wdt_ID | Company | Contact | City, State | Phone | Website | Name of instrument | Type of instrument | Operational type/Model type | List price/First year sold in U.S. | Targeted hospital bed size/Targeted test volume | Company manufactures instrument | Other models in this family of analyzers | No. of units in clinical use in U.S./Outside U.S. (countries) | Dimensions (H × W × D)/Instrument footprint | Weight empty/Weight fully loaded | No. of different measured assays onboard simultaneously | No. of user-definable (open chemistry) channels | Test throughput per hour/Assay run | Chemistry | No. of direct ion-selective electrode channels | Detection methods | Stat time until completion/specimen throughput for | • Ion-selective electrode | • Basic metabolic panel | • Complete metabolic panel | Typical time delay from ordering stat test until aspiration of sample | Immunoassay | Fully automated microplate immunoassay system | Methodologies supported | Separation methodologies | Stat time until completion of a ß-hCG test | • Typical time delay from test order to aspiration of sample | Stat time until completion of a cTn test | • Typical time delay from test order to aspiration of sample | Approximate No. of tests per reagent set/Reagent type | Reagents refrigerated onboard/Reagents ready to use | Reagent lot tracking/Reagent inventory | Reagent form/Reagents barcoded | Separate reagent pack for each | Walkaway capability/Walkaway duration | Design of sample-handling system | Uses washable cuvettes/Uses disposable cuvettes | Min.–max. sample volume that can be aspirated at one time | Min. reaction volume/Min. specimen volume/Min. dead volume | Dedicated pediatric sample cup | Primary tube sampling | Accommodates most standard tube sizes/Accepts nonstandard tube sizes | Pierces caps on primary tubes | Protects against probe collision | Detects clots/liquid level/short sample | Detection or quantitation for hemolysis, icterus, lipemia, clots | Dilutes patient samples onboard/Susceptibility to carryover | Automatic rerun capability | Sample volume can be diluted to rerun out-of-linear-range high results | Sample volume can be concentrated to rerun out-of-linear-range low results | Analyzer requires dedicated water supply | Autocalibration/ Multipoint calibration supported | Typical calibration frequency for ISE/therapeutic drugs/drugs of abuse/general chemistries/ immunoassays | Automatic programmable start/Automatic programmable shutdown | Onboard real-time QC/Onboard software capability to review QC | Supports multiple QC lot numbers per analyte | Waste management | Sample barcode-reading capability/ Autodiscrimination | Lab can control analyzer from remote computer | Instrument can diagnose its own malfunctions | System malfunctions can be diagnosed via remote monitoring | UPS backup power supply | Data-management capability/LIS or EHR systems interfaced | LIS interface provided/ Bidirectional interface capability | Modem servicing provided/Service engineer on-site response time | Mean time between failures | Average scheduled maintenance time by lab personnel | Maintenance records kept onboard for user/vendor | Maintenance training demonstration module onboard | Training included with purchase/Avg. time for basic user training | Advanced operator training/Extra charge for follow-up or advanced training | Warranty provided/Cost of annual service contract (24 h/7 d) | Distinguishing features (supplied by company) | Additional Features | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | Abbott Point of Care | Jeff Abney | jeff.abney@abbott.com | Princeton, NJ | 609-454-9000 | https://www.pointofcare.abbott/us/en/home | i-STAT 1 analyzer | combination chemistry/immunoassay | discrete/handheld | —/2000 | all/— | yes (also sold by McKesson, Henry Schein, Medline) | — | > 30,000/> 10,000 (Europe, Latin America, Africa, Middle East, Asia Pacific) | 9.25 × 3 × 2.85 in./< 1 