Real-Time PCR Instrument
Completes runs in less than 40 minutes
The 7500 Fast Dx Real-Time PCR Instrument from Life Technologies Inc, Carlsbad, Calif, is a 96-well, five-color, real-time PCR instrument. In September 2009, the 7500 Fast Dx received 510(k) clearance from the FDA for use with the CDC human influenza virus, real-time RT-PCR detection and characterization panel (rRT-PCR Flu Panel). 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 ?t a range of security needs. The instrument is supported by the assurance service plan for diagnostics, which includes instrument installation qualification, operation qualification, and performance qualification (IQ/OQ/PQ); spectral calibration and software setup; emergency repair, including parts and labor, and OQ/PQ after any major part change; and planned maintenance every 12 months.
Life Technologies Inc
Kit for Parainfluenza Strains
Diagnosis and differentiation of viral respiratory disease
Gen-Probe Inc, San Diego, offers ProParaflu+, a real-time multiplex RT-PCR kit for detection and differentiation of parainfluenza 1, parainfluenza 2, and parainfluenza 3. It serves as a tool for the diagnosis and differentiation of viral respiratory disease. ProParaflu+ is compatible with automated nucleic-acid extraction technology, which minimizes hands-on time and expedites time to results, which can be obtained in 2 hours from ProFlu+ nucleic acids.
hMPV Detection Kit
Real-time RT-PCR kit
Pro hMPV+ is a real-time RT-PCR kit for detection of human metapneumovirus (hMPV) from nasopharyngeal swab (NP) specimens obtained from individuals exhibiting signs and symptoms of acute respiratory illness. Results can be obtained in as little as 2 hours from ProFlu+ nucleic acids. The test is compatible with automated nucleic-acid extraction technology, which minimizes hands-on time and expedites results.
Diagnostic Influenza Test
Aids in diagnosis of Influenza A and B
Sekisui Diagnostics LLC, Framingham, Mass, offers an easy-to-run, easy-to-read rapid test to aid in the diagnosis of influenza A and B from nasal swab specimens, suited for nonwaived labs and physician’s offices. The test differentiates between influenza A and B. Purchase of the product includes two additional test sticks for running external quality control. The test is suited for room-temperature storage. Controls are included in the kit.
Sekisui Diagnostics LLC
Streptococcus Pneumoniae Test
Rapid identification of S. pneumoniae in urine, CSF
The BinaxNOW® Streptococcus pneumoniae test from Alere North America Inc, Orlando, Fla, provides accurate, rapid identification of S. pneumoniae in urine and cerebral spinal fluid (CSF) with an easy-to-use technology, aiding physicians in providing rapid, focused therapy.
Alere North America Inc
Influenza Detection Tests
Gen-Probe Inc, San Diego, offers ProFlu+, a real-time multiplex RT-PCR kit for detection and differentiation of influenza A, influenza B, and RSV. ProFlu+ is a molecular test for detection of influenza, and a common internal control allows for reflex testing to other Prodesse assays. Results can be obtained in less than 4 hours. ProFAST+ is a real-time multiplex RT-PCR kit for detection and differentiation of influenza A virus subtypes seasonal A/H1, seasonal A/H3, and 2009 H1N1 influenza virus. ProFAST+ is a companion assay for ProFlu+. Subtyping results are available in 2 hours from ProFlu+ nucleic acids.
Viral Transport Medium
Collection, transport, maintenance, and storage of viruses
Universal Transport Medium (UTM) from COPAN Diagnostics, Murrieta, Calif, is the company’s room-temperature-stable viral transport medium for collection, transport, maintenance, and long-term freeze storage of viruses, such as influenza H1N1, chlamydia, mycoplasma, and ureaplasma specimens. UTM has been used successfully for rapid antigen testing, DFA, culture, and for molecular-based assays. UTM systems are available with two different tube sizes and different media fill volumes. UTM tubes are available in bulk or as patient-collection packs that incorporate different combinations of polyester or flocked swabs and media tubes to suit different work patterns and preferences. Three glass beads in each tube facilitate the release and dispersion of patient sample material and virus particles from the swab during vortexing, while the skirted tube with distinctive internal conical shape enables centrifugation of samples and allows the tubes to stand upright on the laboratory bench.
