Point of Care
Blood-glucose and ß-ketone monitoring system
The Precision XceedPro Blood Glucose and ß-Ketone Monitoring System is a whole blood, patient-side testing system designed to help minimize bedside glucose-testing errors. TrueID technology helps minimize the chance of patient identification errors with active confirmation of three patient identifiers. TrueMeasure test-strip technology with GDH-NAD chemistry minimizes interference from more than 65 substances, including maltose. TrueAccess information technology helps ensure only certified operators perform tests, with warnings of impending certification expiration. The ergonomic and easy-to-use POC system tests both blood glucose and blood ketone for a comprehensive glycemic-control solution. The company’s wireless-connectivity solution makes it possible to transfer test results wirelessly to the patient’s electronic chart to make bedside-test data available to physicians rapidly.
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Abbott Diabetes Care
Test corrects for interference
StatStrip Point-of-Care Glucose Monitors feature Multi-Well test-strip technology that delivers lab-like accuracy at the bedside with six-second glucose results. StatStrip glucose strips measure and correct for hematocrit interference, avoiding potential glucose errors due to abnormal hematocrits. It also eliminates other interferences including acetaminophen, ascorbic acid, uric acid, maltose and oxygen. Its small 1-mL sample volume allows for the use of the thinnest lancet, reducing patient pain and the potential for blood exposure to the operator.
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Nova Biomedical
HCV rapid test uses fingerstick whole blood
Eliminating the need for a blood draw, the OraQuick HCV Rapid Antibody Test is a single-use immunoassay for the qualitative detection of hepatitis C virus (HCV) antibodies in fingerstick whole-blood specimens. This test, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with HCV (state of infection or associated disease not determined) in persons with signs or symptoms of hepatitis and in persons at risk for hepatitis C infection. The rapid, point-of-care test provides results in 20 minutes. The product also is available for use with venous whole-blood specimens in persons at risk for HCV infection.
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OraSure Technologies
Wireless point-of-care testing system
The i-STAT 1 Wireless handheld point-of-care blood analyzer allows for real-time transmission of diagnostic test results directly from the patient bedside. The handheld analyzer saves time by allowing caregivers to perform tests at the bedside and transmit test results immediately to be reviewed by physicians anywhere they have access to electronic records. The device prompts users step by step through the testing process, and operator and patient information can be entered via barcode scanner. An operator lockout function prevents unauthorized users from performing or viewing test results. Weighing 18 ounces, the analyzer needs only two or three drops of blood to provide lab quality results. The device accepts various cartridges for specific tests.
Abbott Laboratories
Cassette-based POC analyzer
The ABL90 FLEX analyzer, designed for point-of-care testing, measures 16 parameters, including blood gases, electrolytes, metabolites, and CO-oximetry, in 35 seconds from 65-µL samples. The system delivers blood-gas results in 35 seconds and processes up to 44 samples per hour, with automatic sample mixing in just seven seconds and sample aspiration in just five seconds. The analyzer features built-in, automatic quality management for accuracy and regulatory compliance, and utilizes easy-to-replace sensor cassette and solution packs for high uptime and low maintenance. With a small footprint (about the area of a sheet of paper), the system fits easily in the lab or point-of-care areas.
Radiometer America
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Point-of-care detection of H pylori
The BreathID System is a breath-test platform capable of analyzing parts-per-million changes in carbon 13 and carbon 12 ratios in a patient’s breath — intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in initial diagnosis and post treatment monitoring of H pylori infection. The system detects the presence of H pylori, the bacteria associated with peptic ulcers and gastric cancer, through a 13C-urea breath test. The patient is connected to the device via an external nasal cannula and asked to breathe normally. The device will automatically determine the end of the test and print out the results. The system typically offers results within 10 minutes.
Exalenz Bioscience
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POC blood analysis system
The portable IRMA TruPoint blood-analysis system tests blood gases, hematocrit, electrolytes, and other chemistries at the point of care. The battery-operated device features an extensive, flexible test menu with single-use cartridges available in a variety of analyte configurations. On average, patient results are available in less than 90 seconds. Each disposable cartridge is self-calibrating, requires no additional reagents, and is stored at room temperature. The portable system includes an onboard printer, interactive touch-screen, bar-code scanning, automatic electronic QC, data-management system, and connectivity. A Luer-Lock sampling port and overflow chamber helps minimize wasted cartridges resulting from inadvertent introduction of air bubbles and/or sample overflow.
