RR Mechatronics QCACF5AA2C Starrsed Control User Manual
- June 8, 2024
- RR Mechatronics
Table of Contents
RR Mechatronics QCACF5AA2C Starrsed Control
Product Information
| Product name: | Started Control Level A |
|---|---|
| Article number: | QRR 049002 |
| LOT number: | QACF5AA2C |
| Expiry date: | 2025-03-23 |
| LOT release date: | 2023-12-22 |
Specifications
| Specification | Validated value |
|---|---|
| Value Range | 34-54 |
| Mean value | 44 |
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
Started Control is composed of stabilized human red cells suspended in a
buffered, preservative fluid.
PRECAUTIONS
WARNING AND PRECAUTIONS
Contains human source material. Handle as potentially infectious.
Each donor unit used in preparation for 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 the 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 about this product must be reported to
the distributor and/or manufacturer and the competent local authorities.
LIMITATIONS
- Started Control is to be used for Erythrocyte Sedimentation Rate testing only and shall not be used to control any other hematology procedure.
- Started Control shall not be used as a standard.
- Started 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
Started Control is provided in ready-to-use sample tubes and is used in the
same manner as patient samples. Started 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 thorough 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 to the instructions for loading patient samples (see instruments “Instructions For Use”).
Started ESR analyzer in Citrate mode: Immediately after re-suspending, transfer the necessary amount of material into a pre-citrated tube according to 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 to the instructions for loading patient samples (see instruments “Instructions For Use”) -
4. After each use, restore the tube as described in the section STORAGE AND STABILITY.
Note:
- Interrliner, Starrsed ST, Starrsed RS: the contents of one tube is sufficient for three Control samples.
- Started TL: the contents of one tube are sufficient for two Control samples.
- Do not mix residual material with material from other tubes. Do not reuse 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 tube’s 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 conditions and procedures. It is recommended that each laboratory establish its means and acceptable ranges and use those provided only as guides. Whenever the Controls fail to perform consistently within the acceptable ranges according to local quality procedures, patient results should be considered invalid. If results vary outside the specified assay ranges, check the instrument and follow procedures. If 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
SCANNER
Erythrocyte Sedimentation Rate Control for Starrsed ESR Analyzers\
LOT: QCACF5AA2C
MORE INFORMATION
- 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
Starred is a registered trademark of RR Mechatronics.
A 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 inserts 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
- RR Mechatronics Manufacturing B.V.
- De Corantijn 13, 1689 AN, Zwaag
- The Netherlands www.rrmechatronics.com
Version: QCACF5AA2C (2023-12)
FAQ
- What is the Starrsed Control Level A used for?
- As this is a certificate of analysis, the specific use of Starrsed Control Level A is not detailed here; however, it is likely a quality control product for laboratory purposes.
- How can I find more information about the safety of this product?
- Safety-related information can be found in the Safety Data Sheet (SDS) which is referenced in the certificate.
- Where can I get technical information or instructions for using this product?
- Technical information and instructions for use are provided in the Package insert that accompanies this product.
- What should I do if I have questions about this analysis?
- If you have any questions regarding the certificate of analysis, you should contact the Quality Assurance & Regulatory Affairs department via the provided email address [email protected].