Test for Lactose Intolerance
Simple breath test
Commonwealth Labs, Norwell, Mass, introduces a new test to diagnose lactose intolerance. After ingesting a lactose solution, the patient provides breath samples every 60 minutes over a 3-hour time period. Samples are then mailed to the laboratory. Analysis of the samples yields data on hydrogen and/or methane production during the digestive process. The graph produced using this data provides key indicators of the existence/extent of lactose malabsorption and is a clear and understandable tool that physicians may share with patients in reviewing their test results. Data from this test may also assist physicians in evaluating cases of irritable bowel syndrome.
Built on the Sensititre susceptibility platform
TREK Diagnostic Systems, Cleveland, introduces two new susceptibility plates—the YeastOne susceptibility plate for in vitro diagnostics and the research-use-only Sensititre Xtra Gram Negative MIC plate—both built on the company’s Sensititre pAlatform of susceptibility products. YeastOne is the first FDA-cleared in vitro diagnostic-labeled susceptibility product for testing Candida species. It isolates against four commonly prescribed FDA-cleared antifungal agents: voriconazole, fluconazole, 5-flucytosine, and itraconazole. The plate features standard 24-hour incubation, easy-to-read colorimetric end points, and on-scale QC ranges. The Sensititre Xtra plate incorporates 21 antimicrobic compounds, including doripenem, colistin, polymixin B, doxycycline, minocycline, ertapenem, and imipenem. Plates can be read manually with TREK’s Vizion® system, or read using the automated ARIS 2X System.
TREK Diagnostic Systems
CELLview Cell Culture Dish
Designed for high-res microscopy
The new CELLview product family, developed by Greiner Bio-One GmbH, Kremsmuenster, Austria, combines the convenience of a standard plastic cell culture dish with the high optical quality of a glass bottom. This new development facilitates high-resolution microscopic imaging of in vitro cultivated cells. The CELLview cell culture dish has been designed specifically for high-resolution microscopy and live cell analysis fulfilling the mentioned quality standards. The embedded, autofluorescence-free glass bottom enables detailed, noninvasive imaging of in vitro cultivated cells, ensures maximum spectral transmission, and prevents depolarization of light. The unique subdivided version of the dish for multiplex analyses reduces the required amount of cells and reagents and allows significant time savings in the test procedure.
Greiner Bio-One GmbH
Vitamin D Assay
Fast, sensitive, acetonitrile free
Spark Holland, Emmen, the Netherlands, has developed a new method for low-level determination of the 25-mono-hydroxy-metabolites of vitamin D2 and D3 in plasma. The assay is completely acetonitrile free, which avoids problems associated with the current acetonitrile shortage. Quantitation levels of around 1 ng/mL are reported using the Symbiosis™ system for HPLC with integrated Solid Phase Extraction linked to an Applied Biosystems API 4000 Mass Spectrometer. The assay involves almost no manual handling, as plasma samples are diluted with a newly developed protein-disrupting buffer, which also contains the internal standard. Samples are then placed in the autosampler for direct injection into the SPE-LC-MS/MS system.
T Cell Fx and MBL Pathway Function Tests
Evaluates response of patients’ immune systems
IBT Laboratories, Lenexa, Kan, launches both the T Cell Fx™ test and the Mannan Binding Lectin (MBL) pathway function test to evaluate the response of patients whose immune systems may be compromised for a variety of reasons. The MBL pathway function test evaluates the effectiveness of the MBL pathway, which is useful for assessing children with persistent, recurrent infections to determine whether their innate immune system is compromised, and for managing transplant and oncology patients by identifying when prophylactic measures are appropriate. The T Cell Fx test provides a complete evaluation of the ability of a patient’s T cells to protect from viruses, yeast, and bacteria. The test looks at peripheral blood mononuclear cells from whole blood to help physicians identify primary immunodeficiency in children with recurrent infections.
Rapid electroelution of nucleic acids and proteins
G-CAPSULE™, from G-Biosciences, St Louis, is a simple electroelution device that excises DNA or protein bands from agarose and polyacrylamide gels and elutes samples in a final volume of ~30 µL. Electroelution through the device is a gentle method that eliminates the risks of damage to DNA or protein samples commonly encountered in the use of glass milk, spin columns, binding columns, and other popular techniques. The method is simple to perform and eliminates additional steps involving washing, spinning, heating, or precipitation. The device contains two parts: G-Pick™ and G-Trap™. The user simply picks up the protein or nucleic acid band with the G-Pick and assembles it with the G-Trap. The assembled product can be submerged in electrophoresis buffer on a horizontal electrophoresis system, and the protein or nucleic acid is rapidly eluted into the G-Trap.
Q and S HyperCel Ion Exchange Sorbents
Optimum protein capture and impurity removal
Pall Life Sciences, East Hills, NY, introduces the Pall Q and S HyperCel™ ion exchange sorbents for processing large amounts of protein during the capture and intermediate steps of purification. The new sorbents with Q and S chemistries share the same HyperCel media platform with the company’s mixed-mode sorbents (MEP, HEA, and PPA HyperCel). HyperCel sorbents are structured on a mechanically and chemically stable base matrix designed for protein capture and impurity removal. The Q and S sorbents, which are suitable for laboratory and process-scale use, help process recombinant proteins, monoclonal antibodies, plasma derivatives, and other proteins from various feedstock. They are available in a variety of packaging configurations, including 1-mL prepacked PRC columns designed for fast methods optimization and selectivity screening.
