Urine Chemistry Controls for POCT
Independent QC for reliable patient test results
Liquichek Urinalysis, qUAntify and qUAntify Plus QC products from Bio-Rad, Hercules, Calif, are designed for rapid test environments where open vial stability at room temperature is needed. Easy-to-use packaging configurations include dropper bottles, centrifuge tubes and 120mL for larger labs. Liquid formulations add to user convenience by eliminating the need to reconstitute. Unity Interlaboratory Program allows users to keep track of QC results and quickly compare with other peer group users.
Bio-Rad Laboratories
(800) 224-6723; www.bio-rad.com
Rapid, Molecular TB Test
Also detects whether the strain may be multidrug-resistant
Cepheid, Sunnyvale, Calif, has just received FDA approval for its Xpert® MTB/RIF test for the rapid molecular detection of Mycobacterium tuberculosis complex (MTB-complex) DNA. Results can be made available to clinicians in about 2 hours. Designed for use on the company’s GeneXpert Systems, the test also detects the presence of mutations associated with resistance to rifampin, a critical first-line drug for treatment of the disease and a reliable surrogate marker of strains that may be multidrug-resistant (MDR-TB). While TB in the United States is at its lowest level since 1953, rapid and accurate diagnosis of TB continues to be a challenge, especially among immunocompromised patients and the elderly. For complete information, visit www.cepheid.com.
Cepheid
(408) 541-4191; www.cepheid.com
Liquid Urinalysis Control
Well suited for point-of-care testing
The Acusera Liquid Urinalysis control from Randox Laboratories, Kearneysville, WVa, is designed for use in the quality control of both manual and automated methods of urine test strip analysis. Assayed ranges are provided for 13 parameters. The liquid, ready-to-use test is available in either 12-mL vials or 25-mL dropper bottles and is particularly well suited for point-of-care testing.
Randox Laboratories-US Ltd
(866) 472-6369; www.randox.com
Respiratory Panel
Tests for 20 viruses and bacteria
The FDA-cleared FilmArray Respiratory Panel from BioFire Diagnostics Inc, Salt Lake City, is a multiplex PCR that tests for a comprehensive panel of 20 viruses and bacteria known to cause upper respiratory tract infections. The panel is run on the FilmArray system, which integrates sample preparation, amplification, detection, and analysis into one system. Requiring only 2 minutes of hands-on time, the panel has a total run time of about 1 hour.
BioFire Diagnostics Inc
(801) 736-6354; www.filmarray.com
Blood Gas Control
Use in routine monitoring of 10 blood gas parameters
The Acusera Blood Gas Control from Randox Laboratories, Kearneysville, WVa, is an aqueous control designed for use in the routine monitoring of 10 blood gas parameters. It is designed for use on a wide range of blood gas analyzers. The aqueous material is provided in easy-to-open ampules for added convenience.
Randox Laboratories-US Ltd
(866) 472-6369; www.randox.com
Liquid Cardiac Control
Monitors nine cardiac parameters
The Acusera Liquid Cardiac Control from Randox Laboratories, 
Kearneysville, WVa, is designed for use in the routine monitoring of nine cardiac parameters, including CK-MB (Mass), D-dimer, digoxin, homocysteine, Hs CRP, myoglobin, NT-proBNP, troponin I, and troponin T. The control is made with 100% human serum, meaning there are no animal constituent parts used in the manufacture of the product: It will behave in the same manner as a patient sample, with no shifts experienced when changing a batch of reagent.
Randox Laboratories-US Ltd
(866) 472-6369; www.randox.com
Smartphone-Based Reader
Gives immediate results
The Novarum Reader from Novarum DX Limited, Scotland, UK, uses smartphone-based software that can be developed to read any lateral flow test. Developed by NovarumDX, a joint venture company between BBI Solutions and Albagaia, the device provides reliable, reproducible readings and gives immediate pass/fail results.