ITC
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INR testing at the point of care
The INRatio2 point-of-care monitor obtains a prothrombin time (PT) and international normalized ratio (INR) result using one drop of blood from a fingerstick for oral anticoagulation management. A two-channel onboard quality control runs on every test with no need for external liquid quality control or extra strips. With single button operation and an icon-based interface, the test results are displayed in less than 60 seconds as an INR only; PT seconds and INR, INR, PT, and QC; or INR and QC, whichever the user prefers. Test results are shown on the large LCD screen with easy-to-read digits and stores up to 60 test results in memory. The device uses a power adapter or four AA batteries and features a built-in port for printing/electronic communication.
HemoSense/Inverness Medical
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Point-of-care urine testing
The
DiaScreen 50 Urine Chemistry Analyzer tests urine specimens for the presence of leukocytes, specific gravity, urobilinogen, glucose, ketone, bilirubin, protein, nitrite, blood, and pH. The analyzer is designed for use with DiaScreen Reagent Strips for Urinalysis. The strips screen for numerous health conditions and are available in 15 different configurations with up to 10 analytes per strip. The analyzer may be used with three or more analytes per strip. The device has a throughput of 50 strips per hour and a memory capacity of 200 test results, which can be downloaded to a computer. The system flags abnormal test results with an asterisk and offers an easy-to-read printout. Patient identification information may be entered with the standard keypad, keyboard or bar-code reader.
ARKRAY
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Blood-gas CO-Oximeter/electrolyte analyzer
The
compact GEM Premier 4000 analyzer provides blood-gas,
electrolyte, metabolites, and CO-Oximetry measurements (e.g., Glu, Lac,
Hct, tHb, O2Hb, COHb, HHb, MetHb) to allow consistent, accurate results
throughout the hospital, at the point of care, and in the lab.
Easy-to-use touch-screen displays make selecting and customizing
parameters simple. Self-contained multiuse cartridges incorporate all
components for patient testing. The system is maintenance-free — just
replace the cartridge every 30 days. The analyzer can process 20 samples
per hour, with results available in less than two minutes. Software is
included to automate quality control and continuously detect, correct,
and document to ensure quality results and compliance. Remote management
software enables access to any network-connected analyzer to view
results, monitor performance, and verify standard configurations
regardless of operator or testing location.
Instrumentation Laboratory
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Rapid urine drug-screen tests
TOX/SeeTM
is a one-step, hand-held, point-of-care testing device for the
qualitative detection of drugs or drug metabolites in human urine. Tests
are available for the detection of amphetamine (1,000 ng/mL),
barbiturates (300 ng/mL), benzodiazepines (300 ng/mL), buprenorphine (10
ng/mL), cocaine (300 ng/mL), Ecstasy (500 ng/mL), methadone (300 ng/mL),
methamphetamine (1,000 ng/mL), opiates (300 ng/mL and 2,000 ng/mL),
oxycodone (100 ng/mL), phencyclidine (25 ng/mL), propoxyphene (300
ng/mL), THC (50 ng/mL), and tricyclic antidepressants (1,000 ng/mL). A
variety of test combinations are available from single drugs to the
simultaneous detection of as many as 12 drugs per cassette. The device
features integrated test controls, easy-to-read results, and an 18-month
shelf life at room temperature. The completed test card can be
photocopied and archived for health and legal records. Results are
available in less than five minutes and are stable for reading for up to
one hour.
Bio-Rad Laboratories Inc.
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Control for urine dipsticks/strip readers
Sentry
Urinalysis Control comes in a formula that does not require any
dilution or reconstitution and can be stored at room temperature for 12
months, with 18-month stability at 2°C to 8°C. This control works on
most major brands of urine dipsticks and automated strip readers. The
urinalysis controls are supplied in two levels, 2 x 25 mL each level per
kit. Level 1 is an abnormal control, and Level 2 is a normal control
with hCG and microalbumin. The ready-to-use liquid controls are prepared
with human and animal proteins and with various chemical additives.
These chemicals interact with the dipstick reactant pads to produce
specific color changes that mimic actual normal and/or abnormal urine
samples. Preservatives have been added to inhibit microbial growth. This
control is also intended to be used to verify the performance of various
hCG test kits.
Thermo Fisher Scientific
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Compact glucose meter
The
CLIA-waived StatStrip Xpress glucose monitor can be operated in
situations where glucose-meter interface capability is not needed. The
meter features six-second analysis time, color touch-screen operation,
and simple operating steps — making bedside glucose testing fast and
easy for point-of-care staff. The small 1.2-microliter sample size
results in easy sample acquisition and minimal pain for the patient.
StatStrip multiwell test strips measure and eliminate glucose errors due
to varying hematocrit levels, and also eliminates interference due to
maltose, galactose, xylose, oxygen, acetaminophen, uric acid, and
ascorbic acid. The device requires no calibration codes and has a data
storage capacity of 400 tests.
