American Association for Clinical Chemistry
Better health through laboratory medicine
July 2007 Clinical Laboratory News: New Product Review

   
July 2007: Volume 33, Number 7



ARCHITECT® c16000™ and ARCHITECT® ci16200™ Analyzers*

Introducing the ARCHITECT c16000 clinical chemistry analyzer, adding a high-speed option for large laboratories with complex workloads. Designed to enhance productivity, the instrument helps labs manage patient samples efficiently and offers fast turnaround times for test results, processing up to 1,800 tests per hour. The analyzer can also be seamlessly integrated with the ARCHITECT i2000SR® immunoassay system, creating the ARCHITECT ci16200™ configuration, which processes up to 2,000 tests per hour. *Available outside the U.S

 

ARCHITECT® i1000SR® Analyzer

The ARCHITECT i1000SR immunoassay system is intended for low- to mid-volume laboratories providing productivity enhancements normally reserved for larger labs. The system utilizes identical CHEMIFLEX® technology, reagents, and software as other ARCHITECT immunoassay systems, delivering expected equivalent resSults. Designed to enhance productivity, the system's robotic sample handler provides continuous access to both reagents and samples. The system allows customized sample prioritization for consistent STAT turnaround times, processing up to 100 tests per hour with 1-Step STAT assays. The ARCHITECT i1000SR system is designed for future integration with the ARCHITECT c4000™ chemistry system creating the ARCHITECT ci4100™ configuration. Currently in development.

 

AxSYM®/ARCHITECT® Common Carrier System

The STA-Staclot dRVV Screen and Confirm assays are fully automated tests for the detection of lupus anticoagulants (LA) in patient plasma by the diluted Russell viper venom method. Each reagent is bar coded for ease of use on the STA line of analyzers. The STA Staclot dRVV Screen test utilizes a reagent with a low phospholipid concentration that enhances its sensitivity and a prolongs clotting time. The STA Staclot dRVV Confirm test utilizes a reagent with a high phospholipid concentration that neutralizes the LA present in the plasma for a shorter clotting time. The tests are not affected by contact factor deficiencies, factor VIII and IX deficiencies, or other specific inhibitors, and the assays are not affected by samples containing therapeutic levels of heparin. In conjunction with the Staclot LA STA assay, the Staclot dRVV Screen and Confirm assays fulfill the recommendations establishing by ISTH.

 

MULTIGENT® Assays

A broad menu of drugs-of-abuse and toxicology testing is available on the TDxFLx®, IMx®, AxSYM®, AEROSET® and ARCHITECT® systems. Introducing the recently-completed menu of the clinical chemistry MULTIGENT semi-quantitative drugs-of-abuse menu with the launch of phencyclidine and propoxyphene assays, adding to the available menu of amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, ecstasy, ethanol, methadone, and opiates. Additionally, the toxicology menu is on its way to being completed with the launch of acetaminophen and salicylate assays. The remaining toxicology assays, tricyclic antidepressants, serum barbiturates, and serum benzodiazepines, are projected for launch by early 2008.

 

ARCHITECT System Acute Viral Hepatitis Panel

Announcing the addition of apolipoprotein B (ApoB) to the VAP Cholesterol Test. The VAP Test directly measures all major lipoproteins and subclasses. The ApoB parameter is a proprietary, patent-pending calculation based on the VAP Test Technology. The ApoB parameter is a significant addition to the VAP Cholesterol Test because it provides more precise information that allows physicians to stratify risk, lower LDL target levels, and treat patients more aggressively. The addition of a precise ApoB calculation without additional cost is a watershed moment for the healthcare community. For 20 years this has been the Holy Grail for researchers looking to accurately calculate ApoB using standard lipid parameters rather than ordering a separate test.

 

AxSYM® Anti-CCP Assay

The AxSYM Anti-CCP assay is now available for the AxSYM analyzer. Rheumatoid arthritis is a systematic autoimmune disease affecting approx. 1% of the general population. The disease is characterized by an inflammation of the synovial joints, which in turn can lead to progressive joint destruction and severely impact the quality of life. It is widely accepted that early therapy is vital in preventing irreversible damage and hence the need to diagnose rheumatoid arthritis as early in the disease course as possible. These findings indicate a very important role for AxSYM Anti-CCP antibodies to assist in the diagnosis and management of RA.

 

ARCHITECT Anti-HCV Supplemental Test Exclusion


Announcing the ARCHITECT Anti-HCV assay with supplemental test exclusion to the CDC guidelines for anti-HCV testing. Samples with an S/CO value >5.0 may be reported to physicians without further antibody analysis. Adopting the CDC guidelines improves the accuracy and utility of reported anti-HCV results in managing patients with hepatitis C virus. Moreover, this exclusion saves time and money by removing the need for costly RIBA supplemental testing. The ARCHITECT Anti-HCV assay is a fully automated, chemiluminescent microparticle immunoassy (CMIA) for the qualitative detection of antibody to hepatitis C virus (anti-HCV) in human serum and plasma.

