Immunoassay
Comprehensive immunoassay control
The Acusera Immunoassay Premium Plus Control represents a comprehensive third party control with instrument and method specific values provided for 54 analytes. The inclusion of routinely run tumor markers, therapeutic drugs and such other important parameters as intact PTH and Vitamin D allows laboratories to consolidate their control use while ultimately saving money. Three levels are available, spanning the complete clinical range; both Ferritin and Vitamin B12 are present at levels suitable for anemia monitoring, while ultra-low TSH levels eliminate the need for a separate control. The control sample is manufactured from 100% human serum, providing a matrix similar to the patient sample and reducing interference due to antibody specificity. Once reconstituted, the material is stable for seven days at +2-8oC or four weeks at -20oC, minimizing unnecessary waste. With a shelf life of up to four years, problems and costs associated with lot crossovers are also minimized.
Randox Laboratories Ltd
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Therapeutic drug management
The new ARK Methotrexate Assay, which is pending FDA clearance, is being presented by its manufacturer as part of the next generation of TDM assays. Applicable on clinical chemistry analyzers, its liquid-stable, ready-to-use formulation delivers an assay with a limit of detection below 0.05 µmol/L. Specificity in the presence of 7-hydroxymethotrexate is excellent. The calibration range extends from 0 to1.20 µmol/L, and high concentrations may be tested after dilution with a provided buffer. Calibration range and high range controls are available.
ARK Diagnostics, Inc.
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Drug monitoring immunoassays
The QMS Everolimus is the newest addition to a full menu of immunosuppressant drug monitoring immunoassays. The Everolimus assay was developed using the Quantitative Microsphere Systems technology, incorporating microparticle beads, and is based on a competitive inhibition principle. There are applications for a variety of clinical chemistry analyzers. This assay recently received FDA clearance for the management of kidney transplant patients receiving Everolimus therapy. Training and service is available from a Field Technical Service Team, and a 24/7 hotline is available to provide ongoing support.
Thermo Fisher Scientific—Clinical Diagnostics
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Manufacturing validated applications
Ortho Clinical Diagnostics is offering manufacturing validated applications (MVAs) from Thermo Fisher Scientific for use on Ortho’s VITROS® 5600 Integrated System and its VITROS® 5,1 FS Chemistry System. Applications will allow customers to run immunosuppressant drug assays and Drug of Abuse assays. This is the first time the company is supporting applications for assays validated by an external third party. Clinical chemistry tests offered cover major disease states including cardiology, oncology, endocrinology, infectious disease, thyroid, metabolic conditions, and anemia. Covering 90% of the top 100 assays and 99% of laboratory test volume, the systems offer standardized reagents and results, enabling labs to better manage inventories and costs and be confident in test results from platform to platform.
Ortho Clinical Diagnostics
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CLIA-waived IFOBT
In February 2009 the American College of Gastroenterology (ACG) released an update in CRC (colorectal cancer) guidelines. The new wording stated that the ACG “supports the joint guideline recommendation that older guaiac-based fecal occult tests be abandoned as a method for CRC screening.” The ACG instead “recommends the FIT as the preferred cancer detection kit.” In support of this guideline, the Hemosure IFOBT has been introduced, a rapid, convenient, and odorless qualitative sandwich dye conjugate immunoassay for the determination of human hemoglobin in feces. It is typically used for colorectal cancer screening, in an effort to detect a malignancy that has high cure rates when discovered at its earliest stages. One notable distinction of this assay is that it has no drug or diet distinctions.
Hemosure, Inc
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Expanded functionality saves work and time
The AIA-2000 Automated Immunoassay Analyzer delivers 200 results per hour with expanded functionality designed to increase workflow and minimize operator time. The user can load up to 960 tests (48 trays) in an easy-load sorter, increasing walk-away time to approximately four hours. Tip capacity is 576, and tips can be added or changed at any time. Sample racks can be loaded with any combination of 200 bar-coded primary tubes or sample cups. The AIA-2000 features fully automated daily maintenance and record keeping, automatic inventory management, and automated pre-treatment (for assays that require this step). In addition, it features a 17-inch touch screen panel and improved user interface, allowing easy access to most of the controls from the screen. Multiple robotic arms and new staging platforms speed sample processing.
Tosoh
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Detect hCG in serum or urine
The
Status First hCG Serum/Urine Test
is a simple immunoassay for the qualitative detection of hCG in serum or urine for the early confirmation of pregnancy. This test is intended to be used with the DXpress Reader. Three drops of specimen are added to the device and inserted into the reader. Results are display and print in five minutes. The easy-to-use reader stores and manages up to 1,000 patient results and has an on-board printer for hard copy results.
LifeSign
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Detect both HIV antigen and antibodies
The ARCHITECT HIV Ag/Ab Combo assay is a chemiluminescent microparticle immunoassay for the simultaneous qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in human adult and pediatric serum and plasma (EDTA and heparin). The assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection, and can also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in pregnant women. This test, which runs on the company’s ARCHITECT family of diagnostic-testing instruments, may detect HIV infection days earlier than antibody-only tests.
Abbott Laboratories
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Chemistry and immunoassay processing
The VITROS 5600 Integrated System is a high-capacity system that enables chemistry and immunoassay samples to be processed in parallel. This “one-tube-in, one-tube-out” approach can optimize turnaround time and productivity by intelligently accounting for variable sample and test mixes, eliminating the need to split the sample on the analyzer or move sample trays between modules. The equipment has no water or drainage requirements, allowing flexibility in instrument location. With more than 120 available assays available, the system is capable of integrating routine chemistry, immunoassay, and infectious-disease assays, including HIV, onto a single platform.
