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

 


total P1NP

The total P1NP assay from Roche Diagnostics is useful for monitoring therapy of patients with osteoporosis. It detects increased bone turnover in postmenopausal women and is sensitive to significant changes induced by anabolic or anti-resorptive therapies. The advantages of the automated serum total P1NP include: little diurnal variability allowing for draws at any time, unlike previous markers; rapid, 18-minute assay time; and intra- and inter-assay variations lower than 2% and 5%, respectively. Total P1NP documents changes that exceed the LSC in a majority of individuals.


 
ONLINE TDM Tobramycin

The ONLINE TDM Tobramycin assay is based on a homogeneous enzyme  immunoassay technique used for the quantitative analysis of tobramycin in human serum or plasma. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phospahte dehydrogenase (G6PDH) for antibody binding sites.  Enzyme activity decrease upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. The 12-week, onboard stability of the cobas c pack along with calibration stability allow for a convenient and economical method for therapeutic drug measurement of tobramycin in serum, K2 or K3 EDTA or sodium or lithium heparin plasma, sodium citrate or fluoride oxalate plasma.

 


 
proBNP II

The Roche Diagnostics ProBNP II assay, launched in April, is a 2nd-generation assay using monoclonal antibodies for the detection of NT-proBNP. Monoclonal antibodiesprovide consistent high quality through improved lot-to-lot consistency and excellent precision, ranging from 1.6%–4.6% CV over the full measuring range. The unique NT-proBNP claim, “aid in the assessment of increased risk of cardiovascular events in patients who have stable coronary artery disease (CAD),” promotes quality management of cardiovascular risk with patients diagnosed with CAD and creates an outreach growth opportunity for labs.

 


ONLINE TDM Pheonobarbital  

The ONLINE TDM Phenobarbital assay is a homogenous immunoassay based on kinetic interaction of microparticles in solution (KIMS). Microparticles coated with phenobarbital rapidly aggregate in the presence of a phenobarbital antibody. The presence of phenobarbital in the sample inhibits particle lattice formation, generating a classic inhibition curve with the maximum rate of aggregation at the lowest phenobarbital concentration. The 90-day onboard stability of the cobas c pack, along with calibration stability and 200 test cobas c pack configuration, allows for a convenient and economical method for TDM of phenobarbital in serum, K2 or K3 EDTA, or sodium or lithium-heparin plasma on the Roche cobas c 501 analyzers.


ONLINE TDM Quinidine
  

The ONLINE TDM Quinidine assay is a homogenous immunoassay based on kinetic interaction of microparticles in solution (KIMS). Microparticles coated with quinidine rapidly aggregate in the presence of a quinidine antibody. The presence of quinidine in the sample inhibits particle lattice formation, generating a classic inhibition curve with the maximum rate of aggregation at the lowest quinidine concentration. The 12-week onboard stability of the cobas c pack, along with calibration stability, allows for a convenient and economical method for TDM of quinidine in serum, K2 or K3 EDTA, or sodium or lithium-heparin plasma on the Roche cobas c 501 analyzers.

 


 
Sample Validity Testing 
 

The new Roche Diagnostics Sample Validity Tests for use on the Roche Hitachi MODULAR ANALYTICS systems include the test reagents, assay-specific calibrators, and multi-constituent controls for: pH, specific gravity, nitrites, chromates, oxidants, and creatinine. These assays fulfill SAMSHA-mandated requirements to test for sample adulteration in certified labs and provide convenient system packaging and enhanced performance for high-throughput labs.


 
Elecsys Anti-TSHR assay 
  

Introducing the fully automated Elecsys Anti-TSHR assay for detection of autoantibodies to the TSH receptor. This high-throughput immunoassay will add to Roche’s broad thyroid menu. The Anti-TSHR assay is intended to be used as an aid in the assessment of patients with suspected Graves’ disease, the leading cause of hyperthyroidism. Graves’ disease affects approximately 750,000 people in the U.S. and nearly 32 million people worldwide. Early and accurate diagnosis supports Roche’s Passion to Improve Lives. *Pending FDA Clearance.

 


 
Elecsys PTH STAT  

Parathyroid hormone plays an adjunct role as a functional measure of parathyroid surgery, confirming the adequacy of parathyroid gland resection. Using the 9-minute Parathyroid Hormone (PTH) test during parathyroid surgery provides faster results for surgeons, which may result in shorter surgeries for patients. Used on Roche’s Elecsys 1010 and 2010 systems and cobas e 411 analyzer, the test was FDA cleared in late 2007 for use during surgery. A 9-minute STAT PTH application is also in development for the Roche Diagnostics cobas® 6000 analyzer series.


