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20 / CAP TODAY February 2010

Bedside glucose testing systems

HemoCue Inc. ITC

40 Empire Dr. 8 Olsen Ave.

Lake Forest, CA 92630-2244 Edison, NJ 08820

800-323-1034 800-631-5945

Part 4 of 7

www.hemocue.com www.itcmed.com

Name of instrument/First year sold

Glucose 201 Analyzer/2002 IRMA TRUpoint (glucose module)/—

Professional or home use

professional use professional use

List price

— $350

Units sold in U.S./Outside U.S./In 2009

— —

Part of series of similar or related models

yes no

Dimensions (H x W x D)/Weight

6.3 × 3.4 × 1.7 in/0.77 lb 5 × 9.5 × 13.5 in/6 lb (IRMA TRUpoint)

Analytical method/Technology/Enzyme system used

absorbance photometry/glucose dehydrogenase glucose only: reﬂectance photometry, glucose oxidase

Price per disposable reagent system unit

— —

No. of dispos. reag. system units per basic package

25 in vial/box; 4 vials/boxes per package 50 strips

No. of times analyses performed using 1 reag. system unit

1 1

Dispos. units shelf life/Reag. unit storage requirements

9 months from manufacture date/refrigeration strip: 18 months/room temperature

Digital readout size/Keypad input capability

0.5 in/none 4.5 x 2.5 in/menu selection, numeric, alphabetic

How results are displayed

plasma equivalent values true values

Specimen types/Sampling techniques

whole blood, venous, capillary, or arterial/exact amount of blood is drawn

into the cuvette by capillary force

whole blood/drop, capillary transfer, touchable strip

Minimum specimen volume required

5 µL 1 drop

Suitable for samples from well/Sick neonates

— yes/yes

Time from sample intro. to result availability

40–240 seconds <45 seconds

Batteries used/No. used/Avg. life of one set

AA/4/150 hours rechargeable NIMH battery/1/3 years

Avg. expected life of device/Mean time between failures

7 years/>5 years >5 years/<3% warranty return rate

Device warranty/Service options

2 years at no extra cost/— 1 year/extended warranty service available

Loaners provided

yes 24-hour replacement upon request

User list or user group

— yes

Toll-free No. for customer questions/Hours

800-323-1674, 6 a m –5 p m PST 800-631-5945/24 hours, 7 days

Training and certif. program/No. training days provided

yes/as needed yes/depends on No. of operators

Avg. time for lab to complete maintenance

daily: ≤5 minutes clean glucose module as needed, 2 minutes

Special cleansing procedures

no no

Internal QC recommended or required

system must be veriﬁed on testing days using commercially available

controls

based on hospital-speciﬁc policy

Between instrument CV (based on PT) at these levels:

• <50 mg/dL

not available 4.39%

• 100–200 mg/dL

3.8 3.44%

• >400 mg/dL

≥272 mg/dL=2.9 4.97%

• Program name, year/Challenge No./Level of mean glucose challenge sample

Equalis (Swedish PT program), 2003/2003-03; 2003-07/272 mg/dL; 120

mg/dL

data from 2000 AACC poster

Accuracy/Compared to what reference method or device

±10% or ±6 mg/dL; corr=0.994/wet chemical glucose dehydrogenase,

ID-GCMS

r >0.98/YSI

Precision/Compared to what reference method or device

within run CV 1.9% (108 mg/dL)/— 3.44–4.97 CV across runs/—

Linear range

0–444 mg/dL 0–500 mg/dL

Suggested dynamic, measurement range

0–444 mg/dL 0–500 mg/dL

Contraindications

no excessive H

0 loss or dehydration

Known interferences/High-altitude interference

grossly lipemic samples, methemoglobin, glucosamine/no sodium ﬂuoride/no

Restrictions based on hematocrit

no yes, <25% high results, >60% low results

Electronic, optical function checks

internal electronic self-test automatically checks that the instrument’s

optronic unit is working properly

optical self-zeroing; has LED to detect errors & internal check strip that is

part of strip holder, automatically done with every test

Sample quantity checks

visual inspection uses LED to determine sufﬁcient quantity

When auto lock or shutdown occurs

— user ID failure, QC failure, lockout if reagent expired or if control lot &

reagent not entered

User deﬁnes QC lockout intervals/Lockout can be circumvented

no/no yes/no

Device supports bar-code scanning of

no bar-code scanner bar-code scanner available

Method of analyst ID/ID required

— touchscreen/optional or required, QA user setup

Internal memory size/Max. No. patient results stored

— 4 MB RAM, 4 MB ROM, 256 KB nonvolatile/200 patient results

Information transfer capability:

• Meters connect to

— data management system, which connects to LIS/HIS; also directly to

LIS/HIS

• How meters are connected to external system to upload results/

No. installations

— direct serial/—, modem dial-in/—, Ethernet/—

• Info. contained in transmission to external system

— device unique identiﬁers, operator & patient IDs, results, QC identiﬁers,

results dates & times, strip/material lots, up to 3 alphanumeric notes,

result ﬂags, reference range/QC limits, software revision, sample types

Hardware/software for data mgmt. system

— nondedicated IBM compatible PC, Integrated Data Management System

No. of different mgmt. reports system can produce

— 6

Contents downloaded from DMS to meter

— strip lot Nos., valid control values, valid operator IDs

System connected (live installations) to which LISs/HISs:

—

• using screen animation/screen scraping

— major vendors

• using standard HL7 interface

— major vendors

• using proprietary protocol interface

— none

Use 3rd-party interfacing tool/engine for LIS/HIS interfaces

— yes, through laboratory data systems

Distinguishing features (provided by vendors)

CLIA-waived; indicated for diagnosis of diabetes mellitus; not

hematocrit-dependent; lab veriﬁcation of patient home meter

integrated workstation with IRMA TRUpoint (blood gas, electrolytes,

BUN, creatinine, lactate, cartridge glucose test, Hct); 1 user interface,

1 in-service program, 1 data management system

Tabulation does not represent an endorsement by the College of American Pathologists.

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