Product Application

BLOOD COLLECTION TUBES INSTRUCTION FOR USE

 INTENDED USE 

Blood Collection Tubes, Holders and Needles are used together as a system for the collection of venous blood. tubes are used to collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory. The patient population can be children and adults. The user profile can be doctors, nurses, and adequately trained healthcare personnel. NOTE: Please refer to Table 1.1 to see detailed intended use according to tube types. 

PRODUCT DESCRIPTION 

tubes are fitted with color coded caps. The tubes, additive concentrations, volumes of liquid additives, and their permitted tolerances, as well as the blood-to-additive ratio, are in accordance to the requirements and recommendations of the international standards ISO 6710 “Single- use containers for venous blood specimen collection“. Additive choice depends on the analytical test method. It is specified by the manufacturer of the test reagents and/or instrument on which the test is performed. Tube interiors are sterile. 

SUMMARY AND PRINCIPLES 

The Blood Collection Tubes is a common laboratory test used to indicate patient conditions such as acute tissue damage, chronic infection and chronic inflammation. The Blood Collection Tubes measures the rate that erythrocytes separate from human plasma and settle to the bottom of a tube of anticoagulated blood. Blood Collection Tubes results are reported in millimeters that the plasma-erythrocyte interface falls in a designated perpendicular tube of anticoagulated whole blood per hour. Blood Collection Tubes results become elevated due to the formation of erythrocyte rouleaux, which is caused mainly by alterations in plasma and erythrocyte factors.There may be situations where the sample cannot be analyzed immediately after it is drawn and must be transported or preserved for future analysis. Blood Collection Tubes -Vacuum Tubes preserve the integrity of the patient sample for sed rate analysis until processing and testing can be performed. Samples can be maintained from the time of blood collection for up to 72 hours prior to analysis when transported and/or stored at 2 °C to 10 °C, or up to 4 hours at 18 °C to 30 °C. Safety Coated Blood Collection Tubes -Vacuum Tubes are designed with an outer plastic coating that contains glass and blood specimens in the event of breakage, reducing the risk of injury and potential exposure to bloodborne pathogens. Reports from an independent packaging consultant demonstrate that Safety Coated Blood Collection Tubes Vacuum Tubes are significantly more impact resistant than glass collection tubes, substantially reducing accidentalbreakage. 

PRECAUTIONS

 1. For In Vitro Diagnostic Use. 2. All patient blood samples should be treated as if they are capable of transmitting infections and should be handled with appropriate precautions. Avoid contact with skin and mucous membranes. 3. Used tubes containing blood should not be disposed of in general waste, but should be disposed with infectious medicalwaste. 4. The product is intended for use as supplied. Adulteration by dilution or addition of any materials to the product as supplied, prior to direct draw or transfer procedures, invalidates the intended use of the product. 5. Storage of tubes at or below 0 °C may result in breakage.

 LIMITATIONS

 1. For Single Use Only. 2. The quantity of blood drawn may vary with altitude, temperature, barometric or venous pressure, tube age and technique. Vacuum Tubes are intended to be used with a standard vacutainer blood collection device The use of a butterfly or other alternate blood collection device may affect the volume of blood drawn. 3. Partial draw tubes (1.2ml) may fill more slowly than full draw tubes (2.0ml) of the same size. Under filling tubes will affect the final dilution of the sample, which may introduce variability into final results. Allow evacuated tubes to fill to completion. 4. The level of vacuum within the 1.2ml High Altitude Vacuum Tube is slightly increased relative tothe standard 1.2ml product. Use of this High Altitude tube at lower elevations (approximately 2500 ft. above sea level and below) may result in tubes filling well above the recommended product fill line.

Coagulation Tubes 

Coagulation Tubes are filled with buffered tri-sodium citrate solution. Citrate concentrations of either 0.109 mol/l (3.2 %) or 0.129 mol/l (3.8 %) are available. The choice of the concentration depends upon the policies of the laboratories. The mixing ratio is 1 part citrate to 9 parts blood. Coagulation Tubes are used for coagulation tests. 

CTAD Tubes 

CTAD Tubes are used for coagulation tests especially for patients taking heparin therapy. In addition to main component sodium citrate, CTAD Tubes contain theophylline, adenosine and dipyridamole which help prevention of in vitro platelet activation. Thereby provides high accuracy in hemostasis tests of patients even taking heparin therapy. Citrate concentrations of CTAD Tubes is 0.109 mol/l (3.2 %). The mixing ratio is 1 part citrate to 9 parts blood. 

Serum Tubes 

All Serum Tubes are coated with micronised silica particles which activate clotting when tubes are gently inverted. Serum Tubes with Gel contain a barrier gel that is present in the bottom of the tube. The specific gravity of this material lies between the blood clot and the serum. During centrifugation the barrier gel moves upward to the serum - clot interface, where it forms a stable barrier separating the serum from fibrin and cells. Serum may be aspirated directly from the collection tube, eliminating the need for transfer to another container. Serum tubes are used for determinations in serum for routine clinical chemistry tests and hormones, TDM. 

