mLabs and qLabs Platforms

Name: mLabs and qLabs Platforms - Amaris Medical Solutions
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The mLabs and qLabs Platforms are integrated point-of-care testing systems manufactured by Micropoint Bioscience for rapid quantitative measurement of coagulation parameters (PT/INR, ACT), cardiac markers (troponin I, CK-MB, NT-proBNP), hemoglobin/hematocrit, electrolytes (Na+, K+, iCa), blood gases (pH, pCO2, pO2), glucose, ketones, and infectious disease markers. The qLabs platform specializes in coagulation and electrolyte testing using electrochemical technology, while the mLabs platform focuses on immunoassay and photometric testing for cardiac, hematology, and infectious disease applications. Features include portable design, touchscreen interface, rechargeable battery, USB/Bluetooth connectivity, and compatibility with single-use disposable test cards. Test times range from 1-15 minutes with sample volumes of 2-100 µL. Primary clinical applications include anticoagulation management (warfarin monitoring), cardiac surgery and intervention support (ACT monitoring), emergency cardiac diagnosis (troponin), anemia screening, diabetes management, critical care electrolyte and blood gas analysis, and infectious disease testing in endemic regions. Critical safety precautions include proper test card storage (temperature-sensitive), regular quality control, operator training, single-use lancets, and infection control protocols. Essential point-of-care testing solution for hospitals, clinics, emergency departments, surgical suites, and anticoagulation clinics.

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Categories: DIAGNOSTIC EQUIPMENT, Analyzers, Diagnostic Kits, LABORATORY EQUIPMENT AND SUPPLIES, Multi-Parameter Monitors, PATIENT MONITORING AND LIFE SUPPORT Tags: Blood Gas Analyzer, Cardiac Markers, Coagulation Monitor, Electrolyte Analyzer, Hemoglobin Meter, INR Monitor, Micro point Bioscience, mLabs, Point Of Care Testing, PTINR, qLabs, Troponin

Description

mLabs and qLabs Platforms

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Point-of-Care Coagulation Monitoring (PT/INR):

Primary Use: The qLabs platform provides quantitative measurement of Prothrombin Time (PT) and International Normalized Ratio (INR) from a fingerstick blood sample, enabling rapid monitoring of patients on oral anticoagulation therapy (warfarin) and guiding dose adjustments to maintain therapeutic range.
How it helps: Saves patients on blood thinners from frequent trips to the lab, allowing them to monitor their INR in minutes at their doctor’s office or even at home, ensuring their medication is keeping them safe from clots without causing dangerous bleeding.

2. Activated Clotting Time (ACT) Measurement:

Primary Use: Used in surgical and critical care settings to monitor heparin anticoagulation during cardiac surgery, percutaneous coronary interventions (PCI), and hemodialysis, ensuring adequate anticoagulation while minimizing bleeding risk.
How it helps: Gives cardiac surgeons and interventional cardiologists real-time feedback on blood thinning during procedures, ensuring patients receive exactly the right amount of heparin to prevent clots during heart surgery without risking excessive bleeding.

3. Hemoglobin and Hematocrit Testing:

Primary Use: The mLabs platform offers quantitative measurement of hemoglobin (Hb) and hematocrit (Hct) for rapid anemia screening, preoperative assessment, and monitoring of patients with bleeding disorders or chronic conditions.
How it helps: Provides instant answers about blood oxygen-carrying capacity at the bedside, helping doctors identify anemia quickly and make immediate decisions about transfusions or iron therapy.

4. Glucose and Ketone Monitoring:

Primary Use: Provides quantitative measurement of blood glucose and beta-hydroxybutyrate (ketones) for diabetes management and monitoring of diabetic ketoacidosis (DKA) in point-of-care settings.
How it helps: Helps diabetic patients and their healthcare teams catch dangerous ketoacidosis early, when a patient’s blood is becoming too acidic from lack of insulin, allowing for prompt treatment before life-threatening complications develop.

5. Cardiac Marker Testing:

Primary Use: Enables rapid quantitative measurement of cardiac troponin I (cTnI), CK-MB, and NT-proBNP for early diagnosis of acute myocardial infarction and assessment of heart failure in emergency and critical care settings.
How it helps: Provides emergency physicians with lab-quality cardiac test results in minutes, confirming or ruling out heart attacks and guiding treatment decisions while patients are still in the emergency department.

