AmpliTrol III

For HIV-1, Hepatitis B and C

Bio-Rad Laboratories Inc, Hercules, Calif, a multinational manufacturer and distributor of life science research products and clinical diagnostics, has announced the availability of AmpliTrol III, a liquid stable, third-party multianalyte quality control designed for nucleic acid testing (NAT) labs. This product is designed for use with qualitative in vitro diagnostic procedures for the detection of HIV-1, hepatitis B virus (HBV), and hepatitis C virus (HCV) nucleic acids in human serum or plasma. The control is used as a full-process positive external run control to monitor sample preparation, amplification, and detection procedures with many commercially marketed NAT systems such as the Roche COBAS AmpliScreen HIV-1 v1.5, Roche AmpliScreen HBV, Roche AmpliScreen HCV v2.0, and Chiron Procleix HIV-1/ HCV assays. Routine use provides laboratories with the means to monitor assay performance and assure quality on an ongoing basis. AmpliTrol III, conveniently packaged for commercial screening assays, is supplied as a ready-to-use liquid that can be sampled in the same manner as a test specimen.

Bio-Rad Laboratories Inc
(800) 224-6723
www.bio-rad.com

AtheNA Multi-Lyte

Tests for multiple diseases in a single well

Inverness Medical Professional Diagnostics, a wholly owned subsidiary of Inverness Medical Innovations Inc, Princeton, NJ, has made available the AtheNA Multi-Lyte MMRV IgG Test System, based on Luminex’s proprietary xMAP technology. The test system is intended for the qualitative detection of IgG-class antibody to measles, mumps, rubella, and varicella zoster in human serum simultaneously in a single well. The system allows for more reliable and accurate results over current methodologies since each result is the median of at least 50 discrete events. The system has the capability to report results separately and/or simultaneously and allows for additional results to be obtained well after the sample is discarded by analyzing data stored within the system. The system uses the proprietary Intra-Well Calibration Technology. Designed to provide improved accuracy, the technology includes a multipoint standard curve within the bead suspension. Each patient sample is calibrated internally without any user intervention. The standard curve is designed to self-adjust based upon the unique characteristics of the patient or control serum.

Inverness Medical Professional Diagnostics
(800) 257-9525
www.invernessmedicalpd.com

Liaison Borrelia Burgdorferi Assay

Early-stage Lyme disease detection

DiaSorin Inc, Stillwater, Minn, has received FDA clearance for its Liaison Borrelia burgdorferi assay. The company has joined the efforts of researchers to improve serological testing for Lyme disease by developing this new chemiluminescent immunoassay that couples high specificity and sensitivity. The improved specificity of the assay makes it possible to identify the reactive samples in the first testing step, reducing the amount of subsequent Western Blot testing. It is the first automated assay with greater sensitivity to detect early stages of the disease, enabling the clinician to identify patients who require prompt antibiotic treatment. DiaSorin is now expanding the infectious disease testing menu on the Liaison platform, which couples the advantages of automation and random access with the accuracy of chemiluminescience technology. The assay provides rapid results (35 minutes to first result) and fast turnaround time (90 results per hour).

DiaSorin
(800) 328-1482
www.diasorin.com

Dual Path Platform Technology

New platform for POC testing

Chembio Diagnostic Systems Inc has developed the patented Dual Path Platform (DPP) Technology as a platform for next-generation, rapid diagnostic testing. This technology allows freedom to operate in the point-of-care (POC) sector and offers a novel, low-cost, rapid methodology as an alternative to established single-path, lateral-flow formats. Advantages of DPP include increased analytical and clinical sensitivity, multiplexing capabilities, and quantifiable results. DPP provides RT storage, ready-to-use reagents, minimal sample volumes, prolonged shelf life, and an internal control. The technology is available for applications in diverse global diagnostic markets for human assays, food safety, bioterrorism, and environmental testing.

Chembio Diagnostic Systems Inc
(631) 924-1135
www.chembio.com

Tigris DTS System

Can process 500 samples in 8 hours

The Tigris DTS System from Gen-Probe, San Diego, automates all phases of molecular diagnostics testing from sample preparation, amplification, and detection to reporting results. Integrating the system with Aptima assay kits for nucleic acid testing offers true freedom from hands-on processing. The Tigris system is a high-throughput instrument for automating NAT testing, for use in the clinical, diagnostic, and blood screening markets. By utilizing direct tube sampling technology and an exclusive penetrable cap on the sample collection tube, the Tigris system allows for minimal contamination and safer, more convenient sample removal. Sample transport is simplified, sample handling is minimized, and laboratory cross-contamination is reduced. Tigris has the ability to process approximately 500 samples in an 8-hour shift and up to 1,000 samples in approximately 13 hours. Two systems can be operated under the supervision of a single lab technician.

Gen-Probe
(858) 410-8986
www.gen-probe.com

TrepSure

Detects both IgG and IgM

Trinity Biotech, Berkeley Heights, NJ, has announced the introduction of the TrepSure syphilis test to its current line of infectious disease test kits. TrepSure is a polyvalent assay for detection of IgG and IgM in varied stages of syphilis. It has high specificity and sensitivity, at 99+. A cocktail of recombinant antigens allows improved detection of syphilis with few false positives. TrepSure allows for objective reading of results, with no interpretation bias. Black-and-white results allow increased reporting accuracy. TrepSure uses neat sera or plasma, so there is no need for dilution of sera or plasma. It includes bar-code reading for positive patient ID and LIS interface to download worklist and upload results.

Trinity Biotech
(908) 898-1500
www.trinitybiotech.com

DiversiLab

Automates tracking source and spread of infection

bioMérieux, Durham, NC, through its subsidiary, Bacterial Barcodes Inc, recently introduced DiversiLab, a system that automates the process for tracking the source and spread of microbial infection or contamination. The system offers fast, precise solutions that are easy to implement in order to determine the source of an outbreak, understand how it spreads, take the necessary steps to control it, and monitor its epidemiology. DiversiLab is a useful tool for tracking health care-associated infections in hospitals. Based on patented rep-PCR technology, microbial isolates can quickly and accurately be distinguished at the subspecies and strain level. DiversiLab uncovers hidden reservoirs of resistance and can provide automated strain typing in about 4 hours. The system automates the previously cumbersome method of strain typing and allows for better genotypic characterization of bacteria, yeast, and molds, which helps identify the source and stop the spread of further infection.

bioMérieux
(800) 682-2666
www.biomerieux-usa.com

TrinBlot

Automated Western Blot testing system

Trinity Biotech, Berkeley Heights, NJ, has introduced the TrinBlot System, which comprises two main components—the TrinBlot processor and scanner. These components work with patented software to automate Western Blot testing, reducing technologist hands-on time. Additional benefits are derived from the convenience of the digitalized Western Blot results that can be uploaded to an LIS, or forwarded to physicians or other clinicians electronically. The processor automates the company’s MarBlot Western Blot Lyme products using a tray that performs multiple assays simultaneously. Once the assays are processed, the scanner uses innovative 3D scanning technology to digitalize test strips directly from the processor reaction tray and upload the results into the main system. Software then detects test-strip bands and links them to specific reference strips for Western Blot results. Test results are reviewed and verified by lab technicians before forwarding to physicians and clinicians.

Trinity Biotech
(908) 898-1500
www.trinitybiotech.com