3gAllergy™ Specific IgE (SPE) Universal Kit Controls English

tested and found nonreactive for syphilis; for antibodies to HIV 1 and 2; for hepatitis B surface antigen; and for antibodies to hepatitis C.

3gAllergy™ Specific IgE (SPE) Universal Kit Controls are assayed, bi-level controls intended for use with the IMMULITE 2000 and IMMULITE 2500 3gAllergy™ Specific IgE assays. They are intended as an aid in monitoring day-to-day assay performance.

Sodium azide, at concentrations less than 0.1 g/dL, has been added as a preservative. On disposal, flush with large volumes of water to prevent the buildup of potentially explosive metal azides in lead and copper plumbing.

Catalog Number: L2UNC1–2

Procedure

Control Lot: 0121

Assay in the same manner as patient samples, according to the procedure provided in the appropriate package insert.

Control Expiration: 2011-02

Materials Supplied Control 1 and 2 (L2UNC1, L2UNC2) Two sets of two vials, containing 2 mL each of human IgE in a nonhuman serum matrix, with preservative. Stable at 2–8°C for 30 days after opening, or for 6 months (aliquotted) at –20°C. Note that barcoded aliquot labels are supplied in the kit and must be applied to the sample tube to be read by the barcode reader. The 3gAllergy™ Specific IgE (SPE) Universal Kit Controls are to be used with 3gAllergy™ Specific IgE Control Antibody (L2UNS2) which is to be transferred into the serially-coded Allergen Holder Wedges (L2AW1–3). The controls are intended for monitoring the adjustment and calibration of the assay. The controls are intended to be assayed as unknowns, in the same manner as patient samples, in the context of an internal quality control program. Each control should be identified by its lot number (read from the vial) and the date it was opened/reconstituted.

Note: The 3gAllergy™ Specific IgE (SPE) Universal Kit Controls must be run with the 3gAllergy™ Specific IgE Control Antibody in the Allergen Holder Wedge. Target Values, kU/L Level

Mean

SD

2SD Range

IMMULITE 2000 3gAllergy™ Specific IgE Universal Kit Kit lots 266 IMMULITE 2500 3gAllergy™ Specific IgE Universal Kit Kit lots 182 L2UNC10121

2.7

0.24

2.2 – 3.2

L2UNC20121

11.8

1.18

9.4 – 14.2

IMMULITE 2000 3gAllergy™ Specific IgE Universal Kit Kit lot 280 and above IMMULITE 2500 3gAllergy™ Specific IgE Universal Kit Kit lot 190 and above L2UNC10121

2.3

0.20

1.9 – 2.7

L2UNC20121

10.3

1.03

8.2 – 12.4

Technical Assistance Warnings and Precautions For in vitro diagnostic use. Follow universal precautions, and handle all components as if capable of transmitting infectious agents. Source materials derived from human blood were

In the United States, contact Siemens Healthcare Diagnostics Technical Services department. Tel: 877.229.3711. Outside the United States, contact your National Distributor. www.siemens.com/diagnostics

3gAllergy Specific IgE Universal Kit Controls (PIL2UNC-42, 2009-07-22)

1

The Quality System of Siemens Healthcare Diagnostics Products Ltd. is certified to ISO 13485:2003.

Hinweise und Vorsichtsmaßnahmen Zur In-vitro-Diagnostik.

Deutsch 3gAllergy™ Spezifisches IgE (SPE) Universal Kit-Kontrollen Die 3gAllergy™ spezifisches IgE (SPE) Universal Kit-Kontrollen sind getestete Kontrollen in zwei Konzentrationen für die IMMULITE 2000 und IMMULITE 2500 3gAllergy™ spezifisches IgE Assays, zur Bestimmungen von spezifischem IgE. Sie dienen zur täglichen Qualitätskontrolle dieses Tests. Katalognummer: L2UNC1–2

Die generell geltenden Vorsichtsmaßnahmen sind einzuhalten und alle Komponenten als potenziell infektiös zu behandeln. Alle aus menschlichem Blut gewonnenen Materialien wurden auf Syphilis, Antikörper gegen HIV-1 und HIV-2, Hepatitis-B-Oberflächenantigen und Hepatitis-C-Antikörper untersucht und als negativ befundet. Bestimmten Komponenten wurde Natriumazid (