Qualitative detection of respiratory syncytial virus
The QuickVue RSV 10 test from Quidel Corp, San Diego, is a dipstick immunoassay that allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) directly from nasopharyngeal swab or nasopharyngeal aspirate/wash specimens for symptomatic patients 5 years of age and younger. QuickVue RSV 10 has few procedural steps. Results are seen in 10 minutes or less with 30 seconds’ hands-on time. A color-coded procedure card helps demonstrate each step of the test. The kit contains everything needed to run the test, as well as both positive and negative controls, and may be stored at room temperature with a 24-month shelf life from date of manufacture. A single sample can be used to run both the QuickVue RSV 10 test and QuickVue Influenza A+B test.
Real-Time PCR Kit
Detects human Adenovirus serotypes 1 to 51
ProAdeno+ from Gen-Probe Inc, San Diego, is a real-time PCR kit for the detection of human Adenovirus serotypes 1 to 51 and is FDA cleared for respiratory indications. With results available in as little as 3 hours, ProAdeno+ is easy to use and implement in the lab.
Strep A Test
Detection of group A streptococcal antigen
The QuickVue+ Strep A test from Quidel Corp, San Diego, allows for the rapid detection of group A streptococcal antigen directly from throat swabs and beta-hemolytic colonies on blood agar plates. A clearly distinguishable +/- end point and two-reagent extraction make testing easy. A Test Complete indicator appears in about 5 minutes to let users know the test can be read. Overall accuracy of the test is 98%, with a sensitivity of 95% and a specificity of 98%. The built-in controls satisfy CLIA requirements for daily QC. The kit stores at room temperature and contains positive and negative external controls.
No internal absorbent core
COPAN Diagnostics, Murrieta, Calif, offers patented flocked swabs, which are comprised of a solid molded plastic applicator shaft with a tip that can vary in size and shape. The tip of the applicator is coated with short nylon fibers arranged in a perpendicular fashion. This perpendicular arrangement results from a process called flocking, where the fibers are sprayed onto the tip of the swab, while it is held in an electrostatic field. This process creates a highly absorbent thin layer with an open structure. Unlike traditional fiber-wound swabs, Copan flocked swabs have no internal absorbent core to disperse and entrap the specimen; the entire sample stays close to the surface for fast and complete elution. The perpendicular nylon fibers act like a soft brush and allow improved collection of cell samples.
H1N1 Influenza Assay
Detects Influenza A and B,2009 H1N1
Simplexa™ Influenza H1N1 (2009) from Focus Diagnostics Inc, Cypress, Calif, is a real-time RT-PCR assay intended for the in vitro qualitative detection and discrimination of influenza A and 2009 H1N1 influenza viral RNA. The assay was built in response to the 2009 H1N1 global influenza pandemic. Focus was granted the first commercial Emergency Use Authorization (EUA) from the FDA for the Focus Reference Laboratory’s Influenza A H1N1 (2009) assay, and another EUA in October 2009 for the Simplexa™ Influenza A H1N1 (2009) assay on the 3M™ Integrated Cycler (pictured). The assay was cleared for in vitro diagnostics use in May 2010.
Focus Diagnostics Inc
Influenza A+B Test
Differentiates influenza type A and type B antigens
The QuickVue Influenza A+B test from Quidel Corp, San Diego, detects and differentiates influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal wash, and/or nasal aspirate specimens. The test detects the highly conserved antigens in the viral nucleoproteins and is not adversely affected by the appearance of different influenza strains. QuickVue Influenza A+B is an easy-to-use test that has one step (nasal wash/aspirate), three steps (nasal/nasopharyngeal swab), and uses one reagent. Results are seen in 10 minutes or less with 90 seconds’ hands-on time. A color-coded procedure card helps demonstrate each step of the test. The kit contains everything needed to run the test, as well as both positive and negative controls, and may be stored at room temperature with a 24-month shelf life from date of manufacture. A single sample can be used to run both the QuickVue Influenza A+B test and the QuickVue RSV 10 test.
Detects Influenza A and B, RSV RNA
Simplexa™ Flu A/B & RSV from Focus Diagnostics Inc, Cypress, Calif, is a real-time RT-PCR assay intended for the in vitro qualitative detection and discrimination of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA. The assay was built after the 2009 H1N1 pandemic, which highlighted gaps in testing for influenza and accelerated the movement toward molecular diagnostics. Focus Diagnostics met the testing needs for 2009 H1N1 with its Simplexa Influenza H1N1 (2009) kit, and brings the same quality with its Simplexa Flu A/B and RSV assay.
Focus Diagnostics Inc