Macroarraydx REF 31-0800-02 QualityXplorer Macro Array Diagnostics Instructions
- June 12, 2024
- MacroArrayDX
Table of Contents
QUALITYXPLORER
INSTRUCTION FOR USE
INTENDED USE
The QualityXplorer is an accessory to control the assay procedure of ALEX²
Allergy Xplorer.
The medical device contains a mixture of antibodies that react with defined
allergens on the ALEX² Allergy Xplorer and is used by trained laboratory staff
and medical professionals in a medical laboratory.
DESCRIPTION
The QualityXplorer is to be used as quality control for monitoring specified
limits (process control charts) in combination with the ALEX² test procedure.
Important information for the user!
For the correct use of the QualityXplorer, it is necessary for the user to
carefully read and follow these instructions for use. The manufacturer assumes
no liability for any use of this product which is not described in this
document or for modifications by the user of the product.
SHIPMENT AND STORAGE
The shipment of the QualityXplorer takes place at ambient temperature
conditions.
Nevertheless, the QualityXplorer must be stored, after spinning down of the
liquid, in an upright position immediately upon delivery at 2-8°C. Stored
correctly it can be used until the indicated expiration date.
| The QualityXplorers are only intended for one determination per vial.
Before opening, briefly spin down the liquid in the vials. After opening the
vials, they are to be used immediately for analysis.
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| The human blood components used in the manufacture of the
QualityXplorer have been tested and found negative for HBsAG, HCV and
antibodies to the HI virus.
WASTE DISPOSAL
Dispose the used QualityXplorer sample with laboratory chemical waste. Follow all national, state, and local regulations regarding disposal.
GLOSSARY OF SYMBOLS
| Catalogue number
---|---
| Contains sufficient for
| Indicates a control material that is intended to verify the results in the
expected positive range
| Do not use if packaging is damaged
| Batch code
| Consult instructions for use
| Manufacturer
| Do not re-use
| Use-by date
| Temperature limit
| For Research Use Only
****| Caution
REAGENTS AND MATERIAL
The QualityXplorer is packaged separately. Expiration date and storage temperature are indicated on the label. The reagents are not to be used after their expiry date.
****| The use of the QualityXplorer is not batch-dependent and can therefore
be used independently of the ALEX² Kit batch used.
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Item| Quantity| Properties
---|---|---
QualityXplorer
(REF 31-0800-02)| 8 vials à 200 µl
Sodium Azide 0,05%| Ready to use. Store at 2-8°C until expiry date.
The composition of the QualityXplorer and the corresponding acceptance
intervals of the individual antibodies are stored in the RAPTOR SERVER
Analysis Software for each lot of the QualityXplorer. Using the QC module in
RAPTOR SERVER Analysis Software, the results of the QualityXplorer
measurements can be displayed in tabular or graphical form.
After a minimum number of measurements (e.g. 20 measurements), instrument-
specific intervals (2 and 3 standard deviations) can be displayed via the QC
module in RAPTOR SERVER Analysis Software. In this way, the laboratory-
specific intervals for each allergen can be determined more precisely.
WARNINGS AND PRECAUTIONS
-
It is recommended to wear hand and eye protection as well as lab coats and follow good laboratory practices (GLP) when preparing and handling reagents and samples.
-
In accordance with good laboratory practice, all human source material should be considered potentially infectious and handled with the same precautions as patient samples. The starting material is partially prepared from human blood sources. The
product was tested non-reactive for Hepatitis B Surface Antigen (HBsAg), antibodies to Hepatitis C (HCV) and antibodies to HIV-1 and HIV-2. -
The reagents are for in vitro use only and not to be used for internal or external use in humans or animals.
-
Upon delivery, the containers must be checked for damage. If any component is damaged (e.g., buffer container), please contact MADx (support@macroarraydx.com) or your local distributor. Do not use damaged kit components, this may affect kit performance.
-
Do not use expired kit components
WARRANTY
The herein presented performance data were obtained using the procedure outlined in this Instructions for Use. Any change or modification in the procedure may affect the results and MacroArray Diagnostics disclaims all warranties expressed (including the implied warranty of merchantability and fitness for use) in such an event. Consequently, MacroArray Diagnostics and its local distributors shall not be liable for damages indirect or consequential in such an event.
© Copyright by MacroArray Diagnostics
MacroArray Diagnostics (MADx)
Lemböckgasse 59/Top 4
1230 Vienna, Austria
+43 (0)1 865 2573
www.macroarraydx.com
Version number: 31-IFU-02-EN-03
Released: 01-2023
MacroArray Diagnostics
Lemböckgasse 59/Top 4
1230 Vienna
macroarraydx.com
CRN 448974 g
www.macroarraydx.com
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