Nova Biomedical
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Point-of-care hemoglobin/hematocrit testing
The
HemoPoint H2 Hemoglobin Data Management System (DMS) is
indicated for the quantitative determination of hemoglobin in arterial,
venous, or capillary whole blood in a point-of-care setting. Using a
single drop of blood, the system offers accurate results for both
hemoglobin and hematocrit (calculated) tests in as little as 10 seconds.
The DMS utilizes bar-code identification of operators, patients, and
control intervals, as well as Bluetooth connectivity to PCs for
continual monitoring of patient and user data, including applied
consumables and quality controls. The test system stores up to 4,000
patient results and 500 QC results, features a proprietary “soft-load”
cuvette holder to minimize contamination of the optic lens.
Stanbio Laboratory
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Quick results for diabetics
The
Avie A1c hemoglobin A1c (HbA1c) point-of-care test provides for the
quantitative measurement of HbA1c in diabetic patients. Using blood
from a finger prick and a single-use disposable cartridge, results are
displayed on the screen of the hand-held reader within three minutes.
The colorimetric reader with screen uses electronically coded
cartridges, connects to an ancillary printer, and is available with
optional customizable data-management software. The test requires no
sample preparation or patient fasting, can be performed using capillary
or venous specimen, and provides a percentage as well as the calculated
average glucose concentration. The device is NGSP certified for accuracy
and CLIA-waived by the FDA.
MEC Dynamics
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Hand-held analyzer for bedside testing
The
i-STAT 1 System hand-held analyzer provides reliable test using as
little as two drops of blood and a test cartridge. Utilizing self-contained test
cartridges, along with the Precision PCx and PCx Plus glucose test strips, the
system delivers lab-accurate testing for blood gases, electrolytes, chemistries,
coagulation, hematology, glucose, and cardiac markers (cTnI). The portable,
battery-operated system includes 18 different pre-configured cartridges that
automatically perform a one-point calibration prior to analyzing patient
samples. Samples are processed immediately and provide results in two minutes.
Up to 5,000 results can be stored automatically on the device, can be printed
directly to an external printer, and are sent automatically to the LIS/HIS.
Abbott Point of Care
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Data-management system for point of care
The
RALS-Plus point-of-care data-management system is a connectivity system for
POC tests. Providing users with total control of their program with the click of
an icon, all results that have been downloaded can be viewed; results that have
been flagged based on set criteria can be displayed; all system operators can be
electronically managed; and weekly and monthly reports can be sent via e-mail.
RALS-Web enables users to remotely connect to the RALS-Plus database and access
key information from any device using a computer connected on the hospital
network. The system also enables users of ITC’s AVOXimeter 4000 and AVOXimeter
1000E to automatically manage, report, and electronically transfer patient
CO-oximetry and oximetry results and data to the database and the hospital’s
LIS.
Medical Automation Systems
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Point-of-care lead testing
Safe,
easy to use, and inexpensive, LeadCare II
delivers in just three minutes quantitative blood-lead results equivalent to
those reported by outside laboratories. The system removes all the complications
formerly associated with blood-lead testing — waiting days for lab results,
spending staff time and resources trying to contact patients for follow-up
care, or tracking down results for record-keeping, reporting, or compliance
purposes. The POC blood-lead testing system can use a capillary or venous sample
and can be combined with other routine blood tests, such as hemoglobin and ZPPH,
a test for iron-deficiency anemia. The lightweight portable device can run on
four AA batteries or an AC adapter.
Magellan Biosciences
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Malaria test results in 15 minutes
BinaxNOW
Malaria is an in vitro
immunochromatographic assay for the qualitative detection of
Plasmodium antigens circulating in the venous and capillary EDTA whole
blood of individuals with signs and symptoms of malarial infection. The rapid
laboratory test for the differential diagnosis of a malaria-infection test
targets the histidine-rich protein II (HRPII) antigen specific to
Plasmodium falciparum and a pan-malarial antigen, common to all four
malaria species capable of infecting humans —
P falciparum, P vivax, P ovale, and P malariae. It is intended
to aid in the rapid diagnosis of human malaria infections and to aid in the
differential diagnosis of
P falciparum infections from other less virulent malarial infections.
The simple, three-step test provides results in 15 minutes.
Inverness Medical
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Rapid diagnosis of infectious mononucleosis
For
the detection of the Epstein-Barr virus (EBV) and infectious mononucleosis (IM),
the
VIDAS EBV test comprises a panel of three markers used together to
detect specific antibodies and determine the stage of infection. The test
provides results in 40 minutes. The new test is useful for diagnosis since IM
symptoms are similar to those of other diseases that are infectious (strep
throat, toxoplasmosis, rubella) or non-infectious. Prompt diagnosis helps avoid
the inappropriate use of antibiotics and enables doctors to advise their
patients on curtailing contact sports or avoiding alcohol and certain
medications to prevent complications.
bioMérieux
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