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Abbott Molecular, m2000 RealTime System (Molecular, 2018)

Abbott Molecular, m2000 RealTime System (Molecular, 2018)

Automated molecular platforms, October 2018

Contact Information

Abbott Laboratories
Abbott Molecular Division
Vladimir Nozinic
Des Plaines, IL

Name of instrument m2000 RealTime System composed of m2000sp and m2000rt modules
Country where designed/Manufactured/Reagents manufactured U.S./Switzerland, Singapore/U.S.
Instrument FDA cleared or approved/Platform yes/preanalytical and analytical
First year sold in U.S./Sold internationally/Installed 2007/2005/2005
Dimensions in inches (H × W × D)/Footprint in square feet/Noise generated in dB m2000sp: 73.6 × 57.1 × 31.3/12.4/—; m2000rt: 19.3 × 13.4 × 17.8/1.7/<85 (1m)
Supplied with UPS/BTU yes/m2000sp: 4,100 (1,200 Wh); m2000rt: 3,241.5 (950 Wh)
Physical contamination control features instrument hood, unidirectional process flow design, optimized anti-drip pipetting and rinse steps, confined waste containers, aerosol barrier pipette tips, sealed PCR plate
List price/Price for sample extraction and amplification detection modules
Purchase options/Minimum test volume requirements straight purchase, reagent rental, lease/none
Co. performs installation, operation, and performance qualifications/Electrical requirements yes/m2000sp: 100–240 VAC at 50–60 Hz; m2000rt: 100–240 VAC at 50–60 Hz
Labor and parts warranties/Advanced operator training 1 year/yes
Delivery time/Delivery charges/Installer/Time to install on site as requested/—/Abbott Molecular/m2000sp: 24 hrs.; m2000rt: 8 hrs.
Training location/No. of techs that can receive initial training/Length of training/Retraining at company facility on and off site/2/3 days/yes
Test menu HIV-1, HIV-1 qual, HCV, HCV Gt, HBV, CTNG, CT, CMV, high-risk HPV, EBV, VZV, parvo B19, MTB, MTB RIF/INH resistance, Zika, IDH2, HBV sequencing
No. of tests for which analyzer has FDA-cleared applications/CE mark 7/15
Tests available on instrument in U.S./Outside U.S. CTNG, HBV, HCV, HCV GT, HIV-1, HIV-1 qual (RUO), CMV, Zika, IDH1, IDH2/CMV, CT, CTNG, EBV, HBV, HCV, HCV GT, HR HPV, HIV-1, HIV qual, VZV, MTB, MTB RIF/INH resistance, Zika, IDH2, HBV sequencing
Tests not available in U.S. but submitted to FDA/Available in other countries only —/CT, high-risk HPV, parvo B19, VZV, MTB, MTB RIF/INH resistance, HIV-1 qual, HIV-1 viral load with DBS sample type, HBV sequencing
Research-use-only assays/Tests in development HIV-1 qual (U.S.)/—
Open-channel capabilities/Start-up and preparation time yes/20–30 min. for initial setup
Model type of sample-handling system/Maximum sample load capacity m2000sp/96
Minimum specimen volume/Sample volume flexibility/Other sample volumes available 0.2 mL/yes (FDA protocols include 0.2, 0.4, 0.5, 0.6, and 1.0 mL)/0.05–4.0 mL
Minimum dead volume/Pediatric sample volume/Primary tube sampling 0.2 mL/0.2 mL/yes
Sample tube sizes/Sample barcode reading/Autodiscrimination in 1D or 2D 11.5–16 mm diameter/yes/no
Sample barcode languages/Sample types available in open mode Codabar, codes 39, 128, and 93, UPCA, Interleaved 2 of 5/plasma, serum, urine, whole blood, swabs, dried blood spots, CSF, breast milk, semen, others
Clot detection/Open extraction platform/Sample types (open extraction) yes/yes/plasma, serum, urine, whole blood, swabs, dried blood spots, CSF, breast milk, semen, others
Amplification reagents or methods supported real-time PCR
No. of different assays onboard at once/Programmed or calibrated at once 1 with standard operation, 2 with MaxCycle†, 12 with open mode/—
Tests per container set/Multiple reagent configurations supported 24–192/nucleic acid: DNA, RNA, total nucleic acid; master mix: up to 4 reagents
Reagent container placed directly on system/Onboard test auto inventory yes/yes
Determines reagent volume in container/Reagent barcode reading/Reagents barcoded yes/yes/yes
Monitors expiration date/Auto lot recognition or calibration yes/yes
Auto detection of adequate reagent or specimen/Reagents available yes/—
Reagent reconstitution required/Chemical contamination control no/not required (UNG optional)
Onboard test auto inventory/Capable of inventory monitoring by barcode yes/yes
System is open to homebrew/General-purpose reagents allowed yes/yes
Same capabilities when third-party reagent used/Lot sequestering available yes/yes
Closed-vial stability for amplification reagents/Extraction reagents 18 months at -10°C/18 months at 15°–30°C
