Point of Care

Blood-gas CO-Oximeter/electrolyte analyzer

Instrumentation LaboratoryThe 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

Bio-RadTOX/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

Thermo Fisher ScientificSentry 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

Nova BiomedicalThe 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

Stanbio LaboratoryThe 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

MEC DynamicsThe 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

Abbott Point of CareThe 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

Medical Automation SystemsThe 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

Magellan BiosciencesSafe, 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

Inverness MedicalBinaxNOW 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

bioMerieuxFor 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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