 

AxSYM® Active-B12 Assay

Announcing the launch of the active-B12 holotranscobalamin (HoloTC) assay on the fully automated AxSYM analyzer. This new assay represents the first automated method for the determination of HoloTC in serum or plasma. Active-B12 levels are low in patients with biochemical signs of vitamin B12 deficiency, such as high levels of methylmalonic acid and/or homocysteine. Low values have also been reported in vegetarians, vegans, and apparently healthy elderly populations.


Precision Xceed Pro™ System

The Precision Xceed Pro point-of-care diabetes monitoring system is designed with proprietary TrueID™ and TrueMeasure® technologies to address the challenges of point-of-care testing in real-world conditions. TrueID patient identification technology is designed to display patient name, gender, and date of birth for operator confirmation. Glucose and ß-ketone test strips with TrueMeasure technology are designed to detect an adequate sample prior to initiating the assay and to require only a small amount of blood. The Precision Xceed Pro system is under development; it has not been cleared by the FDA for sale in the U.S. The performance characteristics of this product have not been established.



Advanced® Model 2020 Multi-Sample Micro-Osmometer

Requiring only a 20-µL sample, the Advanced Model 2020 Micro-Osmometer uses a small sample volume to optimize precision and accuracy while maximizing productivity, testing up to 20 samples without reloading. Test sequences can be interrupted to run a STAT test, without affecting the overall workflow. The instrument's memory stores and retrieves up to 200 results. The calibration routine controlled by a microprocessor; therefore, it is very stable and does not require frequent maintenance. The on-board printer connects to an external printer, computer, or barcode scanner, and the LCD panel can be set to display commands and results in 11 languages, making it the osmometer of choice in laboratories worldwide.


Affimetrix Clinical Services Laboratories (ACSL)

ACSL specializes in clinical trial and patient testing services for gene expression monitoring, genotyping, and chromosomal copy number analysis based on the proven GeneChip® platform. Standard services include: automated or manual DNA/RNA extraction from a variety of sample types; assay validation and optimization for clinical laboratory practice; automated or manual assay services for clinical trials or patient testing; and standardized, reproducible analysis methods with integrated data management and reporting capabilities. Optional services are: documentation of protocols and processes, onsite training for clinical laboratory personnel on diagnostic assays, and sample preparation and storage.



INSTANT-VIEW® Test

The INSTANT-VIEW test is a true one-step, saliva-based, rapid immunoassay for the detection of cocaine, methamphetamine, opiates, THC, and amphetamine or PCP. The subject places the device inside their mouth for 2 to 4 minutes, and then the results are read visually or scanned with an electronic reader. Results are obtained in 4 to 7 minutes—no additional handling steps are required. Witnesses can easily observe the test, thus making it difficult to adulterate results. This one-step system will have great utility in on-scene applications where the reliability of the test and quick assay turnaround time is critical.



S40 Clinical Chemistry Analyzer

Introducing the S40 clinical chemistry analyzer. This revolutionary desktop clinical chemistry system combines the accuracy and flexibility of large-scale systems with the ease of use and convenience required in the POL setting.



ROLLER 10 ESR Analyzer

Using new patented technology, the ROLLER 10 fully-automated erythrocyte sedimentation rate analyzer reports results in 20 seconds from the primary tube. The ESR test accuracy has been improved with the introduction of the first reliable, standardized quality control by latex controls, calibrators, and the external quality evaluation for intra-laboratory control programs. A new multiparameter card provides associated parameters such as anemia factor, hematocrit, hemoglobin, viscosity, and aggregation factor, all performed simultaneously to the ESR analysis. The combination of these features offers new added value in the diagnosis of inflammatory states.



Vitamin Identification Assays

Determination of vitamins with methods such as HPLC or cultivation of bacteria requires a lot of time and personnel. Now with the new ID-Vit® assays, biologically active B-group vitamins can be determined turbidometrically through bacterial growth in microtiter plates. Microtiter plate wells are coated with non-infectious microorganisms that metabolize the analyte. With the addition of media, including the samples, standards, or controls, the bacteria are revitalized and grow in proportional to the amount of vitamin present in the sample. ID-Vit assays are available for vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, pantothenic acid, folic acid, and biotin.

 

A New Prognostic Factor for Arteriosclerosis

The ADMA direct ELISA detects ADMA in serum and plasma with an excellent correlation to LC/MS. An endogenous inhibitor of NO synthase, elevated ADMA - asymmetric dimethylarginine concentrations - in blood cause deficiency of endothelial produced NO and endothelial dysfunctions. Both are considered to be an essential contribution to the development of arteriosclerosis. In dialysis patients, the degree of arteriosclerosis correlates significantly with elevated ADMA levels in blood, making ADMA an important prognostic cardiovascular risk factor for patients with arteriosclerosis, coronary artery disease, peripheral arterial occlusive disease, hypertension, chronic heart failure, hypercholesterolemia, chronic renal failure, or diabetes mellitus.

