Molecular Lab Consulting and Web-Based Interpretations

Conduct high-value molecular tests in-house

Access Genetics, Minneapolis, provides comprehensive molecular laboratory consulting, training, and support services, as well as Web-based diagnostic interpretations, to leading clinical laboratories nationwide. Its staff of molecular lab experts assists CLIA-certified, highly complex labs with the implementation and ongoing operation of in-house molecular diagnostic programs. Using its Web-based molecular information system, Access Genetics' partner labs conduct high-value genetic tests for inherited disorders, infectious diseases, and other panels, often with existing resources and staff. The company's certified medical technologists and ACMG-certified pathologists support in-house programs with online, real-time interpretations and reporting. The turnkey molecular testing model is designed to help labs overcome many of the common barriers associated with establishing in-house molecular capabilities. Access Genetics recommends a tailored, cost-effective, and state-of-the-art suite of hardware, software, prepackaged supplies, process guides, and Web-based tools; along with staff training, technical support, and other consultative services.

Access Genetics (888) 250-4407; www.access-genetics.com

Accurate Liquid Delivery

Rapid verification

Artel, Westbrook, Me, offers its Pipette Calibration System (PCS) and Multichannel Verification System (MVS), tools that rapidly verify the accuracy and precision of liquid-delivery devices. With the ability to measure small volumes at the benchtop level, the technologies provide data integrity and help laboratories avoid failed assays, inefficiency, and noncompliance. As tested liquid volumes decrease in size, minor fluctuations have a greater impact on assay results because the chemistries of the measured reactions are more sensitive. Designed to offset this risk in molecular laboratories where technicians typically work with volumes in the 10-µL to 20-µL range and employ liquid-handling instrumentation throughout the testing process, the Artel PCS can be used to verify single-channel devices and MVS can be used to verify multichannel and automated devices. The systems are based on ratiometric photometry, which measures light absorption by two reagents to combat problems associated with small-volume measurement. Completing calibration in minutes, the MVS and PCS also provide automated calculation and documentation of NIST-traceable results.

Artel (207) 854-0860; www.artel-usa.com

Nucleic Acid Sample Preparation

Output to a range of labware formats

Beckman Coulter Inc, Fullerton, Calif, has introduced the Vidiera NsP Nucleic Sample Preparation Platform for flexible, automated extraction and downstream reaction setup. The platform can prepare up to 96 patient samples from primary tubes in just 21¼2 hours; and performs onboard quantitation, normalization, and PCR reaction setup in 30 minutes each. Based on the company's proprietary primary tube-handling technology and proven Biomek automation, this platform can replace several instruments, enabling labs to centralize preanalytical functions in one room. The platform allows the use of a variety of primary tube sizes and can output to a wide range of labware formats. The system's software provides flexible results reporting and security levels. Predefined, editable protocols automate extraction, quantitation, normalization, and reaction setups; while user-defined protocols accommodate home-brew extraction applications. Through an agreement with Qiagen GmbH, Beckman Coulter will offer custom QIAamp extraction reagents for the reliable and efficient purification of viral nucleic acids from serum and plasma samples, as well as genomic DNA from blood samples. The Vidiera NsP platform and reagents are designed for both virology and pathology applications and can be integrated with Beckman Coulter's new Vidiera NsD Nucleic Sample Detection System.

Beckman Coulter Inc (800) 742-2345; www.beckmancoulter.com

Extractable Quality Control

Validated on most CF test methods

Maine Molecular Quality Controls Inc, Scarborough, Me, has received FDA clearance for its Introl CF Panel I Control, an extractable quality control for cystic fibrosis molecular test systems. The control contains 42 mutations and polymorphisms, including those required by ACMG and ACOG, and can monitor all 42 variants efficiently in just three or four bottles. The control has been validated on most extractions and CF test methods; and works well for daily quality control, lot-to-lot comparisons, and new method validations. Quality-control documentation is streamlined, and technologist time is reduced by having lot numbers to track. This line of products is extractable and therefore monitors the extraction step as required by regulations and best practice. The increasing complexity of molecular assays makes quality control of the extraction step important, because variations in the amount of DNA can affect test results in unexpected ways. Introl CF Panel I is a reproducible source of reference material to monitor system performance over time to predict system problems before failure occurs.

Maine Molecular Quality Controls Inc (207) 885-1072; www.mmqci.com

Nucleic Sample Detection

Able to rush samples

Beckman Coulter Inc, Fullerton, Calif, makes the Vidiera NsD Nucleic Sample Detection Platform, a fully automated system that detects postamplification nucleic acids. The new platform for molecular pathology labs separates DNA molecules by capillary electrophoresis, with software features that deliver a high degree of productivity and flexibility. The platform has the capacity to run two 96-well plates, and the second plate can be added while the first plate is running. This plate flexibility allows technicians to add rush samples during the run. Vidiera NsD significantly reduces the technician time required to separate nucleic acids for further analysis, running batches of eight samples in as little as 30 minutes. The technician can change onboard supplies such as separation gels and capillary arrays. The platform is offered with accessories to help high-complexity laboratories develop assays in the fields of hematology, oncology, cardiovascular health, and inherited disorders.

Beckman Coulter Inc (800) 742-2345; www.beckmancoulter.com

PCR-based Test

Offers fully automated specimen preparation

The Cobas AmpliPrep/Cobas Amplicor HIV-1 Monitor Test, version 1.5, is a PCR-based test that offers fully automated specimen preparation followed by fully automated amplification and quantification of the HIV-1 RNA for viral load monitoring. The key innovation in these upgraded products is the automation of specimen preparation using the Cobas AmpliPrep instrument. The Cobas AmpliPrep was designed to deliver consistent specimen preparation for nucleic acid tests. The power of automation for the specimen-preparation process yields enhanced operational efficiencies for laboratories that use PCR-based diagnostic tests for the quantification of HIV RNA and the detection of HCV RNA. Roche Diagnostics also offers the Cobas AmpliPrep/Cobas Amplicor HCV Test, version 2.0, which provides fully automated specimen preparation followed by fully automated amplification and detection of the HCV viral RNA.

Roche Diagnostics (317) 845-2000; www.roche-diagnostics.us

NGEN Reagents

Analyte Specific

NGEN brand analyte-specific reagents are available for clinical laboratories interested in developing homebrew clinical tests for specific human genetic and microbial applications. The NGEN RVA ASR detects nucleic acid sequences from the following viruses: human parainfluenza (HPIV) 1, 2, and 3; influenza (INF) A and B; and respiratory syncytial viruses (RSV) A and B. While all seven viruses are detected, the assay does not distinguish between RSV A and RSV B. The NGEN Factor V/prothrombin ASR detects sequences associated with both the Factor V and prothrombin genes. This ASR interrogates the G1691A mutation on the Factor V (Leiden) gene and the G20210A mutation on the prothrombin gene. The NGEN CFTR plus ASR in development has been completely redesigned from its Nanogen predecessor. All 23 recommended ACOG markers can be interrogated from a single amplification step. The region amplified by the ASR includes more than 600 CFTR markers, which allows laboratories to include additional markers associated with regional populations without requiring a secondary amplification. NGEN reagents are used to detect nucleic acid sequences for specific organisms or genetic mutations. These reagents can be used with PCR amplification and hybridization-detection systems using fluorescently labeled probes on a streptavadin-bound substrate.

Nanogen Inc (877) 626-6436; www.nanogen.com