6. Blood Gas and Electrolyte Analysis:

Primary Use: Select platforms offer measurement of pH, pCO2, pO2, sodium, potassium, and ionized calcium for rapid assessment of acid-base status and electrolyte imbalances in critically ill patients.
How it helps: Gives intensive care teams immediate information about a patient’s acid-base balance and electrolyte levels, guiding life-saving interventions for patients in respiratory failure, shock, or with dangerous electrolyte disturbances.

7. Multi-Parameter Infectious Disease Testing:

Primary Use: Supports testing for various infectious disease markers including dengue, malaria, and other febrile illnesses, enabling rapid differential diagnosis in endemic regions.
How it helps: Helps doctors in tropical regions quickly determine whether a fever is caused by dengue, malaria, or other infections, ensuring patients receive the right treatment without delay.

SECONDARY & SUPPORTIVE USES

1. Primary Care and Community Health Screening: Used in physician offices and community health centers for routine health screening and monitoring of chronic conditions, bringing laboratory-quality testing to everyday practice.

2. Emergency Department Triage: Rapid multi-parameter testing enables quick assessment of patients presenting with chest pain, shortness of breath, altered mental status, or suspected coagulopathy, helping prioritize care for the sickest patients.

3. Surgical and Perioperative Monitoring: Used in operating rooms and recovery units to monitor coagulation status, hemoglobin levels, and electrolyte balance during and after surgical procedures, ensuring patient safety.

4. Anticoagulation Clinics: Dedicated PT/INR testing supports management of patients on warfarin therapy, enabling dose adjustments without laboratory delays, streamlining care for patients on blood thinners.

5. Cardiac Catheterization Laboratories: ACT monitoring ensures optimal heparin dosing during interventional cardiology procedures, protecting patients during angioplasty and stent placement.

6. Hemodialysis Centers: Monitoring of clotting times and hemoglobin levels in patients undergoing dialysis, ensuring the safety and effectiveness of dialysis treatments.

7. Research and Clinical Trials: Used in clinical research settings requiring rapid, accurate point-of-care testing with data management capabilities, contributing to medical advances.

KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

Product Type: Portable, multi-parameter point-of-care testing platforms for quantitative measurement of various clinical parameters.
Manufacturer: Micropoint Bioscience (mLabs and qLabs platforms).
Platform Models:
- qLabs Coagulation Monitor: Specialized for PT/INR and ACT testing.
- qLabs Electrolyte Analyzer: For blood gas and electrolyte measurement.
- mLabs Immunoanalyzer: For cardiac markers and infectious disease testing.
- mLabs Hematology Analyzer: For hemoglobin and hematocrit.
- mLabs Glucose/Ketone Meter: For diabetes monitoring.
Measurement Principles:
- qLabs: Electrochemical and impedance technology.
- mLabs: Fluorescence immunoassay and photometry.
Sample Types: Capillary whole blood (fingerstick), venous whole blood, serum, or plasma depending on test.
Sample Volume: 2-100 µL depending on test and platform.
Test Time: 1-15 minutes depending on parameters.
Display: Backlit LCD or color touchscreen with intuitive interface.
Memory: Stores 500-2000 test results with date and time stamps.
Connectivity: USB, Bluetooth, and optional Wi-Fi for data transfer and LIS/HIS integration.
Power Source: Rechargeable lithium-ion battery and AC adapter.
Operating Temperature: 10-35°C (varies by platform).
Operating Humidity: 10-85% non-condensing.

