Quality Control; Symbols Used - IDS IGFBP-3 Control Mode D'emploi

IDS IGFBP-3 Control
5. Materials
Materials Provided
CTL1
Lyophilised phosphate BSA buffer matrix containing IGFBP-3 and sodium azide as preservative (<0.1%),
CTL2
3 each of 3 concentration levels, 1.0 mL
CTL3
Materials Required But Not Provided
Standard Materials
IS-310400 IDS-iSYS Multi-Discipline Automated System
or
IS-810400 IDS-i10
IS-4400 IDS-iSYS Insulin-like Growth Factor Binding
Protein 3 (IGFBP-3)
IS-CC100 IDS-iSYS Cuvettes
IS-CS100 IDS-iSYS System Liquid (Syst. l)
IS-CW100 IDS-iSYS Wash Solution (Wash S)
IS-CT100 IDS-iSYS Triggers Set
IS-6010 IDS-iSYS Cartridge Check System (CCS)
IS-CSC105 Sample Cups (500 µL)
IS-DS200 IDS-iSYS D-SORB Solution
6. Assay Procedure
6.1 Preparation of the Controls
The IDS IGFBP-3 controls are lyophilised. Reconstitute immediately before use. Add 1.0 mL of distilled or deionised water to
each bottle. Replace the stopper. Leave for 10 minutes to reconstitute with occasional gentle vortexing / mixing by hand before
use. Care should be taken to avoid the formation of foam.
Following reconstitution, and within 15 minutes, the IGFBP-3 controls should be aliquoted for single-use only in 200µL portions,
and frozen at -20°C. It is advised that the IGFBP-3 controls should not be used directly after the initial reconstitution step but that
they should be run following an initial freeze-thaw cycle of the prepared aliquots. Each aliquot should not undergo more than one
freeze-thaw cycle. The IGFBP-3 assay controls and calibrators should be measured after storage at the same conditions.
When using frozen controls, thaw at room temperature and mix well before use. Ensure that the controls are at room temperature
before they are placed on the system. Controls should be placed on the system within 30 minutes of thawing. Thawed aliquots
should not be re-frozen.
Proceed according to the instructions of the System User Manual.

6.2 Quality Control

Use the IDS IGFBP-3 Control Set for quality control and for the calibration of IDS IGFBP-3 assay. During a calibration, all control
levels should be measured in duplicate.
Other suitable control material can be used in addition to the IDS IGFBP-3 Control Set for quality control. Controls should be
tested at (or near) the beginning of every run containing patient samples in accordance with local, state and/or federal regulations
or accreditation requirements and your laboratory's quality procedure.
The control values must be within the specified acceptable ranges. If a control is out of its specified range, the associated test
results are invalid, and samples must be retested. Recalibration may be required.

7. Symbols Used

Catalogue Number
In Vitro Diagnostic Device
Rx Only Caution: Federal law restricts this device to
sale by or on the order of a physician
(Only for US)
Immunodiagnostic Systems Limited,
10 Didcot Way, Boldon Business Park,
Boldon, Tyne & Wear, NE35 9PD, UK
Tel.: +44 191 519 0660
e-mail: info.uk@idsplc.com
IS- 4430 , V07
• Fax: +44 191 519 0760
•
www.idsplc.com
12 April 2019
Optional equipment / materials
IS-4435 IDS-iSYS Insulin-like Growth Factor
Binding Protein 3 (IGFBP-3)
Calibration Verifiers
IS-XP01 IDS-iSYS XPrep
IS-IM100 IDS Immunocleaner
IS-DW225 Disposable Waste Bags
(not available for IS-310400)
Precision Pipetting Devices
Manufacturer
Applied in accordance with directive 98/79/EC
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