Pall Life Sciences
MaxDiscovery Toxicity Assay Kits
Blood-based in vivo toxicity assays
The MaxDiscovery Toxicity Assay Kits, from Bioo Scientific, Austin, Tex, monitor in vivo toxicity by measuring liver and heart function in serum samples. The simple test allows the rapid, colorimetric determination of well-characterized functional markers of liver and heart toxicity. The test is ideal for monitoring toxic effects caused by administration of siRNA, DNA plasmids, transfection agents, or other therapeutic treatments during preclinical studies. The assays can be used in a range of mammals, including mice and rats, providing a powerful tool to assess and reduce the toxicity of drugs formulations and to improve drug-delivery methods.
Improved hemoglobin system
Stanbio Laboratory, Boerne, Tex, releases its CLIA-waived improved hemoglobin system, HemoPoint® H2. The new test system offers a 4,000-test-result memory, faster time to result, and battery backlighting feature. A hemoglobin and calculated hematocrit result can now be read in as little as 10 seconds, and time to result is approximately 65% faster. The system provides both a hemoglobin and hematocrit result, using a single drop of whole blood, with one simple test.
Certified Reference Materials
UV linearity reference sets extended
Starna Scientific, Atascadero, Calif, extends the absorbance-scale range of its potassium dichromate linearity set of Certified Reference Materials to make multipoint linearity checks across the UV absorbance range. Starna’s new potassium dichromate linearity offering requires no preparation time and has been created to prove the linearity of the spectrophotometer UV absorbance scale up to 3.5 A using a range of 0 to 240 mg/L solutions. The company’s Certified Reference Materials provide a convenient and recognized validation method. Full documentation on measurement, handling, and storage is also provided with each set of CRMs.
The Retic-Chex Linearity from Streck, Omaha, Neb, now includes assay values for the new Sysmex XE-5000 hematology analyzer. Designed to verify the accuracy and linear reportable range of the retic parameter, Retic-Chex Linearity’s instrument-specific assay values offer immediate verification without calculations. The product’s 5-day open-vial stability offers customers the flexibility to run the product on more than one instrument. Complete linearity and calibration verification reports are provided at no additional charge, which is useful for demonstrating compliance for CLIA and CAP regulations. The product is also assayed for the Sysmex XE-2100™, XT 2000i™, and the Siemens Healthcare Diagnostics ADVIA® 120/2120.
Multianalyte quality control
Bio-Rad Laboratories Inc, Hercules, Calif, offers its new 5-mL dropper bottle configuration for AmpliTrol™ III, a liquid-stable, third-party multianalyte quality control. This product is designed for use by nucleic acid testing (NAT) laboratories with qualitative in vitro diagnostic procedures for the detection of Human Immunodeficiency Virus, Type 1 (HIV-1), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) nucleic acids in human serum or plasma. It is a full-process positive control used in the same manner as a patient specimen to monitor sample preparation, amplification, and detection procedures with many commercially available NAT systems. The new configuration has a 60-day open-vial stability when stored at 2–8ºC. Routine use provides laboratories with the means to monitor assay performance and assure quality on an ongoing basis.
Bio-Rad Laboratories Inc
RBC Lysis Buffer
For optimal lysis of red blood cells
G-Biosciences, St Louis, offers its RBC Lysis Buffer, which is designed for the optimal lysis of erythrocytes, while having minimal effect of lymphocytes, when used as directed. RBC Lysis Buffer is ideal for the isolation of white blood cells that are free from red blood cells. Since a majority of blood cells are red blood cells, the lysis step concentrates the nucleated white blood cells, which is important in the isolation of DNA and RNA from blood. Using RBC Lysis Buffer eliminates the need for toxic organic solvents or chaotropes. RBC Lysis Buffer is recommended for researchers using the Ficoll-Hypaque technique.
OptiQuant-S HCV RNA Quantification Panel
Helps to optimize HCV assays
AcroMetrix, Benicia, Calif, releases the OptiQuant-S HCV RNA Quantification Panel. This new panel utilizes proprietary SynTura™ technology and provides laboratories with a critical component to fully optimize Hepatitis C molecular assays. SynTura technology allows insertion of synthetic sequences into a mammalian RNA virus, which were shown to be stable in replication and capable of forming infectious RNase-resistant virus particles. This new proprietary system can be used for designing defined RNA positive controls, quantification standards, internal controls, and calibrators. The product is currently intended for research use only.
Detect all O-serogroups tested
ViroStat, Inc, Portland, Me, releases six new monoclonal antibodies to Salmonella. These pan-Salmonella antibodies detect all O-serogroups tested. They do not cross react with related species including E. coli, Shigella, Citrobacter, or Klebsiella, among others. The antibodies recognize the common core region of Salmonella LPS. Applications include ELISA, IFA, and lateral flow immunoassay. Pairing recommendations are also available. A downloadable data sheet for the antibodies is available on the company’s Web site.
MTB ACE Detection Test
Detects both extrapulmonary and pulmonary TB
The Seeplex MTB ACE detection test, from Seegene, Rockville, Md, uses a single multitarget amplification for specific detection of M. tuberculosis, and is based on the company’s novel DPO™ (Dual Priming Oligonucleotides) PCR technology. IS6110 is the most widely used target gene for detecting M. tuberculosis. However, several M. tuberculosis strains lack the insertion sequence IS6110. By simultaneously amplifying IS6110 and MPB64, the test is able to identify infections that would otherwise go undiagnosed in a procedure that produces no false-positive and false-negative results. The test can detect both extrapulmonary and pulmonary TB from various specimens, such as sputum, body fluid, bronchial washing, urine, stool, CSF, and bone marrow aspiration.