 
ONLINE TDM Lidocaine
  

The ONLINE TDM Lidocaine assay is a homogenous immunoassay based on kinetic interaction of microparticles in solution (KIMS). Microparticles coated with lidocaine rapidly aggregate in the presence of a lidocaine antibody. The presence of lidocaine in the sample inhibits particle lattice formation, generating a classic inhibition curve with the maximum rate of aggregation at the lowest lidocaine concentration. The 12-week onboard stability of the 75 test cobas c pack, along with calibration stability, allow for a convenient and economical method for TDM of lidocaine in serum, K2 or K3 EDTA, or sodium or lithium-heparin plasma on the Roche Diagnostics cobas c 501 analyzers.


 
ONLINE TDM Amikacin 
 

The ONLINE TDM Amikacin assay is a homogenous immunoassay based on kinetic interaction of microparticles in solution (KIMS). Microparticles coated with amikacin rapidly aggregate in the presence of an amikacin antibody. The presence of amikacin in the sample inhibits particle lattice formation, generating a classic inhibition curve with the maximum rate of aggregation at the lowest amikacin concentration. The 12-week onboard stability of the cobas c pack, along with calibration stability, allow for a convenient and economical method for TDM of amikacin in serum, K2 or K3 EDTA, or sodium or lithium heparin plasma on the Roche Diagnostics cobas c 501 analyzers.


 
Lithium colorimetric assay 

Introducing the Lithium colorimetric assay (Li) for the Roche Diagnostics cobas c 501 analyzer. Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change in absorbance that is directly proportional to the concentration of lithium in the sample. The assay uses a liquid, ready-to-use reagent packaged in a cobas c pack and the C.f.a.s. calibrator, the calibrator common to most general chemistry assays. Acceptable samples include serum and K2-EDTA and Na-heparin plasma. The 100-test Lithium cobas c pack is stable for 4 weeks onboard the cobas c 501 analyzer, providing a convenient method for lithium analysis.
 


CoaguChek® XS Anticoagulation Monitoring Systems

The CoaguChek XS System uses exclusive smart technology to help ensure accurate PT/INR results at the POC and offers the flexibility and control healthcare professionals need to confidently manage a wide range of anticoagulation patients. The system includes extended data management and QC capabilities to help clinics and other facilities that manage high volumes of patients. Using the CoaguChek XS system at the POC may help hospital-based labs realize the benefits of systematic anticoagulation management, such as immediate therapy adjustments and lower indirect costs of patient management (Wurster, M., Doran, T. Anticoagulation management: A new approach. Disease Management, 2006; 4:201-209.)

 


ACCU-CHEK® Inform II Blood Glucose Monitoring System

The next generation in POC blood glucose monitoring systems from Roche Diagnostics, the ACCU-CHEK Inform II System is designed to help healthcare professionals ensure patient safety and enhance patient care. Ideally suited for the ICU, the system is designed to use ACCU-CHEK Performa test strips that use the proven ACCU-CHEK Aviva consumer strip technology. Design goals include a 0.6-µL sample size, under-dose detection, optional wireless technology, enhanced patient identification (EPID) features, other test entry, observed test sequence, and patient history query capabilities. *Pending FDA clearance.
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High Speed Sorter with Bulk Loading Module

Sarstedt’s High Speed Sorter is a modular front- and back-end system that automates time-consuming lab processes. Options include identification, sorting, decapping, aliquotting, recapping, and the new bulk loading module that eliminates the pre-racking of incoming specimens—tubes are simply “dumped” into a hopper for walk-away processing. Two components of the system, the Decapper DC 1200 and Recapper RC 1200, are available as benchtop or stand-alone units that process up to 1,200 screw-cap, push-cap, or evacuated tubes per hour.
 


Little Dipper™ Processor for FISH 

From day one, this robotic system automates processing of FISH samples using Vysis or other probes, including post-hybridization steps. The Little Dipper processor provides precise temperature control and washing action that enhances test results and day-to-day reproducibility. It also can be used for processing microarrays used in new aCGH tests from Agilent, Roche/NimbleGen, Illumina, and others.
 


MINICAP

With a small footprint, the MINICAP instrument is designed to optimize and completely automate electrophoresis testing in low- to medium-volume laboratories. Simply placea bar-coded primary tube on the system and walk away. A continuous-access sample wheel allows for the addition of samples at any time, and true-positive sample ID is achieved with full traceability. The MINICAP Protein 6 assay is FDA cleared for separation and quantitation of the six major serum protein fractions by capillary electrophoresis.. The MINICAP reagent compartment accommodates multiple assay buffers in anticipation of future menu expansion.
 


BS-400

The new BS-400 fully-automatic clinical chemistry analyzer extends the excellent reputation of the BS series family renowned for high performance. The BS-400 is a truly random access and open system for routine and special chemistries, including specific proteins and electrolytes. It provides a flexible work platform for end users with reliable product quality. With throughput of constant 400 chemistry tests per hour, the BS-400 is an ideal workstation as a main system, back-up system, or for specialties.