sq. ft. | < 2 lbs./< 2 lbs. | — | — | —/2–10 min. | up to 26 | potentiometry, amperometry, conductometry | 2 min./20–25 | 2 min./20–25 | — | none | yes (up to 26 tests per unit) | potentiometry, amperometry, conductometry | none necessary | 10 min. | none | 10 min. | none | —/self-contained single use | no/— | no/no | dry chemistry, liquid chemistry (closed reagent system)/yes | no/no | yes/2–10 min. or 1 specimen or up to 13 tests | — | no/no | 17–95 µL | — | no | no | no/no | no | no | yes/yes/yes | detection for hemolysis, icterus, lipemia, clots | no/— | no | no | no | no | yes (calibrants are not stored onboard)/yes (recommended avg. frequency: each test) | —/—/—/each test/each test | yes/yes | yes/yes | yes | manually by user | yes (Interleaved 2 of 5, Codabar, Code 39, Code 128, EAN 8, EAN 13)/— | yes | yes (operator intervention required to order parts) | yes | no | optional add-on/— | yes (additional cost)/no | —/— (product replacement within 24 hrs.) | — (displays error codes for troubleshooting) | — | — | — | —/4 hrs. (at customer site) | yes (at customer site)/no | yes (1 year)/— | handheld portable analyzer; unit use system can perform chemistry, blood gas, cardiac marker, and coagulation tests; CLIA-waived tests, including glucose and creatinine; uses 2–3 drops of whole blood or plasma | ||||
2 | Awareness Technology | Rafael Castillo | rcastillo@awaretech.com | Palm City, FL | 772-283-6540 | https://www.awaretech.com | ChemWell 2910 | combination chemistry/immunoassay | batch, random access, discrete/benchtop | $29,000/1998 | 200/daily: 200–500; monthly: 200–400 | yes (also sold by GMI, Monobind, ASI, others) | ChemWell Fusion, ChemWell-T, ChemWell 2902 | 380/6,000 (worldwide) | 18.625 × 36.25 × 21.5 in./< 7.905 sq. ft. | 77 lbs./78 lbs. | 15 (12 can be run and calibrated at one time) | — | 200 (27 tests in throughput)/6–120 min. | — | photometry | — | assay dependent | assay dependent | assay dependent | yes (27–44 tests per unit; 96 wells per microplate) | enzyme immunoassay, colorimetric analysis | none necessary, coated microwell | assay dependent | assay dependent | assay dependent | assay dependent | assay dependent | yes (12ϒ–15ϒC on optional cooling accessory)/yes | yes/yes | liquid chemistry (open reagent system)/no | no/yes | yes/480 min. | rack (custom reagent and sample rack) | yes/yes | 2–250 µL | 100 µL/100 µL/100 µL | no | yes | yes/yes (13 mm) | no | yes | no/yes/yes | assay dependent | yes (can be programmed to perform dilutions prior to analysis)/— | yes | yes | yes | no | no (calibrants can be stored onboard)/yes (recommended avg. frequency: test dependent) | — | no/no | yes/yes | yes | manually by user, automated collection onboard instrument, direct to drain | yes (Code 39)/no | yes | yes (operator intervention required to order parts) | yes | no | onboard/— | yes/no | no/— | 400 days (displays error codes for troubleshooting) | daily: 15 min. | no/no | no | yes (1 training slot)/4 days (at customer or vendor site) | yes (at customer or vendor site)/yes | yes (1 year from date of shipment)/contract dependent | vertical plate reading for biochemistries; 2-in-1 utility with the ability to run in ELISA mode or biochemistry mode; low-cost analyzer that saves on reagent use; open system; remote access; software included (free) | ||||
3 | Awareness Technology | Rafael Castillo | rcastillo@awaretech.com | Palm City, FL | 772-283-6540 | https://www.awaretech.com | ChemWell-T | chemistry | batch, random access, discrete/benchtop | $14,000/2014 | 200/— | yes (also sold by distribution partners) | — | 150/4,000 (worldwide) | 20.87 × 19.69 × 18.5 in./2.853 sq. ft. | 37 lbs./— | 15 (12 can be run and calibrated at one time) | — | 100/— | — | photometry | — | — | — | — | — | — | — | — | — | — | — | —/open reagent system | yes (8ϒ–15ϒC)/variable; reagent specific | yes/yes | liquid chemistry (open reagent system)/no | — | yes/120 min. or ~16–20 