Blood Analysis System
Provides results in under 1 minute
The Epoc blood analysis system from Siemens Healthineers, Tarrytown, NY, is a handheld, wireless device for performing comprehensive blood analysis at the patient’s side, using a single room-temperature test card, with results in under 1 minute. The Epoc system accelerates clinical decisionmaking with customized critical ranges and fast, wireless transmission of patient results, which are easily integrated into any laboratory information system. To streamline patient testing, the full-panel test card offers 13 analytes and automatic calibration prior to analysis. An integrated barcode reader provides easy verification of patient and operator identities. Only 92 ?L of blood is required for the full panel of tests.
Siemens Healthineers
(888) 588-3916; www.usa.healthcare.siemens.com
Critical Care Blood Gas Analyzer
Delivers 10-test profile
Nova Stat Profile blood gas/critical care analyzers from Nova Biomedical, Waltham, Mass, offer a broad menu of 20 tests.Nova’s Stat Profile Prime features zero-maintenance cartridge technology consisting of individual cartridges for biosensors; calibrators; and automated, onboard, external liquid quality control. This design optimizes cartridge life, improves analyzer uptime, and eliminates the waste, downtime, and higher costs of older, combined calibrator and sensor cartridge systems. Stat Profile Prime delivers a full 10-test profile in just 60 seconds for Cl, Glu, Hct, iCa, K, Lac, Na, PCO2, pH, and PO2.
Nova Biomedical
(800) 822-0911; www.novabio.us
I
mmunoassay Systems
Provide objective digital results
BD, Franklin Lakes, NJ, offers the BD Veritor line of immunoassay products—the BD Veritor system and the BD Veritor Plus system—which give objective, lab-quality test results within minutes to healthcare providers and laboratorians in near-patient settings. The point-of-care systems have waived status under the Clinical Laboratory Improvement Amendments of 1988 for rapid detection of influenza A and B. The systems eliminate the subjectivity of visual interpretation of test results by providing objective digital results. The systems can also help detect infectious diseases such as respiratory syncytial virus (RSV) and group A strep, and enable providers to review patient results while the patient is still on site, and to make earlier intervention decisions.
BD
(201) 847-6800; www.bd.com
Hemoglobin Analyzer
Operates up to 100 hours
The HemoPoint H2 hemoglobin analyzer from EKF Diagnostics USA, Boerne, Texas, provides lab-accurate hemoglobin and hematocrit results from a single test, with results in as little as 30 seconds. HemoPoint H2 uses NXT generation microcuvettes to draw only 8 ?L of whole blood from a fingerstick. The microcuvette design eliminates air bubbles in the optical reading window, giving consistent results with fewer fingersticks. HemoPoint H2’s backlit, intuitive touchscreen displays test results, time, and status of the unit’s rechargeable battery. The unit will operate up to 100 hours on a full charge. The analyzer has waived status under the Clinical Laboratory Improvement Amendments of 1988.
EKF Diagnostics USA
(830) 249-0772; www.ekfusa.com
Urea Breath Test
Detects H. pylori bacteria
Exalenz Bioscience Ltd, Modiin, Israel, has received FDA clearance for its BreathID Hp point-of-care system and BreathID Hp lab system for use in detecting Helicobacter pylori bacteria in children aged 3 to 17. The systems aim to facilitate H. pylori diagnosis of large numbers of breath samples that are collected and delivered to a centrally located laboratory. The systems can perform sequential diagnosis in a fully automated and undisrupted process, minimizing potential human error. Exalenz also holds a new drug approval for the 13C urea substrate used in the test.
Exalenz Bioscience
(888) 392-5369; www.exalenz.com
Rapid Zika Test
Requires 10 µL of blood
The DPP Zika system from Chembio Diagnostics Inc, Medford, NY, is the first rapid Zika test to receive an FDA emergency use authorization for use in laboratories certified to perform high- and moderate-complexity testing under the requirements of the Clinical Laboratory Improvement Amendments of 1988. The system includes the DPP Micro Reader and the DPP Zika IgM assay, which provides results in 15 to 20 minutes from only 10 µL of blood. The test is authorized for the presumptive detection of Zika virus IgM antibodies in fingerstick whole blood, EDTA venous whole blood, EDTA plasma, or serum specimens collected from individuals meeting CDC Zika virus clinical or epidemiological criteria, from 8 days to 12 weeks after the onset of clinical symptoms.
Chembio Diagnostics
(844) 243-6246; www.chembio.com
POC Vaginosis Diagnostic
Designed in lateral-flow format
The BVPro from Mologic Ltd, Bedford, UK, is a rapid point-of-care test for patients presenting with symptoms of vaginosis. The 15-minute, point-of-care diagnostic uses a vaginal swab sample to detect sialidase enzyme activity, which is a well-established clinical marker of bacterial vaginosis. The CE-marked diagnostic has been designed in the familiar lateral-flow format, so that the visual result is easy to interpret. The test offers a rapid alternative to current methods, such as wet-mount microscopic analysis or test tube-based color-change assays, which are time-consuming and often provide ambiguous results.
Mologic
[email protected]; www.mologic.co.uk
Human Chorionic Gonadotropin Test
Uses single drop of blood
The AdexusDx human chorionic gonadotropin (hCG) point-of-care test from NowDiagnostics Inc, Springdale, Ark, uses a single drop of capillary or whole blood to diagnose pregnancy earlier than urine-based tests. The test has received FDA premarket notification (510(k)) clearance and is registered under the terms of the Clinical Laboratory Improvement Amendments of 1988. The test is an immunoassay used for the qualitative detection of hCG in human whole blood, plasma, or serum, and can detect pregnancy approximately 2 to 8 days earlier than commonly available urine-based tests. Results are available 10 minutes after the test is used.
NowDiagnostics
(844) 207-3370; www.nowdx.com
Real-Time PCR Platform
Automates testing process
Utilizing polymerase chain reaction (PCR) technology, the CobasLiat system from Roche Diagnostics USA, Indianapolis, fully automates the testing process, simplifies workflow, and enables healthcare professionals to perform molecular testing in a variety of settings. Definitive results are generated in 20 minutes or less to aid a treatment decision.The Cobasinfluenza A/B and respiratory syncytial virus (RSV) test detects and differentiates influenza A virus RNA, influenza B virus RNA, and RSV RNA. The test has been validated on more than 40 commonly found strains of influenza A and B and seven commonly found strains of RSV.
Roche Diagnostics USA
(800) 428-5076; www.usdiagnostics.roche.com
Diagnostic Platform and Flu Test
Displays results on an intuitive touchscreen
The Alere BinaxNow influenza A and B card 2 from Abbott, Abbott Park, Ill, is available for exclusive use with the new Alere Reader. The Alere Reader is a diagnostic platform that detects, identifies, and analyzes the completed lateral-flow assay, displays results on an intuitive touchscreen, and has the capability to seamlessly link to electronic medical records. The combined test and platform comply with FDA’s new requirements for rapid influenza diagnostic tests. Both products are expected to be available for the 2018–2019 flu season.
Abbott
(224) 667-6100; abbott.com
