PRODUCT SPOTLIGHT: November 2012: Infectious Disease Testing


OraSure OraQuick advance HIVRapid HIV-1/2 Antibody Test

Results in as little as 20 minutes

The OraQuick Advance® Rapid HIV-1/2 antibody test from OraSure, Bethlehem, Pa, is an FDA-approved, CLIA-waived, rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2. It does so with greater than 99% accuracy in as little as 20 minutes, using an oral fluid, fingerstick or venipuncture whole blood, or plasma sample. The test is designed for use by laboratories, physician’s offices, public health and outreach organizations, and emergency departments.

OraSure Technologies Inc

(800) 869-3538;

BioFire FilmArraySystem2Respiratory Panel

Simple, 2 minutes of hands-on time

The FDA-cleared FilmArray respiratory panel from BioFire Diagnostics Inc, Salt Lake City, is a user-friendly multiplex PCR that tests for a comprehensive panel of 20 viruses and bacteria commonly known to cause upper respiratory tract infections. The panel runs on the FilmArray system, which integrates sample preparation, amplification, detection, and analysis into one system. Requiring 2 minutes of hands-on time, the FilmArray respiratory panel has a total run time of about 1 hour.

BioFire Diagnostics Inc

(801) 736-6354;


For accurate, routine testing

MRSA/SA ELITe MGB® is a qualitative, real-time PCR test for the direct detection of MRSA and S. aureus DNA purified from human nasal swabs. The test, from ELITech Molecular Diagnostics, Princeton, NJ, simplifies MRSA and S. aureus prevention and surveillance by accurately detecting S. aureus with a low false negative and false positive rate. False negative and false positive results of MRSA and S. aureus present serious health care and economic challenges for health care providers. The design of the test addresses a critical unmet need for routine screening of nasal swabs for MRSA and S. aureus by offering better detection, effective control, and prevention for improved patient outcomes.

ELITech Molecular Diagnostics

(877) 797-5822;

G-Sphere small-300x240Synthetic Genes

Provide stable, consistent control

The solution to improve and simplify quality control from Phthisis Diagnostics, Charlottesville, Va, is the G-Sphere® Molecular Standards product line. G-Sphere® Molecular Standards are synthetic genes that provide stable, consistent, and abundant controls for many organisms and virtually any molecular assay. They are consistent, meeting cGMP standards; useful for positive, internal, extraction, or other controls; and made of nonhazardous material.

Phthisis Diagnostics

(434) 293-8180;

OraSure The OraQuick.HCV Rapid Antibody TestHCV Rapid Antibody Test

More than 98% accurate

The OraQuick® HCV test from OraSure, Bethlehem, Pa, is an FDA-approved, CLIA-waived, point-of-care test for detecting HCV antibodies in fingerstick and venipuncture whole blood. The simple platform enables health care providers to deliver an accurate diagnosis in 20 minutes. With clinically proven performance, the test is greater than 98% accurate and is designed to be used in laboratories, public health settings, physician’s offices, community health clinics, and emergency departments.

OraSure Technologies Inc

(800) 869-3538;

cobas 4800 sytemCT/NG Test

Offers automation of nucleic acid purification

The cobas® CT/NG Test from Roche Diagnostics, Indianapolis, detects Chlamydia trachomatis and Neisseria gonorrhoeae in a multiplex dual probe real-time PCR assay. It may be used with vaginal swab specimens self-collected in a clinical setting or with male urine from symptomatic or asymptomatic individuals. The cobas 4800 system offers true walk-away automation of nucleic acid purification, PCR setup, and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. It also runs the cobas HPV Test and cobas BRAF V600 Mutation Test and needs minimal daily maintenance.

Roche Diagnostics

(800) 428-5076;

Abbott HIV assayHIV, HIV-2 Diagnostic

Designed for children and pregnant women

The ARCHITECT HIV Ag/Ab Combo assay from Abbott, Abbott Park, Ill, is a chemiluminescent microparticle immunoassay (CMIA) for the simultaneous qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in human serum and plasma. The assay is an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in pediatric subjects as young as 2 years old and in pregnant women. HIV combination assays help to identify acute HIV infections that cannot be detected by antibody-only assays. As a result, the tests can aid in the early diagnosis of acute HIV infection, early counseling, and treatment of an infected patient, and the unknowing transmission of the virus to others.


(847) 937-6100;

Simple NA smallNucleic Acid Extraction Kit

DNA/RNA can be used right away or stored

The E-Sphere® Simple NA Kit from Phthisis Diagnostics, Charlottesville, Va, uses a streamlined process to extract total nucleic acids from samples prior to PCR and other molecular applications. Using a high-performance enzyme, the E-Sphere process is faster than traditional methods involving beads, silica, binding, washing, and eluting. A sample is first homogenized using the E-Sphere Buffer. In the second step, the thermostable E-Sphere Enzyme digests inhibitory material and releases DNA and RNA from samples at 75°C. During the final step, the proprietary E-Sphere clean-up column purifies the total nucleic acid. High-quality DNA/RNA is extracted for molecular applications, or it can be stored at ≤ -20°C for future use. The process can purify 12 samples in less than 30 minutes.

Phthisis Diagnostics

(434) 293-8180;

Life Technologies - 7500 Fast Dx RT-PCR left facing flatReal-Time PCR Instrument

For use with CDC human influenza virus

The 7500 Fast Dx Real-Time PCR Instrument from Life Technologies Inc, Carlsbad, Calif, is a 96-well, five-color, real-time PCR instrument. The instrument received 510(k) clearance from the FDA in 2009 for use with the CDC human influenza virus, real-time RT-PCR detection and characterization panel (rRT-PCR Flu Panel), and Quidel’s Molecular Influenza A+B and hMPV assays. The instrument’s fast mode completes runs in less than 40 minutes, and the instrument accommodates tube strips, which can be capped immediately after pipetting each sample. Security features such as user login, user-permission settings, system auditing, and e-signature approvals are customizable to a range of security needs.

Life Technologies Inc

(800) 955-6288;

Roche cobas HPV TestHPV Test

Provides results on the highest-risk genotypes

The cobas® HPV Test, from Roche Diagnostics, Indianapolis, enables health care providers and their patients to know more about a patient’s cervical cancer risk. It simultaneously provides pooled results on high-risk HPV genotypes and individual results on the highest-risk genotypes, HPV 16 and HPV 18, which are responsible for more than 70% of cervical cancer cases. The three-in-one test gives health care providers three results from one sample and one test. The test runs on the fully automated cobas 4800 system.

Roche Diagnostics

(800) 428-5076;

Roche AmpliPrep.TaqManCMV Viral Load Test

Helps manage patients, especially those with suppressed immune system

The new cytomegalovirus viral load test from Roche Diagnostics, Indianapolis, is the first FDA-approved laboratory test for quantifying DNA of this potentially deadly virus. Physicians use information from the test, called AmpliPrep/cobas® TaqMan®, to help them manage patients who have been diagnosed with CMV disease, specifically patients with an immune system that has been suppressed for solid organ transplantation. In this population, the test can be used to assess virological response to antiviral treatment. The real-time polymerase chain reaction (PCR)-based CMV test provides standardization of CMV viral load monitoring with traceability to the WHO International CMV standard. It is designed for use on Roche’s fully automated cobas AmpliPrep/cobas TaqMan System.

Roche Diagnostics

(800) 428-5076;