American Association for Clinical Chemistry
Better health through laboratory medicine
2008 New Product Review


VITROS® Troponin I ES

Ortho-Clinical Diagnostics announces the availability of the VITROS Troponin I ES assay with improved low-end sensitivity. The assay is for use with the VITROS® ECi/ECiQ Immnuodiagnostic System using Intellicheck® Technology. VITROS Troponin I ES is used for the quantitative measurement of cardiac Troponin I in human serum and plasma to aid in the assessment of myocardial damage and risk stratification. The VITROS Troponin I ES assay is concurrent with the recommendations as described by the Joint European Society of Cardiology/American College of Cardiology Committee (ESC/ACC) for acceptable imprecision in a high-sensitivity troponin I assay.

VITROS® ECi/ECiQ Immunodiagnostic System - Enhanced Productivity Module

Ortho-Clinical Diagnostics announces the availability of the Enhanced Productivity Module (EPM) for the VITROS ECi/ECiQ Immunodiagnostic Systems with Intellicheck® Technology. The EPM Increases uninterrupted system processing time and the number of assays processed and reported. The Enhanced Productivity Module (EPM) builds on the benefits and functionality of the VITROS® ECi/ECiQ Immunodiagnostic Systems, with the EPM providing true productivity and workflow improvements by upgrading the VITROS® ECi/ECiQ System with extended universal wash reagent and liquid waste management.



Ortho-Clinical Diagnostics announces the availability of four new infectious disease assays in international markets excluding the U.S. The assays, for use on the VITROS® ECi/ECiQ Immunodiagnostic System, are the VITROS® Rubella IgM, the VITROS® Toxoplasma IgM and the VITROS® Cytomegalovirus (CMV) IgG and IgM assays. These four new assays complement the already available VITROS Rubella IgG and VITROS Toxoplasma IgG assays. Infections with these agents are most significant during pregnancy, as they are associated with congenital defects of the newborn. These assays provide critical information to physicians caring for women prior to and during pregnancy.

VITROS® 5600 Integrated System

Ortho-Clinical Diagnostics is developing the VITROS 5600 Integrated System, a high-capacity system uniquely designed to integrate more than 120 immunoassays and clinical chemistry assays on one system. The system will seamlessly integrate five proven VITROS® technologies to provide high quality results, no sample carryover, and no reagent carryover. It will include MicroSlide™, MicroTip™, MicroWell™, Intellicheck®, and MicroSensor™ technologies. The system will introduce a sample-centric design to optimize productivity, eliminating the need to move samples on a track or create sample aliquots. It is being designed to be easy to use with infrequent calibration and minimal maintenance. Integration by design! *In development.


VITROS® 3600 Immunodiagnostic System

Ortho-Clinical Diagnostics is developing the VITROS 3600 Immunodiagnostic System, a high-capacity immunoassay system for routine and specialty immunoassay testing using three proven VITROS® technologies: MicroWell™ with proprietary Enhanced Chemiluminescence, Intellicheck®, and MicroSensor™ technologies provide high quality results without compromising workflow. The broad menu will include cardiac, thyroid, metabolic, endocrine, anemia, oncology, prenatal, and infectious disease assays. Productivity is expected to be enhanced by using intelligent sample management to optimize and prioritize assay processing. Allowing reagents and consumables to be replaced while operating also optimizes productivity. The VITROS 3600 Immunodiagnostic System: integrity and productivity by design! *In development.


VITROS® Anti-HIV 1+2 assay

Ortho-Clinical Diagnostics announces the availability in the U.S., Puerto Rico and U.S. territories of a new diagnostic assay for the detection of antibodies to HIV types 1 and/or 2. The VITROS Anti-HIV 1+2 assay can be run in a fully automated, random access format on the VITROS® ECi/ECiQ Immunodiagnostic System with Intellicheck® technology. Results are readily available in less than 50 minutes. This marks the first anti-HIV 1+2 test in the U.S. capable of running in full random access at any time, with other tests, and providing immediate result reporting upon test completion.


enGen™ Recapper and Flex Decapper

Ortho-Clinical Diagnostics announces two new modules for the enGen Laboratory Automation System. The Flex Decapper removes both screw caps and traditional stoppers from tubes with randomly mixed heights and widths. This new Decapper uses sensors to determine the height and width of each tube and processes 600 tubes per hour. The Recapper applies universal caps to primary tubes ranging in size from 13mm x 75mm to 16mm x 100mm, as well as to aliquoter secondary tubes.The Recapper holds 2,000 caps on board, allows reloading without interrupting operation, and processes 500 tubes per hour.


Ortho-Clinical Diagnostics introduces a new Web site,, that provides blood bank customers online access to electronic antigram profiles specific for ORTHO Reagent Red Cell products (e.g. Selectogen®, Surgiscreen®, Resolve® Panel A, Resolve® Panel B, and Resolve® Panel C). Antigrams are required for these red blood cell products to complete the tests and give the labs the information needed to transfuse the correct units of blood. Previously, antigram files have been in paper format only, requiring customers to manually enter the data into software-assisted antibody identification systems. Electronic antigram profiles increase ease of use and eliminate non-value added work.