2. TECHNICAL & PERFORMANCE PROPERTIES

PT/INR (qLabs):
- Measurement Range: PT: 9-120 seconds; INR: 0.8-8.0.
- Accuracy: Correlation with reference methods R² >0.95.
- Sample Volume: 10-15 µL capillary or venous blood.
- Test Time: 2-5 minutes.
ACT (qLabs):
- Measurement Range: 50-1000 seconds.
- Sample Volume: 15-20 µL.
- Test Time: 2-5 minutes.
Hemoglobin (mLabs):
- Measurement Range: 4-24 g/dL.
- Accuracy: ±0.3-0.5 g/dL compared to reference.
- Sample Volume: 10 µL.
- Test Time: 60 seconds.
Cardiac Markers (mLabs):
- Troponin I: Detection limit <0.01 ng/mL.
- NT-proBNP: Broad dynamic range for heart failure assessment.
- Test Time: 10-15 minutes.
Electrolytes (qLabs Electrolyte):
- Parameters: Na+, K+, iCa, pH, pCO2, pO2, Hct.
- Sample Volume: 100 µL.
- Test Time: 60 seconds.
Quality Control: Built-in system controls; external controls available for each test type.
Calibration: Factory calibrated; lot-specific calibration data on test cards/strips.

3. PHYSICAL & OPERATIONAL PROPERTIES

Dimensions: 150-200 mm × 80-120 mm × 30-50 mm (varies by platform).
Weight: 300-800 grams (portable).
Display: Backlit LCD or 4.3-7 inch color touchscreen depending on model.
Controls: Touchscreen or membrane keypad.
Test Cartridges/Strips: Single-use, disposable test cards or strips containing all reagents.
Cartridge Storage: Store at 2-8°C or room temperature depending on test type.
Printer: Some models include built-in thermal printer; external printer option.
Ports: USB, Ethernet, Bluetooth.
Barcode Reader: Optional integrated or external scanner.
Carrying Case: Available for portable use.

4. SAFETY & COMPLIANCE ATTRIBUTES

Regulatory Status: Class II medical devices requiring FDA 510(k) clearance; CE marked for IVD use.
Quality Standards: Manufactured under ISO 13485.
Electrical Safety: Compliant with IEC 60601-1.
EMC Compliance: IEC 60601-1-2.
Biocompatibility: Test cartridge materials meet ISO 10993 for blood contact.
Latex-Free: All components latex-free.
Data Security: Compliant with relevant data protection regulations.
Quality Control: Regular QC required with each new lot of test cards/strips.
CLIA Waiver: Some tests may be CLIA waived for point-of-care use.

5. STORAGE & HANDLING ATTRIBUTES

Platform Storage: Store at room temperature (15-30°C) in a clean, dry environment; protect from dust, humidity, and direct sunlight.
Test Cartridge/Strip Storage: Store per manufacturer instructions (typically 2-8°C or room temperature); do not freeze.
Sample Handling: Test fresh capillary or venous blood within recommended time; use appropriate anticoagulant where required.
Quality Control: Run control materials with each new lot and as required by laboratory protocol.
Cleaning: Wipe exterior with soft, damp cloth; use approved disinfectant wipes; do not immerse.
Battery Maintenance: Keep battery charged; recharge as needed; replace when battery life degrades.
Software Updates: Install manufacturer updates as available.
Calibration Verification: Annual verification recommended per institutional protocol.

6. LABORATORY & CLINICAL APPLICATIONS

Primary Application: Integrated point-of-care testing platform for rapid quantitative measurement of coagulation parameters, cardiac markers, hemoglobin, electrolytes, blood gases, and metabolites across multiple clinical settings.
qLabs Platform Applications:
- Anticoagulation Management: PT/INR monitoring for warfarin patients.
- Cardiac Surgery/Interventions: ACT monitoring for heparin management.
- Critical Care: Electrolyte and blood gas analysis.
mLabs Platform Applications:
- Anemia Screening: Hemoglobin and hematocrit measurement.
- Diabetes Management: Glucose and ketone monitoring.
- Cardiac Diagnosis: Troponin I, CK-MB, NT-proBNP for chest pain evaluation.
- Infectious Disease: Dengue, malaria, and other febrile illness testing.
Sample Collection and Testing:

Select appropriate test card/strip for required parameters.
Collect blood samples via fingerstick or venipuncture.
Apply sample to test card/strip as directed.
Insert card into analyzer; test runs automatically.
Results displayed in 1-15 minutes.
Review, document, and transmit results as needed.

Quality Assurance: Regular QC testing; operator training; maintenance of temperature logs for reagent storage.

SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

Infection Control: Lancets and sampling devices single-use only; dispose in sharps containers. All blood samples are potentially infectious.
Hand Hygiene: Wash hands before testing; clean patient's fingers thoroughly.
Test Card Handling: Do not use expired cards; allow refrigerated cards to reach room temperature before use.
Quality Control: Run controls with each new lot and periodically as required.
Operator Training: Personnel must be trained on proper use of each platform and test type.
Interferences: Be aware of substances that may interfere with specific tests (e.g., hematocrit, bilirubin, lipids).
Patient Identification: Ensure correct patient identification before testing and recording results.
Storage: Store test cards per manufacturer; temperature excursions may affect accuracy.
Electrical Safety: Use only supplied power adapter; protect from liquid spills.

2. FIRST AID MEASURES

Needlestick/Sharps Injury: Wash area vigorously with soap and water; report immediately; follow institutional exposure protocol.
Blood Spill: Contain with absorbent material; disinfect area with 10% bleach solution.
Eye Contact with Blood: Flush eyes with copious water for 15 minutes; seek medical attention.
Card Leak or Breakage: Carefully remove fragments; disinfect area; dispose of biohazard waste.

3. FIRE FIGHTING MEASURES

Flammability: Plastic components and reagents are combustible.
Extinguishing Media: For electrical fire, use CO₂ or dry chemical (Class C) extinguisher.
Power Off: Disconnect power if safe to do so.

mLabs and qLabs Platforms

mLabs and qLabs Platforms

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Point-of-Care Coagulation Monitoring (PT/INR):

How it helps: Saves patients on blood thinners from frequent trips to the lab, allowing them to monitor their INR in minutes at their doctor’s office or even at home, ensuring their medication is keeping them safe from clots without causing dangerous bleeding.

2. Activated Clotting Time (ACT) Measurement:

Primary Use: Used in surgical and critical care settings to monitor heparin anticoagulation during cardiac surgery, percutaneous coronary interventions (PCI), and hemodialysis, ensuring adequate anticoagulation while minimizing bleeding risk.

How it helps: Gives cardiac surgeons and interventional cardiologists real-time feedback on blood thinning during procedures, ensuring patients receive exactly the right amount of heparin to prevent clots during heart surgery without risking excessive bleeding.

3. Hemoglobin and Hematocrit Testing:

Primary Use: The mLabs platform offers quantitative measurement of hemoglobin (Hb) and hematocrit (Hct) for rapid anemia screening, preoperative assessment, and monitoring of patients with bleeding disorders or chronic conditions.

How it helps: Provides instant answers about blood oxygen-carrying capacity at the bedside, helping doctors identify anemia quickly and make immediate decisions about transfusions or iron therapy.

4. Glucose and Ketone Monitoring:

Primary Use: Provides quantitative measurement of blood glucose and beta-hydroxybutyrate (ketones) for diabetes management and monitoring of diabetic ketoacidosis (DKA) in point-of-care settings.

How it helps: Helps diabetic patients and their healthcare teams catch dangerous ketoacidosis early, when a patient’s blood is becoming too acidic from lack of insulin, allowing for prompt treatment before life-threatening complications develop.

5. Cardiac Marker Testing:

Primary Use: Enables rapid quantitative measurement of cardiac troponin I (cTnI), CK-MB, and NT-proBNP for early diagnosis of acute myocardial infarction and assessment of heart failure in emergency and critical care settings.

How it helps: Provides emergency physicians with lab-quality cardiac test results in minutes, confirming or ruling out heart attacks and guiding treatment decisions while patients are still in the emergency department.

6. Blood Gas and Electrolyte Analysis:

Primary Use: Select platforms offer measurement of pH, pCO2, pO2, sodium, potassium, and ionized calcium for rapid assessment of acid-base status and electrolyte imbalances in critically ill patients.

How it helps: Gives intensive care teams immediate information about a patient’s acid-base balance and electrolyte levels, guiding life-saving interventions for patients in respiratory failure, shock, or with dangerous electrolyte disturbances.

7. Multi-Parameter Infectious Disease Testing:

Primary Use: Supports testing for various infectious disease markers including dengue, malaria, and other febrile illnesses, enabling rapid differential diagnosis in endemic regions.

How it helps: Helps doctors in tropical regions quickly determine whether a fever is caused by dengue, malaria, or other infections, ensuring patients receive the right treatment without delay.