specimens or up to 40 tests | rack | yes/yes (can store up to 40 cuvettes) | 2–388 µL | 240 µL/2 µL/40 µL | no | yes | yes/yes (custom reagent and sample racks available) | no | yes | no/yes/yes | — | yes (can be programmed to perform dilutions prior to analysis)/— | yes | yes | yes | no | no (calibrants can be stored onboard)/yes (recommended avg. frequency: test dependent) | — | no/no | yes/yes | yes | direct to drain | yes (Code 39)/no | yes | yes (operator intervention required to order parts) | yes | no | onboard/— | no/no | no/— | 400 days (displays error codes for troubleshooting) | daily: 15 min. | no/no | no | yes (1 training slot)/2 days (at customer or vendor site) | yes (at customer or vendor site)/— | yes (1 year from date of shipment)/contract dependent | compact low-cost analyzer that saves on reagent use; flexibility of hardware/software; software included (free) | ||||
4 | Beckman Coulter | Onyi Nacionales | onacionales@beckman.com | Brea, CA | 800-526-3821 | https://www.beckmancoulter.com | Access 2 | immunoassay | continuous random access/benchtop | —/2001 | —/annual: < 40,000 | yes (also sold by McKesson, Henry Schein, Medline, Thermo Fisher Scientific) | Unicel DxI 600, Unicel DxI 800 | — | 19.5 × 39 × 24 in./6.5 sq. ft. | 200 lbs./— | 24 (24 can be run and calibrated at one time) | — | up to 100/13–55 min. | — | — | — | — | — | — | no | chemiluminescence | magnetic particle | 15 min. | 36 sec. | 17 min. | 36 sec. | 50 per pack or 100 per kit/self-contained multiuse | yes (2ϒ–8ϒC)/yes | yes/yes | liquid chemistry (closed reagent system)/yes | no/no | yes/180 min. or 60 specimens | rack | no/yes (can store up to 294 cuvettes) | 5–200 µL | varies by assay/varies by assay/80 μL | yes (dead volume: 80 μL) | yes | yes/no | no | no | yes/yes/yes | detection for clots; hemolysis, icterus, lipemia not available | yes (can be programmed to perform dilutions prior to analysis)/— | no | yes | no | no | no (calibrants are not stored onboard)/yes (recommended avg. frequency: 28 days) | —/—/—/—/28 days | no (< 5 min. start-up time)/no | no/yes | yes | automated collection onboard instrument | yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/no | yes | yes (operator intervention required to order parts) | yes | no | onboard/Cerner, Antrim, CCA, Chemware, Dawning Technologies, ADAC, Dynamic Healthcare, Antek, Siemens, McKesson, more | yes (included in instrument price)/yes (host query) | yes/< 24 hrs. | 1.4 down service calls per year (displays error codes for troubleshooting) | daily: 7 min.; weekly: 12 min. | no/no | yes | yes (2 training slots)/2 days (at vendor site) | yes (at vendor site)/— | yes (1 year)/— | offers the robustness of a reference laboratory immunoassay analyzer in convenient size of a benchtop system; standardization of results and reagents across all volume segments; reliable benchtop system providing the same high-quality results as the core lab | ||||
5 | Beckman Coulter | Onyi Nacionales | onacionales@beckman.com | Brea, CA | 800-526-3821 | https://www.beckmancoulter.com | AU480 | chemistry | continuous random access/floor standing | —/2009 | —/annual: 50,000–250,000 | yes (also sold by McKesson, Henry Schein, Medline, Thermo Fisher Scientific) | DxC 700 AU, AU 5800 | — | 47.5 × 57 × 30 in./18.5 sq. ft. | 926 lbs./— | 63 (63 can be run and calibrated at one time) | 18 (76 can be active simultaneously) | 800 (400 photometric, 800 with ISE)/8.5 min. | 3 | photometry, potentiometry | 4.5 min./400 specimens per hr. | 12.5 min./133 specimens per hr. | 14.5 min./72 specimens per hr. | 60 sec. | — | — | — | — | — | — | — | 200– > 1,000 (varies by assay)/self-contained multiuse | yes (4ϒ–12ϒC)/yes | yes/yes | liquid chemistry (open reagent system)/yes | no/no | yes/80 specimens | rack | yes/no | 1–25 µL | 90 µL/41 µL or 1 uL with 4 mm above gel barrier/50 µL | yes (dead volume: 50 µL) | yes | yes/yes (primary, secondary tubes: 11.5–16 × 