Heparin Tubes

The interior of the tube wall is coated with lithium heparin or sodium heparin. The anticoagulant heparin activates antithrombins, thus blocking the coagulation cascade and producing a whole blood / plasma sample instead of clotted blood plus serum. Plasma Tubes with Lithium Heparin and Gel contain a barrier gel in the tube. The specific gravity of this material lies between the blood cells and plasma. During centrifugation the gel barrier moves upward providing a stable barrier separating the plasma from cells. Plasma may be aspirated directly from the collection tube, eliminating the need for manual transfer to another container. Heparin Tubes are used for plasma determinations of routine clinical chemistry tests. Lithium determinations should not be performed in Lithium Heparin tubes. Sodium determinations should not be performed inSodium Heparin tubes. 

EDTA Tubes 

K2 EDTA and K3 EDTA Tubes are used for testing whole blood in haematology. EDTA Tubes may be used for routine immunohematology testing (i.e. red cell grouping), Rh typing and antibody screens, viral marker testing in screening laboratories. The interior of the tube wall is coated with either EDTA K2 or EDTA K3. The EDTA binds calcium ions thus blocking the coagulation cascade. Blood smearing should be done within 3 hours after blood collection. Tubes are used for testing whole blood in the clinical haematology laboratory within 24 hours at room temperature. EDTA K2/Gel Tubes are used for testing plasma in molecular diagnostics and viral load detection. 

Glucose Tubes 

Glucose Tubes are available with different additives. The tubes contain an anticoagulant and a stabilizer. EDTA, sodium fluoride and potassium oxalate. Glucose Tubes are suitable for the analysis of glucose concentration within 48 hours.

Blood Collection Tubes 

Blood Collection Tube are used for blood sedimentation rate testing. Blood Collection Tubes measurements refer to the Westergren method. Blood Collection Tubes contain a 3.2% buffered trisodium citrate solution (0.109 mol/l). Choice of the concentration depends on the laboratory policy. The mixing ratio is 1 part citrate solution to 4 partsblood. 

Cross Match Tubes 

Cross Match Tubes are used to test compatibility of recipient and donor blood prior to blood transfusion. Potential risk of hemolytic reactions can be avoided by this way. Cross Match Tubes are available with different additives. The interior of tubes are coated with either clot activator or anticoagulant (K2 EDTA or K3 EDTA) thus enables crossmatch tests with both serum and whole blood. Cross Match Tubes have pink-colored caps that make them easily identified. There is no specified color code for the closures of crossmatch tubes. 

Blood Grouping Tubes

Blood Grouping Tubes help preservation of erythrocytes by means of citric acid, dextrose and anticoagulant sodium citrate and used for cell preservation or blood grouping. Blood Grouping Tubes are available with two different formulations of the additives: ACD-A or ACD- B. Blood Grouping Tubes have yellow-colored caps but there is no specified color code for the closures of blood grouping tubes. 

Trace Element Tubes

 Trace Element Tubes are used to test presence of trace elements such as Iron, Zinc, Copper, Mercury, and Lead in the blood. Trace Element Tubes contains clot activator or K2 EDTA or sodium heparin in order to enable tests of serum, plasma or whole blood. Trace Element Tubes have dark blue-colored caps but there is no specified color code for the closures of trace element tubes.

 Thrombin-based Serum Tubes 

Thrombin-based Serum Tubes allow rapid blood clotting (maximum 5 minutes) meeting the requirements of units that have patients with blood clotting problems or units that require rapid test results. Thrombin-based Serum Tubes are plastic tubes with a pre-defined vacuum for exact draw volumes. They are fitted with orangecolored caps according to the defined color codes. Additive choice depends on the analytical test method. It is specified by the manufacturer of the test reagents and/or instrument on which the test is performed. Tube interiors are sterile. Thrombin-based Serum Tubes are coated with micronized silica particles. In order to provide rapid clotting, a thrombin- based clot activator reagent is sprayed to the tube interior. When tubes are gently inverted, blood clotting is activated by complete mixing of blood with thrombin-based clot activator. Thrombin-based Serum Tubes with Gel contain a barrier gel that is present in the bottom of the tube. The specific gravity of this material lies between the blood clot and the serum. During centrifugation the barrier gel moves upward to the serum - clot interface, where it forms a stable barrier separating the serum from fibrin and cells. Serum may be aspirated directly from the collection tube, eliminating the need for transfer to another container. Thrombin-based Serum tubes are used for determinations in serum for routine clinical chemistry tests and hormones, TDM especially which requires rapid results. 