SECONDARY & SUPPORTIVE USES

1. Primary Care and Community Health Screening: Used in physician offices and community health centers for routine health screening and monitoring of chronic conditions, bringing laboratory-quality testing to everyday practice.

2. Emergency Department Triage: Rapid multi-parameter testing enables quick assessment of patients presenting with chest pain, shortness of breath, altered mental status, or suspected coagulopathy, helping prioritize care for the sickest patients.

3. Surgical and Perioperative Monitoring: Used in operating rooms and recovery units to monitor coagulation status, hemoglobin levels, and electrolyte balance during and after surgical procedures, ensuring patient safety.

4. Anticoagulation Clinics: Dedicated PT/INR testing supports management of patients on warfarin therapy, enabling dose adjustments without laboratory delays, streamlining care for patients on blood thinners.

5. Cardiac Catheterization Laboratories: ACT monitoring ensures optimal heparin dosing during interventional cardiology procedures, protecting patients during angioplasty and stent placement.

6. Hemodialysis Centers: Monitoring of clotting times and hemoglobin levels in patients undergoing dialysis, ensuring the safety and effectiveness of dialysis treatments.

7. Research and Clinical Trials: Used in clinical research settings requiring rapid, accurate point-of-care testing with data management capabilities, contributing to medical advances.

1. BASIC IDENTIFICATION ATTRIBUTES

Product Type: Portable, multi-parameter point-of-care testing platforms for quantitative measurement of various clinical parameters.

Manufacturer: Micropoint Bioscience (mLabs and qLabs platforms).

Platform Models:

qLabs Coagulation Monitor: Specialized for PT/INR and ACT testing.

qLabs Electrolyte Analyzer: For blood gas and electrolyte measurement.

mLabs Immunoanalyzer: For cardiac markers and infectious disease testing.

mLabs Hematology Analyzer: For hemoglobin and hematocrit.

mLabs Glucose/Ketone Meter: For diabetes monitoring.

Measurement Principles:

qLabs: Electrochemical and impedance technology.

mLabs: Fluorescence immunoassay and photometry.

Sample Types: Capillary whole blood (fingerstick), venous whole blood, serum, or plasma depending on test.

Sample Volume: 2-100 µL depending on test and platform.

Test Time: 1-15 minutes depending on parameters.

Display: Backlit LCD or color touchscreen with intuitive interface.

Memory: Stores 500-2000 test results with date and time stamps.

Connectivity: USB, Bluetooth, and optional Wi-Fi for data transfer and LIS/HIS integration.

Power Source: Rechargeable lithium-ion battery and AC adapter.

Operating Temperature: 10-35°C (varies by platform).

Operating Humidity: 10-85% non-condensing.

2. TECHNICAL & PERFORMANCE PROPERTIES

PT/INR (qLabs):

Measurement Range: PT: 9-120 seconds; INR: 0.8-8.0.

Accuracy: Correlation with reference methods R² >0.95.

Sample Volume: 10-15 µL capillary or venous blood.

Test Time: 2-5 minutes.

ACT (qLabs):

Measurement Range: 50-1000 seconds.

Sample Volume: 15-20 µL.

Test Time: 2-5 minutes.

Hemoglobin (mLabs):

Measurement Range: 4-24 g/dL.

Accuracy: ±0.3-0.5 g/dL compared to reference.

Sample Volume: 10 µL.

Test Time: 60 seconds.

Cardiac Markers (mLabs):

Troponin I: Detection limit <0.01 ng/mL.

NT-proBNP: Broad dynamic range for heart failure assessment.

Test Time: 10-15 minutes.

Electrolytes (qLabs Electrolyte):

Parameters: Na+, K+, iCa, pH, pCO2, pO2, Hct.

Sample Volume: 100 µL.

Test Time: 60 seconds.

Quality Control: Built-in system controls; external controls available for each test type.

Calibration: Factory calibrated; lot-specific calibration data on test cards/strips.

3. PHYSICAL & OPERATIONAL PROPERTIES

Dimensions: 150-200 mm × 80-120 mm × 30-50 mm (varies by platform).

Weight: 300-800 grams (portable).