Ortho-Clinical Diagnostics announces the availability of the AlbaQ-Check kit for QC testing in blood-bank laboratories. The AlbaQ-Chek Simulated Whole Blood Controls, manufactured by Alba Bioscience, is the only standardized QC kit in North America for use with Ortho-Clinical Diagnostics’ proprietary ID-MTS™ gel technology. It can be used with the ID-MTS™ Gel Test™ when performed either manually or in the automated format on ORTHO ProVue.® The addition of AlbaQ-Chek to the ID-MTS Gel Test menu offers Ortho-Clinical Diagnostics’ ORTHO ProVue and Gel customers improved efficiency, standardization, and error reduction through a cost-effective product.


The Parker Smart Syringe Probe dramatically shortens clinical lab instrument design time and improves performance by enabling simpler and more efficient processes with its compact size and integrated intelligence. It replaces bulky syringe pumps in liquid handling and diagnostic equipment, eliminating the use of transfer lines and consequently improving accuracy and precision. At 8 mm in diameter and weighing only 26 g, probes have 9-mm centers with each syringe drive operating independently. With its patented technology, small footprint, use of serial communications, and easy serviceability, the Parker Smart Syringe Probe helps optimize instrument design.

EliA™ - Excellence in Autoimmune 

For more than 30 years, Phadia has revolutionized immunoassay technology and advanced the science of allergy and immunology as the worldwide leader in specific IgE blood testing. From this platform of proven performance, Phadia is proud to introduce EliA Autoimmune assays. EliA Autoimmune assays are fully automated, moderately complex, and run on the proven ImmunoCAP instrument systems (100ε/250). EliA Autoimmune assays include: CCP antibodies (cyclic citrullinated peptide); Celikey® tTG antibodies (tissue transglutaminase); gliadin antibodies; and Symphony ANA and dsDNA antibodies. Visit Phadia booth #1331 or contact Customer Service at 800.346.4364to learn how EliA Autoimmune assays can enhance your lab’s performance and bottom line.

Cystatin C reagent for automated chemistry analyzers

Pointe Scientific introduces a new latex-enhanced, immunoturbidimetric assay for the quantitative determination of cystatin C in serum or plasma. Applied to automated chemistry analyzers, this cystatin C reagent shows correlation with other commercially available cystatin C assays, excellent precision, minimal interference, and an extended assay range to 10 mg/L. Unlike creatinine measurements for estimating glomerular filtration rate (eGFR), the Pointe Scientific Cystatin C reagent is not dependent on age, sex, race, weight, or other parameters. Cystatin C is widely reported to be a much better indicator of early kidney damage and can detect more accurately and more quickly any changes in renal function.


Ferritin reagent for automated chemistry analyzers

Pointe Scientific introduces a new latex-enhanced, immunoturbidimetric assay for the quantitative determination of ferritin in serum or plasma. Applied to automated chemistry analyzers, this ferritin (hs) method shows correlation with established chemiluminescent methods, excellent precision, and minimal interference. Ferritin calibrators are referenced to WHO 94/572 3rd IS reference standard. Measurements can be obtained within minutes along with other anemia markers such as iron and TIBC, eliminating the need for split sample testing on different analyzers. Measuring ferritin is useful in assessing iron stores for the evaluation of iron deficiency anemia, chronic gastrointestinal bleeding, and other chronic inflammatory disorders.


The PATHFAST immunochemistry analyzer is a compact, fully automatic instrument suitable for a hospital or POCT. The PATHFAST comes complete with an integrated computer, LCD touch screen, and printer. Results for most assays are available in as little as 15 minutes. Convenient, ready-to-use, all-in-one reagent cartridges and the ability to use whole blood saves time. Six different assays or up to six samples may be run simultaneously. The PATHFAST is ideal for use in hospitals, emergency rooms, clinics, and the physician office lab settings.


The ABL80 FLEX CO-OX incorporates the patented oximetry technology found in Radiometer’s benchtop analyzers, making it available in a portable, cartridge-based instrument. Radiometer’s ultra-sonic hemolyzation is well-established as superior to chemical hemolyzation, demonstrating superior measurement performance and zero risk of contamination from chemical agents. The ABL80 FLEX CO-OX offers the portability and ease-of-use advantages already benefiting users of the ABL80 FLEX platform. Its small footprint, rapid start-up, and fast measurement time make it ideal for use in clinical areas, while full connectivity and auto QC ensure the lab maintains control of the testing process. *Pending FDA clearance.

Safe-Wrap™ Blood Collection Tubes  

RNA Medical’s Safe-Wrap and Safe-Wrap Combo Blood Collection Tubes are now CE Marked. Safe-Wrap tubes are Mylar®-wrapped glass capillaries, treated with calcium-balanced lithium heparin. The puncture-resistant film minimizes the risk of broken glass and is regulatory compliant. Safe-Wrap Combo Tubes are used with i-STAT blood gas, electrolyte, and chemistry cartridges requiring samples of 95 µL or 65 µL. The line markings and adjustable porous plug assures that the correct volume is collected, and the plunger provides easy sample dispensing. Safe-Wrap Blood Collection Tubes, with markings at 55 µL, 110 µL, and 165 µL, are used with most other blood gas systems.