Vacutainer (EDTA/PLAIN)

Name: Vacutainer (EDTA/PLAIN) - Amaris Medical Solutions
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Vacutainer (EDTA/PLAIN) is a sterile, evacuated blood collection tube (lavender/purple top) containing EDTA anticoagulant (K2EDTA or K3EDTA, 1.5-2.0 mg/mL blood) for hematology, blood banking, flow cytometry, and molecular diagnostics. Available in draw volumes 2-10 mL, glass or PET plastic, with color-coded stopper and sterile interior. EDTA chelates calcium, preventing coagulation while preserving cellular morphology. Primary clinical applications include complete blood count (CBC) and differential, blood typing and antibody screening (ABO/Rh, Coombs), hemoglobin A1c (HbA1c) testing, flow cytometry and immunophenotyping (CD4 counts), molecular diagnostics and PCR testing, sickle cell screening and hemoglobin electrophoresis, and parasitology (malaria smears). Critical safety precautions include filling to completion (correct blood-to-additive ratio), gentle inversion 8-10 times immediately after collection, never using for chemistry or coagulation testing, and proper disposal as biohazardous waste. Essential collection tube for hematology and immunohematology.

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Categories: CONSUMABLES AND DISPOSABLES, Catheters and Tubing, DIAGNOSTIC EQUIPMENT, Diagnostic Kits, Lab Consumables, LABORATORY EQUIPMENT AND SUPPLIES Tags: Blood Collection Tube, EDTA Tube, Hematology Tube, K2EDTA, Lavender Top Tube, Purple Top Tube, Vacutainer

Description

Vacutainer (EDTA/PLAIN)

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Hematology and Complete Blood Count (CBC) Testing:

Primary Use: EDTA (ethylenediaminetetraacetic acid) tubes are the standard anticoagulant tubes for hematology testing, preserving cellular morphology and preventing clotting for accurate CBC, white blood cell differential, platelet counts, and red blood cell indices.
How it helps: Ensures that every blood cell looks exactly as it would in the body, allowing laboratory professionals to count and examine cells accurately and giving doctors reliable information about anemia, infection, and blood disorders.

2. Blood Banking and Immunohematology:

Primary Use: Used for blood typing (ABO and Rh), antibody screening, cross-matching, and direct antiglobulin tests (Coombs test) in transfusion medicine, where EDTA preserves red blood cell antigens without affecting antigen-antibody reactions.
How it helps: Protects patients receiving blood transfusions by ensuring donor and recipient blood types are perfectly matched, preventing potentially fatal transfusion reactions.

3. Hemoglobin A1c (HbA1c) Testing:

Primary Use: EDTA whole blood is the preferred specimen for HbA1c analysis, used to monitor long-term glycemic control in diabetic patients.
How it helps: Provides diabetics and their doctors with a clear picture of blood sugar control over the past three months, guiding treatment decisions that can prevent devastating complications like blindness and kidney failure.

4. Flow Cytometry and Immunophenotyping:

Primary Use: Essential for immunophenotyping of leukemias and lymphomas, lymphocyte subset analysis (CD4 counts), and other flow cytometry applications where viable cells are required.
How it helps: Helps oncologists classify exactly what type of cancer a patient has and track how well the immune system is functioning, guiding personalized cancer treatment.

5. Molecular Diagnostics and PCR Testing:

Primary Use: EDTA whole blood is used for DNA extraction and PCR-based testing for genetic disorders, infectious diseases (viral load), and pharmacogenomics, as EDTA does not inhibit PCR reactions.
How it helps: Enables sophisticated genetic testing that can identify inherited disorders, measure viral levels in HIV or hepatitis, and even predict how patients will respond to certain medications.

6. Sickle Cell Screening and Hemoglobin Electrophoresis:

Primary Use: EDTA blood is used for sickle cell tests, hemoglobin electrophoresis, and HPLC for detecting hemoglobinopathies.
How it helps: Detects inherited blood disorders like sickle cell disease and thalassemia, providing crucial information for patients and their families about conditions that affect red blood cells.

7. Parasitology and Peripheral Blood Smears:

Primary Use: EDTA blood is used for preparing thin and thick blood films for malaria diagnosis and other parasitic infections, with preserved cellular morphology.
How it helps: Allows laboratory professionals to see malaria parasites clearly in blood samples, leading to rapid diagnosis and treatment of this potentially fatal infection.

SECONDARY & SUPPORTIVE USES

1. Glycated Albumin and Fructosamine Testing: Used for alternative glycemic markers when HbA1c is unreliable, providing additional options for monitoring diabetes in certain situations.

