REF 31-0800-02 QualityXplorer
Product Information – QualityXplorer
The QualityXplorer is a product designed for analysis and
determination purposes. It is important for users to carefully read
and follow the instructions provided in the user manual to ensure
correct usage. The manufacturer assumes no liability for any use of
the product that is not described in the document or for any
modifications made by the user.
Before opening the vials, it is recommended to briefly spin down
the liquid inside. The QualityXplorers are intended for single use
per vial and should be used immediately after opening for
analysis.
The human blood components used in the manufacture of
QualityXplorer have been tested and found negative for HBsAG, HCV,
and antibodies to the HI virus.
After usage, dispose of the used QualityXplorer sample with
laboratory chemical waste, following all national, state, and local
regulations regarding disposal.
The product packaging contains various symbols indicating
important information such as the catalogue number, quantity,
control material, batch code, manufacturer, use-by date,
temperature limit, and cautionary notes.
The QualityXplorer is packaged separately and has an expiration
date and storage temperature indicated on the label. The reagents
should not be used after their expiry date.
The composition of the QualityXplorer and the acceptance
intervals of the individual antibodies are stored in the RAPTOR
SERVER Analysis Software for each lot. The software allows users to
display the results of QualityXplorer measurements in tabular or
graphical form. The QC module in the software can also display
instrument-specific intervals based on a minimum number of
measurements, enabling more precise determination of
laboratory-specific intervals for each allergen.
Users should be aware of warnings and precautions provided in
the user manual for safe and effective usage of the product.
The performance data presented in the user manual were obtained
using the outlined procedure. Any change or modification in the
procedure may affect the results, and the manufacturer disclaims
all warranties expressed or implied in such events. The
manufacturer and its local distributors shall not be liable for any
indirect or consequential damages in such events.
Product Usage Instructions
- Read and familiarize yourself with the user manual and
instructions for use provided with the QualityXplorer. - Before opening the vials, briefly spin down the liquid
inside. - Open the vials and use them immediately for analysis.
- Dispose of the used QualityXplorer sample with laboratory
chemical waste, following all national, state, and local
regulations regarding disposal. - Refer to the symbols provided on the packaging for important
information such as catalogue number, quantity, control material,
batch code, manufacturer, use-by date, temperature limit, and
cautionary notes. - Check the expiration date and storage temperature indicated on
the label of the QualityXplorer. Do not use the reagents after
their expiry date. - Install RAPTOR SERVER Analysis Software and access the QC
module to view and analyze the results of QualityXplorer
measurements in tabular or graphical form. - Use a minimum number of measurements to display
instrument-specific intervals via the QC module in RAPTOR SERVER
Analysis Software for more precise determination of
laboratory-specific intervals for each allergen. - Follow all warnings and precautions provided in the user manual
for safe and effective usage of the product.
www.macroarraydx.com
QUALITYXPLORER INSTRUCTION FOR USE
I. 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.
II. 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.
III. 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.
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.
MacroArray Diagnostics · Lemböckgasse 59/Top 4 · 1230 Vienna · macroarraydx.com · CRN 448974 g
Page 1 of 4
www.macroarraydx.com
IV. WASTE DISPOSAL
Dispose the used QualityXplorer sample with laboratory chemical waste. Follow all national, state, and local regulations regarding disposal.
V. GLOSSARY OF SYMBOLS
Catalogue number Contains sufficient for <n> tests 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
MacroArray Diagnostics · Lemböckgasse 59/Top 4 · 1230 Vienna · macroarraydx.com · CRN 448974 g
Page 2 of 4
www.macroarraydx.com
Caution
VI. 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.
Item
QualityXplorer (REF 31-0800-02)
Quantity
8 vials à 200 µl Sodium Azide 0,05%
Properties
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.
VII. 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.
MacroArray Diagnostics · Lemböckgasse 59/Top 4 · 1230 Vienna · macroarraydx.com · CRN 448974 g
Page 3 of 4
www.macroarraydx.com
· 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
VIII. 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
Page 4 of 4
