MacroArray Diagnostics Quality Xplorer RUO Instructions

MacroArray Diagnostics Quality Xplorer RUO

SPECIFICATIONS

• Product Name: QualityXplorer (RUO)
• Basic UDI-DI: 91201229231JX
• REF: 31-0800-02
• Quantity: 8 vials, 200 µl each
• Composition: Sodium Azide 0.05%
• Storage: 2-8°C (after spinning down liquid, in an upright position immediately upon delivery)
• Intended Use: Research Use Only (RUO) as quality control for monitoring specified limits (process control charts) in combination with ALEX, ALEX3 and ALEX Panels (ALEX Air, ALEX Food) test procedures.
• Reagents: Ready to use. Not to be used after expiry date.
• Lot Dependency: Not lot-dependent; can be used independently of ALEX/ALEX3/ALEX Panels Kit lot.

LANGUAGE DISCLAIMER

These Instructions for Use (IFU) are provided in multiple languages. In the event of any discrepancies or inconsistencies between the English version and any translated version, the English version shall prevail and be considered the authoritative reference.

DESCRIPTION

The QualityXplorer is a product for research use only (RUO) and is to be used as quality control for monitoring specified limits (process control charts) in combination with ALEX², ALEX3 and ALEX Panels (ALEX Air, ALEX Food) test procedure.
These Instructions for Use are applicable for the following product:

INTENDED PURPOSE

• The QualityXplorer is a product for research use only (RUO) to examine and monitor the processing of ALEX², ALEX3 and ALEX Panels.
• The product contains a mixture of antibodies that react with defined allergens on the ALEX², ALEX3 and ALEX Panels and is used by trained laboratory staff.

Important information for users!

• 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 the liquid, in an upright position immediately upon delivery at 2-8°C.
• Stored correctly it can be used until the indicated expiration date.

QualityXplorer precipitates
If you encounter precipitates (see image below) in your QualityXplorer sample tube, please shortly vortex and spin down before use. This way, reliable results can be assured.

The QualityXplorer is 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 manufacturing of the QualityXplorer have been tested and found negative for HBsAG, HCV, and antibodies to the HI virus.

WASTE DISPOSAL

• Dispose of the used QualityXplorer sample with laboratory chemical waste.
• Follow all national, state, and local regulations regarding disposal

SYMBOLS

GLOSSARY OF SYMBOLS

MATERIAL

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 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.

PRECAUTIONS

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. Theproduct 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 research use only (RUO). They are 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@madx.com) or yourlocal distributor. Do not use damaged kit components, this may affect kit performance.
• Do not use reagents beyond their expiration dates.
• For detailed instructions on the safe disposal of the device, refer to Chapter V of the IFU.

WARRANTY

The performance data were obtained using the procedure outlined in these 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.

CHANGE HISTORY

TROUBLESHOOTING

• Precipitates in Sample: If precipitates are observed, briefly vortex the vial and spin down the liquid before use. This ensures reliable results.
• Expired Product: Do not use the QualityXplorer after its expiry date. Ensure proper storage at 2-8°C to maintain product integrity until the expiration date.
• Inconsistent Results: Ensure that the Instructions for Use are carefully followed. Verify proper storage conditions and handling procedures (e.g., spinning down before use, immediate use after opening).

MORE INFO

• Copyright by MacroArray Diagnostics
• MacroArray Diagnostics (MADx) Lemböckgasse 59, Top 4
• 1230 Vienna, Austria
• +43 (0)1 865 2573
• www.madx.com
• Version number: 31-IFU-02-EN-06