APPLICATIONS 

Specimen Collection and Handling Recommended Order of Draw: 1. Blood culture/ no additive tubes 2. Coagulation 3. Serum with and without gel 4. Heparin with and without gel 5. EDTA 6. Glucose 7. Others *When drawn first then only suitable for routine tests (i.e. PT and APTT)

Prevention of Backflow 

Most evacuated blood collection tubes contain chemical additives. Therefore it is important to avoid possible backflow from the tube, due to the possibility of adverse patient reactions. To prevent backflow from tube into the patient’s arm, observe the following precautions: 1. Place patient’s arm in a downward position. 2. Hold tube with the cap uppermost. 3. Release tourniquet as soon as blood starts to flow intotube. 4. Make sure tube contents do not touch cap or end of the needle duringvenipuncture.

INSTRUCTIONS FOR USE

 1. Direct Draw Method a. Follow the CLSI Approved Standard, “Procedures for the Collection of Diagnostic Blood Specimens by Venipunctur” Vacuum Tubes are intended to be used with a standard vacutainer blood collection device. b. Insert the Vacuum Tube into the plastic holder and hold the tube so the cap is flush against the needle holder as the sample is being collected. c. Angle the tube so the blood stream hits the glass wall before mixing with the citrate solution to minimize the formation of blood foam. d. The vacuum will automatically draw the appropriate amount of blood into the tube. Watch for an air bubble to rise in the sample as the tube fills to indicate the draw is complete and remove the tube immediately. e. The ideal fill level and acceptable fill range are indicated on the tube. 

2. Transfer Method a. Samples drawn into an evacuated EDTA tube may be transferred into the Vacuum Tube. Do not remove anticoagulant from tube before transfer. Refer to CLSI guidelines for EDTA tube stability. b. Mix the EDTA tube thoroughly by inverting the tube 6 to 8 times. c. Transfer the sample from the EDTA tube into the Vacuum Tube up to the fill line. d. The ideal fill level and acceptable fill range are indicated on the tube. 

3. Mix the citrate solution with the sample immediately after drawing or transferring by inverting the tube 8 to 10 timesTo ensure adequate mixing, hold the tube at a 35° angle and invert the tube so the air bubble reaches the opposite end of the tube between everyinversion. 

4. Additional identification labels placed on the tube must be placed outside the scanning area of the tube .Place any additional labels as close to the cap as possible, over the Streck label. Leave a space of at least 5mm between the blood level and any additional labels. 

5. Tube Labeling Sleeves are available to provide an easy method of identifying samples without obstructing the blood column during analysis. Abbreviated instructions follow; refer to Tube Labeling Sleeve IFU for complete instructions. a. Remove all 5 labeling sleeves from the sheet by folding along the perforated edges. Separate the individual labeling sleeves by folding along the perforated lines between each sleeve. b. Collect or transfer a valid blood specimen into an Vacuum Tube. c. Bend both sides of the labeling sleeve by creasing the tabs along the scored lines as shown in Figure1. d. Insert the tube through the hole in the labeling sleeve with the tabs pointing up around the rubber stopper as shown in Figure 2. e. Apply the patient-specific identification label across both tabs of the labeling sleeve as shown in Figure3.

Disposal 

1. The general hygiene guidelines and legal regulations for the proper disposal of infectious material should be considered and followed. 2. Disposable gloves prevents the risk of infection. 3. Contaminated or filled blood collection tubes must be disposed of in suitable biohazard disposal containers, which can then be autoclaved and incinerated afterwards. 4. Disposal should take place in an appropriate incineration facility or through autoclaving (steamsterilization). 

STORAGE CONDITIONS 

Store tubes at 4–25°C (40–77° F). 

NOTE: Avoid exposure to direct sunlight. Exceeding the maximum recommended storage temperature may lead to impairment of the tube quality (i.e. vacuum loss, drying out of liquid additives, coloring, etc.) 

WARNING/PRECAUTIONS 

1. Do not use tubes if foreign matter is present! 2. Handle all biological samples and blood collection “sharps“(lancets, needles, luer adapters, and blood collection sets) according to the policies and procedures of your facility. 3. Obtain appropriate medical attention in the case of any exposure to biological samples (for example, through a puncture injury), since they may transmit HIV (AIDS), viral hepatitis, or other blood-bornepathogens. 4. Discard all blood collection “sharps” in biohazard containers approved for theirdisposal. 5. Transferring a sample from a syringe to a tube is not recommended. Additional manipulation of sharps increases the potential for needle stick injury. In addition, depressing the syringe plunger during transfer can create a positive pressure, forcefully displacing the stopper and sample and causing a potential blood exposure. Using a syringe for blood transfer may also cause over or under filling of tubes, resulting in an incorrect blood- to-additive ratio and potentially incorrect analysis results. 6. Do not use tubes after their expiration date. 7. Blood Collection Tubes are for single use. Do not reuse the tube after use, as pressure and sterility loss may occur in the tube that contacts the needle. 

CONTRAINDICATIONS 

It is not anticipated that there may be a direct harm as it does not have direct contact with people. However, contraindications may occur due to misdiagnosis if the product does not fulfill its intended use.