Streck ESR-Vacuum Tubes Gebrauchsanleitung

ESR-Vacuum Tubes
INSTRUCTIONS FOR USE
INTENDED USE
ESR-Vacuum Tubes are evacuated tubes used for the collection of venous blood. ESR-Vacuum Tubes
are used to transport and process blood for testing the Erythrocyte Sedimentation Rate (ESR) of
whole blood in the clinical laboratory.
ESR analysis can be performed over a 72-hour period following collection and storage at 2 °C-10 °C
in an ESR-Vacuum Tube.
SUMMARY AND PRINCIPLES
The ESR test is a common laboratory test used to indicate patient conditions such as acute tissue
damage, chronic infection and chronic inflammation. The ESR test measures the rate that erythrocytes
separate from human plasma and settle to the bottom of a tube of anticoagulated blood. ESR results
are reported in millimeters that the plasma-erythrocyte interface falls in a designated perpendicular
tube of anticoagulated whole blood per hour. ESR 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. ESR-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-10 °C, or up to 4 hours at 18 °C-30 °C.
Safety Coated ESR-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 ESR-Vacuum Tubes are significantly more impact resistant than glass collection tubes,
substantially reducing accidental breakage.
ESR-Vacuum Tubes are available in 1.2ml and 2.0ml vacuum draw configurations, and are designed
specifically for use with the ESR-100, ESR-8 and ESR-Auto Plus
analyzers. Blood samples are collected in ESR-Vacuum Tubes and mixed with tri-sodium citrate
to avoid coagulation. After the tube is mixed, it is placed in the ESR instrument. Each instrument
automatically prints or downloads the ESR result at 30 minutes or 1 hour, depending on the program
selected. 1.2ml ESR-Vacuum Tubes, 1.2ml High Altitude ESR-Vacuum Tubes and 1.2ml Safety Coated
ESR-Vacuum Tubes are also compatible with the ESR-10 Manual Rack, which produces a manual ESR
result in 30 minutes.
REAGENTS
ESR-Vacuum Tubes contain 3.2% buffered tri-sodium citrate (0.109 M) additive (4NC).
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 medical waste.
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.
6. SDS can be obtained at www.streck.com, by calling 800-843-0912, or by calling your local
supplier.
STORAGE AND STABILITY
ESR-Vacuum Tubes are stable through the expiration date when stored at 2 °C-30 °C. Samples can be
maintained from the time of blood collection for up to 72 hours prior to analysis when transported or stored at
2 °C-10 °C, or up to 4 hours at 18 °C-30 °C.
INDICATION OF PRODUCT DETERIORATION
1. Inability to obtain expected ESR results may indicate product deterioration.
2. Discoloration of the product may be caused by overheating or freezing during shipping or
storage.
3. Repeat the ESR run to confirm erroneous results; if the same result is obtained, contact Streck
Technical Services at 800-843-0912 or technicalservices@streck.com.
INSTRUCTIONS FOR USE
1. Direct Draw Method
a. Follow the CLSI Approved Standard, "Procedures for the Collection of Diagnostic Blood
Specimens by Venipuncture." ESR-Vacuum Tubes are intended to be used with a standard
vacutainer blood collection device.
b. Insert the ESR-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 ESR-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 ESR-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 times. To 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 every inversion.
4. Additional identification labels placed on the tube must be placed outside the scanning area of the
5. ESR Tube Labeling Sleeves (Streck part number 240363) are available to provide an easy method
LIMITATIONS
® automated sedimentation rate
1. For Single Use Only.
2. The quantity of blood drawn may vary with altitude, temperature, barometric or venous pressure,
3. Partial draw tubes (1.2ml) may fill more slowly than full draw tubes (2.0ml) of the same size. Under
4. The level of vacuum within the 1.2ml High Altitude ESR-Vacuum Tube is slightly increased relative
EXPECTED RESULTS
The ESR-Vacuum Tube should be filled with blood to the appropriate fill level indicated in the
Limitations section above. When the ESR-Vacuum Tube is filled properly and tested in an ESR
instrument according to the manufacturer's instructions, the results obtained on fresh blood samples
will correlate with the Modified Westergren Method.
REFERENCES
1. Clinical and Laboratory Standards Institute, H01, Procedures for the collection of diagnostic blood
2. Clinical and Laboratory Standards Institute, H02, Procedures for the erythrocyte sedimentation
3. Clinical and Laboratory Standards Institute, H03, Tubes and additives for venous and capillary
ORDERING INFORMATION
Please call our Customer Service Department toll free at 800-228-6090 for assistance. Additional
information can be found online at www.streck.com.
GLOSSARY OF SYMBOLS
See the Instructions (IFU) tab under Resources on the product page at www.streck.com.
See www.streck.com/patents for patents that may be applicable to this product.
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.
of identifying samples without obstructing the blood column during analysis. Abbreviated
instructions follow; refer to ESR 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 ESR-Vacuum Tube.
c. Bend both sides of the labeling sleeve by creasing the tabs along the scored lines as shown in
Figure 1.
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
Figure 3.
Bend at scored lines
Figure 1
tube age and technique. ESR-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.
filling tubes will affect the final dilution of the sample, which may introduce variability into final
results. Allow evacuated tubes to fill to completion.
to the 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.
ESR-Vacuum Tubes 1.2ml
Nominal Capacity 1.3ml
Ideal Fill Level 60mm ± 5mm 100mm ± 8mm
specimens by venipuncture. Approved Standard - Sixth Edition.
rate test. Approved Standard - Fifth Edition.
blood specimen collection. Approved Standard - Sixth Edition.
Streck
7002 S. 109 Street, La Vista, NE 68128 USA
Figure 2
2.0ml 1.2ml High Altitude 1.2ml Safety Coated
2.2ml 1.6ml
60mm ± 5mm 60mm ± 5mm
EC REP
ARK ®
M M Europe
EDI
11, rue Emile Zola, BP 2332
38033 Grenoble Cedex 2, France
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label
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Figure 3
1.3ml
350438-24
2018-09