 

Multimeric Adiponectin ELISA Kit

Introducing the ALPCO ELISA kit, the only ELISA kit capable of quantifying HMW, MMW, LMW, and total adiponectin concentrations in a single-test system. Adiponectin, an adipocytokine, circulates in human blood in various oligomeric complexes, including trimeric low molecular weight (LMW), hexameric middle molecular weight (MMW), and high molecular weight (HMW). Recent publications suggests that the HMW adiponectin/total adiponectin ratio in circulation is a better indicator of T2DM, metabolic syndrome, and vascular disease pathogenesis than measurements of total adiponectin alone. Until recently, analysis of adiponectin multimers required laborious and time-consuming techniques such as gel filtration and velocity gradient.



PCS®plus with the Latest Pipette Tracker™ Enhancements

The PCSplus system with the latest Pipette Tracker™ (APT) software enhancements is a total management system for quality control of pipettes and pipetting. PCSplus automates data collection, facilitates scheduling compliance, documents pipette performance, produces reports, and helps lab managers monitor pipetting quality. The APT Enhancements package includes a bar code scanner and label printer that makes identifying and printing calibration stickers a snap. Bar code and calibration labels for each pipette indicate the last calibration, next calibration, and technician identification. Data maintained by PCSplus for all calibrations and verifications can be analyzed for performance trends, and technicians' pipetting proficiency can be quickly tested and documented.


VAP® Cholesterol Test

Announcing the addition of apolipoprotein B (ApoB) to the VAP Cholesterol Test. The VAP Test directly measures all major lipoproteins and subclasses. The ApoB parameter is a proprietary, patent-pending calculation based on the VAP Test Technology. The ApoB parameter is a significant addition to the VAP Cholesterol Test because it provides more precise information that allows physicians to stratify risk, lower LDL target levels, and treat patients more aggressively. The addition of a precise ApoB calculation without additional cost is a watershed moment for the healthcare community. For 20 years this has been the Holy Grail for researchers looking to accurately calculate ApoB using standard lipid parameters rather than ordering a separate test.



 

INFINITI™ CYP 2C9-VKORC1 ASR

Announcing the availability of a new multi-variate panel of 15 genetic variants for 2C9/VKORC1 that allows for improved characterization of patients from diverse ethnic backgrounds. Pharmacogenetic analysis of warfarin metabolizing enzyme CYP450 2C9 and the gene encoding Vitamin K epoxide reductase complex 1 (VKORC1) have been shown to influence warfarin maintenance dose. Patients of Chinese ancestry display a greater sensitivity to warfarin than do Europeans, while African-Americans are less sensitive. The INFINITI analyzer is an automated multiplexing, microarray platform that delivers amplified sample to results without manual intervention. The analyte specific reagent (ASR) includes the Intellipac™ and Amp Mix products.

INFINITI™ HPV-Quad ASR

Announcing the availability of a new HPV viral type identification assay for the INFINITI analyzer, allowing labs to simultaneously detect 15 HPV types in four individual samples with a single assay. Human papillomavirus (HPV) types 16, 18, 59, 45, and 33 have been associated with greater risk in developing both squamous and adenocarcinoma cervical cancers. The INFINITI analyzer is a fully automated, multiplexing, microarray processing platform that delivers amplified sample to results without manual intervention. The INFINITI HPV-Quad ASR simultaneously detects a total of 15 HPV types in a single patient sample, including the individual identification of 5 major high risk types while providing test results four times faster. The analytical and performance characteristics have not been established for the analyte specific reagent (ASR).



ChroMate™ 8-Channel Microplate Reader

Introducing the ChroMate instrument, a compact, eight-channel microplate reader with a streamlined design and minimal footprint, offering superb optics to fit any size lab bench. The ChroMate microplate reader and your PC team up to provide rapid reading and full access to high-level software, reporting, curve fitting, and data storage to meet the requirements of modern laboratories. The ChroMate instrument and its software are ready to “plug and play” with your PC.

 


AxSYM® Active-B12 Assay

The AxSYM Active-B12 assay is a microparticle enzyme immunoassay (MEIA) for the quantitative determination of human holotranscobalamin (HoloTC) in human serum or plasma. Active-B12 is used as an aid in the diagnosis and assessment of vitamin B12 deficiency. The AxSYM Active- B12 assay measures the bio-available form of vitamin B12. Studies have shown that, depending on the total B12 assay and the patient population, an indeterminate zone exists between approximately 150–300 pmol/L. There is likely to be misclassification of B12 status if relying on total serum B12 alone. This direct, fully automated test does not require sample pre-treatment, unlike several total vitamin B12 assays.

 

AxSYM® Anti-CCP Assay

The AxSYM anti-CCP assay is a microparticle enzyme immunoassay (MEIA) designed for the semi-quantitative determination of anti-CCP antibodies in serum and plasma. Detection of antibodies is used as an aid in the diagnosis of rheumatoid arthritis (RA) and should be used with other clinical information. Incorporating features such as short assay times of 19 minutes to first result, extended dynamic range, ready-to-use reagents, auto-dilution facility, stored calibration curve, and full automation, the AxSYM anti-CCP test is an ideal platform for the routine testing of this important parameter.