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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
vladimir.nozinic@abbott.com
Des Plaines, IL
224-361-7338



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.