Storage temp. requirement for amplification reagents/Extraction reagents -10°C/15°–30°C
Shipment temp. requirement for amplification reagents/Extraction reagents frozen on dry ice/15°–30°C
Minimum/Maximum reagent shelf-life guarantee 3 months/18 months
Autocalibration or autocalibration alert/Multipoint calibration supported no/yes
Assay calibrations required by end user/Calibrants can be stored onboard yes/yes
Multiple calibrant lots stored for same assay/Required calibration frequency yes/calibration curves stored for up to 6 months
Length of assay calibration/Typical calibration frequency valid for 6 months/6 months
Onboard real-time QC/Supports multiple QC lot numbers per assay yes/yes
Auto shutdown*/Instrument warm-up time/Onboard software reviews QC yes/sample extraction: none; amplification detection: 15 min./yes
Total number of controls per batch for 24 tests/48 tests/72 tests/96 tests 2–3 controls dependent on assay regardless of run size (1–96)
Walkaway capacity/Tech hands-on time (both for batch of 96 samples) up to 6 hrs. or 89 percent walkaway time/30 min.
Uses disposable pipette tips/Maximum number of pipette tips stored yes/864
Time between start and initial result/Instrument automatic shutdown assay and run-size dependent/yes
Startup programmable/Remote system monitoring/Waste required for disposables no/yes/plastic and liquid waste containers onboard
Windows technology/Mouse or touchscreen/Modular add-on capability yes/mouse/yes
Service contracts available/Mean time between failures/To repair failures standard, extended, premium/m2000sp: 275 days; m2000rt: 688 days/m2000sp: 3.8 hrs.; m2000rt: 3.3 hrs.
Turnaround time for problem solving by phone/Email/Field service immediate response/24-hr. response/variable, as per contract
No. of U.S. field reps/Service engineer on-site response time/Hours and days available 37/based on contract/M–F, 8 am–5 pm, extended hrs. based on contract
Guaranteed response time/Modem servicing avail./System diagnose own malfunctions yes/yes (when requested)/yes
Order parts via modem/Onboard error codes/Maintenance training demo module no/yes/yes
Average maintenance time for lab personnel/Onboard maintenance records daily: <10 min.; weekly: 45 min.; monthly: 15 min./yes
Preventive maintenance per year for sample extraction/Amplification detection 1/1
Downtime for preventive maintenance/Spare parts on site 4–12 hrs./yes
Software and LIS interface:
• Patient demographics and insurance data available via rules-based architecture no
• Data retrieval or Internet connectivity yes
• Online real-time help, QC, stats, and management reports/Evaluates results validity yes/yes
• Priority processing no
• Supports accession No. redundancy/Specimen carrier and level identification no/yes
• Unique barcode per container/Multistop routing (1 tube to many workstations)
• Specimen scheduling/Routes test to workstation/Automatic reflex, repeat, dilutions no/—/—
• Sample storage and retrieval software supports CLSI standards no
• LIS(s) interfaced live with lab automation systems/How LIS(s) interfaced with LAS no/—
• QC results transferred automatically to LIS/Data-management capability yes/yes
• Interfaces operational in active user sites yes
• Rules-based control subsystem/Process control via control subsystem yes/yes
• LIS operates simultaneously with assays running yes
• Uses LOINC to transmit orders and results/Unidirectional interface capability no/yes
• Results immediately transmitted to LIS/Interface available to auto specimen-handling system yes/yes
• Stores QC lot files/Worklist edit capability/Viewable PCR graphs yes/yes/yes
• Can print, archive, transmit data yes
Distinguishing features (supplied by company) automates and enables consolidation of multiple commercial NAAT tests, LDTs, and third-party assays; accommodates a diverse sample type flexibility while providing barcoded traceability of primary or laboratory tubes; run control and calibrator efficiency, multiple contamination control safeguards, and maxRatio (proprietary PCR curve analysis and validation of result algorithm); mPlus features allow for runs of 1–96 samples with customized workflow and extended reagent use
*for calibration and controls
Note: a dash in lieu of an answer means company did not answer question or question is not applicable †program enables co-cycling of HIV and HCV in same batch
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.