RR Mechatronics A006578 Level A Starrsed Control Instructions
- June 1, 2024
- RR Mechatronics
Table of Contents
RR Mechatronics A006578 Level A Starrsed Control
Product Information
Specifications
- Product Name: Starrsed Control
- Intended Purpose: In-vitro diagnostic quality control material for monitoring the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures
- Composition: Stabilized human red cells suspended in a buffered, preservative fluid
Product Usage Instructions
Storage and Stability
Store Starrsed Control as per the manufacturer’s instructions.
Do not use past the expiration date.
Procedure
- Rub the Starrsed Control tube between hands until packed cells are completely re-suspended.
- Place the tube on a roller mixer for at least 15 minutes for thorough mixing. Avoid foaming. Do not vortex.
- Load or draw the sample immediately after mixing.
- If using Starrsed ESR analyzer in EDTA mode: Load the Starrsed Control tube directly into the analyzer following patient sample loading instructions.
- If using Starrsed ESR analyzer in Citrate mode: Transfer the necessary amount of material to a pre-citrated tube, close the tube, invert it at least 12 times, then load the sample into the analyzer according to instructions.
- After each use, restore the tube as described in the storage and stability section.
Expected Value Range
Starrsed Control is assayed for Starrsed ESR analyzers. The software
calculates a temperature-corrected result based on the assayed mean value
encoded in the tubes barcode, which is lot-specific.
FAQ
Q: Can Starrsed Control be used for procedures other than Erythrocyte
Sedimentation Rate testing?
A: No, Starrsed Control is intended for ESR testing only and should not
be used for any other hematology procedure.
Q: How many Control samples can be obtained from one tube of Starrsed
Control?
A: The contents of one tube provide enough material for a specific number
of Control samples based on the product variant (Interrliner, Starrsed ST,
Starrsed RS, or Starrsed TL).
INTENDED PURPOSE
In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures.
SUMMARY AND PRINCIPLE
Good laboratory practice requires that stable reference material is used to
verify the precision of testing equipment and procedures. Starrsed Control is
used as one would use a whole blood patient specimen in sedimentation rate
procedures. Two levels of control are used to monitor within the normal and
abnormal clinical range.
REAGENTS
Starrsed Control is composed of stabilized human red cells suspended in a
buffered, preservative fluid.
WARNING AND PRECAUTIONS
Contains human source material. Handle as potentially infectious.
Each donor unit used in preparation of Starrsed Control has been tested and
found non-reactive for antibodies to Human Immunodeficiency Virus
(HIV-1/HIV-2), Hepatitis B Surface Antigen (HBsAg) and antibodies to Hepatitis
C (HCV).
No test method can assure complete absence of infectious agents. Therefore
Starrsed Control should be handled with the same precautions used with patient
specimens.
This product should be disposed of as medical waste.
Any serious incident that has occurred in relation to this product must be
reported to the distributor and/or manufacturer and the competent local
authorities.
LIMITATIONS
Starrsed Control is to be used for Erythrocyte Sedimentation Rate testing only
and shall not be used to control any other hematology procedure.
Starrsed Control shall not be used as a standard.
Starrsed Control should not be used past the expiration date.
RR Mechatronics as supplier of the Starrsed Control shall not be liable for
any claimed damages arising from other than intended usage.
STORAGE AND STABILITY
Store Starrsed Control at 18°-30°C (64°-86°F).
DO NOT FREEZE. DO NOT EXPOSE TO EXCESSIVE HEAT.
STORE THE TUBES UPRIGHT WITH THE CAP ON TOP.
Unopened, this product is stable until the expiration date (see tube label and
insert), typically 540 days after production. Once the tube has been used (cap
has been punctured or cap was removed) the product remains stable for 31 days
at room temperature 18°-30°C (64°-86°F). Avoid prolonged exposure of tubes to
light. Tubes should remain ‘closed’ at all times after each use.
PROCEDURE
Starrsed Control is provided in ready-to-use sample tubes and is used in the
same manner as patient samples. Starrsed Control is to be used for the
Westergren method with dilution only as prescribed by the “ICSH review of the
measurement of the ESR” (2011) and the “CLSI Procedures for the ESR Test;
Approved standard; H02-A5” (2011).
-
Rub the Starrsed Control tube between hands until packed cells have been completely re-suspended. (See also video instruction) https://portal.rrmechatronics.com/whatiseqas/)
-
Place tube for at least 15 minutes on a roller mixer or rotator mixer for thoroughly mixing. Avoid foaming. DO NOT VORTEX.
NOTE: To ensure consistent and reproducible results, the Control material must be thoroughly mixed and handled in the same manner each time. -
Load or draw the sample immediately after mixing.
Starrsed ESR analyzer in EDTA mode: Load the Starrsed Control tube directly into the analyzer according the instructions for loading patient samples (see instruments “Instructions For Use”).
Starrsed ESR analyzer in Citrate mode: Immediately after re-suspending, transfer the necessary amount of material into a pre-citrated tube according instructions of the tube manufacturer. Close the tube with the mixture and invert at least 12 times, then load the sample into the analyzer according the instructions for loading patient samples (see instruments “Instructions For Use”) -
After each use, restore tube as described in section STORAGE AND STABILITY.
Note:
Interrliner, Starrsed ST, Starrsed RS: the contents of one tube is sufficient
for three Control samples.
Starrsed TL: the contents of one tube is sufficient for two Control samples.
Do not mix residual material with material from other tubes. Do not re-use
empty tubes.
EXPECTED VALUE RANGE
Starrsed Control is assayed for the Starrsed ESR analyzers. The software
always calculates a temperature-corrected result because only temperature-
corrected results can be compared with the assayed mean value. The assayed
mean value is derived from validation measurements on multiple instruments at
different sites. The assayed mean value is encoded in the tubes barcode and is
lot-specific.
Individual laboratory means should fall within the lot-specific acceptable
range; however, laboratory means may vary from the listed values during the
life of this product. Variations between laboratories may be caused by
differences in instrument condition and procedures. It is recommended that
each laboratory establish its own means and acceptable ranges and use those
provided only as guides.Whenever the Controls fail to perform consistently
within the acceptable ranges according local quality procedures, patient
results should be considered invalid. If results vary outside the specified
assay ranges, check instrument and followed procedures. It difficulties
persist, contact your supplier for further assistance and/or instructions.
QUALITY CONTROL PROGRAM
A Quality Control Program is incorporated in the application software of all
Starrsed analyzers. For more information contact your Starrsed instrument
provider.
ORDERING INFORMATION
A0026578 Starrsed Control, level A, Tube vol 4.6 ml, Product packaging 6 x 4.6 ml
RR Mechatronics [email protected] De Corantijn 13
1689 AN Zwaag , The Netherlands
Tel: +31 229 291 129
|
20 Altieri Way. Unit#4 Warwick, RI 02886 , USA Tel: +1 888 431-6101
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Starrsed is a registered trademark of RR Mechatronics.
Version of batch data in the upper left region of this sheet: QCACF5AA2C
(2023-12) Version of the remaining text: V12 (2023-08)
This package insert in other languages:
http://www.rrmechatronics.com/product/consumables/Starrsed_Control/package-
inserts
Document: PI_A0026578_V12_QCACF5AA2C (A0030003-A01-EN)
Rev. 12:
Doc. Nr A0030003 added