster Response and Refugee Camps: Rapid deployment in temporary health facilities during natural disasters and refugee crises .
15. Post-Market Surveillance and Clinical Research: Supports clinical research studies requiring quantitative urinalysis parameters.
KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

  • Device Type: A semi-automated, portable urine test strip analyzer using reflectance photometry for quantitative and semi-quantitative measurement of up to 14 urinary parameters .
  • Designation: CL-50 Plus Semi-Automated Urine Analyzer, HTI CL-50 Plus, Semi-Auto Urine Test Strip Analyzer, Portable Urinalysis Analyzer .
  • Key Components:
    • Optical System: LED reflectance photometry with wavelengths at 550nm, 620nm, and 720nm .
    • Test Strip Compatibility: Accepts H10, H11, H13, and H14 multi-parameter urine test strips .
    • Display: LCD display with user-friendly menu interface .
    • Printer: Built-in thermal printer for immediate result documentation .
    • Memory: Internal storage for 1,000 test results .
    • Connectivity: RS-232 output, PS/2 input, parallel port .

2. TECHNICAL & PERFORMANCE PROPERTIES

  • Methodology: Reflectance photometry (reflectance spectrophotometry) with LED light source .
  • Measurement Wavelengths: 550nm, 620nm, 720nm .
  • Throughput (Continuous): Up to 120 tests per hour .
  • Throughput (Single): 60 tests per hour .
  • Test Time: 60 seconds per test .
  • Parameters (14 Parameters): pH, Nitrite, Specific Gravity, Blood (hemoglobin), Glucose, Bilirubin, Urobilinogen, Ketones, Leukocytes, Protein, Calcium, Creatinine, Microalbumin, Ascorbic Acid .
  • Operating Modes: Single strip mode, continuous mode .
  • ** Incubation Time:** 1 minute .
  • Result Correction: Automatic correction eliminating interference from pH, specific gravity, and urine color .
  • Memory Capacity: 1,000 test results with date and time stamp .
  • Display Type: LCD display .
  • Printer: Built-in thermal printer .
  • Connectivity: RS-232 serial (output only), PS/2 port, Parallel printer port .
  • Barcode Reader: Optional (external) .
  • Calibration: Automatic self-check and internal calibration for strip sensitivity .
  • Languages: English, Russian, Spanish .
  • Electrical Requirements: 110-240V, 60/50Hz, universal voltage .
  • Operating Temperature: 15-30°C .
  • Operating Humidity: ≤ 80% .
  • Dimensions (W x H x D): 240 x 190 x 115 mm .
  • Weight: 1.3 kg .
  • Portability: Briefcase-portable; can be carried in one hand .

3. PHYSICAL & OPERATIONAL PROPERTIES

  • Construction: Benchtop/portable design with durable plastic housing; compact footprint .
  • Portability: Lightweight at 1.3 kg; briefcase-portable for mobile health applications .
  • Display: LCD screen with intuitive menu interface and real-time operational alerts .
  • Operation: Semi-automated; user inserts test strip, instrument reads, results displayed and printed automatically; single-strip and continuous operation modes .
  • Strip Detection: Automatic checking for ready-to-test strips .
  • Timers: Countdown timer with audible alerts for test start and completion .
  • Calibration: Automatic internal calibration for strip sensitivity; self-check on startup .
  • Quality Control: Internal calibration verification; external QC materials compatible.
  • Data Management: 1,000 result memory; results can be printed, stored, or exported via RS-232 .
  • Alerts: Real-time operational alerts for instrument status; audible alerts for test completion .
  • Connectivity Options: RS-232 for data export to LIS; external barcode reader support; external printer support.
  • Maintenance: Minimal daily maintenance; user-replaceable thermal paper.

4. SAFETY & COMPLIANCE ATTRIBUTES

  • Regulatory Status: In Vitro Diagnostic (IVD) medical device; requires country-specific registration per local regulations. Manufactured by High Technology Inc. (HTI), USA .
  • Safety Certifications: CE marked; compliant with applicable international safety standards.
  • Infection Control: No direct sample contact; uses standard test strips; standard precautions recommended.
  • Electrical Safety: Wide voltage compatibility (110-240V, 60/50Hz) for international use; ground protection; low power consumption .
  • Operating Environment: Designed for indoor laboratory or point-of-care use at 15-30°C; maximum humidity 80% .
  • Quality Assurance: Internal self-check and calibration; external QC materials available.

5. STORAGE & HANDLING ATTRIBUTES

  • Storage: Store in a clean, dry environment at 15-30°C; protect from dust, vibration, and direct sunlight .
  • Cleaning: Wipe exterior with soft, damp cloth using mild detergent; follow standard disinfection protocols for clinical surfaces.
  • Test Strip Storage: Store test strips per manufacturer instructions; protect from humidity; check expiration dates.
  • Maintenance: 12-month manufacturer warranty typical ; annual calibration verification recommended.
  • Installation: Benchtop installation requires minimal footprint (240 x 190 x 115mm) with access to electrical outlet; optional connectivity to LIS via RS-232 .
  • Portability: Designed for easy transport; briefcase-portable for mobile health outreach .

6. LABORATORY & CLINICAL APPLICATIONS

  • Primary Application: Semi-automated urinalysis for UTI diagnosis, diabetes screening, preeclampsia detection, chronic kidney disease monitoring, and liver disease screening in clinical laboratories, physician offices, mobile health units, and point-of-care settings .
  • Clinical Role: Essential diagnostic instrumentation for primary care, obstetrics, nephrology, endocrinology, emergency medicine, pediatrics, and geriatrics; particularly valuable in resource-limited and remote healthcare settings where traditional laboratory access is unavailable .
SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

  • Biohazard Exposure: Treat all samples as potentially infectious; use standard precautions (gloves, lab coat) when handling urine specimens; dispose of test strips per facility biohazard protocol.
  • Electrical Safety: Use properly grounded outlet; wide voltage tolerance (110-240V, 60/50Hz) ensures safe international use .
  • Test Strip Handling: Use only manufacturer-recommended test strips (H10, H11, H13, H14); do not use expired or improperly stored strips; handle strips by end only to avoid contamination .
  • Quality Control: Run external QC materials per laboratory schedule; verify calibration before patient testing.
  • Environmental Conditions: Operate within specified temperature (15-30°C) and humidity (≤80%) ranges for accurate results .
  • Interference: High levels of ascorbic acid (vitamin C) may interfere with certain test parameters; review results in clinical context.
  • Cleaning: Clean spills immediately; follow facility disinfection protocols.

2. FIRST AID MEASURES

  • Sample Exposure: Wash exposed skin immediately with soap and water; flush eyes with water for 15 minutes; follow institutional exposure management protocol.
  • Electrical Malfunction: Disconnect power immediately; do not attempt repair; contact service provider.
  • Thermal Printer: Printer may become warm during operation; allow to cool before servicing.

3. FIRE FIGHTING MEASURES

  • Flammability: Electrical hazard; test strips 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.