2. Cytogenetics and Karyotyping: EDTA blood can be used for chromosome analysis and karyotyping, helping diagnose genetic disorders.

3. Trace Element Analysis: Some EDTA tubes certified for trace element-free applications, allowing accurate measurement of minerals and heavy metals in blood.

4. Research and Clinical Trials: Used extensively in research protocols requiring whole blood or plasma, contributing to medical advances.

5. Veterinary Medicine: Standard anticoagulant tube for hematology in veterinary practice, helping veterinarians care for animal patients.

6. Erythrocyte Sedimentation Rate (ESR): Some EDTA tubes can be used for ESR testing within specific timeframes, monitoring inflammation.

7. Blood Lead Level Testing: EDTA blood is used for toxicology screening for lead and other heavy metals, protecting children and workers from environmental toxins.

KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

Product Type: Evacuated blood collection tube containing EDTA anticoagulant.
Common Names: EDTA Tube, Lavender Top Tube, Purple Top Tube, Blood Collection Tube, Vacutainer.
Tube Color: Lavender (purple) cap (standard); pink cap for blood banking applications.
EDTA Type: K2EDTA (spray-dried) or K3EDTA (liquid) - both suitable for most applications.
EDTA Concentration: 1.5-2.0 mg/mL blood (standard).
Additive Form: Spray-dried (coated on tube wall) or liquid (less common).
Draw Volume: 2 mL, 3 mL, 4 mL, 5 mL, 6 mL, 7 mL, 8 mL, 10 mL (typical).
Tube Material: Glass or PET (plastic) with sterile interior.
Closure: Stopper with color coding; may have safety closure options.

2. TECHNICAL & PERFORMANCE PROPERTIES

Anticoagulant Mechanism: EDTA chelates calcium ions, preventing coagulation cascade by removing calcium required for clotting factors.
Cell Morphology Preservation: Maintains red and white blood cell morphology for up to 24 hours at room temperature.
Stability:
- CBC: 24 hours at room temperature, 48 hours at 4°C.
- Blood Smears: Best within 4 hours, acceptable up to 24 hours.
- HbA1c: 7 days at 4°C, months frozen.
Fill Volume Accuracy: Vacuum draws exact specified volume; underfilling or overfilling affects blood-to-additive ratio.
Mix Requirements: Gentle inversion 8-10 times immediately after collection.
Interferences: EDTA can interfere with certain assays (some chemistry tests, some drug levels); not for chemistry testing.
PCR Compatibility: Does not inhibit PCR reactions; suitable for molecular diagnostics.

3. PHYSICAL & OPERATIONAL PROPERTIES

Tube Dimensions: 13 × 75 mm (2-4 mL), 16 × 100 mm (6-10 mL).
Closure Material: Rubber stopper (butyl or synthetic) with color coding.
Label Area: Clear, writable surface for patient identification.
Sterility: Sterile interior; vacuum maintains sterility.
Shelf Life: 12-24 months from manufacture date.
Storage: Store at 15-25°C; avoid temperature extremes.

4. SAFETY & COMPLIANCE ATTRIBUTES

Regulatory Status: Class II medical device requiring FDA 510(k) clearance; CE marked for IVD use.
Quality Standards: Manufactured under ISO 13485; meets CLSI standards for blood collection.
Sterility: Sterile; SAL 10⁻⁶.
Biohazard Precautions: Blood samples potentially infectious; handled with universal precautions.
Disposal: Dispose of used tubes as biohazardous waste.
Latex-Free: Stoppers are latex-free (most manufacturers).
Safety Engineered: Some models include safety closure to reduce needlestick risk.

5. STORAGE & HANDLING ATTRIBUTES

Storage: Store unopened tubes at 15-25°C; protect from direct sunlight and temperature extremes.
Expiration: Do not use beyond expiration date; vacuum and additive integrity compromised.
Inspection: Before use, check for cracks, visible particulates, or additive discoloration.
Collection: Fill to completion; underfilled tubes alter blood-to-additive ratio, affecting results.
Mixing: Invert gently 8-10 times immediately after collection to ensure proper mixing.
Centrifugation: If plasma needed, centrifuge at 1,000-1,300 x g for 10-15 minutes.
Transport: Transport at room temperature or refrigerated per test requirements.

