Product Specifications

Description

Immunoassay analyzer with chemiluminescence testing methodology using advanced acridinium ester technology

Test Throughput

Atellica IM 1300 Analyzer: up to 220 tests per hour;

Atellica IM 1600 Analyzer: up to 440 tests per hour

Walkaway Time

Atellica IM 1300 Analyzer: up to 7.5 hours;

Atellica IM 1600 Analyzer: up to 5 hours

Sample Handling

 

Validated Sample Types

Serum, plasma, amniotic fluid, urine, whole blood (assay-specific)

Sample Integrity Control

Liquid-level sensing, clot detection, bubble detection, short-sample detection; hemolysis, icterus, and lipemia checks applied when connected to the Atellica™ Chemistry Analyzer

Auto-repeat

Automatic repeat testing from the original sample

Sample Dilution

Assay-dependent; can be auto-diluted and repeated when results extend linearity

Auto-reflex

Testing Will perform additional tests based on results of first test or test combination

Sample Carryover Prevention

Disposable sample tips eliminate sample carryover

Sample Volume per Test

10 to 100 μL of sample (varies by assay)

Reaction Area

 

Reaction Cuvettes

Total of 160 cuvette positions: 89 slots in the outer ring and 71 in the inner ring

Reaction Temperature

37°C

Reaction Detection

Photomultiplier tube (PMT)

Assay Reaction Formats

Sandwich, competitive, and antibody-capture/antigen-bridge formats

Assay Times

10–54 minutes, assay-dependent

Assay Technology

Chemiluminescence testing methodology using advanced acridinium ester technology

Reagent Handling

 

Reagent Compartments

42 primary and 35 ancillary reagent positions with refrigeration and humidity control. Continuous and automatic mixing to maintain particle suspension.

Reagent Packs

ReadyPack® cartridge: 50 to 200 tests per pack

Reagent Integrity Control

Reagent pack bar-code identification; automatic tracking and notification of inventory, calibration and control validity, onboard stability, low and expired reagents, detection of reagent bubbles

 

Onboard Stability

4–90 days, assay-dependent

Reagent Inventory Management

Automatic tracking and notification of remaining tests, onboard stability and expiration, calibration, and storage conditions for each pack

Dispensing System

Three probes with liquid-level sensing

Bar-code-labeled Packs

Yes 

Calibration/QC

 

Calibration Interval

Assay-dependent up to 90 days, tracked by software

Calibration Review

Graphical display of calibration curves from a minimum of 20 different reagent lots and 20 reagent packs for each assay

Auto-QC

Automatic, user-defined, assay-specific quality control (when connected to Atellica Sample Handler)

Quality Control Review

Advanced QC package with graphical display of QC in real time, including patient moving averages, Levey-Jennings plots, Westgard rules, RiliBÄK rules; up to 125,000 control results can be stored; archivable to removable media

QC Material

QC material is auto-loaded, tracked, and stored in a 60-position covered and refrigerated compartment and automatically deployed to analyzers when QC is scheduled (when connected to Atellica Sample Handler)

Maintenance

 

Daily

Automated: <30 minutes; hands-on: <5 minutes

Weekly

Automated: <40 minutes; hands-on: <20 minutes.

Monthly

Hands-on: <20 minutes

Miscellaneous

Refer to Operator’s Guide for additional periodic maintenance

Maintenance Logs

Automated onboard scheduling, notification, and reporting