55–102 mm; nested micro cups) | no | yes | yes/yes/yes | detection and quantitation for hemolysis, icterus, lipemia, clots | yes (can be programmed to perform sample dilutions prior to analysis)/0.001 parts per million | yes | yes | yes | yes (20 L/hr. consumption during operation) | yes (calibrants are not stored onboard)/yes (recommended avg. frequency: assay dependent) | 1 day/14 days/14–20 days/30 days/— | no/no | yes/yes | — | direct to drain | yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yes | yes | yes (operator intervention required to order parts) | yes | yes | onboard/Cerner, Antrim, CCA, Chemware, Dawning Technologies, ADAC, Dynamic Healthcare, Antek, Siemens, McKesson, more | yes (included in instrument price)/yes (broadcast download and host query) | yes/< 24 hrs. | 1.2 down service calls per year (displays error codes for troubleshooting) | daily: 6 min.; weekly: 10 min.; monthly: 45 min. | yes/no | yes | yes (2 training slots)/3 days (at customer and vendor sites) | yes (at vendor site)/— | yes (1 year)/— | standardization across the AU family of chemistry analyzers; lower total cost of ownership due to fewer consumables and concentrated reagents; commonly replaced parts can be changed in 3 steps or less, in 60 seconds or less, without tools | ||||
Company | Name of instrument |
Company:
Contact:
Email:
City, State:
Phone:
Website:
Name of instrument:
Type of instrument:
Operational type/Model type:
List price/First year sold in U.S.:
Targeted hospital bed size/Targeted test volume:
Company manufactures instrument:
Other models in this family of analyzers:
No. of units in clinical use in U.S./Outside U.S. (countries):
Dimensions (H × W × D)/Instrument footprint:
Weight empty/Weight fully loaded:
No. of different measured assays onboard simultaneously:
No. of user-definable (open chemistry) channels:
Test throughput per hour/Assay run:
Chemistry:
No. of direct ion-selective electrode channels:
Detection methods:
Stat time until completion/specimen throughput for:
• Ion-selective electrode:
• Basic metabolic panel:
• Complete metabolic panel:
Typical time delay from ordering stat test until aspiration of sample:
Immunoassay:
Fully automated microplate immunoassay system:
Methodologies supported:
Separation methodologies:
Stat time until completion of a ß-hCG test:
• Typical time delay from test order to aspiration of sample:
Stat time until completion of a cTn test:
• Typical time delay from test order to aspiration of sample:
Approximate No. of tests per reagent set/Reagent type:
Reagents refrigerated onboard/Reagents ready to use:
Reagent lot tracking/Reagent inventory:
Reagent form/Reagents barcoded:
Separate reagent pack for each:
Walkaway capability/Walkaway duration:
Design of sample-handling system:
Uses washable cuvettes/Uses disposable cuvettes:
Min.–max. sample volume that can be aspirated at one time :
Min. reaction volume/Min. specimen volume/Min. dead volume:
Dedicated pediatric sample cup:
Primary tube sampling:
Accommodates most standard tube sizes/Accepts nonstandard tube sizes:
Pierces caps on primary tubes:
Protects against probe collision:
Detects clots/liquid level/short sample:
Detection or quantitation for hemolysis, icterus, lipemia, clots:
Dilutes patient samples onboard/Susceptibility to carryover:
Automatic rerun capability:
Sample volume can be diluted to rerun out-of-linear-range high results:
Sample volume can be concentrated to rerun out-of-linear-range low results:
Analyzer requires dedicated water supply:
Autocalibration/ Multipoint calibration supported:
Typical calibration frequency for ISE/therapeutic drugs/drugs of abuse/general chemistries/ immunoassays:
Automatic programmable start/Automatic programmable shutdown:
Onboard real-time QC/Onboard software capability to review QC:
Supports multiple QC lot numbers per analyte:
Waste management:
Sample barcode-reading capability/ Autodiscrimination:
Lab can control analyzer from remote computer:
Instrument can diagnose its own malfunctions:
System malfunctions can be diagnosed via remote monitoring:
UPS backup power supply:
Data-management capability/LIS or EHR systems interfaced:
LIS interface provided/ Bidirectional interface capability:
Modem servicing provided/Service engineer on-site response time:
Mean time between failures:
Average scheduled maintenance time by lab personnel:
Maintenance records kept onboard for user/vendor:
Maintenance training demonstration module onboard:
Training included with purchase/Avg. time for basic user training:
Advanced operator training/Extra charge for follow-up or advanced training:
Warranty provided/Cost of annual service contract (24 h/7 d):
Distinguishing features (supplied by company):
The intersection of news, core labs, and lab costs
June 2023—As CAP TODAY assembled its annual guides to chemistry and immunoassay analyzers (for this issue and the July issue), publisher Bob McGonnagle brought together IVD manufacturers and lab leaders to talk about consolidation and ever-larger health systems, technology, efficiencies, and centralized and decentralized testing.
Of the larger systems and labs, and the decentralization that is also common, Bryan Hanson of QuidelOrtho says, “I look at this as community health 2.0, which is: What will be the interplay between core and central labs and where patients want to be tested?”
Here’s what they had to say when they met online on April 28.
Kaiser Foundation Hospitals announced on April 26 that it acquired Geisinger Health and is creating a nonprofit organization called Risant Health to expand access to value-based care. It will seek to add additional nonprofit health systems. John Waugh, do you have a reaction to this news?
John Waugh, system VP, pathology and laboratory medicine, Henry Ford Health System: It may be the face of things to come, and maybe that’s good. I would rather see this kind of merger or acquisition than publicly traded laboratories taking on laboratories. Those are more frightening because of the disruption it causes people who have built their livelihoods around laboratory careers. I hope for Geisinger that it’s a sign of business as usual because it is a powerhouse and a well-known, well-led organization that many of us look to emulate.
Tom Lorey, can you comment on the acquisition? What has filtered down to Kaiser Permanente leadership?
Thomas S. Lorey, MD, strategic director and senior consultant, pathology and laboratory medicine, Kaiser Permanente Northern California: I share the concerns but it’s potentially a great partnership with one of the best health care organizations in the country that’s closely aligned with Kaiser Permanente’s values, and the idea of forming a nonprofit to ensure the continued independence of that entity is important.
This news points to the ever increasing need to consolidate testing where it makes sense and on a grand scale for optimal efficiency—having advanced analyzers with large menus and connectivity not only of tracks for samples but also IT. Julia Seltmann, what’s your reaction to the news?
Julia Seltmann, senior global marketing manager, Atellica Solution, Siemens Healthineers: This news reflects common trends in laboratories. One is they need to be prepared to be agile. Anything can happen and you don’t know what, but it probably will be a takeover or buyout. You have to be ready to adapt what you have to grow or shrink. You need to think about what you can have in your lab to be ready to change, whether it’s for becoming a spoke with a hub or dealing with financial pressures that will change what you’re doing. Maybe your clinical focus changes to dialysis, which you’ve never done before, or you have to prepare for another pandemic. That’s part of what labs have to build into their thought process when they’re looking at analyzers or how they’re preparing to be agile and adaptable.