Novarum DX Limited
+44 (0) 29 2074 7232; www.novarumreader.com
Multicolor, Qualitative Nucleic Acid
Hybridization Assay
Rapid ID of up to five Candida species
Yeast Traffic Light® PNA FISH® from AdvanDx Inc, Woburn, Mass, provides rapid identification of up to five Candida species, including C. albicans and/or C. parapsilosis, C. tropicalis and C. glabrata, and/or C. krusei, directly from yeast-positive blood cultures in just
90 minutes. The test enables microbiology labs to report identification results 2 to 5 days sooner than with conventional methods to help clinicians select appropriate antifungal therapy (fluconazole versus echinocandin) for patients with candidemia.
AdvanDx Inc
(866) 376-0009; www.advandx.com
Sofia Strep A FIA
Design reduces operator variability
The Sofia Strep A FIA from Quidel Corp, San Diego, is a rapid diagnostic 
test that uses immunofluorescence technology for the rapid qualitative detection of Group A Streptococcal antigen obtained from throat swabs of symptomatic patients. It was released in June 2013. Used with the Sofia Analyzer, this test offers enhanced assay sensitivity with results in 5 minutes and stores at room temperature with 24-month shelf-life from date of manufacture. Unlike a visually read result, Sofia offers an approach with lateral flow simplicity via optical sensors and proprietary algorithms that interpret signals and analyze the data, giving objective results to help reduce operator variability. Two work modes provide flexibility to meet the demand of varying test volumes.
Quidel Corp
(800) 874-1517; www.quidel.com
Handheld Rapid Blood Test Device
Ideal for point-of-care testing
AtomoRapid from BBI Solutions, UK, is a convenient, handheld rapid blood test device that eliminates the need for complex test kits containing multiple items. The integrated, blood-based lateral flow platform was released this year. It is ideal for medical practitioners to use in multiple settings, facilitating point-of-care testing.
BBI Solutions
(800) 423-8199; www.bbisolutions.com
Clostridium Difficile Assay
80-minute turnaround time
The AmpliVue C. difficile assay from Quidel Corp, San Diego, 
is a molecular diagnostic test for the qualitative detection and identification of toxigenic Clostridium difficile bacterial DNA from liquid and unformed stool specimens. Based on an isothermal DNA amplification technology called helicase-dependent amplification (HDA), AmpliVue delivers accurate molecular results that are easily visualized with a test and control line and sensitivity similar to conventional real-time PCR. AmpliVue is an easy-to-read handheld, cassette-based, disposable detection device eliminating the need for capital investment. The total turnaround time is approximately 80 minutes with minimal hands-on time.
Quidel Corp
(800) 874-1517; www.quidel.com
Molecular Test
Pathogen ID reporting with Gram stain results for positive blood cultures
QuickFISH™ from AdvanDx Inc, Woburn, Mass, is a molecular test that is fast enough to allow pathogen 
identification reporting with Gram stain results for positive blood cultures. Staphylococcus QuickFISH provides rapid identification of S. aureus and Coagulase-Negative Staphylococci (CoNS) directly from GPCC-positive blood cultures in just 20 minutes. Enterococcus QuickFISH BC provides rapid identification of E. faecalis and selected other enterococci (OE), directly from GPCPC-positive blood cultures also in 20 minutes. QuickFISH Gram-Negative, which is a new rapid molecular diagnostic test that identifies potentially life-threatening bloodstream infections caused by Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae, is awaiting FDA clearance.
AdvanDx Inc
(866) 376-0009; www.advandx.com
Influenza Test
Utilizes immunofluorescence technology
The Sofia Influenza A+B FIA test from Quidel Corp, San Diego, is a next-generation rapid diagnostic test 
that uses immunofluorescence technology to detect influenza A and influenza B viral nucleoprotein antigens from nasal swab, nasopharyngeal swab (NPS), and NPA/wash samples. The test is run on the Sofia analyzer. Different work modes provide flexibility to meet the demand of varying test volumes, accommodate various work environments, and optimize workflow. Multiple fail-safe features, including user lockout, onboard quality control, and automatic calibration, assure proper operation of the analyzer.
Quidel Corp
(800) 874-1517; www.quidel.com
