Digital readout of results
The BD Veritor™ System for rapid detection of Flu A+B has received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA). The System provides objective results on an easy-to-read digital display, unlike CLIA-waived rapid influenza tests which require a subjective visual test interpretation to determine a positive or a negative test result. This newly designed system incorporates BD's Nano Detection Particle and Adaptive Read Technology. With this combination of technologies, the system offers users a convenient workflow; few, easy steps requiring very little sample preparation; no sample incubation required prior to running the test; ten-minute period for the test to run; and ten seconds of instrument read for final results.
Eliminate nucleic-acid sample extraction process
The FDA has granted 510(k) clearance to Simplexa C. difficile Universal Direct Test on the 3M™ Integrated Cycler for availability in the United States. The test is intended to aid in the diagnosis of Clostridium difficile-associated disease. It uses a proprietary technique to eliminate the time-consuming nucleic-acid sample extraction process required by many other molecular tests. Simplexa tests, running on the 3M™ Integrated Cycler, employ real-time polymerase chain reaction (RT-PCR) to qualitatively detect viruses, bacteria, and other analytes. The test is performed on liquid or unformed human stool samples and detects the toxin B gene (tcdB) of C. difficile, including NAP1. Using the Simplexa test, the entire testing process may be completed in about an hour.
Diagnose influenza within minutes
The Sofia Analyzer and the Sofia Influenza A+B Fluorescent Immunoassay (FIA) for the rapid, differential detection of Influenza types A and B have received Clinical Laboratory Improvement Amendments (CLIA) waiver from the FDA for nasal swab and nasopharyngeal swab specimens only. The simple-to-use Sofia Analyzer and Sofia Influenza A+B FIA employ software and immunofluorescence-based chemistry to yield an automated, objective, and highly reliable result for aiding in the diagnosis of influenza within minutes of obtaining the swab specimen from the patient.
Kit for extracting nucleic acid
The E-Sphere® Simple NA Kit is part of the Simply Molecular® product catalog. The E-Sphere is a simple nucleic-acid extraction method for use with PCR applications. Its enzymatic digestion and proprietary purification process is an alternative to silica spin columns and other extraction methods. No binding, washing, or eluting is required. The E-Sphere simplifies workflow to just three stages and 9 steps, and will extract DNA and RNA from 12 samples in less than 30 minutes, which includes lysis, digestion, and purification. The process limits sample transfers to two, reducing the potential for error and contamination.
Rapid blood culture ID and resistance determination
The sample-to-result Verigene System's latest FDA-cleared infectious disease assay provides multiplexed, automated bacterial identification and resistance determination for the most common Gram-positive blood culture isolates directly from positive blood culture bottles. While conventional microbiological methods may require two to four days to produce bacterial identification and resistance results, this system provides results within 2.5 hours of blood culture positivity. The instrumentation allows for true random access test processing, enabling 24/7 on-demand testing directly from positive blood culture bottles with less than five minutes of user hands-on time per test.
Expanded respiratory panel
FilmArray RP is now FDA-cleared for 20 viral and bacterial respiratory pathogens. It now includes the first FDA cleared assays for eight of the 20 organisms on the panel. It is the only FDA-cleared panel capable of distinguishing between certain bacterial and viral respiratory infections. This advancement in the field of infectious disease detection provides clinical laboratories and physicians with more comprehensive, actionable information to guide treatment decisions and improve patient outcomes. The additional five pathogens are Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Coronavirus 229E, and Coronavirus OC43. Bordetella pertussis outbreaks in recent months have highlighted the need for an FDA-cleared test that can rapidly and accurately distinguish viral infections from more serious bacterial illness.
Testing for influenza type A and type B
The QuickFlu™ is an FDA-cleared in vitro rapid qualitative test for the detection and differentiation of influenza type A and type B. The test specimen is collected with a nasal swab, nasopharyngeal swab, or nasal aspirate/wash, and results are available in as little as 10 minutes. The QuickFlu provides proven clinical performance with >90% sensitivity and specificity vs. virus culture/PCR in all sample types and detected the pandemic 2009 H1N1 in 71.6% of CDC RT-PCR test positive specimens. Each kit includes CDC-recommended flocked swabs. Ready-to-use, room temperature stored reagents allow you to quickly begin testing. Testing can be delayed after specimen collection by up to four hours at room temperature, and longer if refrigerated, without the additional cost of transport media.
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CMV diagnosis
The CMV Brite™ immunofluoresence antigenemia kit is for in vitro diagnostic use as an aid in CMV diagnosis. It uses the well-defined C10/C11 antibody cocktail to detect the CMV lower matrix phosphoprotein (pp65), an early antigen in virus replication, which is abundantly present in antigen-positive polymorphonuclear cells (PBMCs). The kit offers a unique feature which allows for further susceptibility studies of the (positive) isolated PBMC fraction. Features and applications include: for use as an aid in diagnosis of active CMV infection; CMV antigen detection at the cellular level; two-hour turnaround time with the Turbo kit; useful in the following patient populations—bone marrow transplants; solid organ transplants; HIV-infected patients; and AIDS patients.
Easily handle difficult specimens
Snot Buster™ (aka SLSolution) is a premeasured, ready-to-use mucolytic agent, DDT (Dithiothreitol), which liquifies specimens without affecting microscoptic staining, morphology of organisms or polymorphonuclear leukocytes (PMNs), or growth on culture plates. Using the partner tool patent-pending Sputum Dipper™ with its drill-shaped design allows technologists to easily transfer a 1:1 ratio of sputum, irrespective of its consistency, into solution. The Snot Buster and Sputum Dipper provide a convenient and ready-to-use system for improving processing and quality of results from sputum specimens in terms of both culture and Gram staining analysis.