6. LABORATORY & CLINICAL APPLICATIONS

Primary Application: Blood collection for hematology, blood banking, flow cytometry, and molecular diagnostics requiring anticoagulated whole blood or plasma.
Proper Use:
1. Select appropriate tube size for required volume.
2. Perform venipuncture; tube fills automatically by vacuum.
3. Remove tube from holder; immediately invert gently 8-10 times.
4. Label tube with patient identification.
5. Transport to laboratory; process within stability limits.
Tests NOT Suitable for EDTA:

Coagulation studies (use citrate tube).
Most chemistry tests (use serum or heparin tube).
Drug level monitoring (unless specifically validated).
Ammonia, lactate, and certain enzymes.

Limitations: Not for chemistry testing; may interfere with some immunoassays; underfilled tubes cause erroneous results.

SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

Fill Volume: Allow tube to fill to completion; partial fill causes incorrect blood-to-additive ratio, leading to erroneous results (false low hematocrit, cell shrinkage).
Mixing: Invert gently; vigorous shaking causes hemolysis and cell damage. Do not delay mixing - microclots may form.
Closure Safety: Never remove stopper from tube containing blood; aerosolization risk.
Sharps Safety: Used collection needles are sharps; dispose immediately in sharps containers.
Infection Control: Follow universal precautions; all blood samples potentially infectious.
Storage: Store unopened tubes properly; expired tubes may have vacuum loss and additive degradation.
Transport: Package tubes in leak-proof containers for transport.

2. FIRST AID MEASURES

Needlestick 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.
Tube Breakage: Carefully remove fragments with forceps; disinfect area; dispose in sharps container.

3. FIRE FIGHTING MEASURES

Flammability: Plastic tubes are combustible; glass tubes non-combustible.
Extinguishing Media: Use water, foam, CO₂, or dry chemical as appropriate.

Vacutainer (EDTA/PLAIN)

Vacutainer (EDTA/PLAIN)

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Hematology and Complete Blood Count (CBC) Testing:

Primary Use: EDTA (ethylenediaminetetraacetic acid) tubes are the standard anticoagulant tubes for hematology testing, preserving cellular morphology and preventing clotting for accurate CBC, white blood cell differential, platelet counts, and red blood cell indices.

How it helps: Ensures that every blood cell looks exactly as it would in the body, allowing laboratory professionals to count and examine cells accurately and giving doctors reliable information about anemia, infection, and blood disorders.

2. Blood Banking and Immunohematology:

Primary Use: Used for blood typing (ABO and Rh), antibody screening, cross-matching, and direct antiglobulin tests (Coombs test) in transfusion medicine, where EDTA preserves red blood cell antigens without affecting antigen-antibody reactions.

How it helps: Protects patients receiving blood transfusions by ensuring donor and recipient blood types are perfectly matched, preventing potentially fatal transfusion reactions.

3. Hemoglobin A1c (HbA1c) Testing:

Primary Use: EDTA whole blood is the preferred specimen for HbA1c analysis, used to monitor long-term glycemic control in diabetic patients.

How it helps: Provides diabetics and their doctors with a clear picture of blood sugar control over the past three months, guiding treatment decisions that can prevent devastating complications like blindness and kidney failure.

4. Flow Cytometry and Immunophenotyping:

Primary Use: Essential for immunophenotyping of leukemias and lymphomas, lymphocyte subset analysis (CD4 counts), and other flow cytometry applications where viable cells are required.

How it helps: Helps oncologists classify exactly what type of cancer a patient has and track how well the immune system is functioning, guiding personalized cancer treatment.

5. Molecular Diagnostics and PCR Testing:

Primary Use: EDTA whole blood is used for DNA extraction and PCR-based testing for genetic disorders, infectious diseases (viral load), and pharmacogenomics, as EDTA does not inhibit PCR reactions.

How it helps: Enables sophisticated genetic testing that can identify inherited disorders, measure viral levels in HIV or hepatitis, and even predict how patients will respond to certain medications.

6. Sickle Cell Screening and Hemoglobin Electrophoresis:

Primary Use: EDTA blood is used for sickle cell tests, hemoglobin electrophoresis, and HPLC for detecting hemoglobinopathies.

How it helps: Detects inherited blood disorders like sickle cell disease and thalassemia, providing crucial information for patients and their families about conditions that affect red blood cells.

7. Parasitology and Peripheral Blood Smears:

Primary Use: EDTA blood is used for preparing thin and thick blood films for malaria diagnosis and other parasitic infections, with preserved cellular morphology.

How it helps: Allows laboratory professionals to see malaria parasites clearly in blood samples, leading to rapid diagnosis and treatment of this potentially fatal infection.

SECONDARY & SUPPORTIVE USES

1. Glycated Albumin and Fructosamine Testing: Used for alternative glycemic markers when HbA1c is unreliable, providing additional options for monitoring diabetes in certain situations.