Ortho Clinical Diagnostics
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Anemia test and diagnostic index
Together, the Access Soluble Transferrin Receptor (sTfR) Assay and the sTfR/log ferritin index (sTfR Index) act as an aid in the diagnosis of iron-deficiency anemia (IDA) and the differential diagnosis of IDA and anemia of chronic disease (ACD). The fully automated assay used in combination with the index produces a recommended cutoff that can indicate the nature of a patient’s anemia. The assay features an expanded dynamic range reducing the need for dilutions: 3-150 nmol/L, while the sTfR/log ferritin index provides proven clinical sensitivity. First results are available in approximately 35 minutes utilizing 25-μL serum or plasma (heparin) samples.
Beckman Coulter
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Compact immunoassay analyzer
The AIA-360 Immunoassay Analyzer is compact, with a footprint of 16 X 16 X 21 inches and weight of approximately 61 pounds, for physician-office laboratories or small hospital workstations for STAT testing such as cardiac panels, as well as a dedicated system for specialty testing. With a throughput of 36 tests per hour, the analyzer generates its first result in approximately 20 minutes. The system utilizes the same ST (10-minute incubation) reagents as this company’s AIA-2000, AIA-1800, and AIA-600II systems, making it a perfect back-up to the larger analyzers. Because all AIA immunoassay analyzers from this company utilize the same reagents, results are consistent and interchangeable between systems.
Tosoh Bioscience
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Qualitative anti-HCV immunoassay
The Elecsys Anti-HCV Immunoassay is intended for in vitro, qualitative determination of total antibodies to hepatitis C virus (HCV) in human serum and plasma. Results of the 18-minute immunoassay, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in patients with signs and symptoms of hepatitis and in those at risk for hepatitis C infection. The electrochemiluminescence Anti-HCV immunoassay has been approved for use on the cobas e 411 analyzer for low-volume testing and the cobas e 601 and Modular Analytics e 170 analyzers, which are modules of consolidated immunoassay/clinical chemistry systems for mid- and high-volume testing.
Roche Diagnostics
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Simultaneous results for multiple tests
The BioPlex 2200 MMRV IgG kit (measles; mumps; rubella; and the varicella-zoster virus) for use on the company’s BioPlex 2200 system provides simultaneous results for the four tests that are commonly ordered together from a single patient sample to determine a patient’s susceptibility to MMRV. The BioPlex 2200 system is a fully automated, random-access multiplex testing system. It provides clinical laboratories with the capability to rapidly process multiple individual tests in order to conserve patient sample volume, consolidate workstations, and simplify workflow. The system can automatically process up to 100 samples per hour — for a maximum of 2,200 reportable results — with eight hours of walk-away time. First results are available in approximately 20 to 45 minutes, with subsequent patient samples completed approximately every 30 seconds.
Bio-Rad Laboratories
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Rapid hCG detection
The RapidVue hCG test is a lateral-flow pregnancy immunoassay for the qualitative detection of human chorionic gonadotropin (hCG). The three-minute test is CLIA-waived for use with urine samples. The assay’s dipstick requires no specimen manipulation in order to perform the test. The device test detects urinary hCG concentrations greater than 25 mU/mL for the early detection of pregnancy. If hCG is present in the sample, a pink test line along with a blue control line will appear. If hCG is not present in the sample or is present at low levels only, a blue control line will appear.
Quidel
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POC cardiac diagnostic test
The Cardiac 200 is a lateral-flow immunoassay-testing system designed for rapid cardiac-diagnostic needs at the point of care. The system provides quantitative results with a turnaround time of 10 to 19 minutes and uses a unique internal corrected fluorescence-measurement technology to deliver accuracy and reliability that are consistent with the performance expectations of laboratory systems. Offering a full cardiac-marker menu that includes NT-proBNP, troponin I (TnI), CKMB, and myoglobin, the system processes up to 36 tests per hour and offers flexible modular configurations to enable labs to address specific workflow needs.
Roche Diagnostics
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High-throughput automated immunoassay analyzer
The
AIA-2000 Automated Immunoassay Analyzer allows users to load up to
960 tests (48 trays) in an easy-to-load hybrid sorter — increasing
walkaway time to approximately four hours. Features include throughput
of 200 tests/hour, 576 tips (six tip racks), two substrate bottles,
three incubators with different processing steps, two sampling arms for
faster processing of a second reagent, and a full test menu. The system
includes fully automated daily maintenance and record keeping, automatic
inventory management and automated pre-treatment for assays that require
this step. The analyzer features a 17-inch touch-screen panel to allow
for easy access to most of the controls.
Tosoh Bioscience
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Complement to diabetes panel
A
new automated method for the quantitative determination of C-peptide in
human serum, plasma, or urine is available for use on the ARCHITECT
immunoassay analyzer. The new
C-Peptide Assay complements the already existing diabetes assay
panel, which consists of C-peptide and insulin. The clinical-chemistry
panel has assays for glucose, HbA1c, microalbumin, creatinine, and the
lipid panel (LDL, HDL, and triglyceride). The assay has excellent
sensitivity and precision, and a throughput of up to 200 tests per hour.
All C-peptide reagent components are ready to use for increasing
productivity and accuracy.
Abbott Diagnostics
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