Ferritin

Catalog Number: 03737551160

INTENDED USE

Immunoassay for the in vitro quantitative determination of ferritin in human serum and plasma.

RESULTS ARE DETERMINED VIA A CALIBRATION CURVE WHICH IS INSTRUMENT-SPECIFICALLY GENERATED BY 2-POINT CALIBRATION AND A MASTER CURVE PROVIDED VIA THE REAGENT BARCODE.

STORAGE AND STABILITY

Store at 2-8 °C.

CALIBRATION

Traceability: The Ferritin assay ( 03737551) has been standardized against the Ferritin assay ( 11820982). The Ferritin assay ( 11820982) has been standardized against the Enzymun-Test Ferritin method. This in turn has been standardized against the 1st International Standard (IS) NIBSC (National Institute for Biological Standards and Control) “Reagent for Ferritin (human liver)” 80/602. Recovery studies, including a published study​9, to assess traceability of the Elecsys Ferritin assay to more recent international standards (2nd IS 80/578 and 3rd IS 94/572) have been conducted, with results showing very good agreement.

EVERY ELECSYS REAGENT SET HAS A BARCODED LABEL CONTAINING SPECIFIC INFORMATION FOR CALIBRATION OF THE PARTICULAR REAGENT LOT. THE PREDEFINED MASTER CURVE IS ADAPTED TO THE ANALYZER USING THE RELEVANT CALSET.

CALIBRATION MUST BE PERFORMED ONCE PER REAGENT LOT USING FRESH REAGENT (I.E. NOT MORE THAN 24 HOURS SINCE THE REAGENT KIT WAS REGISTERED ON THE ANALYZER). RENEWED CALIBRATION IS RECOMMENDED AS FOLLOWS:

CONTROLS FOR THE VARIOUS CONCENTRATION RANGES SHOULD BE RUN INDIVIDUALLY AT LEAST ONCE EVERY 24 HOURS WHEN THE TEST IS IN USE, ONCE PER REAGENT KIT, AND FOLLOWING EACH CALIBRATION.

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.500-2000 µg/L (ng/mL) (defined by the lower detection limit and the maximum of the master curve). Values below the lower detection limit are reported as < 0.500 µg/L (ng/mL). Values above the measuring range are reported as > 2000 µg/L (ng/mL) (or up to 100000 µg/L (ng/mL) for 50-fold diluted samples).

0.500-2000 ΜG/L (NG/ML) (DEFINED BY THE LOWER DETECTION LIMIT AND THE MAXIMUM OF THE MASTER CURVE). VALUES BELOW THE LOWER DETECTION LIMIT ARE REPORTED AS < 0.500 ΜG/L (NG/ML). VALUES ABOVE THE MEASURING RANGE ARE REPORTED AS > 2000 ΜG/L (NG/ML) (OR UP TO 100000 ΜG/L (NG/ML) FOR 50-FOLD DILUTED SAMPLES).

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test

SPECIFIC PERFORMANCE DATA

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

Precision was determined using Elecsys reagents, pooled human sera, and controls in a protocol(EP5-A2) of the CLSI (Clinical and Laboratory Standards Institute): 2 runs per day in duplication each for 21 days (n = 84). The following results were obtained:

INTERMEDIATE PRECISION

INTERMEDIATE PRECISION

METHOD COMPARISON

A comparison of the Ferritin assay,   03737551 (y) with the Ferritin assay,   11820982 (x) using clinical samples gave the following correlations:

ANALYTICAL SPECIFICITY

Human liver ferritin 100 % recovery