2. Cytogenetics and Karyotyping: EDTA blood can be used for chromosome analysis and karyotyping, helping diagnose genetic disorders.

3. Trace Element Analysis: Some EDTA tubes certified for trace element-free applications, allowing accurate measurement of minerals and heavy metals in blood.

4. Research and Clinical Trials: Used extensively in research protocols requiring whole blood or plasma, contributing to medical advances.

5. Veterinary Medicine: Standard anticoagulant tube for hematology in veterinary practice, helping veterinarians care for animal patients.

6. Erythrocyte Sedimentation Rate (ESR): Some EDTA tubes can be used for ESR testing within specific timeframes, monitoring inflammation.

7. Blood Lead Level Testing: EDTA blood is used for toxicology screening for lead and other heavy metals, protecting children and workers from environmental toxins.

1. BASIC IDENTIFICATION ATTRIBUTES

Product Type: Evacuated blood collection tube containing EDTA anticoagulant.

Common Names: EDTA Tube, Lavender Top Tube, Purple Top Tube, Blood Collection Tube, Vacutainer.

Tube Color: Lavender (purple) cap (standard); pink cap for blood banking applications.

EDTA Type: K2EDTA (spray-dried) or K3EDTA (liquid) - both suitable for most applications.

EDTA Concentration: 1.5-2.0 mg/mL blood (standard).

Additive Form: Spray-dried (coated on tube wall) or liquid (less common).

Draw Volume: 2 mL, 3 mL, 4 mL, 5 mL, 6 mL, 7 mL, 8 mL, 10 mL (typical).

Tube Material: Glass or PET (plastic) with sterile interior.

Closure: Stopper with color coding; may have safety closure options.

2. TECHNICAL & PERFORMANCE PROPERTIES

Anticoagulant Mechanism: EDTA chelates calcium ions, preventing coagulation cascade by removing calcium required for clotting factors.

Cell Morphology Preservation: Maintains red and white blood cell morphology for up to 24 hours at room temperature.

Stability:

CBC: 24 hours at room temperature, 48 hours at 4°C.

Blood Smears: Best within 4 hours, acceptable up to 24 hours.

HbA1c: 7 days at 4°C, months frozen.

Fill Volume Accuracy: Vacuum draws exact specified volume; underfilling or overfilling affects blood-to-additive ratio.

Mix Requirements: Gentle inversion 8-10 times immediately after collection.

Interferences: EDTA can interfere with certain assays (some chemistry tests, some drug levels); not for chemistry testing.

PCR Compatibility: Does not inhibit PCR reactions; suitable for molecular diagnostics.

3. PHYSICAL & OPERATIONAL PROPERTIES

Tube Dimensions: 13 × 75 mm (2-4 mL), 16 × 100 mm (6-10 mL).

Closure Material: Rubber stopper (butyl or synthetic) with color coding.

Label Area: Clear, writable surface for patient identification.

Sterility: Sterile interior; vacuum maintains sterility.

Shelf Life: 12-24 months from manufacture date.

Storage: Store at 15-25°C; avoid temperature extremes.

4. SAFETY & COMPLIANCE ATTRIBUTES

Regulatory Status: Class II medical device requiring FDA 510(k) clearance; CE marked for IVD use.

Quality Standards: Manufactured under ISO 13485; meets CLSI standards for blood collection.

Sterility: Sterile; SAL 10⁻⁶.

Biohazard Precautions: Blood samples potentially infectious; handled with universal precautions.

Disposal: Dispose of used tubes as biohazardous waste.

Latex-Free: Stoppers are latex-free (most manufacturers).

Safety Engineered: Some models include safety closure to reduce needlestick risk.

5. STORAGE & HANDLING ATTRIBUTES

Storage: Store unopened tubes at 15-25°C; protect from direct sunlight and temperature extremes.

Expiration: Do not use beyond expiration date; vacuum and additive integrity compromised.

Inspection: Before use, check for cracks, visible particulates, or additive discoloration.

Collection: Fill to completion; underfilled tubes alter blood-to-additive ratio, affecting results.

Mixing: Invert gently 8-10 times immediately after collection to ensure proper mixing.

Centrifugation: If plasma needed, centrifuge at 1,000-1,300 x g for 10-15 minutes.

Transport: Transport at room temperature or refrigerated per test requirements.

6. LABORATORY & CLINICAL APPLICATIONS

Primary Application: Blood collection for hematology, blood banking, flow cytometry, and molecular diagnostics requiring anticoagulated whole blood or plasma.

Proper Use:

Select appropriate tube size for required volume.