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22 / CAP TODAY February 2010

Bedside glucose testing systems

Nova Biomedical Roche Diagnostics

Sales Department [email protected]

Accu-Chek Customer Care Service Center

200 Prospect St. 9115 Hague Rd., Indianapolis, IN 46256

Waltham, MA 02454 800-440-3638

Part 6 of 7

781-894-0800 or 800-458-5813 www.novabiomedical.com www.roche-diagnostics.us

Name of instrument/First year sold

StatStrip Glucose Monitoring System/2006 AccuData GTS, 1994; AccuData GTS Plus, 2000

Professional or home use

professional use

List price

call for pricing, includes bar-code reader, spare battery, quick reference

guide

$550

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

— 40,000*/5,000/—

Part of series of similar or related models

yes yes

Dimensions (H × W × D)/Weight

6.0 × 3.25 × 1.8 in/0.8 lb 11 × 8.75 × 4 in/5 lb

Analytical method/Technology/Enzyme system used

electrochemistry biosensor–glucose dehydrogenase

Price per disposable reagent system unit

pricing based on volume contingent on contract price

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

50 strips per vial and 100 per box 50 strips per vial

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

1 1

Dispos. units shelf life/Reag. unit storage requirements

24 months from date of manufacture/none 18 months, stable until expiration on vial/<90°F, do not freeze

Digital readout size/Keypad input capability

varies and is deﬁned by the particular ﬁeld/numeric, alphabetic 4 lines by 20 characters LCD/menu selection, numeric

How results are displayed

true values true values

Specimen types/Sampling techniques

whole blood/drop (arterial, venous, capillary, neonatal) whole blood/arterial, venous, capillary, neonate (including cord blood)

Minimum specimen volume required

1.2 µL 4 µL

Suitable for samples from well/Sick neonates

yes/yes yes/yes

Time from sample intro. to result availability

6 seconds 26 seconds

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

3.7 Li Polymer (rechargeable/replaceable)/1/24–36 months 3 V lithium/2/~700 tests

Avg. expected life of device/Mean time between failures

5+ years/— 5 years/10,000 tests

Device warranty/Service options

2 years (extended 5-year warranty at additional cost)/meter replacement AccuData GTS Plus/GTS system will be free from defects in materials &

workmanship through life of Accu-Chek Comfort Curve test strip contract;

overnight replacement, according to warranty policy, is available 24/7 365

days per year

Loaners provided

yes replaced under warranty

User list or user group

no yes (contact local account manager)

Toll-free No. for customer questions/Hours

800-458-5813/24 hours, 7 days, all year 800-440-3638/24 hours, 365 days per year

Training and certif. program/No. training days provided

yes/deﬁned during implementation planning yes/site-speciﬁc according to No. of employees

Avg. time for lab to complete maintenance

no user maintenance none

Special cleansing procedures

no no

Internal QC recommended or required

CLIA requirements 2 levels per day daily, 2 levels

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

• <50 mg/dL

— 53.8 mg/dL SD=4.1 (6,088 labs)

• 100–200 mg/dL

— 191.4 mg/dL CV=4.7% (3,096 labs)

• >400 mg/dL

— 228.5 mg/dL CV=4.6% (6,099 labs)

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

— CAP, 2001/WBG-C/see above

Accuracy/Compared to what reference method or device

R2=0.9978, slope=1.0127–2.0975/YSI 2300 y=0.991 x + 8.4, r=0.980/glucose hexokinase-Hitachi

Precision/Compared to what reference method or device

within run (whole blood=1.9%–3.6%) & (day to day=3.4%–4.7%) linearity

standards/—

controls: low SD=2.83 mg/dL, mid CV=3.08%, high CV=2.82%; blood: low

SD=1.5 mg/dL, mid CV=3.2%, high CV=3.2%/glucose hexokinase

Linear range

10–600 mg/dL 10–600 mg/dL

Suggested dynamic, measurement range

10–600 mg/dL 10–600 mg/dL

Contraindications

— per labeling

Known interferences/High-altitude interference

none/no, operates at altitudes up to 15,000 feet per labeling/none up to 10,150 feet

Restrictions based on hematocrit

none (no Hct interference) yes, glucose <200 mg/dL, 20%–65%; glucose >200, 20%–55%

Electronic, optical function checks

electronic checks for out-of-range glucose results, dosing, out-of-range

Hct results

meter cradle communication with Advantage meter, GTS with code key,

battery voltage test, internal database memory check, internal

conﬁguration check

Sample quantity checks

RapidFill sampling electronically checks for correct strip dosing built-in electronic strip check, visual conﬁrmation of sample volume

When auto lock or shutdown occurs

options include user ID failure, QC failure, required docking for data

transfer

user ID failure (valid op.), QC failure, patient ID length, incorrect code key,

incorrect Advantage meter

User deﬁnes QC lockout intervals/Lockout can be circumvented

yes/no, not if conﬁgured yes/yes (information management system identiﬁes operators who violate

hospital policy)

Device supports bar-code scanning of

operator & patient identiﬁers, reagent, lot No., QC lots operator & patient identiﬁers, comment codes

Method of analyst ID/ID required

medical record ID No., medical billing ID No., Accession ID No./ID required numeric input or bar-code wand scan/yes

Internal memory size/Max. No. patient results stored

1,000 patient samples, 200 QC samples, 4,000 operators/1,000 tests 1,000 total patient, control, linearity, proﬁciency tests/1,000

Information transfer capability:

• Meters connect to

Instrument Manager (NovaNet or Laboratory Data Systems AegisPOC) to

Data Manager (Telcor QML/Quick-Linc or AegisPOC) then to LIS if required

information management system, which in turn connects to LIS/HIS

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

No. installations

hospital network/—; wireless tote/— direct serial/—, modem dial-in/—, hospital network/—

• Info. contained in transmission to external system

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

strip lot Nos., download location, comment codes, proﬁciency & linearity

samples

Hardware/software for data mgmt. system

connects to Telcor QML and Laboratory Data Systems AegisPOC MAS RALS-Plus, MAS RALS-Lite†, MAS RALS-Notebook

†

No. of different mgmt. reports system can produce

provided by Telcor and Laboratory Data Systems varies by Data Manager (customer deﬁned)

Contents downloaded from DMS to meter

strip lot numbers, valid control values, valid operator IDs, patient

demographics, conﬁguration ﬁles, physician IDs, diagnostic codes

strip & QC lot Nos., valid operator IDs, valid control values, linearity values

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

• using screen animation/screen scraping

available through Telcor & Laboratory Data Systems all major LIS vendors including Cerner, Misys, McKesson, Meditech,

SoftLab, Siemens, SIA Molis, Opus, others**

• using standard HL7 interface

yes —

• using proprietary protocol interface

no —

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

yes, Telcor QML/Quick-Linc, Laboratory Data Systems AegisPOC MAS

Distinguishing features (provided by vendors)

measures and eliminates interferences from hematocrit, oxygen,

acetaminophen, ascorbic acid, uric acid, and other electrochemical

substances; no interference from maltose, galactose, or xylose; no

calibration codes required; results reported in 6 seconds using 1.2 µL

of sample; unlimited manual test entry; 1-D and 2-D bar-code capability

available

proven bi-directional network connection from AccuData GTS/GTS

Plus to LIS/HIS; ADT data interface with RALS-Plus/DataCare POC;

uses the Accu-Chek Comfort Curve test strip; universal sampling due

to oxygen-independent chemistry, with reliable results at varying

hematocrit levels

*combined AccuData GTS and AccuData GTS Plus sales

†

Roche exclusive

**both scripted/HL7 are available

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

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